국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
diazepam (UNII: Q3JTX2Q7TU) (diazepam - UNII:Q3JTX2Q7TU)
RedPharm Drug Inc.
diazepam
diazepam 5 mg
ORAL
PRESCRIPTION DRUG
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the
Diazepam Tablets USP 2 mg are scored, round, white tablets imprinted DAN 5621 and 2 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 5 mg are scored, round, yellow tablets imprinted DAN 5619 and 5 supplied in bottles of 100, 500 and 1000. Diazepam Tablets USP 10 mg are scored, round, blue tablets imprinted DAN 5620 and 10 supplied in bottles of 100, 500 and 1000. Dispense in tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Abbreviated New Drug Application
DIAZEPAM - DIAZEPAM TABLET REDPHARM DRUG INC. ---------- DRUG LABEL SECTIONS C16H13CLN2O M.W. 284.74 DIAZEPAM TABLETS USP 2 MG, 5 MG AND 10 MG, FOR ORAL ADMINISTRATION, CONTAIN THE FOLLOWING INACTIVE INGREDIENTS: ANHYDROUS LACTOSE, MAGNESIUM STEARATE AND MICROCRYSTALLINE CELLULOSE. DIAZEPAM TABLETS USP 5 MG ALSO CONTAIN D&C YELLOW NO. 10. DIAZEPAM TABLETS USP 10 MG ALSO CONTAIN FD&C BLUE NO. 1. DES CRIPTION: Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-Chloro-1,3-dihydro-1-methyl-5- phenyl-2_H_-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, and is insoluble in water. The structural formula is represented below: C H ClN O M.W. 284.74 Diazepam Tablets USP 2 mg, 5 mg and 10 mg, for oral administration, contain the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5mg also contain D and C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD and C Blue No. 1. PHARMACOLOGY In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral autonomic blocking action, nor does it produce extrapyramidal side effects; however, animals treated with diazepam do have a transient ataxia at higher doses. Diazepam was found to have transient cardiovascular depressor effects in dogs. Long-term experiments in rats revealed no disturbances of endocrine function. Oral LD of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats. Intraperitoneal administration of 400 mg/kg to a monkey resulted in death on the sixth day. REPRODUCTION STUDIES A series of rat reproduction studies was performed with diazepam in oral doses of 1, 10, 80 and 100 mg/kg. At 100 mg/kg there was a decrease in the number of pregnancies and surviving offspring in these rats. Neonatal survival of rats at doses lower than 100 mg/kg was within normal limits. Several neonates in these rat reproduction studies showed sk 전체 문서 읽기