MR Ampicillin sodium salt powder for injection

  • Trade name of the drug: MR Ampicillin sodium.
  • Active substance (INN): Ampicillin sodium.
  • Dosage form: Powder for the preparation of injection solution.
  • Composition:
  • Each vial contains:
  • Ampicillin sodium salt in terms of active substance ampicillin – 0.5 g or 1.0 g
  • Description: White or almost white powder, hygroscopic.
  • Pharmacotherapeutic group: Antibiotics (group of penicillins).
  • ATC code: J01CA01
Category:

Pharmacological properties

Ampicillin is a broad-spectrum antibiotic from the group of semisynthetic penicillins. It acts bactericidal, suppressing the synthesis of the cell wall of microorganisms. Destroyed by penicillinase. The following microorganisms are permanently sensitive to the preparation: Streptococci A, B, C, F, G, Str. pneumoniae, not producing penicillinases; L. monocytogernes, Corynebacterium diphtheriae, Erysipelotrixrhusopathiae, Eikenella, N. Meningitides, Bordetellapertussis, Clostridiumspp., Propioniobacteriumacnes, Peptostreptococcusp., Actinomycesspp., Leptospiraspp., Treponema; not always sensitive: Enterococcusfaecalis, E.Coli, Proteusmirabilis, Salmonellaspp., Vibriocholerae, H. Influenzae, N.gonorrhoeae, Fusobacteriumspp., Prevotella. The drug is stable: Staphylococcuspp., B. catarrhalis, Klebsiellaspp., Enterobacterspp., C.diversus, C.freundii, Proteusvulgaris, Providenciarettgeri, Morganellamoranii, Y.enterocolitica., Pseudomonasspp., Acinetbacterspp., Xanthomonasspp., Flavobacteriumspp., lcaligenesspp. , Nocardiaspp., Campylobacterspp., Legionellapneumophila, Mycobacteriumspp., Bacteriodesspp., Mycoplasmaspp., Chlamydiaspp.

Pharmacokinetics

After parenteral administration penetrates into tissues and body fluids, it is found in therapeutic concentrations in pleural, peritoneal and synovial fluids, in bile. The drug penetrates the placental barrier, is excreted in the mother’s milk. Half-life is approximately 1 hour, with anuria it increases to 12-20 hours. The main part is excreted from the body by the kidneys, and a very high concentration of antibiotic is created in the urine. The drug with repeated administration does not cumulate, which makes it possible to use it in large doses and for a long time.

Indications for use

Bacterial infections: bronchitis, pneumonia, dysentery, salmonellosis, prolonged carriage of salmonella, cholecystitis, whooping cough, pyelonephritis, urethritis, endocarditis, skin and soft tissue infections, gynecological infections, ear infections, throat, nose, odontogenic infections, meningitis, sepsis and other infections , caused by microorganisms sensitive to the preparation.

Methods of administration and dose

Parenterally: intramuscularly (in / m) and intravenously (iv) (jet or drip). With both methods of administration to adults, 250-500 mg 4-6 times a day; In severe infections, the daily dose can be increased to 10 g or more; children depending on the age in a daily dose: newborns 100 mg / kg, under 1 year 50 mg / kg, 1 to 4 years 50-75 mg / kg, over 4 years 50 mg / kg. The duration of treatment depends on the severity of the condition and the effectiveness of therapy (from 5-10 days to 2-3 weeks or more).

Solution for intramuscular injection is prepared by ectempore, adding to the contents of the vial 2 ml of water for injection or 0.5% solution of novocaine for injection (except for patients who have increased sensitivity to novocaine). For intravenous fluid administration, a single dose of the drug (no more than 2 g) is dissolved in 5-10 ml of sterile water for injection or isotonic sodium chloride solution, injected slowly.

Side effects

Allergic reactions (urticaria, erythema, Quincke’s edema, rhinitis, conjunctivitis, rarely – fever, joint pain, eosinophilia, extremely rarely anaphylactic shock). Possible toxic effects on the central nervous system (with high doses in patients with renal insufficiency), dyspepsia (diarrhea, nausea, vomiting), candidiasis, intestinal dysbiosis.

Contraindications

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), severe liver dysfunction, breastfeeding (during treatment it is necessary to suspend).

Drug Interactions

With simultaneous administration with bacteriostatic antibiotics (tetracycline, chloramphenicol, erythromycin and others) mutual antagonism occurs. Synergism in antimicrobial efficacy is observed with aminoglycoside antibiotics. The joint administration of the probenicide reduces the release of the drug in the urine and leads to an increase in serum levels, while with allopurinol it slows the metabolism of the drug and increases the incidence of skin rash. The drug in rare cases weakens the effect of oral contraceptives.

Special instructions

In case of allergic reactions, it is necessary to stop taking the drug and conduct desensitizing therapy. When using the drug in patients with sepsis, a bacteriolysis reaction (the Yarisch-Gerxheimimer reaction) is possible. Weakened patients with long-term treatment may develop superinfection caused by resistant to the drug microorganisms (yeast-like fungi, gram-negative microorganisms). These patients are advisable in the treatment of the drug to prescribe vitamins of group B and vitamin C, if necessary, give nystatin or levorin. With bronchial asthma, hay fever and other allergic diseases, when necessary, the drug is used with the simultaneous administration of desensitizing agents. It is necessary to systematically monitor the function of the kidneys, liver and blood picture. Care should be taken when prescribing the drug to patients with renal insufficiency. The drug is stored out of the reach of children and should not be used after the expiration date.

Form of issue

Powder for the preparation of an injection solution of 0.5 g or 1.0 g in vials.

Storage conditions

In a dry and dark place, at a temperature of no more than 25 ° C.

Shelf life

2 years.

Conditions of release from pharmacies

On prescription.