DEMEROL- meperidine hydrochloride injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

MEPERIDINE HYDROCHLORIDE (UNII: N8E7F7Q170) (MEPERIDINE - UNII:9E338QE28F)

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

MEPERIDINE HYDROCHLORIDE

Compoziție:

MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

DEMEROL - MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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