"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
WARNING BARBITURATES ARE NOT CHEMICALLY COMPATIBLE IN SOLUTION WITH MEPERGAN (meperidine and promethazine) (MEPERIDINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE) AND SHOULD NOT BE MIXED IN THE SAME SYRINGE.
Mepergan (meperidine and promethazine) is usually administered intramuscularly. However, in certain specific situations, the intravenous route may be employed. INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see " Warnings "). SUBCUTANEOUS ADMINISTRATION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS (see " Contraindications "). INJECTION INTO OR NEAR PERIPHERAL NERVES MAY RESULT IN PERMANENT NEUROLOGICAL DEFICIT.
When used intravenously, the rate should not be greater than 1 mL of Mepergan (meperidine and promethazine) (25 mg of each component) per minute; it is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.
The TUBEX® BLUNT POINT™ Sterile Cartridge Unit is suitable for substances to be administered intravenously only. It is intended for use with injection sets specifically manufactured as "needle-less" injection systems. TUBEX® BLUNT POINT™ is compatible with Abbott's LifeShield® prepierced reseal injection site, Baxter's InterLink® Injection Site, and B. Braun Medical's SafSite® Reflux Valve, Consult manufacturer's recommendations regarding "Directions for Use" of the "needle-less" system. It is also intended for admixture with, and convenient administration of various medicaments when using Drug Vial Adapters for "needle-less" injection systems.
The TUBEX® Sterile Cartridge-Needle Unit is suitable for substances to be administered intravenously or intramuscularly.
The TUBEX® Sterile Cartridge-Needle Unit is designed for single-dose use. VIALS should be used when required doses are fractions of a milliliter, as indicated below.
ADULT DOSE: 1 to 2 mL (25 to 50 mg of each component) per single injection, which can be repeated every 3 to 4 hours.
CHILDREN 12 YEARS OF AGE AND UNDER: 0.5 mg of each component per pound of body weight. The dosage may be repeated every 3 to 4 hours as necessary.
For preanesthetic medication the usual adult dose is 2 mL (50 mg of each component) intramuscularly with or without appropriate atropine-like drug. Atropine sulfate, 0.3 to 0.4 mg, or scopolamine hydrobromide, 0.25 to 0.4 mg, in sterile solution may be mixed in the same syringe with Mepergan (meperidine and promethazine) . Repeat doses of 50 mg or less of both promethazine and meperidine may be administered by either route at 3- to 4-hour intervals, as necessary. As an adjunct to local or general anesthesia, the usual dose is 2 mL (50 mg each of meperidine and promethazine).
Mepergan (meperidine and promethazine) ® (meperidine HCl and promethazine HCl) Injection is available in TUBEX® BLUNT POINT™ Sterile Cartridge Units and Sterile Cartridge-Needle Units, in boxes of 10 TUBEX in TAMP-R-TEL® tamper-resistant packages as follows:
NDC 0008-0235-50, 2 mL size Blunt Point™
NDC 0008-0235-01, 2 mL size (22 gauge x 1- 1 / 4 inch needle).
Mepergan (meperidine and promethazine) (meperidine HCl and promethazine HCl) Injection is also available in vials as follows:
NDC 0008-0234, 10 mL vial.
Do not use if solution is discolored or contains a precipitate.
Protect from light
Use carton to protect contents from light
Store at room temperature, approximately 25° C (77° F)
A Wyeth-Ayerst Company
Philadelphia, PA 19101
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Mepergan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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