Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 23 February 2017

Indication(s)

INDICATIONS & USAGE Carbamazepine is indicated for use as an anticonvulsant drug.

Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe).

Patients with these seizures appear to show greater improvement than those with other types.

Generalized tonic-clonic seizures (grand mal).

Mixed seizure patterns which include the above, or other partial or generalized seizures.

Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).

Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia.

Beneficial results have also been reported in glossopharyngeal neuralgia.

This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

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Advisory information

contraindications

CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc.

Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended.

Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.

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.

Special warnings and precautions

PRECAUTIONS Before initiating therapy, a detailed history and physical examination should be made.

Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients carbamazepine has been associated with increased frequency of generalized convulsions (see INDICATIONS AND USAGE).

Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbance, including second and third degree AV heart block; cardiac, hepatic, or renal damage; adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants; or interrupted courses of therapy with carbamazepine.

AV heart block, including second and third degree block, have been reported following carbamazepine treatment.

This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances.

Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been reported (see ADVERSE REACTIONS and PRECAUTIONS, Laboratory Tests).

In some cases, hepatic effects may progress despite discontinuation of the drug.

In addition rare instances of vanishing bile duct syndrome have been reported.

This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts.

Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan hypersensitivity (DRESS syndrome) and serious dermatologic reactions.

As an example there has been a report of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association with fever and eosinophilia.

Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended that patients given the suspension be started on lower doses and increased slowly to avoid unwanted side effects (see DOSAGE AND ADMINISTRATION).

Carbamazepine suspension contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.

Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine.

Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as well as dermatologic, hypersensitivity or hepatic reactions.

These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice.

The patient should be advised that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician.

In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use.

Patients should be advised that serious skin reactions have been reported in association with carbamazepine.

In the event a skin reaction should occur while taking carbamazepine, patients should consult with their physician immediately (see WARNINGS).

Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Behaviors of concern should be reported immediately to healthcare providers.

Carbamazepine may interact with some drugs.

Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products.

Caution should be exercised if alcohol is taken in combination with carbamazepine therapy, due to a possible additive sedative effect.

Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy.

To enroll, patients can call the toll free number 1-888-233-2334 (see WARNINGS, Usage in Pregnancy subsection).

For genetically at-risk patients (see WARNINGS), high-resolution ' HLA -B * 1502 typing ' is 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.

Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline.

If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely.

Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with this drug since liver damage may occur (see PRECAUTIONS, General and ADVERSE 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.

Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes.

Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction.

Monitoring of blood levels (see 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.

Thyroid function tests have been reported to show decreased values with carbamazepine administered alone.

Hyponatremia has been reported in association with carbamazepine use, either alone or in combination with other drugs.

Interference with some pregnancy tests has been reported.

There has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by

Thorazine ®* solution.

Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril ®, resulted in the occurrence of this precipitate.

Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (see DOSAGE AND ADMINISTRATION).

Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to, the following: When carbamazepine is given with drugs that can increase or decrease carbamazepine levels, close monitoring of carbamazepine levels is indicated and dosage adjustment may be required.

Agents That Increase Carbamazepine Levels CYP3A4 inhibitors inhibit carbamazepine metabolism and can thus increase plasma carbamazepine levels.

Drugs that have been shown, or would be expected, to increase plasma carbamazepine levels include: aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, nefazodone, trazodone, loxapine, * olanzapine, quetiapine *, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e.g. ketaconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors, valproate *.

Agents That Decrease Carbamazepine Levels CYP3A4 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.

* increased levels of the active carbamazepine-10,11-epoxide †decreased levels of carbamazepine and increased levels of the 10,11-epoxide Decreased Levels of Concomitant Medications Carbamazepine is a potent inducer of hepatic CYP3A4 and may therefore reduce plasma concentrations of comedications mainly metabolized by CYP3A4 through induction of their metabolism.

Carbamazepine causes, or would be expected to cause, decreased levels of the following: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, 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, mianserin, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, 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 coadministered 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).

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 isoniazid-induced 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.

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.

Pregnancy Category D (see WARNINGS).

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

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 breastfeeding 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.

Substantial evidence of carbamazepine 's effectiveness for use in the management of children with epilepsy (see INDICATIONS AND USAGE 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.

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.

No systematic studies in geriatric patients have been conducted.

Adverse reactions

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 BOXED WARNING), the liver, 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 have been reported: 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) (see BOXED WARNING), 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.

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.

Some of these cardiovascular complications have resulted in fatalities.

Myocardial infarction has been associated with other tricyclic compounds.

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.

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.

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.

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.

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 (see PRECAUTIONS, Laboratory Tests).

Decreased levels of plasma calcium leading to osteoporosis have been reported.

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.

Usage information

Dosing and administration

DOSAGE & ADMINISTRATION 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 PRECAUTIONS, Drug Interactions).

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.

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 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.

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: 1/2 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 is an extended-release formulation for twice-a-day administration.

When converting patients from carbamazepine conventional tablets to carbamazepine extended-release, the same total daily mg dose of carbamazepine extended-release should be administered.

Carbamazepine extended-release tablets must be swallowed whole and never crushed or chewed.

Carbamazepine extended-release tablets should be inspected for chips or cracks.

Damaged tablets, or tablets without a release portal, should not be consumed.

Carbamazepine extended-release tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.

Epilepsy (SEE INDICATIONS AND USAGE) Adults and children over 12 years of age - Initial: 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 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.

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

Children 6 to 12 years of age - Initial: Either 100 mg b.i.d. for tablets or extended-release tablets, or 1/2 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 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.

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. as tablets, or q.i.d. as suspension.

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: 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, and Pregnancy Category D).

Trigeminal Neuralgia (SEE INDICATIONS AND USAGE) Initial: On the first day, either 100 mg b.i.d. for tablets or extended-release tablets, or 1/2 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 (1/2 teaspoon) q.i.d. for suspension, 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 Initial Dose Subsequent Dose Maximum Daily Dose Indication Tablet * Extended-Release Tablets Suspension Tablet * Extended-Release Tablets Suspension Tablet * Extended-Release Tablets Suspension Epilepsy Under 6 yr 10-20 mg/kg/day b.i.d. or t.i.d. 10-20 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 Dosage and Administration section above) 35 mg/kg/24 hr (see Dosage and Administration section above) 6-12 yr 100 mg b.i.d. (200 mg/day) 100 mg b.i.d. (200 mg/day)?

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 yr 200 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 (12-15 yr) 1200 mg/24 hr (>15 yr) 1600 mg/24 hr (adults, in rare instances) Trigeminal Neuralgia 100 mg b.i.d. (200 mg/day) 100 mg b.i.d. (200 mg/day)?

tsp q.i.d. (200 mg/day) Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 2 tsp (200 mg)/day in increments of 50 mg (?

tsp) q.i.d. 1200 mg/24 hr * Tablet = Chewable or conventional tablets

More information

Category Value
Authorisation number NDA020234
Agency product number 33CM23913M
Orphan designation No
Product NDC 61786-543
Date Last Revised 07-01-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 402506
Marketing authorisation holder REMEDYREPACK INC.
Warnings

Boxed Warning Serious Dermatologic Reactions And Hla-B * 1502 Allele Serious And Sometimes Fatal Dermatologic Reactions, Including Toxic Epidermal Necrolysis (Ten) And Stevens-Johnson Syndrome (Sjs), Have Been Reported During Treatment With Carbamazepine.

These Reactions Are Estimated To Occur In 1 To 6 Per 10,000 New Users In Countries With Mainly Caucasian Populations, But The Risk In Some Asian Countries Is Estimated To Be About 10 Times Higher.

Studies In Patients Of Chinese Ancestry Have Found A Strong Association Between The Risk Of Developing Sjs/Ten And The Presence Of Hla-B * 1502, An Inherited Allelic Variant Of The Hla-B Gene.

Hla-B * 1502 Is Found Almost Exclusively In Patients With Ancestry Across Broad Areas Of Asia.

Patients With Ancestry In Genetically At-Risk Populations Should Be Screened For The Presence Of Hla-B * 1502 Prior To Initiating Treatment With Carbamazepine.

Patients Testing Positive For The Allele Should Not Be Treated With Carbamazepine

Unless The Benefit

Clearly Outweighs The Risk (See Warnings And Precautions, Laboratory Tests).

Aplastic Anemia And Agranulocytosis Aplastic Anemia And Agranulocytosis Have Been Reported In Association With The Use Of Carbamazepine.

Data From A Population-Based Case Control Study Demonstrate That The Risk Of Developing These Reactions Is 5 To 8 Times Greater Than In The General Population.

However, The Overall Risk Of These Reactions In The Untreated General Population Is Low, Approximately Six Patients Per One Million Population Per Year For Agranulocytosis And Two Patients Per One Million Population Per Year For Aplastic Anemia.

Although Reports Of Transient Or Persistent Decreased Platelet Or White Blood Cell Counts Are Not Uncommon In Association With The Use Of Carbamazepine, Data Are Not Available To Estimate Accurately Their Incidence Or Outcome.

However, The Vast Majority Of The Cases Of Leukopenia Have Not Progressed To The More Serious Conditions Of Aplastic Anemia Or

Agranulocytosis.

Because

Of The Very Low Incidence Of Agranulocytosis And Aplastic Anemia, The Vast Majority Of Minor Hematologic Changes Observed In Monitoring Of Patients On Carbamazepine Are Unlikely To Signal The Occurrence Of Either Abnormality.

Nonetheless, Complete Pretreatment Hematological Testing Should Be Obtained As A Baseline.

If A Patient In The Course Of Treatment Exhibits Low Or Decreased White Blood Cell Or Platelet Counts, The Patient Should Be Monitored Closely.

Discontinuation Of The Drug Should Be Considered If Any Evidence Of Significant Bone Marrow Depression Develops.