Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Baclofen Tablets, USP are supplied as: 10 mg: White colored, circular, flat, uncoated tablets with ‘N029’ debossed on one side and scoreline on the other side. Bottles of 14 NDC 71205 – 474 – 14 Bottles of 20 NDC 71205 – 474 – 20 Bottles of 30 NDC 71205 – 474 – 30 Bottles of 60 NDC 71205 – 474 – 60 Bottles of 90 NDC 71205 – 474 – 90 Bottles of 120 NDC 71205 – 474 – 72 Bottles of 180 NDC 71205 – 474 – 78 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free Number: 1-800-206-7821 Manufactured by: Piramal Enterprises Limited, Plot No 67-70, Sector - 2, Pithampur, Madhya Pradesh 454775 INDIA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 December 2019; Principal Display panel -Baclofen Tablets USP, 10mg 60's pack Rx only NDC 71205-474-60 Baclofen Tablets USP, 10 mg 60 Tablets Each tablet contains 10mg baclofen USP Usual Dosage : See package insert for full prescribing information. 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]. Split tablet to be stored at 20° to 25° C (controlled room temperature) for not more than 2 weeks. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured for: Northstar RxLLC Memphis, TN 38141 Manufactured by : Piramal Enterprises Limited, Plot no 67-70, Sector -2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA Mfg.Lic.No.: 25/10/92 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 20614971 EM 14720/b Rev.04/17 Bar code Batch No.: Exp.Date.: 71205-474-60
- HOW SUPPLIED Baclofen Tablets, USP are supplied as: 10 mg: White colored, circular, flat, uncoated tablets with ‘N029’ debossed on one side and scoreline on the other side. Bottles of 14 NDC 71205 – 474 – 14 Bottles of 20 NDC 71205 – 474 – 20 Bottles of 30 NDC 71205 – 474 – 30 Bottles of 60 NDC 71205 – 474 – 60 Bottles of 90 NDC 71205 – 474 – 90 Bottles of 120 NDC 71205 – 474 – 72 Bottles of 180 NDC 71205 – 474 – 78 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free Number: 1-800-206-7821 Manufactured by: Piramal Enterprises Limited, Plot No 67-70, Sector - 2, Pithampur, Madhya Pradesh 454775 INDIA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 December 2019
- Principal Display panel -Baclofen Tablets USP, 10mg 60's pack Rx only NDC 71205-474-60 Baclofen Tablets USP, 10 mg 60 Tablets Each tablet contains 10mg baclofen USP Usual Dosage : See package insert for full prescribing information. 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]. Split tablet to be stored at 20° to 25° C (controlled room temperature) for not more than 2 weeks. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Manufactured for: Northstar RxLLC Memphis, TN 38141 Manufactured by : Piramal Enterprises Limited, Plot no 67-70, Sector -2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA Mfg.Lic.No.: 25/10/92 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 20614971 EM 14720/b Rev.04/17 Bar code Batch No.: Exp.Date.: 71205-474-60
Overview
Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is: 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 10 mg or 20 mg Baclofen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, potato starch, povidone. 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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