CARBATROL Rx

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CARBATROL

Nonnarcotic analgesics
Seizure disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.

Company:

Shire US, Inc.

Select therapeutic use:

Indications for CARBATROL:

Trigeminal or glossopharyngeal neuralgia.

Adult:

200mg once on day 1; increase by 200mg/day every 12hrs as needed; max 1.2g/day. Usual maintenance: 400–800mg/day. Attempt to taper or discontinue every three months.

Children:

See full labeling.

Contraindications:

History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.

Warnings/Precautions:

Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present carbamazepine should not be used; increased risk of severe dermatological reactions. History of cardiac, hepatic, renal, or hematopoietic dysfunction. Not for trivial aches/pains. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Monitor lipid profile, and ophthalmic, hepatic, and renal function. Consider discontinuing if hyponatremia occurs. Increased intraocular pressure. Activation of latent psychosis. Suicidal tendencies (monitor). Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

See Contraindications. Possible hyperpyretic crisis, seizures and death with MAOIs. Carbamazepine levels increased by CYP3A4 inhibitors (eg, cimetidine, macrolides, danazol, delavirdine, diltiazem, fluoxetine, isoniazid, ketoconazole, loratadine, propoxyphene, itraconazole, nicotinamide, niacinamide, valproate, verapamil). Carbamazepine levels decreased by CYP3A4 inducers (eg, cisplatin, doxorubicin, felbamate, phenobarbital, phenytoin, primidone, rifampin, theophylline). May increase levels of clomipramine, phenytoin, primidone. May decrease levels of phenytoin, warfarin, oral contraceptives, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clonazepam, clozapine, delavirdine, ethosuximide, valproate, others metabolized by CYP3A4. May increase lithium toxicity. May reduce effectiveness of hormonal contraceptives and delavirdine. May alter thyroid function with other anticonvulsants. May interfere with some pregnancy tests or thyroid function tests.

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

Dizziness, drowsiness, nausea, vomiting, CHF, edema, hyper- or hypotension, arrhythmias, liver or urinary disorders, dyspnea, lens opacities, arthralgia, fever; rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression, hypersensitivity reactions; others (see full labeling).

How Supplied:

Caps—120

CARBATROL 300mg capsules (Qty:15)

appx. price $32.00

Indications for CARBATROL:

Generalized tonic-clonic, partial, or mixed seizures.

Adult:

Initially 200mg twice daily; increase weekly if needed by 200mg/day. Usual maintenance: 800mg–1.2g/day. 12–15yrs: max 1g/day; >15yrs: usual max 1.2g/day (rarely, max 1.6g daily). All: in 2 divided doses.

Children:

May convert from immediate-release forms of carbamazepine at doses above 400mg/day on a mg/mg basis using a twice-daily regimen. Usual max <35mg/kg per day.

Contraindications:

History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.

Warnings/Precautions:

Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present carbamazepine should not be used; increased risk of severe dermatological reactions. History of cardiac, hepatic, renal, or hematopoietic dysfunction. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Monitor lipid profile, and ophthalmic, hepatic, and renal function. Consider discontinuing if hyponatremia occurs. Increased intraocular pressure. Activation of latent psychosis. Suicidal tendencies (monitor). Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

See Contraindications. Possible hyperpyretic crisis, seizures and death with MAOIs. Carbamazepine levels increased by CYP3A4 inhibitors (eg, cimetidine, macrolides, danazol, delavirdine, diltiazem, fluoxetine, isoniazid, ketoconazole, loratadine, propoxyphene, itraconazole, nicotinamide, niacinamide, valproate, verapamil). Carbamazepine levels decreased by CYP3A4 inducers (eg, cisplatin, doxorubicin, felbamate, phenobarbital, phenytoin, primidone, rifampin, theophylline). May increase levels of clomipramine, phenytoin, primidone. May decrease levels of phenytoin, warfarin, oral contraceptives, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clonazepam, clozapine, delavirdine, ethosuximide, valproate, others metabolized by CYP3A4. May increase lithium toxicity. May reduce effectiveness of hormonal contraceptives and delavirdine. May alter thyroid function with other anticonvulsants. May interfere with some pregnancy tests or thyroid function tests.

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

Dizziness, drowsiness, nausea, vomiting, CHF, edema, hyper- or hypotension, arrhythmias, liver or urinary disorders, dyspnea, lens opacities, arthralgia, fever; rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression, hypersensitivity reactions; others (see full labeling).

How Supplied:

Caps—120

CARBATROL 300mg capsules (Qty:15)

appx. price $32.00