Drug Facts
Composition & Profile
Identifiers & Packaging
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 52817-319-10 100s count 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 52817-320-10 100s count NDC 52817-320-50 500s count NDC 52817-320-00 1000s count 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 52817-318-10 100s count 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 52817-321-10 100s count NDC 52817-321-50 500s count NDC 52817-321-00 1000s count 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. Distributed by: TruPharma, LLC Tampa, FL 33609 Manufactured by: Rubicon Research Pvt. Ltd., Thane 421506, India Rev: 03, 03/24; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-319-10 ) 100 Tablets Baclofen Tablets, USP 5 mg Rx only Rubicon Research Private Limited NDC 52817-319-10; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-10 ) 100 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-10); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-50 ) 500 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-50); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-00 ) 1000 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-00); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-318-10 ) 100 Tablets Baclofen Tablets, USP 15 mg Rx only Rubicon Research Private Limited NDC (52817-320-00); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-10 ) 100 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-10); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-50 ) 500 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-50); PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-00 ) 1000 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-00)
- 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 52817-319-10 100s count 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 52817-320-10 100s count NDC 52817-320-50 500s count NDC 52817-320-00 1000s count 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 52817-318-10 100s count 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 52817-321-10 100s count NDC 52817-321-50 500s count NDC 52817-321-00 1000s count 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. Distributed by: TruPharma, LLC Tampa, FL 33609 Manufactured by: Rubicon Research Pvt. Ltd., Thane 421506, India Rev: 03, 03/24
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-319-10 ) 100 Tablets Baclofen Tablets, USP 5 mg Rx only Rubicon Research Private Limited NDC 52817-319-10
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-10 ) 100 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-10)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-50 ) 500 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-50)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-320-00 ) 1000 Tablets Baclofen Tablets, USP 10 mg Rx only Rubicon Research Private Limited NDC (52817-320-00)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-318-10 ) 100 Tablets Baclofen Tablets, USP 15 mg Rx only Rubicon Research Private Limited NDC (52817-320-00)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-10 ) 100 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-10)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-50 ) 500 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-50)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC ( 52817-321-00 ) 1000 Tablets Baclofen Tablets, USP 20 mg Rx only Rubicon Research Private Limited NDC (52817-321-00)
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. 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: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate. Image
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 40-80 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.