I-Penam Vial

Indications

I-Penam is prescribed for adults and children to treat various infections caused by single or multiple bacteria sensitive to Meropenem. The following infections are indicated for treatment:

• Pneumonia (including nosocomial pneumonia)
• Urinary Tract Infections
• Intra-abdominal Infections
• Gynecological Infections, such as endometritis and pelvic inflammatory disease
• Skin and Skin Structure Infections
• Meningitis
• Sepsis
• Pulmonary Infections in cystic fibrosis
• Empirical Treatment for suspected infections in patients with febrile neutropenia

Note: Use I-Penam only under the guidance of a registered healthcare professional.

Pharmacology

Meropenem, a carbapenem antibiotic, is designed for parenteral use. It exerts its bactericidal effects by disrupting bacterial cell wall synthesis. Its ability to penetrate bacterial cell walls, high stability against serine beta-lactamases, and strong affinity for Penicillin Binding Proteins (PBPs) contribute to its potent activity against a wide range of Gram-positive and Gram-negative bacteria, including both aerobic and anaerobic strains.

Dosage

The dosage and duration of treatment should be tailored to the type and severity of the infection as well as the patient’s condition. The recommended daily dosages are as follows:

Adults:

• The typical dose ranges from 500 mg to 1 g administered intravenously every 8 hours.
• For pneumonia, urinary tract infections, gynecological infections (such as endometritis and pelvic inflammatory disease), and skin infections: 500 mg IV every 8 hours.
• For nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients, and sepsis: 1 g IV every 8 hours.
• Intra-abdominal infections: 500 mg to 1 g every 8 hours.
• For cystic fibrosis: Up to 2 g every 8 hours.
• Meningitis: 2 g IV every 8 hours.

Children:

• For ages 3 months to 12 years: Administer 10 to 40 mg/kg IV every 8 hours, depending on the infection type and severity, pathogen susceptibility, and patient condition.
• Intra-abdominal infections: 20 mg/kg every 8 hours.
• For cystic fibrosis (ages 4-18 years): 25-40 mg/kg every 8 hours.
• Meningitis: 40 mg/kg IV every 8 hours.
• Febrile neutropenia: 20 mg/kg every 8 hours.
• For children over 50 kg, use adult dosages.
• There is limited experience in children with liver or kidney impairments.

Note: Use I-Penam only under the guidance of a registered healthcare professional.

Administration

Meropenem should be administered via intravenous infusion over approximately 15-30 minutes or as an intravenous bolus (5 to 20 ml) over approximately 3-5 minutes.

Note: Use I-Penam only under the guidance of a registered healthcare professional.

Interactions

Probenecid may interfere with I-Penam by competing for active tubular secretion, potentially prolonging the elimination half-life and increasing plasma levels of Meropenem. Additionally, I-Penam can lower serum levels of valproic acid, leading to sub-therapeutic concentrations in some patients.

Contraindications

I-Penam is contraindicated for individuals with a known hypersensitivity to this product.

Side Effects

I-Penam is generally well tolerated; however, side effects may include injection site reactions (inflammation, thrombophlebitis, pain), skin reactions (rash, pruritus, urticaria), and gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea). Other possible effects include headache.

Pregnancy & Lactation

I-Penam falls under Pregnancy Category B. Adequate and well-controlled studies in pregnant women are lacking; thus, the drug should be used during pregnancy only when necessary. Caution is advised when administering Meropenem to nursing mothers, as many medications are excreted in breast milk.

Precautions & Warnings

In the event of an allergic reaction to I-Penam, discontinue use and take appropriate measures. Patients with liver disease should be closely monitored for changes in transaminase and bilirubin levels while using I-Penam.

Use in Special Populations

• Renal Impairment: Dosage may need adjustment in patients with creatinine clearance below 51 ml/min.
• Hepatic Impairment: No dosage adjustment is required for patients with liver function impairment. In hemodialysis patients, I-Penam should be administered after dialysis.
• Elderly: No dosage adjustments are necessary unless creatinine clearance is below 51 ml/min.
• Children: The safety and efficacy of I-Penam in infants under 3 months have not been established.

Overdose Effects

Accidental overdose may occur, particularly in patients with renal impairment. Overdose management should be symptomatic. In individuals with normal kidney function, rapid renal elimination is expected; however, in those with kidney impairment, hemodialysis will help remove I-Penam and its metabolites.

Therapeutic Class

Other beta-lactam antibiotics.

Reconstitution Preparation of Solution:

• For Intravenous Bolus Administration: Reconstitute I-Penam (500 mg or 1 g) using sterile water for injection. Shake to dissolve, yielding a clear and colorless or pale yellow solution.
• For Intravenous Infusion Administration: I-Penam can be directly mixed with compatible infusion fluids and further diluted (50 to 200 ml) as required.

I-Penam is compatible with the following infusion fluids:

• 0.9% sodium chloride
• 5% or 10% glucose
• 5% glucose with 0.02% sodium bicarbonate
• 5% glucose and 0.9% sodium chloride
• 5% glucose with 0.225% sodium chloride
• 5% glucose with 0.15% potassium chloride
• 2.5% and 10% mannitol
• Normosol-M in 5% glucose

It is advisable to use freshly reconstituted solutions. However, potency can be maintained for up to 3 hours at room temperature (up to 25°C) or 13 hours under refrigeration (up to 5°C).