Drug Catalog - Product Detail
CARBAMAZEPINE ER CAPS. CP 300MG 120
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 29033-0004-12 | NOSTRUM LABORATORIES | 120 | 300MG | CAPSULE |
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Description
DESCRIPTION Carbamazepine Extended-Release Capsules is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as 100 mg, 200 mg and 300 mg extended-release capsules of Carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: Carbamazepine Extended-Release Capsules contain a single type of beads designed to provide twice daily dosing of carbamazepine. Inactive ingredients : silicified microcrystalline cellulose, oleic acid, ethylcellulose, medium chain triglycerides, polyethylene glycols, hypromellose and sodium lauryl sulfate. The 100 mg capsule shells contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, titanium dioxide, and are imprinted with black ink; the 200 mg capsule shells contain gelatin, D&C Yellow #10, titanium dioxide, and are imprinted with black ink; and the 300 mg capsule shells contain gelatin, D&C Red #28, FD&C Blue #1, black iron oxide, titanium dioxide, and are imprinted with black ink. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze. carbamazepine-spl-img
How Supplied
HOW SUPPLIED Carbamazepine Extended-Release Capsules are supplied as: 100 mg - Hard gelatin capsule (dark green opaque body with dark green opaque cap) printed with the "NC" / "100" logo in black ink. Supplied in bottles of 120........................ NDC 29033-019-12 200 mg - Hard gelatin capsule (yellow opaque body with yellow opaque cap) printed with the "NC" / "200" logo in black ink. Supplied in bottles of 120........................ NDC 29033-020-12 300 mg - Hard gelatin capsule (purple opaque body with purple opaque cap) printed with the "NC" / "300" logo in black ink. Supplied in bottles of 120........................ NDC 29033-004-12 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE. Manufactured by: Nostrum Laboratories Inc. Kansas City, MO 64120 Rev: October, 2013
Indications & Usage
INDICATIONS AND USAGE Epilepsy Carbamazepine Extended-Release Capsules is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ). Trigeminal Neuralgia Carbamazepine Extended-Release Capsules is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
Dosage and Administration
DOSAGE AND ADMINISTRATION Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests ). Dosage should be adjusted to the needs of the individual patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Carbamazepine Extended-Release Capsules may be taken with or without food. Carbamazepine Extended-Release Capsules may be swallowed whole or may be opened and all the beads sprinkled on a teaspoon of soft food such as applesauce. Make sure all of the food and medicine mixture is swallowed. Do not crush or chew Carbamazepine Extended-Release Capsules or the sprinkled beads. Carbamazepine Extended-Release Capsules is an extended-release formulation for twice a day administration. When converting patients from immediate release carbamazepine to Carbamazepine Extended-Release Capsules extended-release capsules, the same total daily mg dose of carbamazepine should be administered. Following conversion to Carbamazepine Extended-Release Capsules, patients should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions. Epilepsy (see INDICATIONS AND USAGE ) Adults and children over 12 years of age. Initial: 200 mg twice daily. Increase at weekly intervals by adding up to 200 mg/day until the optimal response is obtained. Dosage generally should not exceed 1000 mg per day in children 12-15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults. Maintenance: Adjust dosage to the minimum effective level, usually 800-1200 mg daily. Children under 12 years of age: Children taking total daily dosages of immediate-release carbamazepine of 400 mg or greater may be converted to the same total daily dosage of Carbamazepine Extended-Release Capsules extended-release capsules, using a twice daily regimen. Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine Extended-Release Capsules for use at doses above 35 mg/kg/24 hours can be made. Combination Therapy: Carbamazepine Extended-Release Capsules may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions , and Pregnancy Category D ). Trigeminal Neuralgia (see INDICATIONS AND USAGE ) Initial: On the first day, start with one 200 mg capsule. This daily dose may be increased by up to 200 mg/day every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400-800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.