Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Baclofen (UNII: H789N3FKE8) (Baclofen - UNII:H789N3FKE8)
Med Health Pharma, LLC
Baclofen
Baclofen 10 mg
ORAL
PRESCRIPTION DRUG
Baclofen is 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 may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is 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 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 30. Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted DAN 5731 and 20 supplied in bottles of 30. Dispense in a tight container with a child-resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Watson Laboratories, Inc. Corona, CA 92880 USA Rev: January 2004 Repackaged By: Med-Health Pharma, LLC North Las Vegas, NV 89032 MHP LB-60001 rev00
Abbreviated New Drug Application
BACLOFEN - BACLOFEN TABLET MED HEALTH PHARMA, LLC ---------- DESCRIPTION Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. 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. The structural formula is represented below: C H ClNO M.W. 213.66 Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn). ACTIONS 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 gammaaminobutyric 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. INDICATIONS Baclofen is 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 10 12 2 function. Baclofen ma Prečítajte si celý dokument