Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
Direct_Rx
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 available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1330" on one side and plain on the other side, containing 10 mg Baclofen USP. Available in bottles of 100 , 500 and 1000 . Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1337" on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 100 and 500 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]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA CIB70280B Rev. 03/16
Abbreviated New Drug Application
BACLOFEN- BACLOFEN TABLET DIRECT_RX ---------- BACLOFEN Rx only Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(-4-chlorophenyl)-butanoic acid. The structural formula is: [Chemical Structure] 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: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. 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. 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 pat Přečtěte si celý dokument