Propinen (Powder) Instructions for Use

Marketing Authorization Holder

Tsitko LLC (Russia)

ATC Code

J01DH02 (Meropenem)

Active Substance

Meropenem (Rec.INN registered by WHO)

Dosage Form

Propinen

Powder for solution for intravenous administration 1 g: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous administration white or white with a yellowish tint.

Excipients: sodium carbonate.

1 g – glass vials (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the carbapenem group

Pharmacotherapeutic Group

Antibiotic-carbapenem

Pharmacological Action

An antibiotic of the carbapenem group. It is more stable in relation to dehydropeptidase I than imipenem. It exerts a bactericidal effect by disrupting the synthesis of the bacterial cell wall. It has an affinity for penicillin-binding proteins (PBPs). It is active against most aerobic and anaerobic gram-positive and gram-negative bacteria.

Xanthomonas maltophilia, Enterococcus faecium, methicillin-resistant strains of Staphylococcus spp. are resistant to meropenem.

It is resistant to the action of β-lactamases.

Pharmacokinetics

After intravenous or intramuscular administration, it penetrates well into most body tissues and fluids (including cerebrospinal fluid in patients with meningitis). It is metabolized to form one inactive metabolite. T_1/2 with intravenous administration is 1 hour, with intramuscular administration – 1.5 hours.

Indications

For intravenous administration: treatment of severe infectious and inflammatory diseases caused by one or more pathogens sensitive to meropenem: pneumonia, including hospital-acquired pneumonia; infections of the urinary tract, abdominal cavity, pelvic organs (including endometritis), skin and soft tissues, meningitis, septicemia; suspected bacterial infection with febrile episodes against the background of neutropenia (empirical treatment).

For intramuscular administration: exacerbation of chronic bacterial bronchitis, uncomplicated urinary tract infections.

ICD codes

Dosage Regimen

Intravenous for adults: a single dose varies from 500 mg to 2 g, the frequency of administration and duration of treatment are set individually, depending on the indications and severity of the disease. For children weighing less than 50 kg – 10-12 mg/kg every 8 hours; in children weighing more than 50 kg, doses intended for adults are used.

Intramuscular for adults: 500 mg every 8 hours, for elderly patients – 500 mg every 12 hours.

Adverse Reactions

From the digestive system: abdominal pain, nausea, vomiting, diarrhea, reversible increase in bilirubin level, activity of transaminases, alkaline phosphatase and LDH.

From the blood coagulation system: reversible thrombocytopenia, eosinophilia, neutropenia.

Allergic reactions: skin itching, rash, urticaria.

From the nervous system: headache, paresthesia.

Effects due to chemotherapeutic action: oral candidiasis, vaginal candidiasis, pseudomembranous colitis.

Local reactions: inflammation, thrombophlebitis, pain at the injection site.

Other: in some cases, a positive direct or indirect Coombs test.

Contraindications

Hypersensitivity to meropenem and other drugs of the carbapenem group.

Use in Pregnancy and Lactation

During pregnancy and lactation (breastfeeding), use is possible only in cases where the expected benefit of therapy for the mother outweighs the possible risk to the fetus or child.

In experimental studies, it has been shown that Meropenem is excreted in breast milk.

Use in Hepatic Impairment

Meropenem should be prescribed with caution in liver diseases – treatment should be carried out under the control of transaminase and bilirubin levels.

Use in Renal Impairment

In case of renal impairment, dose adjustment is required depending on the creatinine clearance values.

Pediatric Use

Use in children under 3 months of age is not recommended.

Special Precautions

Meropenem should be prescribed with caution in liver diseases, in diseases of the lower respiratory tract caused by Pseudomonas aeruginosa.

In case of renal impairment, dose adjustment is required depending on the creatinine clearance values.

In liver diseases, treatment should be carried out under the control of transaminase and bilirubin levels.

If there is a history of hypersensitivity reactions to penicillins, carbapenems or other beta-lactam antibiotics, the development of hypersensitivity reactions to meropenem is possible. As with the use of other antibiotics, during treatment with meropenem, the possibility of developing pseudomembranous colitis should be borne in mind.

Meropenem should be used with caution as part of combination therapy with drugs that have a nephrotoxic effect.

Use in children under 3 months of age is not recommended.

Drug Interactions

Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem, causing an increase in its T_1/2 and plasma concentration (concomitant use is not recommended).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.