Merkacin
(Amikacin sulfate)




COMPOSITION

Each vial contains amikacin (as sulphate) 100 mg or 500 mg.

THERAPEUTIC INDICATIONS

- Abdominal cavity infections (including peritonitis);
- Septic endocarditis;
- Sepsis;
- Infections of CNS (including meningitis);
- Infections of upper airways (bronchitis, pneumonia, pleural empyema, abscess of lungs);
- Suppurative infections of skin and soft tissues (including infected burns, infected ulcers and pressure sores of different genesis);
- Frequently recurrent infection of urinogenital tracts (pyelonephritis, cystitis, urethritis, prostatitis, gonorrhea);
- Infections of bile-excreting tracts;
- Infections of bones and joints (including osteomyelitis);
- Wound infection and post-operative infections.

CONTRAINDICATIONS

- Hypersensitization to drug ingredients, and also to other antibiotics of aminoglycoside;
- Severe renal impairment;
- Cochlear neuritis;
- Pregnancy.

ADVERSE EFFECTS

Effects on CNS and peripheral nervous system: headache, somnolence, disbalance of neuromuscular transmission (apnoea), neurotoxicity (muscular twitching, sensation of numbness, tingling, epileptic seizures).
Effects on blood formation system: anemia, leukopenia, granulocytopenia, thrombocytopenia.
Effects on digestive system: nausea, vomiting, increase in activity of hepatic transminases, hyperbilirubinemia.
Effects on urinary tracts system: oliguria, proteinuria, microhematuria; rarely renal impairment.
Effects on sense organs: ototoxicity (hearing impairment, vestibular and labyrinthine disturbances, irreversible deafness), toxic action on vestibular apparatus (discoordination of movements, dizziness, nausea, vomiting).
Allergic reaction: skin eruption, pruritus, skin hyperemia, fever; rarely angioedema.

DOSAGE AND ADMINISTRATION

The dosage regime has been established individually depending on body weight, severity and localization of infection and pathogen sensitivity.
Doses of 5 mg/kg every 8 h or 7.5 mg/kg every 12 h for 10-12 days are prescribed in adults and adolescences IM, IV as stream introduction for 2 minutes or as drop-by-drop introduction.
The maximum dose for adults is up to 15 mg/kg a day, but not more than 1.5 g a day. The initial dose for infants is 10 mg/kg, then 7.5 mg/kg every 12 h for 7-10 days.
The recommended dose for premature newborns is 7.5 mg/kg every 12 h.
In case of infections of respiratory tracts, bacteremia, septicemia, complicated infections of urinogenital tracts, intra-abdominal infections and febrile granulopenia: 15 mg/kg once daily IV for adults and 20 mg/kg for infants older 4 weeks.
In case of bacterial infections of urinary tracts (not complicated): 250 mg every 12 h; the additional dose of 3-5 mg/kg may be prescribed following hemodialysis.
IV injection may be as stream introduction for 2 minutes or as drop-by-drop introduction for 30-60 minutes (in infants 1-2 h).

PREGNANCY AND LACTATION

Merkacin may be applied during pregnancy and lactation only if there are vital indications. Amikacin has penetrated through the placenta and may have influence on fetus; therefore a patient should be informed of potential risk to fetus. Breast-feeding should be ceased if it is necessary to use Merkacin during lactation.

MANUFACTURED FORM

Solution for IM and IV injection is supplied in a vial at a dosage of 100 mg/2 ml or 500 mg/2 ml. One vial is in a carton box with a leaflet. 10 vials of 100 mg/2 ml or 500 mg/2 ml in carton box.

Alimentary Tract and Metabolism

All Products
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Levoximed Infusion
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Merkacin
Orcipol
Ziromin

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