Bacqure Injection 500 mg

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. …

• The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility
• 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 1,000 mg every 8 hours OR 1,000 mg every 6 hours
• See full prescribing information for dosage recommendations
• In pediatric patients
• A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min
• Patients with creatinine clearances of less than 15 mL/min should not receive Imipenem and Cilastatin for Injection (I.V.) unless hemodialysis is instituted within 48 hours
• Reconstitute Imipenem and Cilastatin for Injection, USP (I.V.) vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion
• 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 as shown in Table 1 below
• The dosage recommendations for Imipenem and Cilastatin for Injection (I.V.) represent the quantity of imipenem to be administered
• An equivalent amount of cilastatin is also present in the solution
• These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. …

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 (free acid equivalent) 500 mg imipenem (anhydrous equivalent) and 500 mg cilastatin (free acid equivalent) For Injection: Imipenem and Cilastatin for Injection (I.V.) is a sterile powder mixture for r …

• 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 clinical studies
• In pediatric patients [see Dosage and Administration and Clinical Pharmacology ]
• Imipenem and Cilastatin for Injection (I.V.) is not recommended
• In pediatric patients with CNS infections because of the risk of seizures. …

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 for Injection (I.V.). Of the subjects who received Imipenem and Cilastatin for Injection (I.V.), data are available on approximately 800 subjects who were 65 and over, including approximately 300 subjects who were 75 and over. …

• 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 Imipenem and Cilastatin for Injection (I.V.), other carbapenems, beta-lactams or other allergens
• Counsel patients that antibacterial drugs including Imipenem and Cilastatin for Injection (I.V.) should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold). …

• Imipenem and Cilastatin for Injection (I.V.) 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 (I.V.)

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 (I.V.) 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 (I.V.) 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 ). …

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 (I.V.) 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 (I.V.). …

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 …

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 birth defects, miscarriage, or adverse maternal or fetal outcomes. …

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 hemodialyzable.

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].

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