Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)
Physicians Total Care, Inc.
MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
For the relief of moderate to severe pain For preoperative medication For support of anesthesia For obstetrical analgesia 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 meperid
For Parenteral Use Solutions of DEMEROL for parenteral use are clear and colorless and are available as follows: Carpuject with luer lock 5% (50 mg/mL) 1 10 Uni-Amp unit dose pak 5% (50 mg) 1 25 Uni-Amp unit dose pak 10% (100 mg) 1 25 Uni-Amp unit dose pak 10% (100 mg) 1 1 Carpuject™ are packaged in a Slim-Pak™ tamper detection package. To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand. Blunt cannulas should not be recapped, purposely bent or broken by hand. NOTE: The pH of DEMEROL solutions is adjusted between 3.5 and 6 with sodium hydroxide or hydrochloric acid. Multiple-dose vials contain metacresol 0.1 percent as preservative. No preservatives are added to the ampuls or Carpuject™ sterile cartridge units. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Demerol is not a trademark of Hospira. Revised: June, 2010 Printed in USA EN-2526 Hospira, Inc., Lake Forest, IL 60045 Additional bar code label applied by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
New Drug Application
DEMEROL - MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- DEMEROL meperidine hydrochloride injection, USP CII Rx only DESCRIPTION Meperidine hydrochloride is ethyl 1-methyl-4-phenylisonipecotate 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. DEMEROL injectable is supplied in Carpuject™ with luer lock of 2.5% (25 mg/1 mL), 5% (50 mg/1 mL), 7.5% (75 mg/1 mL), and 10% (100 mg/1 mL). Uni-Amp™ unit dose pak-ampuls of 5% solution (25 mg/0.5 mL), (50 mg/1 mL), (75 mg/1.5 mL), (100 mg/2 mL), and 10% solution (100 mg/1 mL). Multiple- dose vials of 5% and 10% solutions contain metacresol 0.1% as preservative. The pH of DEMEROL solutions is adjusted between 3.5 and 6 with sodium hydroxide or hydrochloric acid. DEMEROL, brand of meperidine hydrochloride, 5 percent solution has a specific gravity of 1.0086 at 20°C and 10 percent solution, a specific gravity of 1.0165 at 20°C. 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 mg 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 parenteral route, but the exact ratio of oral to parenteral effectiveness is unknown. In clinical studies reported in the literature, changes in several pharm Διαβάστε το πλήρες έγγραφο