Thursday, September 15, 2016

Cerose DM


Generic Name: chlorpheniramine, dextromethorphan, and phenylephrine (klor feh NEER a meen, dex troe meh THOR fan, and feh nill EH frin)

Brand Names: Alka-Seltzer Plus Cold and Cough, C-Phen DM, C-Phen DM Drops, Cardec DM, Cardec DM Drops, Ceron-DM, Ceron-DM Drops, Cerose DM, Corfen-DM, CP Dec DM, CP Dec-DM Drops, De-Chlor DM, De-Chlor DR, Dec-Chlorphen DM, Dex PC, DM-PE-Chlor, Donatussin DM Drops, Ed A-Hist DM, HistadecDM, Maxiphen ADT, Mintuss DR, Nasohist-DM, Neo DM Drops, Nohist-DMX, Norel DM, P Chlor DM, PD-Cof, PD-Cof Drops, Poly-Tussin DM, Quartuss DM, Reme Tussin DM, Rondec-DM, Rondec-DM Drops, Rondex-DM, Rondex-DM Drops, Sildec-PE DM, Sildec-PE DM Drops, Tri-Vent DPC, Trital DM, Tussplex DM, Zotex-12D


What is Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


Chlorpheniramine, dextromethorphan, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.


Chlorpheniramine, dextromethorphan, and phenylephrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?


Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Chlorpheniramine, dextromethorphan, and phenylephrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to chlorpheniramine, dextromethorphan, or phenylephrine, or if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • heart disease or high blood pressure;




  • diabetes;




  • a thyroid disorder;




  • a stomach ulcer or a stomach obstruction,




  • emphysema or chronic bronchitis; or




  • an enlarged prostate or urination problems.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine, dextromethorphan, and phenylephrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?


Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.


Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. If you use the effervescent tablet, drop the tablet in 8 ounces of water and allow it to dissolve completely. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Take this medicine with food or milk if it upsets your stomach.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).


What should I avoid while taking Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);




  • confusion, hallucinations;




  • slow, shallow breathing;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • blurred vision;




  • dry mouth;




  • nausea, stomach pain, constipation;




  • mild loss of appetite, stomach upset;




  • warmth, tingling, or redness under your skin;




  • feeling excited or restless;




  • sleep problems (insomnia);




  • restless or excitability (especially in children);




  • skin rash or itching;




  • dizziness, drowsiness;




  • problems with memory or concentration; or




  • ringing in your ears.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Cerose DM (chlorpheniramine, dextromethorphan, and phenylephrine)?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • an antidepressant;




  • a diuretic (water pill);




  • medication to treat irritable bowel syndrome;




  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa)




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure;




  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);




  • bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.



This list is not complete and there may be other drugs that can interact with chlorpheniramine, dextromethorphan, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Cerose DM resources


  • Cerose DM Side Effects (in more detail)
  • Cerose DM Use in Pregnancy & Breastfeeding
  • Cerose DM Drug Interactions
  • Cerose DM Support Group
  • 0 Reviews for Cerose DM - Add your own review/rating


  • Bronkids Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cardec DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ceron-DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

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  • Quartuss DM Prescribing Information (FDA)

  • Trital DM Prescribing Information (FDA)



Compare Cerose DM with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine, dextromethorphan, and phenylephrine.

See also: Cerose DM side effects (in more detail)


Cetrorelix Acetate


Pronunciation: SE-troe-REL-ix AS-e-tate
Generic Name: Cetrorelix Acetate
Brand Name: Cetrotide


Cetrorelix Acetate is used for:

Delaying luteinizing hormone surges and ovulation in women undergoing fertility treatment.


Cetrorelix Acetate is a gonadotropin-releasing hormone (GnRH) antagonist. It works by preventing ovulation from happening before an egg is mature.


Do NOT use Cetrorelix Acetate if:


  • you are allergic to any ingredient in Cetrorelix Acetate, to certain hormones (extrinsic peptide hormones, GnRH, GnRH analogs), or to mannitol

  • you are pregnant, suspect that you may be pregnant, or are breast-feeding

  • you have severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.



Before using Cetrorelix Acetate:


Some medical conditions may interact with Cetrorelix Acetate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have kidney problems

Some MEDICINES MAY INTERACT with Cetrorelix Acetate. However, no specific interactions with Cetrorelix Acetate are known at this time.


Ask your health care provider if Cetrorelix Acetate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Cetrorelix Acetate:


Use Cetrorelix Acetate as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Cetrorelix Acetate. Talk to your pharmacist if you have questions about this information.

  • Cetrorelix Acetate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Cetrorelix Acetate at home, a health care provider will teach you how to use it. Be sure you understand how to use Cetrorelix Acetate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Do not use Cetrorelix Acetate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Cetrorelix Acetate, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Cetrorelix Acetate.



Important safety information:


  • Ovarian Hyperstimulation Syndrome (OHSS) is a possibly life-threatening side effect that may be caused by the use of Cetrorelix Acetate. Contact your doctor immediately if you experience stomach pain, bloating, or swelling; nausea, vomiting, or diarrhea; decreased urination or dark urine; shortness of breath; or sudden weight gain.

  • PREGNANCY and BREAST-FEEDING: Do not use Cetrorelix Acetate if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Cetrorelix Acetate is found in breast milk. Do not breast-feed while taking Cetrorelix Acetate.


Possible side effects of Cetrorelix Acetate:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Mild pain, swelling, redness, bruising, or itching at the injection site.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; diarrhea; dizziness; nausea; shortness of breath; stomach pain, bloating, or swelling; sudden weight gain; unusual cough; vomiting.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Cetrorelix Acetate side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Cetrorelix Acetate:

Store Cetrorelix Acetate in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Cetrorelix Acetate out of the reach of children and away from pets.


General information:


  • If you have any questions about Cetrorelix Acetate, please talk with your doctor, pharmacist, or other health care provider.

  • Cetrorelix Acetate is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cetrorelix Acetate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cetrorelix Acetate resources


  • Cetrorelix Acetate Side Effects (in more detail)
  • Cetrorelix Acetate Use in Pregnancy & Breastfeeding
  • Cetrorelix Acetate Support Group
  • 0 Reviews for Cetrorelix Acetate - Add your own review/rating


Compare Cetrorelix Acetate with other medications


  • Ovulation Induction

Cerebyx



fosphenytoin sodium

Dosage Form: injection
Cerebyx®

(Fosphenytoin Sodium Injection)

Cerebyx Description


Cerebyx® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. Each Cerebyx vial contains 75 mg/mL fosphenytoin sodium (hereafter referred to as fosphenytoin) equivalent to 50 mg/mL phenytoin sodium after administration. Cerebyx is supplied in vials as a ready-mixed solution in Water for Injection, USP, and Tromethamine, USP (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Cerebyx is a clear, colorless to pale yellow, sterile solution.


The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:



The molecular weight of fosphenytoin is 406.24.


IMPORTANT NOTE: Throughout all Cerebyx product labeling, the amount and concentration of fosphenytoin is expressed in terms of phenytoin sodium equivalents (PE). Fosphenytoin's weight is expressed as phenytoin sodium equivalents to avoid the need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Cerebyx should always be prescribed and dispensed in phenytoin sodium equivalent units (PE) (see DOSAGE AND ADMINISTRATION).



Cerebyx - Clinical Pharmacology



Introduction


Following parenteral administration of Cerebyx, fosphenytoin is converted to the anticonvulsant phenytoin. For every mmol of fosphenytoin administered, one mmol of phenytoin is produced. The pharmacological and toxicological effects of fosphenytoin include those of phenytoin. However, the hydrolysis of fosphenytoin to phenytoin yields two metabolites, phosphate and formaldehyde. Formaldehyde is subsequently converted to formate, which is in turn metabolized via a folate dependent mechanism. Although phosphate and formaldehyde (formate) have potentially important biological effects, these effects typically occur at concentrations considerably in excess of those obtained when Cerebyx is administered under conditions of use recommended in this labeling.



Mechanism of Action


Fosphenytoin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin.


After IV administration to mice, fosphenytoin blocked the tonic phase of maximal electroshock seizures at doses equivalent to those effective for phenytoin. In addition to its ability to suppress maximal electroshock seizures in mice and rats, phenytoin exhibits anticonvulsant activity against kindled seizures in rats, audiogenic seizures in mice, and seizures produced by electrical stimulation of the brainstem in rats. The cellular mechanisms of phenytoin thought to be responsible for its anticonvulsant actions include modulation of voltage-dependent sodium channels of neurons, inhibition of calcium flux across neuronal membranes, modulation of voltage-dependent calcium channels of neurons, and enhancement of the sodium-potassium ATPase activity of neurons and glial cells. The modulation of sodium channels may be a primary anticonvulsant mechanism because this property is shared with several other anticonvulsants in addition to phenytoin.



Pharmacokinetics and Drug Metabolism


Fosphenytoin

Absorption/Bioavailability



Intravenous

When Cerebyx is administered by IV infusion, maximum plasma fosphenytoin concentrations are achieved at the end of the infusion. Fosphenytoin has a half-life of approximately 15 minutes.



Intramuscular

Fosphenytoin is completely bioavailable following IM administration of Cerebyx. Peak concentrations occur at approximately 30 minutes postdose. Plasma fosphenytoin concentrations following IM administration are lower but more sustained than those following IV administration due to the time required for absorption of fosphenytoin from the injection site.



Distribution


Fosphenytoin is extensively bound (95% to 99%) to human plasma proteins, primarily albumin. Binding to plasma proteins is saturable with the result that the percent bound decreases as total fosphenytoin concentrations increase. Fosphenytoin displaces phenytoin from protein binding sites. The volume of distribution of fosphenytoin increases with Cerebyx dose and rate, and ranges from 4.3 to 10.8 liters.



Metabolism and Elimination


The conversion half-life of fosphenytoin to phenytoin is approximately 15 minutes. The mechanism of fosphenytoin conversion has not been determined, but phosphatases probably play a major role. Fosphenytoin is not excreted in urine. Each mmol of fosphenytoin is metabolized to 1 mmol of phenytoin, phosphate, and formate (see CLINICAL PHARMACOLOGY, Introduction and PRECAUTIONS, Phosphate Load for Renally Impaired Patients).


Phenytoin (after Cerebyx administration)

In general, IM administration of Cerebyx generates systemic phenytoin concentrations that are similar enough to oral phenytoin sodium to allow essentially interchangeable use.


The pharmacokinetics of fosphenytoin following IV administration of Cerebyx, however, are complex, and when used in an emergency setting (eg, status epilepticus), differences in rate of availability of phenytoin could be critical. Studies have therefore empirically determined an infusion rate for Cerebyx that gives a rate and extent of phenytoin systemic availability similar to that of a 50 mg/min phenytoin sodium infusion.


A dose of 15 to 20 mg PE/kg of Cerebyx infused at 100 to 150 mg PE/min yields plasma free phenytoin concentrations over time that approximate those achieved when an equivalent dose of phenytoin sodium (eg, parenteral Dilantin®) is administered at 50 mg/min (see DOSAGE AND ADMINISTRATION, WARNINGS).


FIGURE 1. Mean plasma unbound phenytoin concentrations following IV administration of 1200 mg PE Cerebyx infused at 100 mg PE/min (triangles) or 150 mg PE/min (squares) and 1200 mg Dilantin infused at 50 mg/min (diamonds) to healthy subjects (N = 12). Inset shows time course for the entire 96-hour sampling period.



Following administration of single IV Cerebyx doses of 400 to 1200 mg PE, mean maximum total phenytoin concentrations increase in proportion to dose, but do not change appreciably with changes in infusion rate. In contrast, mean maximum unbound phenytoin concentrations increase with both dose and rate.



Absorption/Bioavailability


Fosphenytoin is completely converted to phenytoin following IV administration, with a half-life of approximately 15 minutes. Fosphenytoin is also completely converted to phenytoin following IM administration and plasma total phenytoin concentrations peak in approximately 3 hours.



Distribution


Phenytoin is highly bound to plasma proteins, primarily albumin, although to a lesser extent than fosphenytoin. In the absence of fosphenytoin, approximately 12% of total plasma phenytoin is unbound over the clinically relevant concentration range. However, fosphenytoin displaces phenytoin from plasma protein binding sites. This increases the fraction of phenytoin unbound (up to 30% unbound) during the period required for conversion of fosphenytoin to phenytoin (approximately 0.5 to 1 hour postinfusion).



Metabolism and Elimination


Phenytoin derived from administration of Cerebyx is extensively metabolized in the liver and excreted in urine primarily as 5-(p-hydroxyphenyl)-5-phenylhydantoin and its glucuronide; little unchanged phenytoin (1%–5% of the Cerebyx dose) is recovered in urine. Phenytoin hepatic metabolism is saturable, and following administration of single IV Cerebyx doses of 400 to 1200 mg PE, total and unbound phenytoin AUC values increase disproportionately with dose. Mean total phenytoin half-life values (12.0 to 28.9 hr) following Cerebyx administration at these doses are similar to those after equal doses of parenteral Dilantin and tend to be greater at higher plasma phenytoin concentrations.



Special Populations


Patients with Renal or Hepatic Disease

Due to an increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia, the interpretation of total phenytoin plasma concentrations should be made with caution (see DOSAGE AND ADMINISTRATION). Unbound phenytoin concentrations may be more useful in these patient populations. After IV administration of Cerebyx to patients with renal and/or hepatic disease, or in those with hypoalbuminemia, fosphenytoin clearance to phenytoin may be increased without a similar increase in phenytoin clearance. This has the potential to increase the frequency and severity of adverse events (see PRECAUTIONS).


Age

The effect of age was evaluated in patients 5 to 98 years of age. Patient age had no significant impact on fosphenytoin pharmacokinetics. Phenytoin clearance tends to decrease with increasing age (20% less in patients over 70 years of age relative to that in patients 20–30 years of age). Phenytoin dosing requirements are highly variable and must be individualized (see DOSAGE AND ADMINISTRATION).


Gender and Race

Gender and race have no significant impact on fosphenytoin or phenytoin pharmacokinetics.


Pediatrics

Only limited pharmacokinetic data are available in children (N=8; age 5 to 10 years). In these patients with status epilepticus who received loading doses of Cerebyx, the plasma fosphenytoin, total phenytoin, and unbound phenytoin concentration-time profiles did not signal any major differences from those in adult patients with status epilepticus receiving comparable doses.



Clinical Studies


Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15–20 mg PE/kg) of Cerebyx infused at 150 mg PE/min or phenytoin infused at 50 mg/min. The study demonstrated better local tolerance (pain and burning at the infusion site), fewer disruptions of the infusion, and a shorter infusion period for Cerebyx-treated patients (Table 1).
















TABLE 1. Infusion Tolerance of Equivalent Loading Doses of IV Cerebyx and IV Phenytoin
IV Cerebyx

N=90
IV Phenytoin

N=22

*

Percent of patients

Local Intolerance9%*90%
Infusion Disrupted21%67%
Average Infusion Time13 min44 min

Cerebyx-treated patients, however, experienced more systemic sensory disturbances (see PRECAUTIONS, Sensory Disturbances).


Infusion disruptions in Cerebyx-treated patients were primarily due to systemic burning, pruritus, and/or paresthesia while those in phenytoin-treated patients were primarily due to pain and burning at the infusion site (see Table 1).


In a double-blind study investigating temporary substitution of Cerebyx for oral phenytoin, IM Cerebyx was as well-tolerated as IM placebo. IM Cerebyx resulted in a slight increase in transient, mild to moderate local itching (23% of patients vs 11% of IM placebo-treated patients at any time during the study). This study also demonstrated that equimolar doses of IM Cerebyx may be substituted for oral phenytoin sodium with no dosage adjustments needed when initiating IM or returning to oral therapy. In contrast, switching between IM and oral phenytoin requires dosage adjustments because of slow and erratic phenytoin absorption from muscle.



Indications and Usage for Cerebyx


Cerebyx is indicated for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate or deemed less advantageous. The safety and effectiveness of Cerebyx in this use has not been systematically evaluated for more than 5 days.


Cerebyx can be used for the control of generalized convulsive status epilepticus and prevention and treatment of seizures occurring during neurosurgery. It can also be substituted, short-term, for oral phenytoin.



Contraindications


Cerebyx is contraindicated in patients who have demonstrated hypersensitivity to Cerebyx or its ingredients, or to phenytoin or other hydantoins.


Because of the effect of parenteral phenytoin on ventricular automaticity, Cerebyx is contraindicated in patients with sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome.



Warnings


DOSES OF Cerebyx ARE EXPRESSED AS THEIR PHENYTOIN SODIUM EQUIVALENTS IN THIS LABELING (PE=phenytoin sodium equivalent).


DO NOT, THEREFORE, MAKE ANY ADJUSTMENT IN THE RECOMMENDED DOSES WHEN SUBSTITUTING Cerebyx FOR PHENYTOIN SODIUM OR VICE VERSA.


The following warnings are based on experience with Cerebyx or phenytoin.



Status Epilepticus Dosing Regimen


  • Do not administer Cerebyx at a rate greater than 150 mg PE/min.

The dose of IV Cerebyx (15 to 20 mg PE/kg) that is used to treat status epilepticus is administered at a maximum rate of 150 mg PE/min. The typical Cerebyx infusion administered to a 50 kg patient would take between 5 and 7 minutes. Note that the delivery of an identical molar dose of phenytoin using parenteral Dilantin or generic phenytoin sodium injection cannot be accomplished in less than 15 to 20 minutes because of the untoward cardiovascular effects that accompany the direct intravenous administration of phenytoin at rates greater than 50 mg/min.


If rapid phenytoin loading is a primary goal, IV administration of Cerebyx is preferred because the time to achieve therapeutic plasma phenytoin concentrations is greater following IM than that following IV administration (see DOSAGE AND ADMINISTRATION).



Withdrawal Precipitated Seizure, Status Epilepticus


Antiepileptic drugs should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus. When, in the judgement of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class.



Cardiovascular Depression


Hypotension may occur, especially after IV administration at high doses and high rates of administration. Following administration of phenytoin, severe cardiovascular reactions and fatalities have been reported with atrial and ventricular conduction depression and ventricular fibrillation. Severe complications are most commonly encountered in elderly or gravely ill patients. Therefore, careful cardiac monitoring is needed when administering IV loading doses of Cerebyx. Reduction in rate of administration or discontinuation of dosing may be needed.


Cerebyx should be used with caution in patients with hypotension and severe myocardial insufficiency.



Rash


Cerebyx should be discontinued if a skin rash appears. If the rash is exfoliative, purpuric, or bullous, or if lupus erythematosus, Stevens-Johnson syndrome, or toxic epidermal necrolysis is suspected, use of this drug should not be resumed and alternative therapy should be considered. If the rash is of a milder type (measles-like or scarlatiniform), therapy may be resumed after the rash has completely disappeared. If the rash recurs upon reinstitution of therapy, further Cerebyx or phenytoin administration is contraindicated.



Hepatic Injury


Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, have been reported with phenytoin. These incidents have been associated with a hypersensitivity syndrome characterized by fever, skin eruptions, and lymphadenopathy, and usually occur within the first 2 months of treatment. Other common manifestations include jaundice, hepatomegaly, elevated serum transaminase levels, leukocytosis, and eosinophilia. The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes. In these patients with acute hepatotoxicity, Cerebyx should be immediately discontinued and not readministered.



Hemopoietic System


Hemopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression.


There have been a number of reports that have suggested a relationship between phenytoin and the development of lymphadenopathy (local or generalized), including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's disease. Although a cause and effect relationship has not been established, the occurrence of lymphadenopathy indicates the need to differentiate such a condition from other types of lymph node pathology. Lymph node involvement may occur with or without symptoms and signs resembling serum sickness, eg, fever, rash, and liver involvement. In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs.



Alcohol Use


Acute alcohol intake may increase plasma phenytoin concentrations while chronic alcohol use may decrease plasma concentrations.



Usage in Pregnancy


Clinical
A.

Risks to Mother. An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of plasma phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage (see PRECAUTIONS, Laboratory Tests). However, postpartum restoration of the original dosage will probably be indicated.

B.

Risks to the Fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential harm to the fetus.

Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Increased frequencies of major malformations (such as orofacial clefts and cardiac defects), minor anomalies (dysmorphic facial features, nail and digit hypoplasia), growth abnormalities (including microcephaly), and mental deficiency have been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy. There have also been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. The overall incidence of malformations for children of epileptic women treated with antiepileptic drugs (phenytoin and/or others) during pregnancy is about 10%, or two-to three-fold that in the general population. However, the relative contributions of antiepileptic drugs and other factors associated with epilepsy to this increased risk are uncertain and in most cases it has not been possible to attribute specific developmental abnormalities to particular antiepileptic drugs.


Patients should consult with their physicians to weigh the risks and benefits of phenytoin during pregnancy.


C.

Postpartum Period. A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero. This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth.

Preclinical

Increased frequencies of malformations (brain, cardiovascular, digit, and skeletal anomalies), death, growth retardation, and functional impairment (chromodacryorrhea, hyperactivity, circling) were observed among the offspring of rats receiving fosphenytoin during pregnancy. Most of the adverse effects on embryo-fetal development occurred at doses of 33 mg PE/kg or higher (approximately 30% of the maximum human loading dose or higher on a mg/m2 basis), which produced peak maternal plasma phenytoin concentrations of approximately 20 µg/mL or greater. Maternal toxicity was often associated with these doses and plasma concentrations, however, there is no evidence to suggest that the developmental effects were secondary to the maternal effects. The single occurrence of a rare brain malformation at a non-maternotoxic dose of 17 mg PE/kg (approximately 10% of the maximum human loading dose on a mg/m2 basis) was also considered drug-induced. The developmental effects of fosphenytoin in rats were similar to those which have been reported following administration of phenytoin to pregnant rats.


No effects on embryo-fetal development were observed when rabbits were given up to 33 mg PE/kg of fosphenytoin (approximately 50% of the maximum human loading dose on a mg/m2 basis) during pregnancy. Increased resorption and malformation rates have been reported following administration of phenytoin doses of 75 mg/kg or higher (approximately 120% of the maximum human loading dose or higher on a mg/m2 basis) to pregnant rabbits.



Precautions



General: (Cerebyx specific)


Sensory Disturbances

Severe burning, itching, and/or paresthesia were reported by 7 of 16 normal volunteers administered IV Cerebyx at a dose of 1200 mg PE at the maximum rate of administration (150 mg PE/min). The severe sensory disturbance lasted from 3 to 50 minutes in 6 of these subjects and for 14 hours in the seventh subject. In some cases, milder sensory disturbances persisted for as long as 24 hours. The location of the discomfort varied among subjects with the groin mentioned most frequently as an area of discomfort. In a separate cohort of 16 normal volunteers (taken from 2 other studies) who were administered IV Cerebyx at a dose of 1200 mg PE at the maximum rate of administration (150 mg PE/min), none experienced severe disturbances, but most experienced mild to moderate itching or tingling.


Patients administered Cerebyx at doses of 20 mg PE/kg at 150 mg PE/min are expected to experience discomfort of some degree. The occurrence and intensity of the discomfort can be lessened by slowing or temporarily stopping the infusion.


The effect of continuing infusion unaltered in the presence of these sensations is unknown. No permanent sequelae have been reported thus far. The pharmacologic basis for these positive sensory phenomena is unknown, but other phosphate ester drugs, which deliver smaller phosphate loads, have been associated with burning, itching, and/or tingling predominantly in the groin area.


Phosphate Load

The phosphate load provided by Cerebyx (0.0037 mmol phosphate/mg PE Cerebyx) should be considered when treating patients who require phosphate restriction, such as those with severe renal impairment.


IV Loading in Renal and/or Hepatic Disease or in Those With Hypoalbuminemia

After IV administration to patients with renal and/or hepatic disease, or in those with hypoalbuminemia, fosphenytoin clearance to phenytoin may be increased without a similar increase in phenytoin clearance. This has the potential to increase the frequency and severity of adverse events (see CLINICAL PHARMACOLOGY: Special Populations, and DOSAGE AND ADMINISTRATION: Dosing in Special Populations).



General: (phenytoin associated)


Cerebyx is not indicated for the treatment of absence seizures.


A small percentage of individuals who have been treated with phenytoin have been shown to metabolize the drug slowly. Slow metabolism may be due to limited enzyme availability and lack of induction; it appears to be genetically determined.


Phenytoin and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity. Additionally, caution should be exercised if using structurally similar (eg, barbiturates, succinimides, oxazolidinediones, and other related compounds) in these same patients.


Phenytoin has been infrequently associated with the exacerbation of porphyria. Caution should be exercised when Cerebyx is used in patients with this disease.


Hyperglycemia, resulting from phenytoin's inhibitory effect on insulin release, has been reported. Phenytoin may also raise the serum glucose concentrations in diabetic patients. Plasma concentrations of phenytoin sustained above the optimal range may produce confusional states referred to as "delirium,""psychosis," or "encephalopathy," or rarely, irreversible cerebellar dysfunction. Accordingly, at the first sign of acute toxicity, determination of plasma phenytoin concentrations is recommended (see PRECAUTIONS: Laboratory Tests). Cerebyx dose reduction is indicated if phenytoin concentrations are excessive; if symptoms persist, administration of Cerebyx should be discontinued.


The liver is the primary site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity.


Phenytoin and other hydantoins are not indicated for seizures due to hypoglycemic or other metabolic causes. Appropriate diagnostic procedures should be performed as indicated.


Phenytoin has the potential to lower serum folate levels.



Laboratory Tests


Phenytoin doses are usually selected to attain therapeutic plasma total phenytoin concentrations of 10 to 20 µg/mL, (unbound phenytoin concentrations of 1 to 2 µg/mL). Following Cerebyx administration, it is recommended that phenytoin concentrations not be monitored until conversion to phenytoin is essentially complete. This occurs within approximately 2 hours after the end of IV infusion and 4 hours after IM injection.


Prior to complete conversion, commonly used immunoanalytical techniques, such as TDx®/TDxFLx™ (fluorescence polarization) and Emit® 2000 (enzyme multiplied), may significantly overestimate plasma phenytoin concentrations because of cross-reactivity with fosphenytoin. The error is dependent on plasma phenytoin and fosphenytoin concentration (influenced by Cerebyx dose, route and rate of administration, and time of sampling relative to dosing), and analytical method. Chromatographic assay methods accurately quantitate phenytoin concentrations in biological fluids in the presence of fosphenytoin. Prior to complete conversion, blood samples for phenytoin monitoring should be collected in tubes containing EDTA as an anticoagulant to minimize ex vivo conversion of fosphenytoin to phenytoin. However, even with specific assay methods, phenytoin concentrations measured before conversion of fosphenytoin is complete will not reflect phenytoin concentrations ultimately achieved.



Drug Interactions


No drugs are known to interfere with the conversion of fosphenytoin to phenytoin. Conversion could be affected by alterations in the level of phosphatase activity, but given the abundance and wide distribution of phosphatases in the body it is unlikely that drugs would affect this activity enough to affect conversion of fosphenytoin to phenytoin. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in clinically significant effects, caution is advised when administering Cerebyx with other drugs that significantly bind to serum albumin.


The pharmacokinetics and protein binding of fosphenytoin, phenytoin, and diazepam were not altered when diazepam and Cerebyx were concurrently administered in single submaximal doses.


The most significant drug interactions following administration of Cerebyx are expected to occur with drugs that interact with phenytoin. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes.


The most commonly occurring drug interactions are listed below:


  • Drugs that may increase plasma phenytoin concentrations include: acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, cimetidine, diazepam, dicumarol, disulfiram, estrogens, ethosuximide, fluoxetine, H2-antagonists, halothane, isoniazid, methylphenidate, phenothiazines, phenylbutazone, salicylates, succinimides, sulfonamides, tolbutamide, trazodone.

  • Drugs that may decrease plasma phenytoin concentrations include: carbamazepine, chronic alcohol abuse, reserpine.

  • Drugs that may either increase or decrease plasma phenytoin concentrations include: phenobarbital, valproic acid, and sodium valproate. Similarly, the effects of phenytoin on phenobarbital, valproic acid and sodium plasma valproate concentrations are unpredictable.

  • Although not a true drug interaction, tricyclic antidepressants may precipitate seizures in susceptible patients and Cerebyx dosage may need to be adjusted.

  • Drugs whose efficacy is impaired by phenytoin include: anticoagulants, corticosteroids, coumarin, digitoxin, doxycycline, estrogens, furosemide, oral contraceptives, rifampin, quinidine, theophylline, vitamin D.

Monitoring of plasma phenytoin concentrations may be helpful when possible drug interactions are suspected (see Laboratory Tests).



Drug/Laboratory Test Interactions


Phenytoin may decrease serum concentrations of T4 . It may also produce artifactually low results in dexamethasone or metyrapone tests. Phenytoin may also cause increased serum concentrations of glucose, alkaline phosphatase, and gamma glutamyl transpeptidase (GGT).


Care should be taken when using immunoanalytical methods to measure plasma phenytoin concentrations following Cerebyx administration (see Laboratory Tests).



Carcinogenesis, Mutagenesis, Impairment of Fertility


The carcinogenic potential of fosphenytoin has not been studied. Assessment of the carcinogenic potential of phenytoin in mice and rats is ongoing.


Structural chromosome aberration frequency in cultured V79 Chinese hamster lung cells was increased by exposure to fosphenytoin in the presence of metabolic activation. No evidence of mutagenicity was observed in bacteria (Ames test) or Chinese hamster lung cells in vitro, and no evidence for clastogenic activity was observed in an in vivo mouse bone marrow micronucleus test.


No effects on fertility were noted in rats of either sex given fosphenytoin. Maternal toxicity and altered estrous cycles, delayed mating, prolonged gestation length, and developmental toxicity were observed following administration of fosphenytoin during mating, gestation, and lactation at doses of 50 mg PE/kg or higher (approximately 40% of the maximum human loading dose or higher on a mg/m2 basis).



Pregnancy


Category D

(see WARNINGS)



Use in Nursing Mothers


It is not known whether fosphenytoin is excreted in human milk.


Following administration of Dilantin, phenytoin appears to be excreted in low concentrations in human milk. Therefore, breast-feeding is not recommended for women receiving Cerebyx.



Pediatric Use


The safety of Cerebyx in pediatric patients has not been established.



Geriatric Use


No systematic studies in geriatric patients have been conducted. Phenytoin clearance tends to decrease with increasing age (see CLINICAL PHARMACOLOGY: Special Populations).



Adverse Reactions


The more important adverse clinical events caused by the IV use of Cerebyx or phenytoin are cardiovascular collapse and/or central nervous system depression. Hypotension can occur when either drug is administered rapidly by the IV route. The rate of administration is very important; for Cerebyx, it should not exceed 150 mg PE/min.


The adverse clinical events most commonly observed with the use of Cerebyx in clinical trials were nystagmus, dizziness, pruritus, paresthesia, headache, somnolence, and ataxia. With two exceptions, these events are commonly associated with the administration of IV phenytoin. Paresthesia and pruritus, however, were seen much more often following Cerebyx administration and occurred more often with IV Cerebyx administration than with IM Cerebyx administration. These events were dose and rate related; most alert patients (41 of 64; 64%) administered doses of ≥15 mg PE/kg at 150 mg PE/min experienced discomfort of some degree. These sensations, generally described as itching, burning, or tingling, were usually not at the infusion site. The location of the discomfort varied with the groin mentioned most frequently as a site of involvement. The paresthesia and pruritus were transient events that occurred within several minutes of the start of infusion and generally resolved within 10 minutes after completion of Cerebyx infusion. Some patients experienced symptoms for hours. These events did not increase in severity with repeated administration. Concurrent adverse events or clinical laboratory change suggesting an allergic process were not seen (see PRECAUTIONS, Sensory Disturbances).


Approximately 2% of the 859 individuals who received Cerebyx in premarketing clinical trials discontinued treatment because of an adverse event. The adverse events most commonly associated with withdrawal were pruritus (0.5%), hypotension (0.3%), and bradycardia (0.2%).



Dose and Rate Dependency of Adverse Events Following IV Cerebyx


The incidence of adverse events tended to increase as both dose and infusion rate increased. In particular, at doses of ≥15mg PE/kg and rates ≥150 mg PE/min, transient pruritus, tinnitus, nystagmus, somnolence, and ataxia occurred 2 to 3 times more often than at lower doses or rates.



Incidence in Controlled Clinical Trials


All adverse events were recorded during the trials by the clinical investigators using terminology of their own choosing. Similar types of events were grouped into standardized categories using modified COSTART dictionary terminology. These categories are used in the tables and listings below with the frequencies representing the proportion of individuals exposed to Cerebyx or comparative therapy.


The prescriber should be aware that these figures cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.


Incidence in Controlled Clinical Trials - IV Administration To Patients With Epilepsy or Neurosurgical Patients

Table 2 lists treatment-emergent adverse events that occurred in at least 2% of patients treated with IV Cerebyx at the maximum dose and rate in a randomized, double-blind, controlled clinical trial where the rates for phenytoin and Cerebyx administration would have resulted in equivalent systemic exposure to phenytoin.





















































































































TABLE 2. Treatment-Emergent Adverse Event Incidence Following IV Administration at the Maximum Dose and Rate to Patients With Epilepsy or Neurosurgical Patients (Events in at Least 2% of Cerebyx-Treated Patients)
BODY SYSTEM

  Adverse Event
IV Cerebyx

N=90
IV Phenytoin

N=22
BODY AS A WHOLE
  Pelvic Pain4.40.0
  Asthenia2.20.0
  Back Pain2.20.0
  Headache2.24.5
CARDIOVASCULAR
  Hypotension7.79.1
  Vasodilatation5.64.5
  Tachycardia2.20.0
DIGESTIVE
  Nausea8.913.6
  Tongue Disorder4.40.0
  Dry Mouth4.44.5
  Vomiting2.29.1
NERVOUS
  Nystagmus44.459.1
  Dizziness31.127.3
  Somnolence20.027.3
  Ataxia11.118.2
  Stupor7.74.5
  Incoordination4.44.5
  Paresthesia4.40.0
  Extrapyramidal Syndrome4.40.0
  Tremor3.39.1
  Agitation3.30.0
  Hypesthesia2.29.1
  Dysarthria2.20.0
  Vertigo2.20.0
  Brain Edema2.24.5
SKIN AND APPENDAGES
  Pruritus48.94.5
SPECIAL SENSES
  Tinnitus8.99.1
  Diplopia3.30.0
  Taste Perversion3.30.0
  Amblyopia2.29.1
  Deafness2.20.0
Incidence in Controlled Trials - IM Administration to Patients With Epilepsy

Table 3 lists treatment-emergent adverse events that occurred in at least 2% of Cerebyx-treated patients in a double-blind, randomized, controlled clinical trial of adult epilepsy patients receiving either IM Cerebyx substituted for oral Dilantin or continuing oral Dilantin. Both treatments were administered for 5 days.


































































TABLE 3. Treatment-Emergent Adverse Event Incidence Following Substitution of IM Cerebyx for Oral Dilantin in Patients With Epilepsy (Events in at Least 2% of Cerebyx-Treated Patients)
BODY SYSTEM

  Adverse Event
IM Cerebyx

N=179
Oral Dilantin

N=61
BODY AS A WHOLE
  Headache8.94.9
  Asthenia3.93.3
  Accidental Injury3.46.6
DIGESTIVE
  Nausea4.50.0
  Vomiting2.80.0
HEMATOLOGIC AND LYMPHATIC
  Ecchymosis7.34.9
NERVOUS
  Nystagmus15.18.2
  Tremor9.513.1
  Ataxia8.48.2
  Incoordination7.84.9
  Somnolence6.79.8
  Dizziness5.03.3
  Paresthesia3.93.3
  Reflexes Decreased2.84.9
SKIN AND APPENDAGES
  Pruritus2.80.0

Adverse Events During All Clinical Trials


Cerebyx has been administered to 859 individuals during all clinical trials. All adverse events seen at least twice are listed in the following, except those already included in previous tables and listings. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 individuals; infrequent adverse events are those occurring in 1/100 to 1/1000 individuals.


Body As a Whole: Frequent: fever, injection-site reaction, infection, chills, face edema, injection-site pain; Infrequent: sepsis, injection-site inflammation, injection-site edema, injection-site hemorrhage, flu syndrome, malaise, generalized edema, shock, photosensitivity reaction, cachexia, cryptococcosis.


Cardiovascular: Frequent: hypertension; Infrequent: cardiac arrest, migraine, syncope, cerebral hemorrhage, palpitation, sinus bradycardia, atrial flutter, bundle branch block, cardiomegaly, cerebral infarct, postural hypotension, pulmonary embolus, QT interval prolongation, thrombophlebitis, ventricular extrasystoles, congestive heart failure.


Digestive: Frequent: constipation; Infrequent: dyspepsia, diarrhea, anorexia, gastrointestinal hemorrhage, increased salivation, live

cerivastatin


Generic Name: cerivastatin (seh RIH va stah tin)

Brand Names: Baycol


What is cerivastatin?

Cerivastatin was withdrawn from the U.S. market in 2001.


Cerivastatin blocks the production of cholesterol (a type of fat) in the body.


Cerivastatin is used to reduce the amounts of LDL (bad) cholesterol and total cholesterol in your blood. Cerivastatin also reduces the amounts of triglycerides (another type of fat) and apolipoprotein B (a protein needed to make cholesterol) in your blood and increases the amount of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.


Cerivastatin may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about cerivastatin?


Cerivastatin was withdrawn from the U.S. market in 2001.


Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by a fever or flu-like symptoms or yellowing of your skin or eyes. Do not take cerivastatin without first talking to your doctor if you have liver disease. Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol. Do not take cerivastatin if you are pregnant, if you are planning a pregnancy, or if you are breast-feeding a baby.

Who should not take cerivastatin?


Do not take cerivastatin without first talking to your doctor if you have liver disease.

Before taking cerivastatin, tell your doctor if you



  • drink alcoholic beverages,



  • have kidney disease,


  • have a chronic muscular disease, or




  • have seizures or epilepsy.



You may not be able to take cerivastatin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Cerivastatin is in the FDA pregnancy category X. This means that cerivastatin will cause birth defects if it is taken during pregnancy. Cholesterol is very important for the proper development of a baby. Do not take cerivastatin if you are pregnant or are planning a pregnancy. Cerivastatin passes into breast milk and can harm a nursing infant. Do not take cerivastatin if you are breast-feeding a baby.

How should I take cerivastatin?


Take cerivastatin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water.

Eat a low-fat, low-cholesterol diet. To see beneficial effects from cerivastatin, avoid fatty, high-cholesterol foods. Follow your doctor's directions.


Your doctor may want to monitor your liver function with blood tests before starting treatment with cerivastatin, at six and twelve weeks after both the start of your treatment and any increase in dose, and periodically (every 6 months) thereafter. Depending on the results of these tests, your doctor can determine how much monitoring you will require.


Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.


Do not stop taking cerivastatin without first talking to your doctor. It may be weeks or months before beneficial effects from this medication are seen.


Store cerivastatin at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of cerivastatin.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of an overdose of cerivastatin are not known.


What should I avoid while taking cerivastatin?


Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol.

Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.


Cerivastatin side effects


If you experience any of the following serious side effects, stop taking cerivastatin and call your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • muscle aches, pain, or weakness;




  • a fever;




  • "flu-like" symptoms;




  • decreased urine or rust-colored urine;




  • blurred vision; or




  • yellowing of your skin or eyes.



Other, less serious side effects may be more likely to occur. Continue to take cerivastatin and talk to your doctor if you experience



  • gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;




  • dizziness;




  • headache; or




  • a rash.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect cerivastatin?


Do not take cerivastatin without first talking to your doctor if you are taking any of the following medicines:

  • cyclosporine (Sandimmune, Neoral);




  • gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);




  • niacin (Nicolar, Nicobid, Slo-Niacin, others);




  • erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin); or




  • itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral).



The medications listed above may interact with cerivastatin and damage your muscles. Generally, these medicines are not used together.


Drugs other than those listed here may also interact with cerivastatin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More cerivastatin resources


  • Cerivastatin Side Effects (in more detail)
  • Cerivastatin Use in Pregnancy & Breastfeeding
  • Cerivastatin Drug Interactions
  • Cerivastatin Support Group
  • 0 Reviews for Cerivastatin - Add your own review/rating


  • Baycol Consumer Overview



Compare cerivastatin with other medications


  • High Cholesterol
  • Hyperlipoproteinemia Type IIa, Elevated LDL


Where can I get more information?


  • Your pharmacist has additional information about cerivastatin written for health professionals that you may read.

What does my medication look like?


Cerivastatin was withdrawn from the U.S. market in 2001.


See also: cerivastatin side effects (in more detail)


Cervidil


Generic Name: dinoprostone topical (DYE no PROS tone TOP ik al)

Brand Names: Cervidil, Prepidil, Prostin E2


What is Cervidil (dinoprostone topical)?

Dinoprostone is a prostaglandin, a hormone-like substance that is naturally produced by tissues in the body.


Dinoprostone topical is used in a pregnant woman to relax the muscles of the cervix (opening of the uterus) in preparation for inducing labor at the end of a pregnancy.


Dinoprostone topical may be used for purposes not listed in this medication guide.


What is the most important information I should know about Cervidil (dinoprostone topical)?


You should not be treated with this medication if you are allergic to prostaglandins, or if you have active genital herpes with a vaginal lesion, placenta previa, or if your water has broken.

Be sure your doctor knows your entire pregnancy history, especially if you have ever had a C-section or major surgery on your uterus, if you have ever had a baby born in a breech position, or if you have ever had a difficult labor or delivery of a previous child.


Also tell your doctor if you have kidney or liver disease, glaucoma, a history of asthma, if you are 30 years or older, or if your pregnancy is at full term (40 weeks).


After you have received dinoprostone topical, tell your caregivers at once if your contractions slow down or become uneven, or if you have a fever, sudden vaginal bleeding, cough, wheezing, chest tightness, trouble breathing, pale skin, or blue colored lips. After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, including weakness or fainting, unusual bruising, bloody or tarry stools, coughing up blood, sudden weakness or numbness, sudden severe headache, or sudden problems with vision, speech, or balance.

What should I discuss with my health care provider before receiving Cervidil (dinoprostone topical)?


You should not be treated with this medication if you are allergic to prostaglandins, or if you have:

  • active genital herpes with a vaginal lesion;




  • placenta previa (the placenta is below the fetus in your uterus); or




  • if your water has broken.



Be sure your doctor knows your entire pregnancy history, especially:



  • if you have ever had a C-section or major surgery on your uterus;




  • if you have ever had a baby born in a breech position (not head-first); or




  • if you have ever had a difficult labor or delivery of a previous child.



To make sure you can safely use dinoprostone topical, tell your doctor if you have any of these other conditions:


  • kidney disease;

  • liver disease;


  • glaucoma;




  • a history of asthma;




  • if you are 30 years or older; or




  • if your pregnancy is at full term (40 weeks).



How is dinoprostone topical given?


Dinoprostone is a gel that is placed directly onto the cervix through the vagina using a special applicator. Your doctor, nurse, or other healthcare professional will give you this medication.


Dinoprostone is usually given while you are lying on your back. Your doctor may use a vaginal speculum to view your cervix. This will help your doctor determine how much of this medication to use.


After you are given this medication, you will need to remain lying down for at least 15 minutes unless your doctor tells you otherwise.


If your uterus does not respond to dinoprostone within 6 hours, your doctor may apply a second dose.

If your uterus responds to the medication, you may begin having regular uterine contractions within a few hours. You may also be given other medications to help stimulate your uterine contractions and make them more regular.


What happens if I miss a dose?


Since dinoprostone topical is given by a healthcare professional, you are not likely to miss a dose.


What happens if I overdose?


Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include increased contractions or more intense labor pains.


What should I avoid after receiving Cervidil (dinoprostone topical)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Cervidil (dinoprostone topical) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if your contractions slow down or become uneven, or if you have:

  • fever;




  • sudden vaginal bleeding;




  • cough, wheezing, chest tightness, trouble breathing; or




  • pale skin, blue colored lips.




After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:

  • weakness or fainting;




  • unusual bleeding from your nose, mouth, vagina, or rectum;




  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • unusual bruising, purple or red pinpoint spots under your skin;




  • bleeding from a wound, surgical incision, or vein where an IV was placed;




  • any bleeding that will not stop.



Less serious side effects may include:



  • nausea, stomach pain;




  • back pain; or




  • feeling of warmth in the vaginal area.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Cervidil (dinoprostone topical)?


There may be other drugs that can interact with dinoprostone topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Cervidil resources


  • Cervidil Side Effects (in more detail)
  • Cervidil Use in Pregnancy & Breastfeeding
  • Cervidil Drug Interactions
  • Cervidil Support Group
  • 2 Reviews for Cervidil - Add your own review/rating


  • Cervidil Prescribing Information (FDA)

  • Cervidil Inserts MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cervidil Advanced Consumer (Micromedex) - Includes Dosage Information

  • Prepidil Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prepidil Prescribing Information (FDA)

  • Prostin E2 Prescribing Information (FDA)



Compare Cervidil with other medications


  • Abortion
  • Labor Induction
  • Trophoblastic Disease


Where can I get more information?


  • Your doctor or pharmacist can provide more information about dinoprostone topical

See also: Cervidil side effects (in more detail)


Ceta Plus



Generic Name: hydrocodone and acetaminophen (Oral route)


a-seet-a-MIN-oh-fen, hye-droe-KOE-done bye-TAR-trate


Oral route(Solution;Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product .



Commonly used brand name(s)

In the U.S.


  • Anexsia

  • Ceta Plus

  • Co-Gesic

  • Dolorex Forte

  • Hycet

  • Lorcet

  • Lortab

  • Maxidone

  • Norco

  • Stagesic

  • Vicodin

  • Zydone

Available Dosage Forms:


  • Tablet

  • Solution

  • Syrup

  • Elixir

  • Capsule

  • Liquid

Therapeutic Class: Opioid/Acetaminophen Combination


Chemical Class: Hydrocodone


Uses For Ceta Plus


Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.


Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.


Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.


When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.


This medicine is available only with your doctor's prescription.


Before Using Ceta Plus


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen tablets in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen oral solution in children. However, safety and efficacy have not been established in children younger than 2 years of age.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and acetaminophen combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Bromazepam

  • Brotizolam

  • Buprenorphine

  • Butabarbital

  • Butalbital

  • Butorphanol

  • Carisoprodol

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorzoxazone

  • Clobazam

  • Clonazepam

  • Clorazepate

  • Codeine

  • Dantrolene

  • Dezocine

  • Diazepam

  • Estazolam

  • Ethchlorvynol

  • Fentanyl

  • Flunitrazepam

  • Flurazepam

  • Fospropofol

  • Halazepam

  • Hydrocodone

  • Hydromorphone

  • Ketazolam

  • Levorphanol

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Midazolam

  • Morphine

  • Morphine Sulfate Liposome

  • Nalbuphine

  • Nitrazepam

  • Nordazepam

  • Opium

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pentazocine

  • Pentobarbital

  • Phenobarbital

  • Prazepam

  • Propoxyphene

  • Quazepam

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Temazepam

  • Thiopental

  • Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Carbamazepine

  • Escitalopram

  • Isoniazid

  • Phenytoin

  • Warfarin

  • Zidovudine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Addison's disease (adrenal gland problem) or

  • Alcohol abuse, history of or

  • Breathing or lung problems (e.g., asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale, emphysema, hypoxia) or

  • CNS depression or

  • Drug dependence, especially narcotic abuse or dependence, or history of or

  • Enlarged prostate (BPH, prostatic hypertrophy) or

  • Hypothyroidism (an underactive thyroid) or

  • Problems with passing urine—Use with caution. May increase risk for more serious side effects.

  • Brain tumor or

  • Head injuries or

  • Increased pressure in the head—Some of the side effects of hydrocodone can cause serious problems in people who have these medical problems.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Lung disease or

  • Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.

  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of hydrocodone and acetaminophen

This section provides information on the proper use of a number of products that contain hydrocodone and acetaminophen. It may not be specific to Ceta Plus. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.


This medicine should come with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.


Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For moderate to moderately severe pain:
    • For oral dosage form (solution):
      • Adults and teenagers 14 years of age and older—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.

      • Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.

      • Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.

      • Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.

      • Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.

      • Children younger than 2 years of age—Use and dose must be determined by your doctor.


    • For oral dosage form (tablets):
      • Adults—One or two tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 5 to 12 tablets per day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Ceta Plus


It is very important that your doctor check the progress of you or your child while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.


This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.


Before you or your child have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of certain tests may be affected by this medicine.


Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.


Using this medicine while you are pregnant may cause the neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Ceta Plus Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Incidence not known
  • Back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • blood in vomit

  • bluish lips or skin

  • chills

  • choking

  • cough or hoarseness

  • dark urine

  • decrease in the frequency of urination

  • decrease in urine volume

  • difficult or troubled breathing

  • difficulty in passing urine (dribbling)

  • difficulty with breathing

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • fever

  • fever with or without chills

  • general body swelling

  • general feeling of tiredness or weakness

  • headache

  • hives

  • irregular, fast or slow, or shallow breathing

  • itching

  • light-colored stools

  • loss of appetite

  • lower back or side pain

  • nausea or vomiting

  • nosebleeds

  • not breathing

  • painful or difficult urination

  • pale or blue lips, fingernails, or skin

  • pale skin

  • pinpoint red spots on the skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • severe or continuing stomach pain

  • shortness of breath or troubled breathing

  • skin rash

  • sore throat

  • sore tongue

  • sores, ulcers, or white spots on the lips or in the mouth

  • tightness in the chest

  • unable to speak

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • upper right abdominal or stomach pain

  • wheezing

  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Bloody or cloudy urine

  • change in consciousness

  • chest pain or discomfort

  • cold and clammy skin

  • decreased awareness or responsiveness

  • extreme drowsiness

  • general feeling of discomfort or illness

  • increased sweating

  • irregular heartbeat

  • lightheadedness, dizziness, or fainting

  • loss of consciousness

  • no blood pressure or pulse

  • no muscle tone or movement

  • not breathing

  • severe sleepiness

  • slow or irregular heartbeat

  • stopping of heart

  • sudden decrease in the amount of urine

  • unconsciousness

  • unpleasant breath odor

  • vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Drowsiness

  • relaxed and calm

  • sleepiness

Incidence not known
  • Belching

  • changes in mood

  • difficulty having a bowel movement (stool)

  • fear or nervousness

  • feeling of indigestion

  • hearing loss

  • impaired hearing

  • pain in the chest below the breastbone

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Ceta Plus side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More Ceta Plus resources


  • Ceta Plus Side Effects (in more detail)
  • Ceta Plus Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ceta Plus Drug Interactions
  • Ceta Plus Support Group
  • 370 Reviews for Ceta Plus - Add your own review/rating


  • Co-gesic Prescribing Information (FDA)

  • Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hycet Prescribing Information (FDA)

  • Liquicet Prescribing Information (FDA)

  • Lorcet Plus Prescribing Information (FDA)

  • Lortab Consumer Overview

  • Lortab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lortab Prescribing Information (FDA)

  • Maxidone Prescribing Information (FDA)

  • Norco Prescribing Information (FDA)

  • Norco Consumer Overview

  • Vicodin Prescribing Information (FDA)

  • Vicodin Consumer Overview

  • Vicodin ES Prescribing Information (FDA)

  • Vicodin HP Prescribing Information (FDA)

  • Xodol Prescribing Information (FDA)

  • Zolvit Prescribing Information (FDA)

  • Zydone Prescribing Information (FDA)



Compare Ceta Plus with other medications


  • Back Pain
  • Cough
  • Pain
  • Rheumatoid Arthritis