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EQUETRO
Mood disorders
Nonnarcotic analgesics
Seizure disorders
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Drug Name:

EQUETRO Rx

Generic Name and Formulations:
Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.

Company:
Validus Pharmaceuticals

Therapeutic Use:

Indications for EQUETRO:

Acute manic and mixed episodes in bipolar I disorder.

Adult:

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. Switching from immediate-release forms of carbamazepine: give same total daily mg dose using a twice-daily regimen.

Children:

Not recommended.

Contraindications:

Bone marrow depression. Sensitivity to tricyclics. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine, or other NNRTIs.

Warnings/Precautions:

Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present, carbamazepine should not be used; increased risk of severe dermatologic reactions. Patients known to be HLA-A*3101 positive; increased risk of hypersensitivity reactions. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Obtain baseline and periodic evaluations of ophthalmic, renal, and hepatic function (discontinue if aggravated liver dysfunction or active liver disease occurs). Underlying EKG abnormalities or cardiac conduction disturbance. 2nd or 3rd-degree AV heart block. Consider discontinuing if hyponatremia occurs. Avoid in hepatic porphyria. Increased intraocular pressure. Suicidal tendencies (monitor). Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

See Contraindications. Possibly serotonin syndrome with MAOIs. Loss of virologic response with delavirdine, other NNRTIs. Potentiated by CYP3A4 inhibitors (eg, acetazolamide, aprepitant, azole antifungals, 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, ticlopidine, grapefruit juice, protease inhibitors, valproate, verapamil). Antagonized by CYP3A4 inducers (eg, aminophylline, cisplatin, doxorubicin, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline) or antimalarials (eg, chloroquine, mefloquine). May potentiate clomipramine, phenytoin, primidone, cyclophosphamide. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, aripiprazole, others metabolized by CYP3A4 or CYP1A2. May increase lithium toxicity, isoniazid-induced hepatotoxicity. Avoid concomitant temsirolimus, lapatinib; if necessary, adjust dose. Monitor tacrolimus, valproate levels. Symptomatic hyponatremia possible with diuretics. Increased risk of respiratory depression with concomitant other CNS depressants (eg, alcohol, opioid analgesics, benzodiazepines, tricyclics, others). Monitor for rapid recovery from neuromuscular blockade. May interfere with pregnancy tests and thyroid tests. Others (see full labeling).

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

Dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, speech disorder: rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression, hepatic failure; others (see full labeling).

Generic Availability:

NO

How Supplied:

Caps—120

Indications for EQUETRO:

Pain associated with trigeminal neuralgia.

Adult:

Swallow whole, or may open caps and sprinkle on applesauce; do not crush or chew beads. 200mg once on day 1; increase by up to 200mg/day using increments of 100mg every 12hrs as needed; max 1.2g/day. Usual maintenance: 400–800mg/day. Attempt to taper or discontinue every three months. Switching from immediate-release forms of carbamazepine: give same total daily mg dose using a twice-daily regimen.

Children:

Not recommended.

Contraindications:

Bone marrow depression. Sensitivity to tricyclics. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine, or other NNRTIs.

Warnings/Precautions:

Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present, carbamazepine should not be used; increased risk of severe dermatologic reactions. Patients known to be HLA-A*3101 positive; increased risk of hypersensitivity reactions. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Obtain baseline and periodic evaluations of ophthalmic, renal, and hepatic function (discontinue if aggravated liver dysfunction or active liver disease occurs). Underlying EKG abnormalities or cardiac conduction disturbance. 2nd or 3rd-degree AV heart block. Consider discontinuing if hyponatremia occurs. Avoid in hepatic porphyria. Increased intraocular pressure. Suicidal tendencies (monitor). Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

See Contraindications. Possibly serotonin syndrome with MAOIs. Loss of virologic response with delavirdine, other NNRTIs. Potentiated by CYP3A4 inhibitors (eg, acetazolamide, aprepitant, azole antifungals, 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, ticlopidine, grapefruit juice, protease inhibitors, valproate, verapamil). Antagonized by CYP3A4 inducers (eg, aminophylline, cisplatin, doxorubicin, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline) or antimalarials (eg, chloroquine, mefloquine). May potentiate clomipramine, phenytoin, primidone, cyclophosphamide. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, aripiprazole, others metabolized by CYP3A4 or CYP1A2. May increase lithium toxicity, isoniazid-induced hepatotoxicity. Avoid concomitant temsirolimus, lapatinib; if necessary, adjust dose. Monitor tacrolimus, valproate levels. Symptomatic hyponatremia possible with diuretics. Increased risk of respiratory depression with concomitant other CNS depressants (eg, alcohol, opioid analgesics, benzodiazepines, tricyclics, others). Monitor for rapid recovery from neuromuscular blockade. May interfere with pregnancy tests and thyroid tests. Others (see full labeling).

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

Dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, speech disorder: rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression, hepatic failure; others (see full labeling).

Generic Availability:

NO

How Supplied:

Caps—120

Indications for EQUETRO:

Treatment of partial seizures with complex symptomatology (eg, psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns.

Limitations Of use:

Not for the treatment of absence seizures (petit mal).

Adult:

Swallow whole, or may open caps and sprinkle on applesauce; do not crush or chew beads. Initially 200mg twice daily; increase weekly by 200mg/day until optimal response. Usually 12–15yrs: max 1g/day; 15–18yrs: max 1.2g/day; ≥18yrs: max 1.6g/day. All: in 2 divided doses. Switching from immediate-release forms of carbamazepine: give same total daily mg dose using a twice-daily regimen.

Children:

Usually, give daily doses <35mg/kg.

Contraindications:

Bone marrow depression. Sensitivity to tricyclics. During or within 14 days of MAOIs. Concomitant nefazodone, delaviridine, or other NNRTIs.

Warnings/Precautions:

Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present, carbamazepine should not be used; increased risk of severe dermatologic reactions. Patients known to be HLA-A*3101 positive; increased risk of hypersensitivity reactions. Do baseline CBCs then periodically; discontinue if significant bone marrow depression occurs. Obtain baseline and periodic evaluations of ophthalmic, renal, and hepatic function (discontinue if aggravated liver dysfunction or active liver disease occurs). Underlying EKG abnormalities or cardiac conduction disturbance. 2nd or 3rd-degree AV heart block. Consider discontinuing if hyponatremia occurs. Avoid in hepatic porphyria. Increased intraocular pressure. Suicidal tendencies (monitor). Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Elderly. Labor & delivery. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

See Contraindications. Possibly serotonin syndrome with MAOIs. Loss of virologic response with delavirdine, other NNRTIs. Potentiated by CYP3A4 inhibitors (eg, acetazolamide, aprepitant, azole antifungals, 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, ticlopidine, grapefruit juice, protease inhibitors, valproate, verapamil). Antagonized by CYP3A4 inducers (eg, aminophylline, cisplatin, doxorubicin, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline) or antimalarials (eg, chloroquine, mefloquine). May potentiate clomipramine, phenytoin, primidone, cyclophosphamide. May antagonize phenytoin, warfarin, doxycycline, theophylline, haloperidol, acetaminophen, alprazolam, clozapine, oral contraceptives, anticonvulsants, aripiprazole, others metabolized by CYP3A4 or CYP1A2. May increase lithium toxicity, isoniazid-induced hepatotoxicity. Avoid concomitant temsirolimus, lapatinib; if necessary, adjust dose. Monitor tacrolimus, valproate levels. Symptomatic hyponatremia possible with diuretics. Increased risk of respiratory depression with concomitant other CNS depressants (eg, alcohol, opioid analgesics, benzodiazepines, tricyclics, others). Monitor for rapid recovery from neuromuscular blockade. May interfere with pregnancy tests and thyroid tests. Others (see full labeling).

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

Dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, speech disorder: rarely: rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), aplastic anemia, agranulocytosis, bone marrow depression, hepatic failure; others (see full labeling).

Generic Availability:

NO

How Supplied:

Caps—120

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