Meronym, 0,5 g 10 pcs

Infectious diseases, Skin infections, Lung infections (pneumonia), Urinary tract infections, Intestinal infections, Respiratory tract infections

Meronem^® is indicated for the treatment in children (over 3 months) and adults for the following infectious and inflammatory diseases caused by one or more pathogens sensitive to meropenem:

• pneumonias, including nosocomial pneumonias;
• infections of the urinary system;
• infections of the abdomen;
• infections of the skin and its structures;
• meningitis;
• septicemia.

Empirical therapy in adult patients with suspected infection with symptoms of febrile neutropenia in monotherapy or in combination with antiviral or antifungal agents.

The efficacy of Meronem^® has been proven both in monotherapy and in combination with other antimicrobials in the treatment of polymicrobial infections.

Indications

Meronem® is indicated for the treatment in children (over 3 months) and adults of the following infectious and inflammatory diseases caused by one or more pathogens sensitive to meropenem:

pneumonia, including nosocomial pneumonia;
urinary tract infections;
abdominal infections;
infectious and inflammatory diseases of the pelvic organs, such as endometritis;
infections of the skin and its structures;
meningitis;
septicemia.

Empirical treatment of adult patients with suspected infection and symptoms of febrile neutropenia, either alone or in combination with antiviral or antifungal drugs.

The effectiveness of Meronem® has been proven both in monotherapy and in combination with other antimicrobial agents in the treatment of polymicrobial infections.

Pharmacological effect

Meronem has an antibacterial effect.

Special instructions

There is no experience with the use of the drug in pediatric practice in patients with neutropenia or with primary or secondary immunodeficiency.

As with other antibiotics, when meropenem is used as monotherapy in critically ill patients with known or suspected lower respiratory tract infection caused by Pseudomonas aeruginosa, regular susceptibility testing is recommended.

In rare cases, when using the drug Meronem®, as with the use of almost all antibiotics, the development of pseudomembranous colitis is observed, which can vary in severity from mild to life-threatening forms. It is important to remember the possibility of developing pseudomembranous colitis if diarrhea occurs while using the drug Meronem®.

There are clinical and laboratory signs of cross-allergic reactions between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. There are rare reports of cases of hypersensitivity reactions (including fatal ones) when using the drug Meronem®, as well as other beta-lactam antibiotics (see section “Side effects”).

Before initiating meropenem therapy, the patient should be carefully interviewed, paying particular attention to any history of hypersensitivity reactions to beta-lactam antibiotics. Meronem® should be used with caution in patients with a history of such phenomena. If an allergic reaction to meropenem occurs, it is necessary to stop administering the drug and take appropriate measures.

The use of Meronem® in patients with liver disease should be carried out under careful monitoring of transaminase activity and bilirubin concentration.

As with other antibiotics, overgrowth of non-susceptible microorganisms is possible, and therefore constant monitoring of the patient is necessary.

The prevalence of acquired antibiotic resistance of various pathogens may vary depending on the region and time, and it is desirable to have up-to-date information on the resistance of common pathogens in a particular region, especially when treating severe infections. If resistance is such that the effectiveness of the drug against at least some infections becomes doubtful, an expert should be consulted.

Concomitant use of Meronem® and valproic acid preparations is not recommended.

The use of the drug for infections caused by methicillin-resistant staphylococcus is not recommended.

Impact on the ability to drive a car and operate equipment. There have been no studies of the effect of Meronem® on the ability to drive a car or use other equipment. However, it should be taken into account that headache, paresthesia and convulsions may occur when taking Meronem®.

Active ingredient

Meropenem

Composition

Active ingredient:

meropenem trihydrate;

Excipients:

sodium carbonate (anhydrous) – 208 mg

Pregnancy

Pregnancy

The safety of Meronem® in women during pregnancy has not been studied. Animal studies have not shown any adverse effects on the developing fetus.

Meronem® should not be used during pregnancy unless the potential benefit to the mother outweighs the possible risk to the fetus. In each case, the drug must be used under the strict supervision of a physician.

Lactation

Meropenem is detected in animal breast milk in very low concentrations. Meronem® should not be used during breastfeeding, unless the potential benefit to the mother from using the drug outweighs the possible risk to the baby. Having assessed the benefit for the mother, a decision should be made to stop breastfeeding or discontinue taking Meronem®.

Contraindications

history of hypersensitivity to meropenem or other drugs of the carbapenem group;
severe hypersensitivity (anaphylactic reactions, severe skin reactions) to any antibacterial agent having a beta-lactam structure (i.e. penicillins or cephalosporins);
children under 3 months

With caution: simultaneous use with potentially nephrotoxic drugs; patients with gastrointestinal complaints (diarrhea), especially those suffering from colitis.

Side Effects

Hematopoietic system: often – thrombocytosis; uncommon – eosinophilia, thrombocytopenia; rarely – leukopenia, neutropenia, agranulocytosis; very rarely – hemolytic anemia.

Nervous system: uncommon – headache, paresthesia, fainting, hallucinations, depression, anxiety, increased excitability, insomnia; rarely – convulsions.

Gastrointestinal tract: often – nausea, vomiting, diarrhea, increased activity of liver transaminases, alkaline phosphatase, LDH and bilirubin concentration in the blood serum; uncommon – constipation, cholestatic hepatitis; very rarely – pseudomembranous colitis.

Skin and subcutaneous tissue: uncommon – rash, urticaria, itching; very rarely – erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Immune system: very rarely – angioedema, manifestations of anaphylaxis.

CVS: uncommon – heart failure, cardiac arrest, tachycardia, bradycardia, myocardial infarction, decreased or increased blood pressure, thromboembolism of the branches of the pulmonary artery.

Kidneys and urinary tract: uncommon – increased concentration of creatinine in the blood, increased concentration of urea in the blood.

Respiratory tract: infrequently – dyspnea.

Other: often – local reactions (inflammation, thrombophlebitis, pain at the injection site); rarely – vaginal candidiasis and candidiasis of the oral mucosa.

Interaction

Probenecid competes with meropenem for active tubular secretion, inhibiting renal excretion and causing an increase in the half-life and plasma concentration of meropenem.

Overdose

Accidental overdose during treatment is possible, especially in patients with impaired renal function.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

4 years

Manufacturer

ACS Dobfar S.p.A., Italy