CARBAMAZEPINE capsule, extended release

Carbamazepine by

Drug Labeling and Warnings

Carbamazepine by is a Prescription medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Agents that Induce Cytochrome P450 Isoenzymes

Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of carbamazepine are the following:

Cisplatin, doxorubicin HCL, felbamate, rifampin, phenobarbital, phenytoin2, primidone, methsuximide, and theophylline

Thus, if a patient has been titrated to a stable dosage on carbamazepine, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for carbamazepine may be necessary.


  • 2 Phenytoin plasma levels have also been reported to increase and decrease in the presence of carbamazepine, see below.
  • Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes

    Carbamazepine is known to induce CYP1A2 and CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent metabolized by one (or more) of these enzymes. Agents that have been found, or are expected to have decreased plasma levels in the presence of carbamazepine due to induction of CYP enzymes are the following:

    Acetaminophen, alprazolam, amitriptyline, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, doxycycline, ethosuximide, felbamate, felodipine, glucocorticoids, haloperidol, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, midazolam, mirtazapine, nefazodone3, nortriptyline, olanzapine, oral and other hormonal contraceptives4, oxcarbazepine, phenytoin5, praziquantel, protease inhibitors, quetiapine, risperidone, theophylline, topiramate, tiagabine, tramadol, triazolam, trazodone6, valproate, warfarin7, ziprasidone, and zonisamide.

    Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with carbamazepine, it is reasonable to expect that a dose increase for the concomitant agent may be necessary.


  • 3 Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated (see CONTRAINDICATIONS).
  • 4 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 with carbamazepine. Alternative or back-up methods of contraception should be considered.
  • 5 Phenytoin has also been reported to increase in the presence of carbamazepine. Careful monitoring of phenytoin plasma levels following co-medication with carbamazepine is advised.
  • 6 Following co-administration of carbamazepine 400mg/day with trazodone 100mg to 300mg daily, carbamazepine reduced trough plasma concentrations of trazodone (as well as meta-chlorophenylpiperazine [mCPP]) by 76 and 60% respectively, compared to precarbamazepine values.
  • 7 Warfarin's anticoagulant effect can be reduced in the presence of carbamazepine.
  • Agents with Increased Levels in the Presence of Carbamazepine

    Carbamazepine increases the plasma levels of the following agents:

    Clomipramine HCl, phenytoin8, and primidone

    Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with carbamazepine, it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.


  • 8 Phenytoin has also been reported to decrease in the presence of carbamazepine. Careful monitoring of phenytoin plasma levels following co-medication with carbamazepine is advised.
  • Pharmacological/Pharmacodynamic Interactions with Carbamazepine

    Coadministration of carbamazepine with delavirdine may lead to loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors (see CONTRAINDICATIONS).

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

    Given the anticonvulsant properties of carbamazepine, carbamazepine may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of carbamazepine.

    Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with carbamazepine, it is reasonable to expect that a dose adjustment may be necessary.

    Because of its primary CNS effect, caution should be used when carbamazepine is taken with other centrally acting drugs and alcohol.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Administration of carbamazepine to Sprague-Dawley rats for two years in the diet at doses of 25, 75, and 250 mg/kg/day (low dose approximately 0.2 times the maximum human daily dose of 1200 mg on a mg/m2 basis), 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

    (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 and during lactation. The concentrations of carbamazepine and its epoxide metabolite are approximately 50% of the maternal plasma concentration. 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 effectiveness for use in the management of children with epilepsy (see INDICATIONS 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 pathogenic 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.

    Taken as a whole, this information supports a conclusion that the generally acceptable therapeutic range of total carbamazepine in plasma (i.e., 4-12 µg/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

    General

    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 patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards.

    The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system and skin (see BOXED WARNING), and the cardiovascular system.

    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 lowest dosage recommended.

    The following additional adverse reactions were previously reported with carbamazepine:

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

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

    Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

    Immune system disorders: Hypogammaglobulinemia.

    Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, and hepatic failure.

    Pancreatic: Pancreatitis.

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

    Genitourinary 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.

    Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 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/day and higher. Relevance of these findings to humans is unknown.

    Nervous System: 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, and hyperacusis.

    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 with concomitant use of psychotropic drugs.

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

    Eyes: Scattered punctate cortical lens opacities, 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.

    Musculoskeletal System: Bone loss, aching joints and muscles, and leg cramps.

    Metabolism: Fever and chills. Decreased levels of plasma calcium leading to osteoporosis have been reported.

    Other: 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, >60 g (39-year-old man). Highest known doses survived: adults, 30 g (31-year-old woman); children, 10 g (6-year-old boy); small children, 5 g (3-year-old girl).

    Oral LD50 in animals (mg/kg): mice, 1100-3750; rats, 3850-4025; rabbits, 1500-2680; guinea pigs, 920.

    Signs and Symptoms

    The first signs and symptoms appear after 1-3 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.

    Respiration: Irregular breathing, respiratory depression.

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

    Nervous System and Muscles: 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.

    Gastrointestinal Tract: Nausea, vomiting.

    Kidneys and Bladder: Anuria or oliguria, urinary retention.

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

    Combined Poisoning: 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.

    Treatment

    For the most up to date information on management of carbamazepine overdose, please contact the poison center for your area by calling 1-800-222-1222. The prognosis in cases of carbamazepine poisoning is generally favorable. Of 5,645 cases of carbamazepine exposures reported to US poison centers in 2002, a total of 8 deaths (0.14% mortality rate) occurred. Over 39% of the cases reported to these poison centers were managed safely at home with conservative care. Successful management of large or intentional carbamazepine exposures requires implementation of supportive care, frequent monitoring of serum drug concentrations, as well as aggressive but appropriate gastric decontamination.

    Elimination of the Drug

    The primary method for gastric decontamination of carbamazepine overdose is use of activated charcoal. For substantial recent ingestions, gastric lavage may also be considered. Administration of activated charcoal prior to hospital assessment has the potential to significantly reduce drug absorption. There is no specific antidote. In overdose, absorption of carbamazepine may be prolonged and delayed. More than one dose of activated charcoal may be beneficial in patients that have evidence of continued absorption (e.g., rising serum carbamazepine levels).

    Measures to Accelerate Elimination

    The data on use of dialysis to enhance elimination in carbamazepine is scarce. Dialysis, particularly high flux or high efficiency hemodialysis, may be considered in patients with severe carbamazepine poisoning associated with renal failure or in cases of status epilepticus, or where there are rising serum drug levels and worsening clinical status despite appropriate supportive care and gastric decontamination. For severe cases of carbamazepine overdose unresponsive to other measures, charcoal hemoperfusion may be used to enhance drug clearance.

    Respiratory Depression

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

    Hypotension, Shock

    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.

    Convulsions

    Diazepam or barbiturates.

    Warning

    Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should not 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).

    Surveillance

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

    Treatment of Blood Count Abnormalities

    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.

    Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59Fe-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 A2 and F hemoglobin, and (7) serum folic acid and B12 levels.

    A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.

  • DOSAGE AND ADMINISTRATION

    Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Carbamazepine may be taken with or without food. Carbamazepine capsules may be swallowed whole or may be opened and all the beads sprinkled on a teaspoon of soft food such as applesauce. Make sure all of the food and medicine mixture is swallowed. Do not crush or chew carbamazepine capsules or the sprinkled beads.

    Carbamazepine is an extended-release formulation for twice a day administration. When converting patients from immediate release carbamazepine to carbamazepine extended-release capsules, the same total daily mg dose of carbamazepine should be administered. Following conversion to carbamazepine, patients should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions.

    Epilepsy

    (see INDICATIONS AND USAGE)

    Adults and children over 12 years of age

    Initial

    200 mg twice daily. Increase at weekly intervals by adding up to 200 mg/day until the optimal response is obtained. Dosage generally should not exceed 1000 mg per day in children 12-15 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.

    Maintenance

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

    Children under 12 years of age

    Children taking total daily dosages of immediate-release carbamazepine of 400 mg or greater may be converted to the same total daily dosage of carbamazepine extended-release capsules, using a twice daily regimen. 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.

    Combination Therapy

    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 PRECAUTIONS, Drug Interactions).

    Trigeminal Neuralgia

    (see INDICATIONS AND USAGE)

    Initial

    On the first day, start with one 200 mg capsule. This daily dose may be increased by up to 200 mg/day every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily.

    Maintenance

    Control of pain can be maintained in most patients with 400-800 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 to discontinue the drug.

  • HOW SUPPLIED

    Carbamazepine extended-release capsules are supplied in three dosage strengths.

    100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with S433 and 100 mg in white ink.

    Supplied in bottles of 120                         NDC: 66993-407-32

    200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with S433 and 200 mg in white ink.

    Supplied in bottles of 120                         NDC: 66993-408-32

    300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with S433 and 300 mg in white ink.

    Supplied in bottles of 120                         NDC: 66993-409-32

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: 


    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

    To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

  • Medication GuideCarbamazepineExtended-Release Capsules

    Read this Medication Guide before you start taking carbamazepine 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 rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of carbamazepine 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 can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body such as your liver or blood cells. You may or may not have a rash when you get these types of reactions. Call your healthcare provider right away if you have any of these symptoms:

    These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking carbamazepine.

    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?

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

    Stopping carbamazepine suddenly can cause serious problems.

    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 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:

    Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

    What should I tell my healthcare provider before taking carbamazepine?

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

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

    Taking carbamazepine with certain other medicines can 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 including:

    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 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 information about carbamazepine that is written for health professionals.

    For more information call 1-800-828-2088.

    What are the ingredients in carbamazepine?

    Active ingredient: carbamazepine

    Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate and Eudragit.

    In addition:

  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

    NDC: 17856-0407-1

    Carbamazepine

    Extended-Release Capsules

    Should not be used with other
    carbamazepine containing products.


    Rx Only

    100 mg

    Dispense the accompanying
    Medication Guide to each patient.

    LABEL 1

  • INGREDIENTS AND APPEARANCE
    CARBAMAZEPINE 
    carbamazepine capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 17856-0407(NDC:66993-407)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M) CARBAMAZEPINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
    Product Characteristics
    ColorGREEN (green) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code S433;100mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 17856-0407-1100 in 1 BOX, UNIT-DOSE01/31/2020
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA AUTHORIZED GENERICNDA02071212/15/2011
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707repack(17856-0407) , relabel(17856-0407)

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.