IMIPENEM AND CILASTATIN Powder for solution for injection (2022)

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Fresenius Kabi USA, LLC

Λέξεις κλειδιά

63323-322 63323-349

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1. Indications and Usage

1.1 Lower Respiratory Tract Infections Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains ...

2. Dosage and Administration

2.1 Dosage in Adults For Intravenous Injection Only: The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility ...

3. Dosage Forms and Strengths

For Injection Imipenem and Cilastatin for Injection (I.V.) is a sterile powder mixture for reconstitution in single-dose vials containing: 250 mg imipenem (anhydrous equivalent) and 250 mg cilastatin sodium ...

4. Contraindications

Imipenem and Cilastatin for Injection (I.V.) is contraindicated in patients who have shown hypersensitivity to any component of this product.

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely ...

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 ...

6.1. Clinical 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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Imipenem and Cilastatin for Injection (I.V.). Because these reactions are reported voluntarily from a population of uncertain ...

7. Drug Interactions

7.1 Ganciclovir Generalized seizures have been reported in patients who received ganciclovir and Imipenem and Cilastatin for Injection (I.V.). These drugs should not be used concomitantly with Imipenem ...

8.1. Pregnancy

Risk Summary Available data from a small number of postmarketing cases with Imipenem and Cilastatin for Injection (I.V.) use in pregnancy are not sufficient to identify any drug-associated risks for major ...

8.2. Lactation

Risk Summary There are insufficient data on the presence of imipenem/cilastatin in human milk, and no data on the effects on the breastfed child, or the effects on milk production. The developmental and ...

8.4. Pediatric Use

Use of Imipenem and Cilastatin for Injection (I.V.) in pediatric patients is supported by evidence from adequate and well-controlled trials of Imipenem and Cilastatin for Injection (I.V.) in adults and ...

8.5. Geriatric Use

Of the approximately 3,600 subjects ≥ 18 years of age in clinical studies of Imipenem and Cilastatin for Injection (I.V.), including postmarketing studies, approximately 2,800 received Imipenem and Cilastatin ...

8.6. Renal Impairment

Dosage adjustment is necessary in patients with renal impairment [see Dosage and Administration (2.3)]. Adult patients with creatinine clearances of less than or equal to 30 mL/min, whether or ...

10. Overdosage

In the case of overdosage, discontinue Imipenem and Cilastatin for Injection (I.V.), treat symptomatically, and institute supportive measures as required. Imipenem and Cilastatin for Injection (I.V.) is ...

11. Description

Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor ...

12.1. Mechanism of Action

Imipenem and Cilastatin for Injection (I.V.) is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug [see Microbiology (12.4)]. Cilastatin sodium is a renal dehydropeptidase ...

12.3. Pharmacokinetics

Intravenous infusion of Imipenem and Cilastatin for Injection (I.V.) over 20 minutes results in peak plasma levels of imipenem antimicrobial activity that range from 21 to 58 mcg/mL for the 500 mg dose, ...

12.4. Microbiology

Mechanism of Action Imipenem and Cilastatin for Injection (I.V.) is a combination of imipenem and cilastatin. The bactericidal activity of imipenem results from the inhibition of cell wall synthesis. Its ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenem/cilastatin. A variety of bacterial and mammalian tests were performed to evaluate genetic toxicity. The ...

16.1. How Supplied

Imipenem and Cilastatin for Injection, USP (I.V.) is supplied as a sterile powder mixture in single-dose vials containing imipenem (anhydrous equivalent) and cilastatin (free acid equivalent) as follows: ...

16.2. Storage and Handling

Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.) sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17. Patient 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 ...