PRIMAXIN IV 500 mg/100mL
imipenem and cilastatin sodium · INJECTION, POWDER, FOR SOLUTION · Merck Sharp & Dohme LLC
PRIMAXIN IV is a injection, powder, for solution containing imipenem and cilastatin sodium at 500 mg/100mL, taken intravenous. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- PRIMAXIN IV
- Generic Name
- imipenem and cilastatin sodium
- NDC Code (Product)
0006-3516- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 500 mg/100mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA050587
- Marketing Start
- 11/26/1985
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1 ) Urinary tract infections. ( 1.2 ) Intra-abdominal infections. ( 1.3 ) Gynecologic infections. ( 1.4 ) Bacterial septicemia. ( 1.5 ) Bone and joint infections. ( 1.6 ) Skin and skin structure infections. ( 1.7 ) Endocarditis. ( 1.8 ) Limitations of Use: PRIMAXIN is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9 ). PRIMAXIN is not recommended in pediatric patients with CNS infections because of the risk of seizures ( 1.9 ). PRIMAXIN is not recommended in pediatric patients weighing less than 30 kg with impaired renal function ( 1.9 ). Usage: To reduce the development of drug resistant bacteria and maintain the effectiveness of PRIMAXIN and other antibacterial drugs, PRIMAXIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.10 ). 1.1 Lower Respiratory Tract Infections PR…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The dosage of PRIMAXIN in adult patients should be based on suspected or confirmed pathogen susceptibility ( 2.1 ). For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1000 mg every 8 hours OR 1000 mg every 6 hours ( 2.1 ). See full prescribing information for dosage recommendations in pediatric patients ( 2.2 ). A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min ( 2.3 ). Patients with creatinine clearances of less than 15 mL/min should not receive PRIMAXIN unless hemodialysis is instituted within 48 hours ( 2.4 ). Reconstitute PRIMAXIN vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion ( 2.5 ). 2.1 Dosage in Adults For Intravenous Injection Only The dosage of PRIMAXIN in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. The dosage recommendations for PRIMAXIN represent the quantity of imipenem to be administered. An equivalent amount o…
Contraindications
4 CONTRAINDICATIONS PRIMAXIN is contraindicated in patients who have shown hypersensitivity to any component of this product. Known hypersensitivity to any component of PRIMAXIN ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Ganciclovir: Generalized seizures have been reported in patients who received ganciclovir. Do not co-administer unless benefit outweighs risk ( 7.1 ). Probenecid: Concomitant administration of PRIMAXIN and probenecid results in increases in the plasma level and half-life of imipenem. Concomitant administration is not recommended ( 7.2 ). Valproic acid/divalproex sodium: Concomitant use with PRIMAXIN is generally not recommended. Consider other antibacterial drugs to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium ( 5.3 , 7.3 ). 7.1 Ganciclovir Generalized seizures have been reported in patients who received ganciclovir and PRIMAXIN. These drugs should not be used concomitantly with PRIMAXIN unless the potential benefits outweigh the risks. 7.2 Probenecid Concomitant administration of PRIMAXIN and probenecid results in increases in the plasma level and half-life of imipenem. Therefore, it is not recommended that probenecid be given concomitantly with PRIMAXIN. 7.3 Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including PRIMAXIN, to patients receiving valproic ac…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Increased Seizure Potential Due to Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.5) ] The most frequently occurring adverse reactions (≥0.2%) in adults were phlebitis, nausea, diarrhea, vomiting, rash, pain injection site, fever, hypotension, seizures, erythema at injection site, dizziness, pruritus, vein induration, urticaria, somnolence ( 6.1 ). The most frequently occurring adverse reactions (>1%) in pediatric patients greater than or equal to 3 months of age were diarrhea, rash, phlebitis, gastroenteritis, vomiting, IV site irritation, urine discoloration ( 6.1 ). The most frequently occurring adverse reactions (>1%) in neonates to 3 months of age were convulsions, diarrhea, oliguria/anuria, oral candidiasis, rash, tachycardia ( 6.1 ). To report …
Frequently Asked Questions
What is PRIMAXIN IV used for?
PRIMAXIN IV contains imipenem and cilastatin sodium. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is PRIMAXIN IV a controlled substance?
PRIMAXIN IV is not classified as a controlled substance by the DEA.
What is the generic name for PRIMAXIN IV?
The generic name for PRIMAXIN IV is imipenem and cilastatin sodium. There are 2 other brand versions of imipenem and cilastatin sodium.
What is the NDC code for PRIMAXIN IV 500 mg/100mL?
The NDC (National Drug Code) for PRIMAXIN IV 500 mg/100mL is 0006-3516, listed by Merck Sharp & Dohme LLC.