The instruction for use
of medicine for experts
the Trade name
the International unlicensed
name Ampicillin Dosage Form Powder for preparation of solution for intramuscular introduction of 500 mg
active agent – ampicillin sodium salt of 500 mg
Powder of white or almost white color. It is hygroscopic.
The pharmacotherapeutic group
Antimicrobial drug for system use
Penicillin of a broad spectrum of activity
the Code of automatic telephone exchange J01CA01
Pharmacokinetics Later properties of intramuscular introduction the maximum concentration in blood is reached in 1 hour, after intravenous administration – in 15 min. after an injection. Therapeutic significant concentration of an antibiotic in blood are maintained within 4-6 hours. Rather small part (10-30%) contacts proteins of plasma. Ampicillin well gets into fabrics and liquids of an organism. Gets through a placenta. In meningitis the concentration of ampicillin in cerebrospinal fluid can make 70-95% of its concentration in blood plasma. Practically is not exposed to biotransformation. Elimination half-life makes 1 – 1.5 hour, patients with renal failures have 7 – 20 hours. It is allocated in not changed look mainly with kidneys.
the Antibacterial microbicide from group of semi-synthetic penicillin received by acetylation of 6-aminopenicillanic acid by residue of aminophenylacetic acid, kislotoustoychiv. Inhibits a polymerase of a peptidoglikan and transpeptidase, interferes with formation of peptide bonds and breaks late stages of synthesis of a cell wall of the sharing microorganism that leads to decrease in osmotic stability of a bacterial cell and causes its lysis.
It is active concerning gram-positive (alpha and beta and hemolytic streptococci, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp., the majority of enterococci, including Enterococcus faecalis) and gram-negative (Haemophilias influenzae, Neisseria meningilidis, Proteus mirabilis, Pasteurella multocida many types of Salmonella spp., Shigella spp., Escherichia coli) microorganisms, aerobic nesporo the forming bacteria (Listeria spp.).
It is inefficient concerning penitsillinazoprodutsiruyushchy strains of Staphylococcus spp., all strains of Pseudomonas aeruginosa, the majority of strains of Klebsiella spp. and Enterobacter spp.
– pneumonia, chronic bronchitis, lung abscess, etc.
– a pyelitis, pyelonephritis, cystitis, a cholangitis, cholecystitis
– dysentery, a typhoid, salmonellosis
– sepsis, a septic endocarditis
– an ugly face, again infected dermatosis, pasteurellosis, listeriosis
– other diseases caused by microorganisms, sensitive to action of an antibiotic.
The route of administration and doses
enter Ampicillin intramusculary
the Single dose of drug for adults makes 0.5 g, daily – 2-3 g, in heavy infections of 1-2 g each 4-6 hours, the daily dose can be increased up to 10 g. To newborn children drug appoint in a daily dose 100 mg/kg, to children of other age groups – 50 mg/kg. At a heavy course of an infection the specified doses can be doubled.
The daily dose is entered into 4-6 receptions.
Solution for intramuscular introduction is prepared by ex tempore, adding to bottle contents (0.5 g) of 2 ml of water for injections. Treatment duration – 7-10 days depending on disease severity.
– skin rash, a small tortoiseshell, a Quincke’s edema
– in rare instances – an acute anaphylaxis
– dysbacteriosis, gastritis, dryness in a mouth, change of taste, an abdominal pain, vomiting, nausea, diarrhea
– an eosinophilia, hemolytic anemia, a pancytopenia, thrombocytopenia, a granulocytopenia
– acute interstitial nephrite
– increase in content of serumal transaminases
– symptoms of excitement of the central nervous system, twitching of muscles and a spasm
– hypersensitivity to drugs of group of penicillin
– bronchial asthma, hay fever
– heavy abnormal liver functions
– digestive tract diseases in the anamnesis (especially the colitis connected with use of antibiotics)
– an infectious mononucleosis
– a lymphoid leukosis
– the lactation period
Antacids, a glycosamine, depletive, food and aminoglycosides slow down a swelling and painful feelings in the place of an injection of the Contraindication and reduce absorption, ascorbic acid increases absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, Cycloserinum, Vancomycinum, rifampicin) – sinergidny action, bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) antagonistic.
Increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and the prothrombin ratio), reduces efficiency of estrogensoderzhashchy oral contraceptives (it is necessary to use additional methods of contraception), medicines in the course of which metabolism PABK is formed, of ethinylestradiol (in the latter case risk of developing bleedings of ‘break’ increases).
Diuretics, Allopyrinolum, oksifenbutazon, the phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs blocking canalicular secretion increase concentration (due to decrease in canalicular secretion).
Allopyrinolum increases risk of developing skin rash. Reduces clearance and increases toxicity of a methotrexate. Strengthens digoxin absorption.
With care – allergic diseases, a renal failure, children’s age (up to 1 month).
At emergence of allergic reactions it is necessary to stop administration of drug and to carry out the desensibilizing therapy.
The period of pregnancy and a lactation
Use of ampicillin during pregnancy and a lactation perhaps after careful weighing by the attending physician of a ratio of advantage and possible risk
Symptoms – nausea, vomiting, diarrhea, disturbance of introduction and electrolytic balance
Treatment – to wash out a stomach, to appoint salt laxatives, drugs for maintenance of water and electrolytic balance and symptomatic therapy.
A form of release and packing
Powder for preparation of solution for intramuscular introduction, on 500 mg in bottles. 50 bottles place in boxes of cardboard with the application of instructions for use.
To Store storage conditions at a temperature from +18 to +20 °C, in the dry, protected from light place.
To store the place, inaccessible for children!
not to use an expiration date after the expiration date specified on packing.
According to the prescription
JSC Biokhimik Producer, Russia, 430030, Saransk, st. Vasenko, 15 A.
Ph. (8342) 47-00-46
Fax: (8342) 24-21-27, 32-79-41