Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED For 10 mg strength : White to off-white, round flat-faced beveled edged tablets debossed with E' and 6 on one side and scored on the other side. NDC 68071-2289-3 BOTTLES OF 3 Storage Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children Distributed by: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540 Made in India. Rev. January 2020; Package/Label Display Panel PDP
- HOW SUPPLIED For 10 mg strength : White to off-white, round flat-faced beveled edged tablets debossed with E' and 6 on one side and scored on the other side. NDC 68071-2289-3 BOTTLES OF 3 Storage Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children Distributed by: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540 Made in India. Rev. January 2020
- Package/Label Display Panel PDP
Overview
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, 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 baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Mannitol, Pre-Gelatinized Starch, Hypromellose, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate. baclofen-structure
Indications & 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 & 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 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 ).
Warnings & Precautions
WARNINGS a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen is continued during pregnancy, gradually reduce the dose and discontinue baclofen before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal. b. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. c. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage. d. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug. e. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
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.
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