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Carbatrol Generic Name & Formulations
Legal Class
Rx
General Description
Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.
Pharmacological Class
Dibenzazepine.
How Supplied
Caps—120
Manufacturer
Mechanism of Action
Carbamazepine has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Carbamazepine is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.
Carbatrol Indications
Indications
Trigeminal or glossopharyngeal neuralgia.
Carbatrol Dosage and Administration
Adult
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
See full labeling.
Carbatrol Contraindications
Contraindications
History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.
Carbatrol Boxed Warnings
Boxed Warning
Serious dermatologic toxicity and HLA-B*1502 allele. Aplastic anemia and agranulocytosis.
Carbatrol Warnings/Precautions
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 Pharmacokinetics
Absorption
-
Peak plasma concentration: 1.9 ± 0.3 μg/mL.
-
Time to reach peak: 19 ± 7 hours.
Distribution
-
76% plasma protein bound.
Elimination
-
Renal (72%), fecal (28%).
-
Half-life: 35–40 hours. Apparent oral clearance: 25 ± 5 mL/min.
Carbatrol Interactions
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.
Carbatrol Adverse Reactions
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).
Carbatrol Clinical Trials
See Literature
Carbatrol Note
Not Applicable
Carbatrol Patient Counseling
See Literature
Carbatrol Generic Name & Formulations
Legal Class
Rx
General Description
Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.
Pharmacological Class
Dibenzazepine.
How Supplied
Caps—120
Manufacturer
Mechanism of Action
Carbamazepine has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Carbamazepine is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.
Carbatrol Indications
Indications
Generalized tonic-clonic, partial, or mixed seizures.
Carbatrol Dosage and Administration
Adult
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
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
Contraindications
History of bone marrow depression. Sensitivity to tricyclic antidepressants. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine.
Carbatrol Boxed Warnings
Boxed Warning
Serious dermatologic toxicity and HLA-B*1502 allele. Aplastic anemia and agranulocytosis.
Carbatrol Warnings/Precautions
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 Pharmacokinetics
Absorption
-
Peak plasma concentration: 1.9 ± 0.3 μg/mL.
-
Time to reach peak: 19 ± 7 hours.
Distribution
-
76% plasma protein bound.
Elimination
-
Renal (72%), fecal (28%).
-
Half-life: 35–40 hours. Apparent oral clearance: 25 ± 5 mL/min.
Carbatrol Interactions
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.
Carbatrol Adverse Reactions
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).
Carbatrol Clinical Trials
See Literature
Carbatrol Note
Not Applicable
Carbatrol Patient Counseling
See Literature
