Nonnarcotic analgesics:
Indications for: CARBATROL
Trigeminal or glossopharyngeal neuralgia.
Adult Dosage:
Swallow whole; or may open cap and sprinkle contents on a teaspoonful of soft food (eg, applesauce). 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 Dosage:
See full labeling.
CARBATROL Contraindications:
History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.
Boxed Warning:
Serious dermatologic toxicity and HLA-B*1502 allele. Aplastic anemia and agranulocytosis.
CARBATROL Warnings/Precautions:
Not for trivial aches/pains. 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. Nursing mothers: not recommended.
CARBATROL Classification:
Dibenzazepine.
CARBATROL 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, apixaban, clonazepam, clozapine, dabigatran, delavirdine, edoxaban, ethosuximide, rivaroxaban, valproate, others metabolized by CYP3A4. Avoid concomitant apixaban, dabigatran, edoxaban, rivaroxaban. 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:
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).
Drug Elimination:
-
Renal (72%), fecal (28%).
-
Half-life: 35–40 hours. Apparent oral clearance: 25 ± 5 mL/min.
How Supplied:
Caps—120
Seizure disorders:
Indications for: CARBATROL
Generalized tonic-clonic, partial, or mixed seizures.
Adult Dosage:
Swallow whole; or may open cap and sprinkle contents on a teaspoonful of soft food (eg, applesauce). 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 Dosage:
Swallow whole; or may open cap and sprinkle contents on a teaspoonful of soft food (eg, applesauce). 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.
CARBATROL Contraindications:
History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.
Boxed Warning:
Serious dermatologic toxicity and HLA-B*1502 allele. Aplastic anemia and agranulocytosis.
CARBATROL 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 (including conduction disturbances [eg, 2nd- and 3rd-degree AV block]), hepatic, renal, or hematopoietic dysfunction. Do baseline CBCs then periodically; consider discontinuing if significant bone marrow depression occurs. Monitor lipid profile, and ophthalmic, hepatic, and renal function. Consider discontinuing if hyponatremia occurs. Discontinue and initiate alternative therapy if anaphylaxis or angioedema occur; do not rechallenge. Increased intraocular pressure. Activation of latent psychosis. Suicidal tendencies (monitor). Reevaluate periodically. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy. Nursing mothers: not recommended.
CARBATROL Classification:
Dibenzazepine.
CARBATROL 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, apixaban, clonazepam, clozapine, dabigatran, delavirdine, edoxaban, ethosuximide, rivaroxaban, valproate, others metabolized by CYP3A4. Avoid concomitant apixaban, dabigatran, edoxaban, rivaroxaban. 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:
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).
Drug Elimination:
-
Renal (72%), fecal (28%).
-
Half-life: 35–40 hours. Apparent oral clearance: 25 ± 5 mL/min.
How Supplied:
Caps—120
