Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Atlantic Biologicals Corps
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled Substance. Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine
Abbreviated New Drug Application
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ATLANTIC BIOLOGICALS CORPS ---------- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP RX ONLY DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Boysenberry flavor, citric acid, D&C Red 33, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, sucrose and purified water. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4, 5α-epoxy- 3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C H NO H PO • ½ H 0, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C H 0N S•HCl, and the following structural formula: CLINICAL PHARMACOLOGY Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite 18213342 1722 complex. Codeine resembles morphine both structurally Aqra d-dokument sħiħ