País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
Bryant Ranch Prepack
BACLOFEN
BACLOFEN 20 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.
Product: 63629-1286 NDC: 63629-1286-1 30 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-6 56 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-4 60 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-9 84 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-7 90 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-5 100 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-0 112 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-2 120 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-8 140 TABLET in a BOTTLE, PLASTIC NDC: 63629-1286-3 20 TABLET in a BOTTLE, PLASTIC Product: 63629-3193 NDC: 63629-3193-0 120 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-8 15 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-2 20 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-6 30 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-4 45 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-7 56 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-3 60 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-9 84 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-1 90 TABLET in a BOTTLE, PLASTIC NDC: 63629-3193-5 112 TABLET in a BOTTLE, PLASTIC
Abbreviated New Drug Application
BACLOFEN- BACLOFEN TABLET BRYANT RANCH PREPACK ---------- BACLOFEN TABLETS, USP RX ONLY 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: Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch. 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-amino-butyric 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 AND USAGE 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 baclofe Llegiu el document complet