Monograph Details
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Central Nervous System
> Seizure disorders
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CARBATROL |
| Manufacturer |
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Shire US, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Dibenzazepine. |
| Generic Name |
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Carbamazepine 100mg, 200mg, 300mg; ext-rel caps. |
| Indications |
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Generalized tonic-clonic, partial, or mixed seizures. |
| Children |
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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. |
| Adults |
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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. |
| Contraindications |
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History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. |
| Precautions |
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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. Glaucoma. 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 |
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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, haloperidol, 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. |
| Adverse Reactions |
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Dizziness, drowsiness, GI disturbances, heart failure, 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; others (see literature). |
| How Supplied |
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Caps—120 |
| Additional Resources |
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• Related Prescribing Note |
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