Brand Name
Primaxin
Generic Name
Imipenem
View Brand Information FDA approval date: November 26, 1985
Classification: Penem Antibacterial
Form: Injection
What is Primaxin (Imipenem)?
Imipenem and Cilastatin for Injection, USP 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.
Approved To Treat
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Brand Information
PRIMAXIN (imipenem and cilastatin sodium)
1DOSAGE FORMS AND STRENGTHS
For Injection PRIMAXIN is a sterile powder mixture for reconstitution in single-dose containers including vials containing:
- 500 mg imipenem (anhydrous equivalent) and 500 mg cilastatin (free acid equivalent)
2CONTRAINDICATIONS
PRIMAXIN is contraindicated in patients who have shown hypersensitivity to any component of this product.
3ADVERSE REACTIONS
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions
- Seizure Potential
- Increased Seizure Potential Due to Interaction with Valproic Acid
- Clostridioides difficile-Associated Diarrhea (CDAD) [see
- Development of Drug-Resistant Bacteria
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of PRIMAXIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4OVERDOSAGE
In the case of overdosage, discontinue PRIMAXIN, treat symptomatically, and institute supportive measures as required. PRIMAXIN is hemodialyzable.
5DESCRIPTION
PRIMAXIN (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. PRIMAXIN is an antibacterial drug for intravenous administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (
Each single-dose vial of PRIMAXIN contains 500 mg imipenem (equivalent to 530 mg imipenem monohydrate), 500 mg cilastatin (equivalent to 531 mg cilastatin sodium), and 20 mg sodium bicarbonate (used as a buffer). PRIMAXIN 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
6PATIENT COUNSELING INFORMATION
- Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should report any previous hypersensitivity reactions to PRIMAXIN, other carbapenems, beta-lactams or other allergens.
- Counsel patients that antibacterial drugs including PRIMAXIN should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When PRIMAXIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by PRIMAXIN or other antibacterial drugs in the future.
- Counsel patients to inform their physician:
- Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider.
7PRINCIPAL DISPLAY PANEL 250 mg Vial Label
NDC 0006-3514-58
250
IMIPENEM 250 mg (Anhydrous Equivalent)
Rx only250 mg
Merck Sharp & Dohme Corp., a subsidiary of
3514
8PRINCIPAL DISPLAY PANEL 500 mg Vial Label
NDC 0006-3516-59
500
Each vial contains 500 mg imipenem (equivalent to 530 mg
CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
Rx only500 mg
9PRINCIPAL DISPLAY PANEL - 500 mg Vial Package
1 PACKAGE (25 VIALS)
NDC 0006-3516-59
NDC 0006-3516-59
500
Not to be divided.
Each vial contains 500 mg imipenem (equivalent to 530 mg imipenem monohydrate), 500 mg cilastatin
Rx only
Merck Sharp & Dohme LLC
Copyright © 2022 Merck & Co., Inc.
10PRINCIPAL DISPLAY PANEL - Single-Dose ADD-Vantage Vial 250 mg
NDC 0006-3551-58
Single-dose ADD-Vantage
250
PRIMAXIN
(IMIPENEM AND CILASTATIN FOR INJECTION)
IMIPENEM 250 mg (Anhydrous Equivalent)
CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.
ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.
9960800
For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.
Store dry material below 25°C.
After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.
Consult accompanying INSTRUCTIONS FOR USE.
Use only with ADD-Vantage
Rx only
250 mg | No. 3551
Merck Sharp & Dohme Corp., a subsidiary of
11PRINCIPAL DISPLAY PANEL - Single-Dose ADD-Vantage Vial 500 mg
NDC 0006-3552-59
Single-dose ADD-Vantage
500
PRIMAXIN
(IMIPENEM AND CILASTATIN FOR INJECTION)
IMIPENEM 500 mg (Anhydrous Equivalent)
CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.
ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.
9940700
For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.
Store dry material below 25°C.
After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.
Consult accompanying INSTRUCTIONS FOR USE.
Use only with ADD-Vantage
Rx only
500 mg | No. 3552
Merck Sharp & Dohme Corp., a subsidiary of
