Monograph Details
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Central Nervous System
> Seizure disorders
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TEGRETOL-XR |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| 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, 400mg; ext rel tabs. |
| Also |
• TEGRETOL
• TEGRETOL SUSPENSION
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| Indications |
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Generalized tonic-clonic, partial or mixed seizures. |
| Children |
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Do not crush or chew. Take with food. <6yrs: use other forms. ≥6yrs: initially 100mg twice daily; increase weekly if needed by 100mg/day in 2 divided doses; max 1g daily in 2 divided doses. Usual maintenance: 400mg-800mg/day. |
| Adults |
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Do not crush or chew. Take with food. Initially 200mg twice daily; increase weekly if needed by 200mg/day in 2 divided doses. 12–15yrs: max 1g daily; >15yrs: usual max 1.2g daily (rarely, max 1.6g daily). Usual maintenance: 800mg-1.2g/day. 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, or adverse hematologic reaction to other drugs. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Monitor lipid profile, ophthalmic, hepatic, and renal function. Glaucoma. Mixed seizure disorder with atypical absence seizures (may increase generalized convulsions). Activation of latent psychosis. Suicidal tendencies (monitor). Use minimum effective dose and change dose gradually. Avoid abrupt cessation. Convert tabs to susp with same quantity of mg/day in smaller, more frequent doses; convert tabs to XR on mg/mg basis. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers. |
| Interactions |
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Possible hyperpyretic crisis, seizures and death with MAOIs. Increased plasma levels with CYP3A4 inhibitors (eg, cimetidine, propoxyphene, isoniazid, macrolides, calcium channel blockers, loratadine, fluoxetine, ketoconazole, itraconazole, valproate). Decreased plasma levels with CYP3A4 inducers (eg, phenobarbital, phenytoin, rifampin, theophylline). May increase levels of clomipramine, phenytoin, primidone. May decrease levels of phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, others metabolized by CYP3A4. May increase lithium toxicity. May alter thyroid function with other anticonvulsants. Do not give susp formulation simultaneously with other liquid drugs or diluents. May interfere with some pregnancy tests, thyroid function tests. Others (see literature). |
| Adverse Reactions |
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Drowsiness, dizziness, GI upset, heart failure, edema, hyper- or hypotension, arrhythmias, liver and urinary disorders, dyspnea, lens opacities, arthralgia, fever, hyponatremia; rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression; others (see literature). |
| How Supplied |
Tabs 100mg—100
Tabs 200mg—100, 1000
XR tabs—100
Susp—450mL |
| Additional Resources |
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• Related Prescribing Note |
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