Baclofen - Baclofen tablet prescribing information
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 tablets 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
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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal ).
CONTRAINDICATIONS
Hypersensitivity to baclofen.
ADVERSE REACTIONS
The most common is transient drowsiness (10%-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%-15%), weakness (5%-15%) and fatigue (2%-4%). Others reported:
Neuropsychiatric:
Confusion (1%-11%), headache (4%-8%), insomnia (2%-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%-9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal:
Nausea (4%-12%), constipation (2%-6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.
Genitourinary:
Urinary frequency (2%-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.
DESCRIPTION
Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg, 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 or creamy white powder, with a molecular weight of 213.66. It is slightly soluble in water, insoluble in organic solvents, dissolves in dilute mineral acids and alkali hydroxides.
Inactive Ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.
CLINICAL PHARMACOLOGY
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.
HOW SUPPLIED
Baclofen tablets USP, 5 mg are available as white to off white, round, flat-faced, beveled-edge, uncoated tablets debossed with "B1" on one side and "U" on the other side, containing 5 mg baclofen, USP and are supplied as follows:
Bottles of 100………………..….NDC 29300-474-01
Baclofen tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "343" on one side of score line and "U" on the other side of score line on one side of tablet and plain on other side, containing 10 mg baclofen, USP and are supplied as follows:
Bottles of 90………………..….NDC 29300-343-19
Bottles of 100………………….NDC 29300-343-01
Bottles of 500………………….NDC 29300-343-05
Bottles of 1000………………...NDC 29300-343-10
Baclofen tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "344" on one side of score line and "U" on the other side of score line on one side of tablet and plain on other side, containing 20 mg baclofen, USP and are supplied as follows:
Bottles of 90………………..….NDC 29300-344-19
Bottles of 100………………….NDC 29300-344-01
Bottles of 500………………….NDC 29300-344-05
Bottles of 1000………………...NDC 29300-344-10
Store at 20º to 25ºC (68º to 77ºF) [see USP controlled Room Temperature].
Manufactured by:
UNICHEM LABORATORIES LTD.
Ind. Area, Meerut Road, Ghaziabad – 201 003, India
Manufactured for:
East Brunswick, NJ 08816
13014182
05-R-10/2022
