Imipenem And Cilastatin
Generic Name: imipenem and cilastatin
Brand Names:
Imipenem And Cilastatin
11 DESCRIPTION Imipenem and Cilastatin for Injection, USP is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya .
Overview
11 DESCRIPTION Imipenem and Cilastatin for Injection, USP is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya .
Uses
1 INDICATIONS AND USAGE 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. ( 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: • Imipenem and Cilastatin for Injection, USP is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9 ).
Dosage
2 DOSAGE AND ADMINISTRATION • The dosage of Imipenem and Cilastatin for Injection 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 Imipenem and Cilastatin for Injection unless hemodialysis is instituted within 48 hours ( 2.4 ).
Side Effects
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...
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 imipenem and cilastatin for injection 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 imipenem and cilastatin for injection 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 ).
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to imipenem and cilastatin for injection occurs, discontinue the drug immediately ( 5.1 ). • Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with imipenem and cilastatin for injection. 4 CONTRAINDICATIONS Imipenem and cilastatin for injection is contraindicated in patients who have shown hypersensitivity to any component of this product. • Known hypersensitivity to any component of imipenem and cilastatin for injection (4)
Pregnancy
8.1 Pregnancy Risk Summary Available data from a small number of postmarketing cases with imipenem and cilastatin for injection use in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Developmental toxicity studies with imipenem and cilastatin sodium (alone or in combination) administered to mice, rats, rabbits, and monkeys at doses 0.4 to 2.9 times the recommended human dose (RHD), (based on body surface area), showed no drug-induced fetal malformations.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Imipenem and Cilastatin for Injection, USP is supplied as a sterile powder mixture in single-dose vials containing imipenem (anhydrous equivalent) and cilastatin (free acid equivalent) as follows: 500 mg imipenem equivalent and 500 mg cilastatin equivalent, and 20 mg sodium bicarbonate as a buffer: NDC 44567-705-01 single-dose vial NDC 44567-7...
Frequently Asked Questions
What is Imipenem And Cilastatin used for?▼
1 INDICATIONS AND USAGE 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. ( 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: • Imipenem and Cilastatin for Injection, USP is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9 ).
What are the side effects of Imipenem And Cilastatin?▼
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...
Can I take Imipenem And Cilastatin during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from a small number of postmarketing cases with imipenem and cilastatin for injection use in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Developmental toxicity studies with imipenem and cilastatin sodium (alone or in combination) administered to mice, rats, rabbits, and monkeys at doses 0.4 to 2.9 times the recommended human dose (RHD), (based on body surface area), showed no drug-induced fetal malformations.
What are the important warnings for Imipenem And Cilastatin?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to imipenem and cilastatin for injection occurs, discontinue the drug immediately ( 5.1 ). • Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with imipenem and cilastatin for injection. 4 CONTRAINDICATIONS Imipenem and cilastatin for injection is contraindicated in patients who have shown hypersensitivity to any component of this product. • Known hypersensitivity to any component of imipenem and cilastatin for injection (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.