Carbamazepine description, usages, side effects, indications, overdosage, supplying and lots more!

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Carbamazepine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


WARNINGS

WARNINGSANDPRECAUTIONS,Laboratory Tests).





Before prescribing carbamazepine, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.

CARBAMAZEPINE DESCRIPTION



Carbamazepine







CLINICAL PHARMACOLOGY



Mechanism of Action



Pharmacokinetics
PRECAUTIONS, Drug Interactions). Following chronic oral administration of suspension, plasma levels peak at approximately 1.5 hours compared to 4 to 5 hours after administration of conventional carbamazepine tablets, and 3 to 12 hours after administration of carbamazepine extended-release tablets. The CSF/serum ratio is 0.22, similar to the 24% unbound carbamazepine in serum. Because carbamazepine induces its own metabolism, the half-life is also variable. Autoinduction is completed after 3 to 5 weeks of a fixed dosing regimen. Initial half-life values range from 25 to 65 hours, decreasing to 12 to 17 hours on repeated doses. Carbamazepine is metabolized in the liver. Cytochrome P450 3A4 was identified as the major isoform responsible for the formation of carbamazepine-10,11-epoxide from carbamazepine. After oral administration of 14C-carbamazepine, 72% of the administered radioactivity was found in the urine and 28% in the feces. This urinary radioactivity was composed largely of hydroxylated and conjugated metabolites, with only 3% of unchanged carbamazepine.


INDICATIONS & USAGE

Epilepsy



PRECAUTIONS, General).

Trigeminal Neuralgia



CARBAMAZEPINE CONTRAINDICATIONS



WARNINGS

Serious Dermatologic Reactions


SJS/TEN and HLA-B*1502 Allele



Prior to initiating carbamazepine therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present. In deciding which patients to screen, the rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Carbamazepine should not be used in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN (seeWARNINGSandPRECAUTIONS, Laboratory Tests).





Aplastic Anemia and Agranulocytosis


Suicidal Behavior and Ideation



Table 1shows absolute and relative risk by indication for all evaluated AEDs.

Table 1: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis




General
Carbamazepine has shown mild anticholinergic activity; therefore, patients with increased introcular pressure should be closely observed during therapy.





Usage in Pregnancy









PRECAUTIONS

General

INDICATIONS AND USAGE).


ADVERSE REACTIONSandPRECAUTIONS, LaboratoryTests). In some cases, hepatic effects may progress despite discontinuation of the drug.
ADVERSE REACTIONS, OtherandPRECAUTIONS, Information for Patients).



INFORMATION FOR PATIENTS




WARNINGS).



WARNINGS, Usage in Pregnancy).

LABORATORY TESTS

WARNINGS), high-resolutiontypingis recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.

PRECAUTIONS, GeneralandADVERSE REACTIONS). Carbamazepine should be discontinued, based on clinical judgment, if indicated by newly occurring or worsening clinical or laboratory evidence of liver dysfunction or hepatic damage, or in the case of active liver disease.


CLINICAL PHARMACOLOGY) has increased the efficacy and safety of anticonvulsants. This monitoring may be particularly useful in cases of dramatic increase in seizure frequency and for verification of compliance. In addition, measurement of drug serum levels may aid in determining the cause of toxicity when more than one medication is being used.



DRUG INTERACTIONS



Agents That May Affect Carbamazepine Plasma Levels








Effect of Carbamazepine on Plasma Levels of Concomitant Agents




CONTRAINDICATIONS).







CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



USAGE IN PREGNANCY




WARNINGS.)

LABOR & DELIVERY


NURSING MOTHERS



PEDIATRIC USE

INDICATIONS AND USAGEfor 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.


GERIATRIC USE


CARBAMAZEPINE ADVERSE REACTIONS


BOXEDWARNING), the liver, and the cardiovascular system.


Hemopoietic System:Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, anemia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda.
Skin:Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (seeBOXEDWARNING), 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 (e.g., pulmonary embolism), and adenopathy or lymphadenopathy.

Liver:
Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis; very rare cases of 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. There have been very rare reports of impaired male fertility and/or abnormal spermatogenesis.

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, hyperacusis, neuroleptic malignant syndrome.


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, 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.
Musculoskeletal System:Aching joints and muscles, and leg cramps.
Metabolism: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 (seePRECAUTIONS, Laboratory Tests). Decreased levels of plasma calcium leading to osteoporosis have been reported.
Other:Multiorgan hypersensitivity reactions occurring days to weeks or months after initiating treatment have been reported in rare cases. Signs or symptoms may include, but are not limited to fever, skin rashes, vasculitis, lymphadenopathy, disorders mimicking lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and abnormal liver function tests. These signs and symptoms may occur in various combinations and not necessarily concurrently. Signs and symptoms may initially be mild. Various organs, including but not limited to, liver, skin, immune system, lungs, kidneys, pancreas, myocardium, and colon may be affected (seePRECAUTIONS, GeneralandPRECAUTIONS, Information for Patients).


DRUG ABUSE AND DEPENDENCE


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



Signs and Symptoms

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. EEG 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

Elimination of the Drug:Induction of vomiting.

Measures to Reduce Absorption:Activated charcoal, laxatives.
Measures to Accelerate Elimination:Forced diuresis.

Respiratory Depression:
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.


DOSAGE & ADMINISTRATION

(See table below.)
PRECAUTIONS, Laboratory Tests). 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.


Epilepsy
INDICATIONS AND USAGE.)

Adults and Children Over 12 Years of Age
Initial:200 mg b.i.d. Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen 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.Maintenance:Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Children 6 to 12 Years of Age
Initial:100 mg b.i.d. Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily.Maintenance:Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Children Under 6 Years of Age
Initial:10 to 20 mg/kg/day b.i.d. or t.i.d. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d.Maintenance: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
PRECAUTIONS, Drug Interactions,andUsage inPregnancy,Teratogenic Effects,Pregnancy category D).

Trigeminal Neuralgia
INDICATIONS AND USAGE.)
Initial:On the first day, 100 mg b.i.d. 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 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 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 to discontinue the drug.

Dosage Information

*
*Epilepsy DOSAGE AND ADMINISTRATIONabove)Trigeminal Neuralgia *


HOW SUPPLIED





STORAGE AND HANDLING





MEDICATION GUIDE

Carbamazepine Tablets USP and Carbamazepine Tablets, USP (Chewable)


What is the most important information I should know about carbamazepine tablets or carbamazepine tablets (chewable)?
Do not stop taking carbamazepine tablets or carbamazepine tablets (chewable) without first talking to your healthcare provider.

Carbamazepine tablets or carbamazepine tablets (chewable) can cause serious side effects, including:
1. Carbamazepine tablets or carbamazepine tablets (chewable) 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 tablets or carbamazepine tablets (chewable) 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 tablets or carbamazepine tablets (chewable) to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:




2. Carbamazepine tablets or carbamazepine tablets (chewable) may cause rare but serious blood problems. Symptoms may include:





3. Like other antiepileptic drugs, carbamazepine tablets or carbamazepine tablets (chewable) 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 tablets or carbamazepine tablets (chewable) without first talking to a healthcare provider.


What are carbamazepine tablets or carbamazepine tablets (chewable)?




Who should not take carbamazepine tablets or carbamazepine tablets (chewable)?
Do not take carbamazepine tablets or carbamazepine tablets (chewable) if you:





What should I tell my healthcare provider before taking carbamazepine tablets or carbamazepine tablets (chewable)?
Before you take carbamazepine tablets or carbamazepine tablets (chewable), 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.


How should I take carbamazepine tablets or carbamazepine tablets (chewable)?





What should I avoid while taking carbamazepine tablets or carbamazepine tablets (chewable)?


What are the possible side effects of carbamazepine tablets or carbamazepine tablets (chewable)?
is the most important information I should know about carbamazepine tablets or carbamazepine tablets (chewable)?













Get medical help right away if you have any of the symptoms listed above or listed inis the most important information I should know about carbamazepine tablets or carbamazepine tablets (chewable)
The most common side effects of carbamazepine tablets or carbamazepine tablets (chewable) include:







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 tablets or carbamazepine tablets (chewable)?
carbamazepine tabletsat 20to 25(68to 77

carbamazepine tablets(chewable) at 20to 25(68to 77


Keep carbamazepine tablets or carbamazepine tablets (chewable) and all medicines out of the reach of children.
General Information about carbamazepine tablets or carbamazepine tablets (chewable)



What are the ingredients in carbamazepine tablets and carbamazepine tablets (chewable)?


     Carbamazepine tablets:colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate.
     Carbamazepine tablets (chewable):acacia, colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, FD&C Red #40 aluminum lake, flavoring, glycerin, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Carbamazepine


Carbamazepine

Carbamazepine

CARBAMAZEPINE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-677(NDC:0093-0109)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMAZEPINE Carbamazepine 200 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSES
GLYCERIN
lactose monohydrate
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 10 mm 109;TEVA ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-677-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070541 2012-09-04


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