"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(meropenem) for Injection
MERREM® I.V. (meropenem for injection) is a sterile, pyrogen-free, synthetic, broad-spectrum, carbapenem antibiotic for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S•3H2O with a molecular weight of 437.52. Its structural formula is:
MERREM I.V. is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
When constituted as instructed, each 1 g MERREM I.V. vial will deliver 1 g of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg MERREM I.V. vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see DOSAGE AND ADMINISTRATION].
What are the possible side effects of meropenem (Merrem)?
If you experience a rare but serious side effects, stop taking meropenem and seek emergency medical attention or contact your doctor immediately:
- allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
- severe or watery diarrhea;
- a skin rash;
- unusual tiredness or weakness; or
- unusual bleeding or bruising.
Other less serious side effects may be more likely to occur. Continue to use meropenem and talk to your doctor if you experience:
- nausea or...
What are the precautions when taking meropenem (Merrem I.V.)?
Before using meropenem, tell your doctor or pharmacist if you are allergic to it; or to penicillins or cephalosporins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor), kidney disease, stomach/intestinal diseases (e.g., colitis).
This drug may rarely cause headaches, numb/tingling skin, or seizures. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Before having surgery, tell your doctor or...
Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Merrem I.V. Information
Merrem I.V. - User Reviews
Merrem I.V. User Reviews
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