Get your patient on Baclofen - Baclofen tablet (Baclofen)

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.

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS , Abrupt Drug Withdrawal ).

Hypersensitivity to baclofen.

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.

Baclofen, USP is a muscle relaxant and antispastic.

Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is:

C ₁₀ H ₁₂ ClNO ₂ M.W. 213.66

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.

Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate.

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Baclofen Tablets USP, 5 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "16" on one side and "09" on the other side, containing 5 mg baclofen, USP are supplied as follows:

NDC 70710-1609-1 in bottle of 100 tablets with child-resistant closure

Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1285" on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows:

NDC 70710-1285-1 in bottle of 100 tablets with child-resistant closure

NDC 70710-1285-5 in bottle of 500 tablets

NDC 70710-1285-0 in bottle of 1000 tablets

Baclofen Tablets USP, 15 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1666" on one side and scored on the other side, containing 15 mg baclofen, USP are supplied as follows:

NDC 70710-1666-1 in bottle of 100 tablets with child-resistant closure

Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1286" on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows:

NDC 70710-1286-1 in bottle of 100 tablets with child-resistant closure

NDC 70710-1286-5 in bottle of 500 tablets

NDC 70710-1286-0 in bottle of 1000 tablets

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 drugs out of the reach of children.

Manufactured by:

Zydus Lifesciences Ltd.,

Baddi, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 08/23