Velpenem powder d / prig. solution for intravenous injection 1g, No. 1

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 in the presence of neutropenia (empirical treatment).

IV for adults, a single dose varies from 500 mg to 2 g, the frequency of administration and the duration of treatment are set individually, depending on the indications and severity of the disease. 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.

One bottle contains:

Active substance:

meropenem

Hypersensitivity to meropenem and other drugs of the carbapenem group.

pharmachologic effect

Antibiotic of the carbapenem group. More stable with respect to dehydropeptidase I than imipenem. It has a bactericidal effect by disrupting the synthesis of the bacterial cell wall. Has an affinity for penicillin binding proteins (PBPs). 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 ?-lactamases.

Pharmacokinetics

After intravenous or intramuscular injection, it penetrates well into most tissues and body fluids (including cerebrospinal fluid in patients with meningitis). It is metabolized to form one inactive metabolite. T1 / 2 with intravenous administration is 1 hour, with intramuscular administration - 1.5 hours.

Side effect

From the digestive system: abdominal pain, nausea, vomiting, diarrhea, a reversible increase in the level of bilirubin, transaminases, alkaline phosphatase and LDH. From the side of the blood coagulation system: reversible thrombocytopenia, eosinophilia, neutropenia. Allergic reactions: 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. Others: in some cases, positive direct or indirect Coombs' test.

Application during pregnancy and lactation

During pregnancy and lactation (breastfeeding), use is possible only in cases where the expected benefit of therapy to the mother outweighs the possible risk to the fetus or child. Experimental studies have shown that meropenem is excreted in breast milk.

Application for violations of liver function

With caution, meropenem is prescribed for liver diseases - treatment should be carried out under the control of the level of transaminases and bilirubin.

Application for impaired renal function

In case of impaired renal function, correction of the dosage regimen is required depending on the CC values.

Application in children

Not recommended for use in children under 3 months of age.

special instructions

With caution, meropenem is prescribed for liver diseases, for diseases of the lower respiratory tract caused by Pseudomonas aeruginosa. In case of impaired renal function, correction of the dosage regimen is required depending on the CC values. For liver diseases, treatment should be carried out under the control of the level of transaminases and bilirubin. If there is a history of hypersensitivity reactions to penicillins, carbapenems or other beta-lactam antibiotics, hypersensitivity reactions to meropenem may develop. As with the use of other antibiotics, against the background of treatment with meropenem, the likelihood of developing pseudomembranous colitis should be borne in mind. With caution, meropenem is used as part of a combination therapy with drugs that have nephrotoxic effects.Not recommended for use in children under 3 months of age.

Drug interactions

Probenecid competes with meropenem for active tubular secretion and, thus, inhibits renal excretion of meropenem, causing an increase in its T1 / 2 and plasma concentration (simultaneous use is not recommended).