Drug Catalog - Product Detail
BACLOFEN TB 20MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00603-2407-21 | PAR PHARMACEUTICALS | 100 | 20MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below: Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch. MM1
How Supplied
HOW SUPPLIED Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed “2265” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 10: NDC 0603-2406-10 Bottles of 30: NDC 0603-2406-16 Bottles of 90: NDC 0603-2406-02 Bottles of 100: NDC 0603-2406-21 Bottles of 500: NDC 0603-2406-28 Bottles of 1000: NDC 0603-2406-32 Bottles of 2500: NDC 0603-2406-30 Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed “2266” on one side and debossed “V” on the reverse side; and are supplied as follows: Bottles of 10: NDC 0603-2407-10 Bottles of 30: NDC 0603-2407-16 Bottles of 100: NDC 0603-2407-21 Bottles of 500: NDC 0603-2407-28 Bottles of 1000: NDC 0603-2407-32
Indications & Usage
INDICATIONS & USAGE Baclofen is 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 may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen 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 & 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 40–80 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 ).