Baclofen

Indications and Usage Section INDICATIONS AND USAGE Baclofen tablets USP 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 USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are 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 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. (three times in a day) 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. (four times in a day)). 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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS , Abrupt Drug Withdrawal ).

4. Contraindications Hypersensitivity to baclofen.

ADVERSE REACTIONS The most common is transient drowsiness (10 to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%). Others reported: Neuropsychiatric: Confusion (1 to 11%), headache (4 to 8%), insomnia (2 to 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure. Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope. Gastrointestinal: Nausea (4 to 12%), constipation (2 to 6%); and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool. Genitourinary: Urinary frequency (2 to 6%); and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria. Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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, and its structural formula is Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP. Chemical Structure

OVERDOSAGE Signs and symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures. Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Signs and symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.

Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

HOW SUPPLIED Baclofen Tablets, USP 5 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "023" on one side and plain on other side, containing 5 mg baclofen USP packaged in bottles of 100 tablets. NDC 76420-356-30 30s count (repackaged from NDC 52817-319-XX) NDC 76420-356-60 60s count (repackaged from NDC 52817-319-XX) NDC 76420-356-90 90s count (repackaged from NDC 52817-319-XX) NDC 76420-356-01 100s count (relabeled from NDC 52817-319-10) Baclofen Tablets, USP 10 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "024" on one side and score on other side, containing 10 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets. NDC 76420-357-30 30s count (repackaged from NDC 52817-320-XX) NDC 76420-357-60 60s count (repackaged from NDC 52817-320-XX) NDC 76420-357-90 90s count (repackaged from NDC 52817-320-XX) NDC 76420-357-01 100s count (relabeled from NDC 52817-320-10) NDC 76420-357-12 120s count (repackaged from NDC 52817-320-XX) NDC 76420-357-05 500s count (relabeled from NDC 52817-320-50) NDC 76420-357-00 1000s count (relabeled from NDC 52817-320-00) Baclofen Tablets, USP 15 mg are available as a White to off white, round flat-faced, beveled edges tablets debossed with "ΛB1" on one side and plain on the other side, containing 15 mg baclofen USP packaged in bottles of 100 tablets. NDC 76420-358-30 30s count (repackaged from NDC 52817-318-XX) NDC 76420-358-60 60s count (repackaged from NDC 52817-318-XX) NDC 76420-358-90 90s count (repackaged from NDC 52817-318-XX) NDC 76420-358-01 100s count (relabeled from NDC 52817-318-10) Baclofen Tablets, USP 20 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "025" on one side and score on other side, containing 20 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets. NDC 76420-359-30 30s count (repackaged from NDC 52817-321-XX) NDC 76420-359-60 60s count (repackaged from NDC 52817-321-XX) NDC 76420-359-90 90s count (repackaged from NDC 52817-321-XX) NDC 76420-359-01 100s count (relabeled from NDC 52817-321-10) NDC 76420-359-05 500s count (relabeled from NDC 52817-321-50) NDC 76420-359-00 1000s count (relabeled from NDC 52817-321-00) PHARMACIST: Dispense in a well closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501