Carbamazepine by TYA Pharmaceuticals CARBAMAZEPINE tablet

Carbamazepine by

Drug Labeling and Warnings

Carbamazepine by is a Prescription medication manufactured, distributed, or labeled by TYA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Agents That Decrease Carbamazepine Levels

CYP 3A4 inducers can increase the rate of carbamazepine metabolism. Drugs that have been shown, or that would be expected, to decrease plasma carbamazepine levels include:

cisplatin, doxorubicin HCl, felbamate , fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline. 2

  • 2 decreased levels of carbamazepine and increased levels of the 10,11-epoxide

    • Effect of Carbamazepine on Plasma Levels of Concomitant Agents

    Decreased Levels of Concomitant Medications

    Carbamazepine is a potent inducer of hepatic CYP 3A4 and may therefore reduce plasma concentrations of comedications mainly metabolized by CYP 3A4 through induction of their metabolism. Carbamazepine causes, or would be expected to cause, decreased levels of the following:

    acetaminophen, albendazole, alprazolam, aprepitant, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.

    In concomitant use with carbamazepine, monitoring of concentrations or dosage adjustment of the above agents may be necessary.

    Cyclophosphamide is an inactive prodrug and is converted to its active metabolite in part by CYP3A. The rate of metabolism and the leukopenic activity of cyclophosphamide reportedly are increased by chronic administration of high doses of another CYP3A4 inducer. There is a potential for increased cyclophosphamide toxicity when coadministered with carbamazepine. When carbamazepine is added to aripiprazole therapy, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. When carbamazepine is withdrawn from the combination therapy, the aripiprazole dose should be reduced.

    When carbamazepine is used with tacrolimus, monitoring of tacrolimus blood concentrations and appropriate dosage adjustments are recommended.

    The use of concomitant strong CYP3A4 inducers such as carbamazepine should be avoided with temsirolimus. Based on pharmacokinetic studies, if patients must be co-administered carbamazepine with temsirolimus, an adjustment of temsirolimus dosage should be considered. The use of carbamazepine with lapatinib should generally be avoided. Dosage adjustment should be considered if lapatinib is coadministered with carbamazepine. If carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up. If carbamazepine is discontinued, the lapatinib dose should be reduced.

    Coadministration of carbamazepine with nefazodone results in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated. (See ). CONTRAINDICATIONS

    Other Drug Interactions

    Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.

    Concomitant use of carbamazepine and isoniazid has been reported to increase isoniazidinduced hepatotoxicity.

    Concomitant medication with carbamazepine and some diuretics (hydrochlorothiazide, furosemide) may lead to symptomatic hyponatremia.

    Alterations of thyroid function have been reported in combination therapy with other anticonvulsant medications.

    Concomitant use of carbamazepine with hormonal contraceptive products (e.g., oral, and levonorgestrel subdermal implant contraceptives) may render the contraceptives less effective because the plasma concentrations of the hormones may be decreased. Breakthrough bleeding and unintended pregnancies have been reported. Alternative or back-up methods of contraception should be considered.

    Resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents pancuronium, vecuronium, rocuronium and cisatracurium has occurred in patients chronically administered carbamazepine. Whether or not carbamazepine has the same effect on other non-depolarizing agents is unknown. Patients should be monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carbamazepine, when administered to Sprague-Dawley rats for two years in the diet at doses of 25, 75, and 250 mg/kg/day, resulted in a dose-related increase in the incidence of hepatocellular tumors in females and of benign interstitial cell adenomas in the testes of males. Carbamazepine must, therefore, be considered to be carcinogenic in Sprague-Dawley rats. Bacterial and mammalian mutagenicity studies using carbamazepine produced negative results. The significance of these findings relative to the use of carbamazepine in humans is, at present, unknown.

    Usage in Pregnancy

    Pregnancy Category D

    (see ). WARNINGS

    Labor and Delivery

    The effect of carbamazepine on human labor and delivery is unknown.

    Nursing Mothers

    Carbamazepine and its epoxide metabolite are transferred to breast milk. The ratio of the concentration in breast milk to that in maternal plasma is about 0.4 for carbamazepine and about 0.5 for the epoxide. The estimated doses given to the newborn during breast-feeding are in the range of 2 to 5 mg daily for carbamazepine and 1 to 2 mg daily for the epoxide. Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    Substantial evidence of carbamazepine's effectiveness for use in the management of children with epilepsy (see for specific seizure types) is derived from clinical investigations performed in adults and from studies in several in vitro systems which support the conclusion that (1) the pathogenetic mechanisms underlying seizure propagation are essentially identical in adults and children, and (2) the mechanism of action of carbamazepine in treating seizures is essentially identical in adults and children. INDICATIONS AND USAGE

    Taken as a whole, this information supports a conclusion that the generally accepted therapeutic range of total carbamazepine in plasma (i.e., 4 to 12 mcg/mL) is the same in children and adults. The evidence assembled was primarily obtained from short-term use of carbamazepine. The safety of carbamazepine in children has been systematically studied up to 6 months. No longer-term data from clinical trials is available.

    Geriatric Use

    No systematic studies in geriatric patients have been conducted.

  • ADVERSE REACTIONS

    If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.

    The most severe adverse reactions have been observed in the hemopoietic system and skin (see ), the liver, and the cardiovascular system. BOXED WARNING

    The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the low dosage recommended.

    The following additional adverse reactions have been reported:

    Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, anemia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Hemopoietic System:

    Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see ), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis and onychomadesis. In certain cases, discontinuation of therapy may be necessary. Isolated cases of hirsutism have been reported, but a causal relationship is not clear. Skin:BOXED WARNING

    Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), and adenopathy or lymphadenopathy. Cardiovascular System:

    Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

    Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis; very rare cases of hepatic failure. Liver:

    Pancreatitis. Pancreatic:

    Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis or pneumonia. Respiratory System:

    Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been very rare reports of impaired male fertility and/or abnormal spermatogenesis. Genitourinary System:

    Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.

    Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome. There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs. Nervous System:

    Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis. Digestive System:

    Scattered punctate cortical lens opacities, increased intraocular pressure as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes. Eyes:

    Aching joints and muscles, and leg cramps. Musculoskeletal System:

    Fever and chills. Inappropriate antidiuretic hormone (ADH) secretion syndrome has been reported. Cases of frank water intoxication, with decreased serum sodium (hyponatremia) and confusion, have been reported in association with carbamazepine use (see ). Decreased levels of plasma calcium leading to osteoporosis have been reported. Metabolism:PRECAUTIONS, Laboratory Tests

    Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

    A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

  • DRUG ABUSE AND DEPENDENCE

    No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

  • OVERDOSAGE

    Acute Toxicity

    Lowest known lethal dose: adults, 3.2 g (a 24-year-old woman died of a cardiac arrest and a 24-year-old man died of pneumonia and hypoxic encephalopathy); children, 4 g (a 14-year-old girl died of a cardiac arrest), 1.6 g (a 3-year-old girl died of aspiration pneumonia).

    Oral LD in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920. 50

    Signs and Symptoms

    The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent. Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high doses (>60 g) have been ingested.

    Irregular breathing, respiratory depression. Respiration:

    Tachycardia, hypotension or hypertension, shock, conduction disorders. Cardiovascular System:

    Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia, followed by hyporeflexia. Nervous System and Muscles:

    Nausea, vomiting. Gastrointestinal Tract:

    Anuria or oliguria, urinary retention. Kidneys and Bladder:

    Isolated instances of overdosage have included leukocytosis, reduced leukocyte count, glycosuria, and acetonuria. EEG may show dysrhythmias. Laboratory Findings:

    When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same time, the signs and symptoms of acute poisoning with carbamazepine may be aggravated or modified. Combined Poisoning:

    Treatment

    The prognosis in cases of severe poisoning is critically dependent upon prompt elimination of the drug, which may be achieved by inducing vomiting, irrigating the stomach, and by taking appropriate steps to diminish absorption. If these measures cannot be implemented without risk on the spot, the patient should be transferred at once to a hospital, while ensuring that vital functions are safeguarded. There is no specific antidote.

    Induction of vomiting. Elimination of the Drug:

    Gastric lavage. Even when more than 4 hours have elapsed following ingestion of the drug, the stomach should be repeatedly irrigated, especially if the patient has also consumed alcohol.

    Activated charcoal, laxatives. Measures to Reduce Absorption:

    Forced diuresis. Measures to Accelerate Elimination:

    Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicated in severe poisoning in small children.

    Keep the airways free; resort, if necessary, to endotracheal intubation, artificial respiration, and administration of oxygen. Respiratory Depression:

    Keep the patient's legs raised and administer a plasma expander. If blood pressure fails to rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered. Hypotension, Shock:

    Diazepam or barbiturates. Convulsions:

    Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should be used if drugs that inhibit monoamine oxidase have also been taken by the patient either in overdosage or in recent therapy (within 1 week). Warning:not

    Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary reflexes, and kidney and bladder function should be monitored for several days. Surveillance:

    If evidence of significant bone marrow depression develops, the following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency to monitor recovery. Treatment of Blood Count Abnormalities:

    Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) Fe-ferrokinetic studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A and F hemoglobin, and (7) serum folic acid and B levels. A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought. 59212

  • DOSAGE AND ADMINISTRATION

    (SEE BELOW) TABLE

    Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs. (see ). Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents. PRECAUTIONS, Drug Interactions

    Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see ). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. PRECAUTIONS, Laboratory Tests

    Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: ½ teaspoon q.i.d.) and to increase slowly to avoid unwanted side effects.

    Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).

    Carbamazepine extended-release tablets is an extended-release formulation for twice-a-day administration. When converting patients from carbamazepine conventional tablets to carbamazepine extended-release tablets, the same total daily mg dose of carbamazepine extended-release tablets should be administered. Carbamazepine extended-release tablets should be inspected for chips or cracks. Damaged tablets should not be consumed. Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed.

    Epilepsy

    (SEE ) INDICATIONS AND USAGE

    Either 200 mg b.i.d. for tablets and extended-release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d. regimen of carbamazepine extended-release tablets or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Adults and children over 12 years of age-Initial:

    Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily. Maintenance:

    Either 100 mg b.i.d. for tablets or extended-release tablets, or ½ teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. regimen of carbamazepine extended-release tablets or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Adjust dosage to the minimum effective level, usually 400 to 800 mg daily. Children 6 to 12 years of age-Initial:Maintenance:

    10 to 20 mg/kg/day b.i.d. or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made. Children under 6 years of age-Initial:Maintenance:

    Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see , and ). Combination Therapy:PRECAUTIONS, Drug InteractionsPregnancy Category D

    Trigeminal Neuralgia

    (SEE ) INDICATIONS AND USAGE

    On the first day, either 100 mg b.i.d. for tablets or extended-release tablets, or ½ teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or extended-release tablets, or 50 mg (½ teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even discontinue the drug. Initial:Maintenance:

    Dosage Information
    Initial DoseSubsequent DoseMaximum Daily Dose
    IndicationTablet *XR †SuspensionTablet *XR †SuspensionTablet *XR †Suspension
  • * Tablet = Chewable or conventional tablets.
  • † XR = Carbamazepine extended-release tablets
    		•
    Under 6 yr Epilepsy
    		10 to 20 mg/kg/day b.i.d. or t.i.d.10 to 20 mg/kg/day q.i.d.Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.35 mg/kg/24 hr (see section above) Dosage and Administration35 mg/kg/24 hr (see section above) Dosage and Administration
    6 to 12 yr100 mg b.i.d. (200 mg/day)100 mg b.i.d. (200 mg/day)½ tsp q.i.d. (200 mg/day)Add up to 100 mg/day at weekly intervals, t.i.d. or q.i.d.Add 100 mg/day at weekly intervals, b.i.d.Add up to 1 tsp (100 mg)/day at weekly intervals, t.i.d. or q.i.d.1000 mg/24 hr
    Over 12 yr200 mg b.i.d. (400 mg/day)200 mg b.i.d. (400 mg/day)1 tsp q.i.d. (400 mg/day)Add up to 200 mg/day at weekly intervals, t.i.d. or q.i.d.Add up to 200 mg/day at weekly intervals, b.i.d.Add up to 2 tsp (200 mg)/day at weekly intervals, t.i.d. or q.i.d.1000 mg/24 hr (12 to 15 yr) 1200 mg/24 hr (> 15 yr) 1600 mg/24 hr (adults, in rare instances)

    Trigeminal Neuralgia100 mg b.i.d. (200 mg/day)100 mg b.i.d. (200 mg/day)½ tsp q.i.d. (200 mg/day)Add up to 200 mg/day in increments of 100 mg every 12 hrAdd up to 200 mg/day in increments of 100 mg every 12 hrAdd up to 2 tsp (200 mg)/day in increments of 50 mg (½ tsp) q.i.d.1200 mg/24 hr
  • HOW SUPPLIED

    NDC: 64725-4005-1 in a BOTTLE of 100 TABLETS

    [see USP Controlled Room Temperature]. Store Carbamazepine Tablets USP, (Chewable) at 20°C-25°C (68°F-77°F)Protect from light and moisture. Dispense in tight, lightresistant container (USP). Meets USP Dissolution Test 1.

  • HOW SUPPLIED

    White, round, flat beveled-edge, one side scored and engraved "TARO" above and "11" below the score, the other side plain. Carbamazepine Tablets USP, 200 mg:

    Bottles of 100NDC: 51672-4005-1
    Bottles of 500NDC: 51672-4005-2
    Bottles of 1000NDC: 51672-4005-3

    [see USP Controlled Room Temperature]. Store Carbamazepine Tablets USP at 20°-25°C (68°-77°F)Protect from moisture. Dispense in a tight container (USP). Meets USP Dissolution Test 2.

  • HOW SUPPLIED

    White to off-white, round convex tablets embossed with "T91" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 100 mg:

    Bottles of 30NDC: 51672-4123-6
    Bottles of 100NDC: 51672-4123-1
    Bottles of 1000NDC: 51672-4123-3

    White to off-white, round convex tablets embossed with "T26" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 200 mg:

    Bottles of 30NDC: 51672-4124-6
    Bottles of 100NDC: 51672-4124-1
    Bottles of 1000NDC: 51672-4124-3

    White to off-white capsuleshaped tablets embossed with "T29" on one side and plain on the other. Carbamazepine Extended-Release Tablets USP, 400 mg:

    Bottles of 30NDC: 51672-4125-6
    Bottles of 100NDC: 51672-4125-1
    Bottles of 1000NDC: 51672-4125-3

    [see USP Controlled Room Temperature]. Store Carbamazepine Extended-Release Tablets USP at 20°C-25°C (68°F-77°F)Protect from moisture. Dispense in tight container (USP).

  • HOW SUPPLIED

    Orange colored and orange flavored suspension. Carbamazepine Oral Suspension USP, 100 mg/5 mL (teaspoonful):

    Bottles of 450 mLNDC: 51672-4047-9

    Shake well before using.

    [see USP Controlled Room Temperature]. Protect from freezing and from excessive heat. Store Carbamazepine Oral Suspension USP at 20°C-25°C (68°F-77°F)Dispense in a tight, light-resistant container (USP).

    *Thorazine is a registered trademark of GlaxoSmithKline. ®

    *Mellaril is a registered trademark of Novartis Consumer Health, Inc. ®

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110

    Distributed by: , Hawthorne, NY 10532 Taro Pharmaceuticals U.S.A., Inc.

    Revised: April 2013 70725-0413-6

  • MEDICATION GUIDE

    Carbamazepine Tablets USP, Carbamazepine Oral Suspension USP, Carbamazepine Tablets USP (Chewable), and Carbamazepine Extended-Release Tablets USP






    Read this Medication Guide before you start taking Carbamazepine Tablets USP, Carbamazepine Oral Suspension USP, Carbamazepine Tablets USP (Chewable), or Carbamazepine Extended-Release Tablets USP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

    Do not stop taking carbamazepine without first talking to your healthcare provider.

    Stopping carbamazepine suddenly can cause serious problems.

    Carbamazepine can cause serious side effects, including:

    1. Carbamazepine may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

    2. Carbamazepine may cause rare but serious blood problems.

    Symptoms may include:

    3. Like other antiepileptic drugs, carbamazepine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    How can I watch for early symptoms of suicidal thoughts and actions?

    Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    Do not stop carbamazepine without first talking to a healthcare provider.

    Stopping carbamazepine suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

    What is carbamazepine?

    Carbamazepine is a prescription medicine used to treat:

    Carbamazepine is not a regular pain medicine and should not be used for aches or pains.

    Who should not take carbamazepine?

    Do not take carbamazepine if you:

    What should I tell my healthcare provider before taking carbamazepine?

    Before you take carbamazepine, tell your healthcare provider if you:

    , including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your healthcare provider about all the medicines you take

    Taking carbamazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

    Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

    How should I take carbamazepine?

    What should I avoid while taking carbamazepine?

    What are the possible side effects of carbamazepine?

    See " " ? What is the most important information I should know about carbamazepine

    Carbamazepine may cause other serious side effects. These include:

    Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about carbamazepine ?".

    The most common side effects of carbamazepine include:

    These are not all the possible side effects of carbamazepine. For more information, ask your healthcare provider or pharmacist.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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

    How should I store carbamazepine?

    Keep carbamazepine and all medicines out of the reach of children.

    General Information about carbamazepine

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use carbamazepine for a condition for which it was not prescribed. Do not give carbamazepine to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about carbamazepine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about carbamazepine that is written for health professionals .

    What are the ingredients in carbamazepine?

    Active ingredient: carbamazepine

    Inactive ingredients:

    This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: , Hawthorne, NY 10532 Made in Israel
    Taro Pharmaceuticals U.S.A., Inc.

    Revised: April 2013 70725-0413-6

  • PRINCIPAL DISPLAY PANEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    CARBAMAZEPINE 
    carbamazepine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 64725-4005(NDC:51672-4005)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code TARO;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 64725-4005-1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07464910/03/1996
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-4005) , REPACK(64725-4005)
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