Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Promethazine Hydrochloride (UNII: R61ZEH7I1I) (Promethazine - UNII:FF28EJQ494)
Proficient Rx LP
Dextromethorphan Hydrobromide
Dextromethorphan Hydrobromide 15 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS, Drug Interactions ). 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 are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.
This preparation is a clear, yellow colored syrup, containing Promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL) bottles. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE- DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP PROFICIENT RX LP ---------- PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP (PROMETHAZINE HYDROCHLORIDE 6.25 MG/5 ML & DEXTROMETHORPHAN HYDROBROMIDE 15 MG/5 ML) RX ONLY DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α- morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C H NO•HBr•H O, and the following structural formula: Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10_H_-Phenothiazine-10-ethanamine, _N_,_N_, α-trimethyl-, 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 N S•HCl, and the following structural formula: 18 25 2 17 20 2 CLINICAL PHARMACOLOGY DEXTROMETHORPHAN Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is abo Прочитайте повний документ