Drug Catalog - Product Detail
BACLOFEN TB 10MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00832-1024-50 | UPSHER-SMITH | 500 | 10MG | TABLET |
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Description
DESCRIPTION Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Its molecular formula is C 10 H 12 ClNO 2 and its structural formula is: Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 10 mg or 20 mg of baclofen, USP. In addition, each tablet contains the following inactive ingredients: Crospovidone, anhydrous lactose, magnesium stearate and povidone. Chemical Structure
How Supplied
HOW SUPPLIED Baclofen tablets, USP for oral use, are supplied in the following forms: 10 mg – Compressed tablet, white, 5/16" diameter, round; one side scored and debossed BAC and 10 and the other side debossed 832. They are supplied as follows: Bottles of 90 tablets NDC 0832-1024-09 Bottles of 100 tablets NDC 0832-1024-00 Bottles of 500 tablets NDC 0832-1024-50 Bottles of 1,000 tablets NDC 0832-1024-10 20 mg – Compressed tablet, white, 13/32" diameter, round; one side scored and debossed 832 and BC20 and the other side is plain. They are supplied as follows: Bottles of 90 tablets NDC 0832-1025-09 Bottles of 100 tablets NDC 0832-1025-00 Bottles of 500 tablets NDC 0832-1025-50 Bottles of 1,000 tablets NDC 0832-1025-10 Dispense in a tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Revised 1218
Indications & Usage
INDICATIONS AND USAGE Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
Dosage and Administration
DOSAGE AND ADMINISTRATION The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 mg to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days Thereafter additional increases may be necessary, but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.). The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug [see WARNINGS Abrupt Drug Withdrawal ] .