Monograph Details
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Central Nervous System
> Mood disorders
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EQUETRO |
| Manufacturer |
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Validus Pharmaceuticals |
| 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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Acute manic and mixed episodes in bipolar I disorder. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole, or may open caps and sprinkle on applesauce; do not crush or chew beads. Initially 400mg/day in 2 divided doses; adjust in increments of 200mg/day; max 1.6g/day. |
| Contraindications |
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History of bone marrow depression. Sensitivity to tricyclics. 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, adverse hematologic reaction to other drugs, or interrupted courses of carbamazepine. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Monitor lipid profile, and ophthalmic, renal, and hepatic function (discontinue if severe liver dysfunction or active liver disease occurs); consider monitoring blood levels. Increased intraocular pressure. Activation of latent psychosis. Suicidal tendencies (monitor). Reevaluate periodically. Write Rx for smallest practical amount. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. May potentiate clomipramine, phenytoin, primidone. Potentiated by CYP3A4 and/ or epoxide hydrolase inhibitors (eg, cimetidine, propoxyphene, isoniazid, macrolides, calcium channel blockers, loratadine, fluoxetine, ketoconazole, itraconazole, valproate). May increase lithium toxicity. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, other substrates of CYP3A4 or CYP1A2. Antagonized by CYP3A4 inducers (eg, phenobarbital, phenytoin, rifampin, theophylline), possibly antimalarials. Loss of virologic response with delavirdine, other NNRIs. May interfere with pregnancy tests and thyroid tests. Others (see literature). |
| Adverse Reactions |
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Dizziness, somnolence, GI upset, ataxia, pruritus, dry mouth, amblyopia, speech disorder: 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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