TEGRETOL-XR Rx
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Generic Name and Formulations:
Carbamazepine 100mg, 200mg, 400mg; ext-rel tabs.
Company:
Novartis Pharmaceuticals Corp
 
Select therapeutic use: Nonnarcotic analgesics
Seizure disorders
Indications for TEGRETOL-XR:
Trigeminal or glossopharyngeal neuralgia.

Adult:
XR tabs: swallow whole; do not crush or chew. Initially 100mg twice daily with food, gradually increasing in increments of 100mg twice daily as needed. Maintenance: usually 400–800mg daily. Max 1.2g/day. Taper dosage or discontinue if possible at 3 month intervals.

Children:
Not applicable.

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

Warnings/Precautions:
eva luate for presence of HLA-B*1502 allele (esp. in Asians), if present carbamazepine should not be used; increased risk of severe dermatological reactions. Patients known to be HLA-A*3101 positive; increased risk of hypersensitivity reactions. History of cardiac conduction disturbance. 2nd or 3rd degree AV heart block. Cardiac, hepatic, or renal damage, or adverse hematologic reaction to other drugs. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Avoid in hepatic porphyria. Monitor lipid profile, ophthalmic, hepatic, and renal function. Glaucoma. 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. Suspension: avoid in fructose intolerance. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers.

Interactions:
See Contraindications. Possible hyperpyretic crisis, seizures and death with MAOIs. Cross-sensitivity possible with oxcarbazepine. Potentiated by CYP3A4 inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, nefazodone, trazodone, loxapine, olanzapine, quetiapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azole antifungals, acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors, valproate). Antagonized by CYP3A4 inducers (eg, cisplatin, doxorubicin, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline). May potentiate clomipramine, phenytoin, primidone, cyclophosphamide. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, aripiprazole, others metabolized by CYP3A4. May increase lithium toxicity, isoniazid-induced hepatotoxicity. Avoid concomitant temsirolimus, lapatinib; if necessary, adjust dose. Monitor tacrolimus, valproate levels. Symptomatic hyponatremia possible with diuretics. Monitor for rapid recovery from neuromuscular blockade. 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 full labeling).

See Also:
TEGRETOL

TEGRETOL SUSPENSION

Pharmacological Class:
Dibenzazepine.

Adverse Reactions:
Drowsiness, dizziness, nausea, vomiting, heart failure, edema, hyper- or hypotension, arrhythmias, liver and urinary disorders, dyspnea, lens opacities, arthralgia, fever, hyponatremia; bone marrow depression, drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity; rare: serious rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis.

How Supplied:
Tabs—100; XR tabs—100; Susp—450mL
Indications for TEGRETOL-XR:
Generalized tonic-clonic, partial or mixed seizures.

Adult:
Swallow whole; 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.

Children:
Swallow whole; 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.

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

Warnings/Precautions:
eva luate for presence of HLA-B*1502 allele (esp. in Asians), if present carbamazepine should not be used; increased risk of severe dermatological reactions. Patients known to be HLA-A*3101 positive; increased risk of hypersensitivity reactions. History of cardiac conduction disturbance. 2nd or 3rd degree AV heart block. Cardiac, hepatic, or renal damage, or adverse hematologic reaction to other drugs. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Avoid in hepatic porphyria. 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. Suspension: avoid in fructose intolerance. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers.

Interactions:
See Contraindications. Possible hyperpyretic crisis, seizures and death with MAOIs. Cross-sensitivity possible with oxcarbazepine. Potentiated by CYP3A4 inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, nefazodone, trazodone, loxapine, olanzapine, quetiapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azole antifungals, acetazolamide, verapamil, ticlopidine, grapefruit juice, protease inhibitors, valproate). Antagonized by CYP3A4 inducers (eg, cisplatin, doxorubicin, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline). May potentiate clomipramine, phenytoin, primidone, cyclophosphamide. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, aripiprazole, others metabolized by CYP3A4. May increase lithium toxicity, isoniazid-induced hepatotoxicity. Avoid concomitant temsirolimus, lapatinib; if necessary, adjust dose. Monitor tacrolimus, valproate levels. Symptomatic hyponatremia possible with diuretics. Monitor for rapid recovery from neuromuscular blockade. 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 full labeling).

See Also:
TEGRETOL

TEGRETOL SUSPENSION

Pharmacological Class:
Dibenzazepine.

Adverse Reactions:
Drowsiness, dizziness, nausea, vomiting, heart failure, edema, hyper- or hypotension, arrhythmias, liver and urinary disorders, dyspnea, lens opacities, arthralgia, fever, hyponatremia; bone marrow depression, drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity; rare: serious rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis.

How Supplied:
Tabs—100; XR tabs—100; Susp—450mL