Equetro

— THERAPEUTIC CATEGORIES —
  • Mood disorders
  • Nonnarcotic analgesics
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Equetro Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.

    Pharmacological Class

    Dibenzazepine.

    How Supplied

    Caps—120

    Manufacturer

    Validus Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    The mechanism(s) of action of carbamazepine in the treatment of bipolar disorder has not been elucidated. Numerous pharmacological effects of carbamazepine have been described in the published literature (eg, modulation of ion channels [sodium and calcium], receptor-mediated neurotransmission [GABAergic, glutamatergic, and monoaminergic], and intracellular signaling pathways in experimental preparations), but the contribution of these effects to the efficacy of carbamazepine in bipolar disorder is unknown.

    Equetro Indications

    Indications

    Acute manic and mixed episodes in bipolar I disorder.

    Equetro Dosage and Administration

    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 established.

    Equetro Contraindications

    Contraindications

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

    Equetro Boxed Warnings

    Boxed Warning

    Serious dermatologic reactions. Aplastic anemia and agranulocytosis.

    Equetro 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 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective nonhormonal contraception or barrier methods during therapy. Pregnancy. Nursing mothers.

    Equetro Pharmacokinetics

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Renal (major), fecal. Half-life: 35–40 hours.

    Equetro Interactions

    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, anticonvulsants, aripiprazole, oral and subdermal implant contraceptives (consider alternatives), 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).

    Equetro Adverse Reactions

    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).

    Equetro Clinical Trials

    See Literature

    Equetro Note

    Not Applicable

    Equetro Patient Counseling

    See Literature

    Equetro Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.

    Pharmacological Class

    Dibenzazepine.

    How Supplied

    Caps—120

    Manufacturer

    Validus Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    The mechanism(s) of action of carbamazepine in the treatment of bipolar disorder has not been elucidated. Numerous pharmacological effects of carbamazepine have been described in the published literature (eg, modulation of ion channels [sodium and calcium], receptor-mediated neurotransmission [GABAergic, glutamatergic, and monoaminergic], and intracellular signaling pathways in experimental preparations), but the contribution of these effects to the efficacy of carbamazepine in bipolar disorder is unknown.

    Equetro Indications

    Indications

    Pain associated with trigeminal neuralgia.

    Equetro Dosage and Administration

    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 established.

    Equetro Contraindications

    Contraindications

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

    Equetro Boxed Warnings

    Boxed Warning

    Serious dermatologic reactions. Aplastic anemia and agranulocytosis.

    Equetro 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 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective nonhormonal contraception or barrier methods during therapy. Pregnancy. Nursing mothers.

    Equetro Pharmacokinetics

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Renal (major), fecal. Half-life: 35–40 hours.

    Equetro Interactions

    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, anticonvulsants, aripiprazole, oral and subdermal implant contraceptives (consider alternatives), 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).

    Equetro Adverse Reactions

    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).

    Equetro Clinical Trials

    See Literature

    Equetro Note

    Not Applicable

    Equetro Patient Counseling

    See Literature

    Equetro Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carbamazepine 100mg, 200mg, 300mg; ext-rel caps.

    Pharmacological Class

    Dibenzazepine.

    How Supplied

    Caps—120

    Manufacturer

    Validus Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    The mechanism(s) of action of carbamazepine in the treatment of bipolar disorder has not been elucidated. Numerous pharmacological effects of carbamazepine have been described in the published literature (eg, modulation of ion channels [sodium and calcium], receptor-mediated neurotransmission [GABAergic, glutamatergic, and monoaminergic], and intracellular signaling pathways in experimental preparations), but the contribution of these effects to the efficacy of carbamazepine in bipolar disorder is unknown.

    Equetro Indications

    Indications

    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).

    Equetro Dosage and Administration

    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.

    Equetro Contraindications

    Contraindications

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

    Equetro Boxed Warnings

    Boxed Warning

    Serious dermatologic reactions. Aplastic anemia and agranulocytosis.

    Equetro 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 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective nonhormonal contraception or barrier methods during therapy. Pregnancy. Nursing mothers.

    Equetro Pharmacokinetics

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Renal (major), fecal. Half-life: 35–40 hours.

    Equetro Interactions

    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, anticonvulsants, aripiprazole, oral and subdermal implant contraceptives (consider alternatives), 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).

    Equetro Adverse Reactions

    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).

    Equetro Clinical Trials

    See Literature

    Equetro Note

    Not Applicable

    Equetro Patient Counseling

    See Literature

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