البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
NCS HealthCare of KY, LLC dba Vangard Labs
ORAL
PRESCRIPTION DRUG
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. Hypersensitivity to baclofen.
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. 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 0615-8466-39 Blistercards of 30 NDC 0615-8466-05 Blistercards of 15 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 0615-8467-39 Blistercards of 30 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: Advagen Pharma Ltd 666 Plainsboro Road Plainsboro Suite 605, Plainsboro, NJ, 08536, USA Manufactured by: Rubicon Research Private Limited, Ambernath, Dist: Thane, 421506 India Rev: 01, 10/20 20852
Abbreviated New Drug Application
BACLOFEN- BACLOFEN TABLET NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS ---------- BACLOFEN TABLETS, USP RX ONLY DESCRIPTION Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is: C H ClNO 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 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. 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. 10 12 2 INDICATIONS AND 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 rig اقرأ الوثيقة كاملة