Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
Eywa Pharma Inc
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.
For 5 mg strength: White to off-white, round flat faced beveled edged tablets debossed with ‘E’ on one side and ‘8’ on the other side. They are supplied as follows: NDC 71930-066-12 bottles of 100 tablets NDC 71930-066-52 bottles of 500 tablets NDC 71930-066-13 bottles of 1000 tablets For 10 mg strength: White to off-white, round flat-faced beveled edged tablets debossed with ‘E’ and ‘6’ on one side and scored on the other side. They are supplied as follows: NDC 71930-006-12 bottles of 100 tablets NDC 71930-006-52 bottles of 500 tablets NDC 71930-006-13 bottles of 1000 tablets For 20 mg strength: White to off-white, round flat-faced beveled edged tablets debossed with ‘E’ and ‘9’ on one side and scored on the other side. They are supplied as follows: NDC 71930-007-12 bottles of 100 tablets NDC 71930-007-52 bottles of 500 tablets NDC 71930-007-13 bottles of 1000 tablets Storage Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children Distributed by: Eywa Pharma Inc. 2 Research Way, 3rd Floor Princeton, NJ 08540 Manufactured By: Eywa Pharma Inc, 1 Duncan Drive, Cranbury, NJ 08512, USA Rev. Feb 2022
Abbreviated New Drug Application
BACLOFEN - BACLOFEN TABLET EYWA PHARMA INC ---------- 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, with a molecular weight of 213.66. 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, Mannitol, Pre-Gelatinized Starch, Hypromellose, Sodium Starch Glycolate, Colloidal Silicon Dioxide, 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 10 12 2 elimination. 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 Belgenin tamamını okuyun