Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
meperidine hydrochloride (UNII: N8E7F7Q170) (meperidine - UNII:9E338QE28F)
Boehringer Ingelheim
Meperidine Hydrochloride
SOLUTION
50 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Meperidine is indicated for the relief of moderate to severe pain. Meperidine is contraindicated in patients with hypersensitivity to meperidine. Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred with meperidine. If
Meperidine Hydrochloride Tablets USP 50 mg white, scored tablets (Tablets Identified 54 879) NDC 0054-8595-11: Unit dose, 25 tablets per card (reverse numbered), 1 card per shipper. NDC 0054-4595-25: Bottles of 100 tablets. 100 mg white, scored tablets (Tablets Identified 54 163) NDC 0054-8596-11: Unit dose, 25 tablets per card (reverse numbered), 1 card per shipper. NDC 0054-4596-25: Bottles of 100 tablets. Dispense in a well-closed, light-resistant container as defined in the USP/NF. Meperidine Hydrochloride Oral Solution USP 50 mg per 5 mL (unflavored, colorless oral solution) NDC 0054-3545-63: Bottles of 500 mL. DEA Order Form Required . Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] 10003964/01 © RLI, 2005
MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE SOLUTION MEPERIDINE HYDROCHLORIDE- MEPERIDINE HYDROCHLORIDE TABLET BOEHRINGER INGELHEIM ---------- MEPERIDINE HYDROCHLORIDE TABLETS USP MEPERIDINE HYDROCHLORIDE ORAL SOLUTION USP RX ONLY DESCRIPTION Each tablet for oral administration contains: Meperidine Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg, 100 mg Each 5 mL of oral solution for oral administration contains: Meperidine Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg INACTIVE INGREDIENTS The oral solution contains glycerin, hydrochloric acid, maltol, sodium benzoate, sorbitol solution, and water. The tablets contain starch (corn), lactose monohydrate, povidone, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. Chemically meperidine hydrochloride is 1-Methyl-4-phenyl-4-piperidinecarboxylic acid, ethyl ester, hydrochloride, a white crystalline substance with a melting point of 186°C to 189°C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling. Meperidine hydrochloride may be represented by the following structural formula: C H NO • HCL M.W. 283.80 CLINICAL PHARMACOLOGY Meperidine hydrochloride is a narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation. There is some evidence which suggests that meperidine may produce less smooth muscle spasm, constipation, and depression of the cough reflex than equianalgesic doses of morphine. Meperidine, in 60 to 80 mg parenteral doses, is approximately equivalent in analgesic effect to 10 mg of morphine. The onset of action is slightly more rapid than with morphine, and the duration of action is slightly shorter. Meperidine is significantly less effective by the oral than by the pa Leggi il documento completo