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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Seizure Disorders

Prophylactic management of partial seizures with complex symptomatology (psychomotor or temporal lobe seizures), generalized tonic-clonic (grand mal) seizures, and mixed seizure patterns that include partial seizures with complex symptomatology, generalized tonic-clonic seizures, or other partial or generalized seizures.

Greater improvement seen in patients with partial seizures with complex symptomatology than with other types of seizures.

Response in patients with mixed seizures may be variable.

Ineffective in management of absence (petit mal) seizures or myoclonic and akinetic seizures.

May use concomitantly with other anticonvulsants (e.g., phenytoin, phenobarbital, primidone).

Neuropathic Pain

Symptomatic treatment of pain associated with true trigeminal neuralgia.

Beneficial results also reported in glossopharyngeal neuralgia.

Symptomatic treatment of chronic pain arising from other peripheral neuropathic syndromes†.

Not a simple analgesic; do not use for relief of trivial aches or pain.

Schizophrenia

Symptomatic management of the acute phase of schizophrenia†, as an adjunct to therapy with an antipsychotic agent in patients who fail to respond to an adequate trial of the antipsychotic agent alone.

American Psychiatric Association (APA) states that, with the exception of schizophrenic patients whose illness has strong affective components, carbamazepine therapy alone (i.e., monotherapy rather than adjunctive therapy) has not been shown to be substantially effective in the long-term treatment of schizophrenia.

Bipolar Disorder

Treatment and prevention (alone or in combination with other drugs [e.g., antipsychotic agents]) of acute manic or mixed episodes in patients with bipolar disorder†; clinical study results are inconsistent.

APA recommends to reserve for patients unable to tolerate or who have an inadequate therapeutic response to lithium and valproate (e.g., valproic acid, divalproex).

Other Uses

Management of aggression (e.g., uncontrolled rage outbursts) and/or loss of control (dyscontrol) in patients with or without an underlying seizure disorder (e.g., as features of intermittent explosive disorder, conduct disorder, antisocial personality disorder, borderline personality disorder, dementia)†.

Treatment of alcohol withdrawal syndrome†.

Relief of neurogenic pain and/or control of seizures in a variety of conditions including “lightning” pains of tabes dorsalis†.

Relief of pain and control of paroxysmal symptoms of multiple sclerosis†, paroxysmal kinesigenic choreoathetosis†, Klüver-Bucy syndrome†, post-hypoxic action myoclonus†, and acute idiopathic polyneuritis (Landry-Guillain-Barré syndrome)†.

Relief of pain of posttraumatic paresthesia†, diabetic neuropathy† and in children, hemifacial spasm† and dystonia†.

Dosage and Administration

General

Monitoring of plasma concentrations has increased efficacy and safety of anticonvulsants; may be particularly useful if dramatic increase in seizure frequency occurs or for verification of compliance and may aid in determining cause of toxicity when more than one drug is used. May be desirable to monitor serum concentrations of concomitantly administered anticonvulsants and adjust dosages as necessary. (See Interactions and see Plasma Concentrations under Pharmacokinetics.)

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Oral Administration

Extended-release Capsules

Administer orally twice daily without regard to meals. Do not crush or chew extended-release capsules, but may open and sprinkle beads over food (e.g., a teaspoonful of applesauce).

Conventional and Chewable Tablets

Administer chewable or conventional tablets orally 2-4 times daily with meals.

Extended-release Tablets

Administer extended-release tablets orally twice daily with meals.

Swallow extended-release tablets whole; do not crush or chew. Inspect visually for chips or cracks; do not use damaged tablets.

Extended-release tablet coating is not absorbed and may be noticeable in stools.

Suspension

Administer orally 3-4 times daily with meals. Shake well before administration.

Do not administer simultaneously with other liquid preparations. (See Compatibility under Stability.)

NG Tube

To minimize loss of oral suspension because of adherence to PVC tubing, dilute with an equal volume of diluent (e.g., sterile water, 5% dextrose, 0.9% sodium chloride) prior to administration. Flush the tube with 100 mL of diluent after administration. Do not administer with other liquid preparations. (See Compatibility under Stability.)

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Initiate with a low dosage; adjust dosage carefully and slowly according to individual requirements and response. Do not discontinue abruptly due to risk of increased seizure frequency.

When adding to an existing anticonvulsant regimen, add gradually while dosage of other anticonvulsant(s) is maintained or gradually adjusted. (See Specific Drugs, Foods, and Laboratory Tests under Interactions.)

A given dose administered as oral suspension will produce higher peak plasma concentrations than when administered as tablets; initiate therapy with oral suspension with low, frequent doses and increase slowly to reduce risk of adverse effects (e.g., sedation).

To achieve therapeutic serum carbamazepine concentrations more rapidly (in about 2 hours), some clinicians recommend a loading-dose regimen (as oral suspension), preferably in a setting where plasma concentrations and the patient can be monitored closely.

When converting patients from oral tablets to oral suspension, divide total daily dosage administered as tablets into smaller, more frequent doses of suspension (e.g., transfer from twice-daily divided dosing of tablets to 3-times-daily divided dosing of suspension).

When converting patients from conventional, immediate-release formulations to extended-release capsules or tablets, administer same total daily dosage in 2 divided doses.

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Seizure Disorders

Oral

Children <6 years of age: Initially, 10–20 mg/kg daily in 2–3 divided doses as chewable or conventional tablets or 4 divided doses as suspension. Increase dosage at weekly intervals to achieve optimal clinical response, which is generally achieved at maintenance dosages <35 mg/kg daily in 3 or 4 divided doses. If clinical response not achieved, obtain plasma carbamazepine concentrations to determine if in therapeutic range. Safety of dosages >35 mg/kg in a 24-hour period not established.

Children 6–12 years of age: Initially, 100 mg twice daily as tablets (chewable, conventional, or extended-release) or 50 mg 4 times daily as oral suspension. Increase dosage at weekly intervals by up to 100 mg daily using a twice daily divided dosage regimen as extended-release tablets or a 3 or 4 times daily divided dosage regimen as conventional or chewable tablets or oral suspension until optimal response obtained, up to a maximum dosage of 1 g daily. When adequate seizure control is achieved, adjust dosage to minimum effective level, usually 400–800 mg daily.

Children <12 years of age taking a total daily dosage of an immediate release formulation ≥400 mg may be converted to the same total daily dosage of extended-release capsules using a twice daily regimen.

If rapid attainment of therapeutic serum carbamazepine concentrations is desired, some clinicians recommend an initial loading dose (as oral suspension) of 10 mg/kg in children <12 years of age.

Children >12 years of age: Initially, 200 mg twice daily as tablets (conventional, chewable, or extended-release) or extended-release capsules or 100 mg 4 times daily as oral suspension. Increase dosage at weekly intervals by up to 200 mg daily using a twice daily divided dosage regimen as extended-release tablets or a 3 or 4 times daily divided dosage regimen as conventional or chewable tablets or oral suspension until optimal response obtained, up to a maximum dosage of 1 or 1.2 g in children 12–15 or >15 years of age, respectively. When adequate seizure control is achieved, adjust dosage to minimum effective level, usually 800 mg to 1.2 g daily.

If rapid attainment of therapeutic serum carbamazepine concentrations is desired, some clinicians recommend an initial loading dose (as oral suspension) of 8 mg/kg in children ≥12 years of age.

Bipolar Disorder

Oral

Although dosage not established, experts generally recommend administering at the same range in dosage and therapeutic plasma concentrations as in the management of seizure disorders.†

Children >12 years of age: Initially, 200–600 mg daily, given in 3–4 divided doses; titrate dosage upward according to patient response and tolerability.†

In hospitalized patients >12 years of age with acute mania, increase dosage as tolerated in 200-mg daily increments up to 800 mg to 1 g daily, with slower increases thereafter as indicated. Do not exceed 1.6 g daily.†

In less acutely ill outpatients >12 years of age, adjust dosage more slowly, since rapid increases may cause patients to develop adverse GI or nervous system effects. If such adverse effects occur, consider temporary dosage reductions. Once adverse effects resolve, increase dosage again more slowly.†

Maintenance dosages average about 1 g daily, but may range from 200 mg to 1.6 g daily in routine clinical practice.†

Adults

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Seizure Disorders

Oral

Initially, 200 mg twice daily as tablets (chewable, conventional, or extended-release) or capsules or 100 mg 4 times daily as oral suspension.

Increase dosage by up to 200 mg daily at weekly intervals using a twice daily divided dosage regimen as extended-release tablets or capsules or a 3 or 4 times daily divided dosage regimen as conventional tablets or oral suspension until optimal response obtained, up to a maximum dosage of 1.2 g. In rare instances, dosages up to 1.6 g have been used.

When adequate seizure control is achieved, adjust dosage to minimum effective level, usually 800 mg to 1.2 g daily.

Neuropathic Pain

Trigeminal Neuralgia

Oral

Initially, 100 mg twice daily as tablets (conventional or extended-release), 200 mg once daily as extended-release capsules, or 50 mg 4 times daily as suspension on the first day of therapy.

Increase dosage gradually by up to 200 mg daily using 200-mg increments for capsules, 100-mg increments every 12 hours for conventional or extended-release tablets, or 50-mg increments 4 times daily for the suspension until pain is relieved up to a total dosage of 1.2 g daily. The dosage necessary to relieve pain may range from 200 mg to 1.2 g daily.

After pain control is achieved, maintenance dosage of 400–800 mg daily is usually adequate; some patients may require as little as 200 mg daily while others may require 1.2 g daily.

At least once every 3 months, make attempt to decrease dosage to minimum effective level or to discontinue.

Bipolar Disorder

Oral

Dosage not established. Experts generally recommend the same range in dosage and therapeutic plasma concentrations as in the management of seizure disorders.†

Initially, 200–600 mg daily, given in 3–4 divided doses.†

Titrate dosage upward according to patient response and tolerability.†

In hospitalized patients with acute mania, increase dosage as tolerated in 200-mg daily increments up to 800 mg to 1 g daily, with slower increases thereafter as indicated. Do not exceed 1.6 g daily.†

In less acutely ill outpatients, adjust dosage more slowly, since rapid increases may cause patients to develop adverse GI or nervous system effects. If such adverse effects occur, consider temporary dosage reductions. Once adverse effects resolve, increase dosage again more slowly.†

Maintenance dosages average about 1 g daily, but may range from 200 mg to 1.6 g daily in routine clinical practice.†

Prescribing Limits

Pediatric Patients

Seizure Disorders

Oral

Children <6 years of age: Safety of dosages exceeding 35 mg/kg in a 24-hour period not established.

Children 6–15 years of age: Generally should not exceed 1 g daily.

Children >15 years of age: Generally should not exceed 1.2 g daily.

Adults

Seizure Disorders

Oral

Generally should not exceed 1.2 g daily; however, some patients have required up to 1.6–2.4 g daily.

Neuropathic Pain

Trigeminal Neuralgia

Oral

Maximum 1.2 g daily.

Bipolar Disorder

Oral

Maximum 1.6 g daily.†