Buy Tegretol Online

Carbamazepine (carbamazepine)

BOXED WARNING

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) reported; increased risk with presence of HLA-B*1502 allele. Screen patients with ancestry in genetically at risk populations for the presence of HLA-B*1502 prior to initiation of therapy. Avoid in patients testing (+) for the allele unless benefits clearly outweigh risks. Aplastic anemia and agranulocytosis reported; obtain complete pretreatment hematological testing as a baseline and monitor closely if a patient exhibits low/decreased WBC or platelet counts during treatment. Consider discontinuation if evidence of significant bone marrow depression develops.

OTHER BRAND NAMES

Tegretol, Tegretol-XR, Epitol

THERAPEUTIC CLASS

Carboxamide

DEA CLASS

RX

INDICATIONS

Treatment of partial seizures with complex symptomatology (psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns of these, or other partial or generalized seizures. Treatment of pain associated with true trigeminal or glossopharyngeal neuralgia.

ADULT DOSAGE

Trigeminal Neuralgia

Initial (Day 1): 100mg bid (tab/tab, ER) or 1/2 tsp qid sus (200mg/day)
Titrate: May increase by up to 200mg/day using increments of 100mg q12h (tab/tab, Extended-Release [ER]) or 50mg (1/2 tsp) qid sus prn
Maint: 400-800mg/day. Attempt to reduce dose to minimum effective level or even to d/c therapy at least once every 3 months
Max: 1200mg/day

Beneficial results have also been reported in glossopharyngeal neuralgia

Epilepsy

Partial Seizures w/ Complex Symptomatology (Psychomotor, Temporal Lobe), Generalized Tonic-Clonic Seizures (Grand Mal), and Mixed Seizure Patterns of These, or Other Partial or Generalized Seizures:

Initial:
200mg bid (tab/tab, ER) or 1 tsp qid sus (400mg/day)
Titrate: Increase at weekly intervals by adding up to 200mg/day bid (tab, ER) or tid or qid (all other formulations)
Maint: 800-1200mg/day
Max: 1200mg/day; doses up to 1600mg/day have been used

Combination Therapy:
When added to existing anticonvulsant therapy, add gradually while other anticonvulsants are maintained or gradually decreased (except phenytoin, which may have to be increased)

Conversions

From Oral Carbamazepine Tabs to Carbamazepine Sus:
Patients should be converted by administering the same number of mg per day in smaller, more frequent doses

From Carbamazepine Conventional Tabs to Carbamazepine Extended-Release Tabs:
The same total daily mg dose of carbamazepine ER tabs should be administered

PEDIATRIC DOSAGE

Epilepsy

<6 Years:
Initial: 10-20mg/kg/day bid or tid (tab) or qid (sus)
Titrate: Increase weekly to tid or qid (tab/sus)
Maint: Optimal clinical response is achieved at daily doses <35mg/kg
Max: 35mg/kg/day

6-12 Years:
Initial: 100mg bid (tab/tab, Extended-Release [ER]) or 1/2 tsp qid (200mg/day) (sus)
Titrate: Increase at weekly intervals by adding up to 100mg/day bid (tab, ER) or tid or qid (all other formulations)
Maint: 400-800mg/day
Max: 1000mg/day

>12 Years:
Initial: 200mg bid (tab/tab, ER) or 1 tsp qid (400mg/day) (sus)
Titrate: Increase at weekly intervals by adding up to 200mg/day bid (tab, ER) or tid or qid (all other formulations)
Maint: 800-1200mg/day
Max:
12-15 Years: 1000mg/day
>15 Years: 1200mg/day

Combination Therapy:
When added to existing anticonvulsant therapy, add gradually while other anticonvulsants are maintained or gradually decreased (except phenytoin, which may have to be increased)

Conversions

From Oral Carbamazepine Tabs to Carbamazepine Sus:
Patients should be converted by administering the same number of mg per day in smaller, more frequent doses

From Carbamazepine Conventional Tab to Carbamazepine Extended-Release Tabs:
The same total daily mg dose of carbamazepine ER tabs should be administered

ADMINISTRATION

Oral route

Take w/ meals

Sus
Do not administer simultaneously w/ other liquid medications or diluents
Shake well before using

Tab, ER
Swallow whole; do not chew or crush

HOW SUPPLIED

Tab, Chewable: 200mg*, (Tegretol) 100mg*; Sus: (Tegretol) 100mg/5mL [450mL]; Tab: (Tegretol, Epitol) 200mg*; Tab, ER: (Tegretol-XR) 100mg, 200mg, 400mg *scored

CONTRAINDICATIONS

History of previous bone marrow depression, sensitivity to any of the tricyclic compounds (eg, amitriptyline, desipramine, imipramine, protriptyline, nortriptyline), coadministration with nefazodone. Concomitant use of an MAOI or within 14 days after discontinuing an MAOI.

WARNINGS/PRECAUTIONS

D/C at 1st sign of rash; do not resume treatment and consider alternative therapy if signs/symptoms suggest SJS/TEN. Consider risks and benefits of therapy in patients known to be (+) for HLA-A*3101. Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multiorgan hypersensitivity, reported; evaluate immediately if signs/symptoms (eg, fever, lymphadenopathy) are present and d/c if an alternative etiology cannot be established. Caution in patients with history of hypersensitivity reactions to anticonvulsants (eg, phenytoin, primidone, phenobarbital). Increased risk of suicidal thoughts or behavior reported. Has mild anticholinergic activity; closely observe patients with increased intraocular pressure. Consider the possibility of activation of latent psychosis, and confusion or agitation in the elderly. Avoid in patients with history of hepatic porphyria (eg, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda); acute attacks reported. Withdraw gradually to minimize potential of increased seizure frequency. May cause fetal harm and symptoms representing neonatal withdrawal syndrome. Caution in patients with history of cardiac conduction disturbance, cardiac/hepatic/renal damage, adverse hematologic reactions to drugs, interrupted courses of carbamazepine, and mixed seizure disorder; atrioventricular heart block, hepatic effects, and increased frequency of generalized convulsions reported. D/C if new or worsening clinical/lab evidence of liver dysfunction/hepatic damage, or active liver disease develop. Interference with some pregnancy tests, decreased values of thyroid function tests, hyponatremia, renal dysfunction, and eye changes reported. Higher prevalence of teratogenic effects with the use of anticonvulsants in combination therapy; if therapy is to be continued, monotherapy may be preferable for pregnant women. (Sus/Tab, Chewable 200mg) Contains sorbitol; avoid with rare hereditary problems of fructose intolerance. (Tab, ER) Coating is not absorbed and is excreted in the feces; may be noticeable in the stool.

ADVERSE REACTIONS

Dermatologic reactions, aplastic anemia, agranulocytosis, bone marrow depression, dizziness, drowsiness, unsteadiness, N/V.

DRUG INTERACTIONS

See Contraindications. Close monitoring of carbamazepine levels is indicated and dosage adjustment may be required when given with drugs that increase/decrease levels. CYP3A4 inhibitors (eg, azole antifungals, erythromycin, protease inhibitors) may increase levels. Coadministration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine-10,11 epoxide levels; adjust dose and/or monitor levels of carbamazepine when used with loxapine, quetiapine, or valproic acid. CYP3A4 inducers (eg, cisplatin, doxorubicin, rifampin) may decrease levels. May decrease levels of CYP1A2, 2B6, 2C9/19, and 3A4 substrates; monitoring of concentrations or dosage adjustment of the concomitant agents may be necessary. When added to aripiprazole therapy, double aripiprazole dose and if carbamazepine is later withdrawn, reduce aripiprazole dose. When used with tacrolimus, monitoring of tacrolimus levels and appropriate dosage adjustments are recommended. Avoid with temsirolimus; consider dose adjustment of temsirolimus if coadministration is a must. Avoid with lapatinib; gradually titrate up dose of lapatinib if carbamazepine is started in a patient already taking lapatinib and reduce lapatinib dose when carbamazepine is discontinued. Monitor concentrations of valproate when carbamazepine is introduced or withdrawn in patients using valproic acid. May cause, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphine, bupropion, citalopram, clonazepam, clozapine, corticosteroids (eg, prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (eg, felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapine, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, TCAs (eg, imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide. May increase cyclophosphamide toxicity. May increase risk of neurotoxic side effects with lithium. Increased isoniazid-induced hepatotoxicity reported with isoniazid. May lead to symptomatic hyponatremia with some diuretics (eg, HCTZ, furosemide). Alterations of thyroid function reported with other anticonvulsant medications. May decrease levels of hormonal contraceptive products (eg, oral and levonorgestrel subdermal implant contraceptives) that may render contraceptives less effective; consider alternative or back-up method of contraception. Resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents (eg, pancuronium, vecuronium, rocuronium) reported with chronic carbamazepine administration; monitor closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher. (Sus) Occurrence of stool precipitate reported with liquid chlorpromazine or thioridazine; avoid simultaneous administration with other liquid medicinal agents or diluents.

PREGNANCY AND LACTATION

Category D, not for use in nursing.

MECHANISM OF ACTION

Carboxamide; has not been established. Appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Depresses thalamic potential and bulbar and polysynaptic reflexes.

PHARMACOKINETICS

Absorption: Tmax=1.5 hrs (sus), 4-5 hrs (tab), 3-12 hrs (tab, ER). Distribution: Plasma protein binding (76%); crosses the placenta; found in breast milk. Metabolism: Liver via CYP3A4; carbamazepine-10,11-epoxide (active metabolite). Elimination: Urine (72%; 3% unchanged), feces (28%); T1/2=25-65 hrs (initial), 12-17 hrs (repeated doses).

ASSESSMENT

Assess for hypersensitivity to the drug, known sensitivity to any of the tricyclic compounds, mixed seizure disorder, history of cardiac conduction disturbance, renal/hepatic impairment, any other conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions. Perform detailed history and physical exam prior to treatment. Screen for HLA-B*1502 and HLA-A*3101 allele in suspected populations. Obtain baseline CBC with platelet and reticulocyte counts, serum iron, LFTs, complete urinalysis, BUN determinations, and eye examination (eg, including slit-lamp exam, funduscopy, and tonometry).

MONITORING

Monitor for signs/symptoms of dermatologic reactions, DRESS, bone marrow depression, aplastic anemia, agranulocytosis, increase in seizure frequency, emergence or worsening of depression, suicidal thoughts/behavior, unusual changes in mood/behavior, latent psychosis, confusion or agitation in elderly patients, hepatic effects, and other adverse reactions. Periodically monitor WBC and platelet counts, LFTs, serum drug levels, complete urinalysis, BUN determinations, and eye examinations.

PATIENT COUNSELING

Inform of the early toxic signs and symptoms of a potential hematologic problem, dermatologic, hypersensitivity, or hepatic reactions; advise to report to physician even if the signs and symptoms are mild or when occurring after extended use. Instruct to immediately contact physician if a skin reaction occurs. Counsel about the increased risk of suicidal thoughts and behavior; advise to report behaviors of concern immediately and to be alert for the emergence/worsening of symptoms of depression, any unusual changes in mood or behavior, the emergence of suicidal thoughts, or behavior/thoughts about self-harm. Advise to report the use of any other prescription or nonprescription medications or herbal products. Instruct to exercise caution when taken with alcohol due to a possible additive sedative effect. Inform that drowsiness or dizziness may occur; caution against hazardous tasks. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

STORAGE

Tab, Chewable: 20-25°C (68-77°F). Protect from light/moisture. (Tegretol) Tab, Chewable: ≤30°C (86°F). Protect from light/moisture. Sus: ≤30°C (86°F). Tab: ≤30°C (86°F). Protect from moisture. Tab, ER: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture. (Epitol) Tab: 20-25°C (68-77°F). Protect from moisture.

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