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(imipenem and cilastatin) for Injection
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN® I.V. and other antibacterial drugs, PRIMAXIN I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
For Intravenous Injection Only
PRIMAXIN I.V. (Imipenem and Cilastatin for Injection) is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase l), with sodium bicarbonate added as a buffer. PRIMAXIN I.V. is a potent broad spectrum antibacterial agent for intravenous administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4S•H2O, and its structural formula is:
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:
PRIMAXIN I.V. is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. (See Compatibility And Stability.) PRIMAXIN I.V. 250 contains 18.8 mg of sodium (0.8 mEq) and PRIMAXIN I.V. 500 contains 37.5 mg of sodium (1.6 mEq). Solutions of PRIMAXIN I.V. range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
What are the possible side effects of imipenem and cilastatin (Primaxin IM, Primaxin IV)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats;
- diarrhea that is watery or bloody;
- confusion, tremors, hallucinations, seizure (convulsions);
- feeling light-headed, fainting;
- fever, chills, body aches, flu symptoms;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored...
What are the precautions when taking imipenem and cilastatin for injection (Primaxin I.V.)?
Before using imipenem with cilastatin, tell your doctor or pharmacist if you are allergic to either of its ingredients; 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, liver disease, stomach/intestinal diseases (e.g., colitis).
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.
During pregnancy, this medication...
Last reviewed on RxList: 5/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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