for medical use
of AMPICILLIN medicine
the Trade name
the International unlicensed
name Ampicillin Dosage Form Powder for preparation of solution for intravenous and intramuscular administration of 500 mg, 1000 mg, 2 g
One bottle contains
active agent – sodium ampicillin (in terms of ampicillin) 500 mg, 1000 mg and 2 g
Powder of white color. It is hygroscopic
Antibacterial drugs for system use. Beta laktamnye antibacterial drugs – Penicillin.
Penicillin of a broad spectrum of activity
the ATX J01CA01 Code
Pharmacokinetics Communication properties with proteins of plasma – 20%. At parenteral administration (in/in, in oil) concentration in blood exceeds created at intake. It is evenly distributed in bodies and body tissues, it is found in therapeutic concentration in pleural, peritoneal, amniotic and synovial liquids, liquor, contents of blisters, urine (high concentrations), a mucous membrane of intestines, bones, a gall bladder, lungs, tissues of female genitals, bile, in a bronchial secret (in a purulent bronchial secret accumulation weak), paranasal sinuses, liquid of a middle ear, saliva, fruit fabrics. Badly gets through a blood-brain barrier, but its permeability increases at inflammation of a meninx.
Elimination half-life of drug (T1/2) – 1–2 h.
It is removed mainly by kidneys (70-80%), in urine very high concentrations of not changed antibiotic, partially with bile, at nursing mothers are created – with milk. Does not kumulirut. Is removed at a hemodialysis.
Ampicillin – an antibiotic of a broad spectrum of activity from group of semi-synthetic penicillin. Works bakteritsidno due to suppression of synthesis of a cell wall of bacteria. 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 aerobic bacteria: Staphylococcus spp. (the strains which are not producing penicillinase and other beta lactamelements, Streptococcus spp., including alpha and beta and hemolytic streptococci, Streptococcus pneumoniae), Bacillus anthracis, Listeria spp. It is moderately active against the majority of enterococci of Clostridium spp. majority of enterococci of Enteroccocus spp. (including Enteroccocus faecalis).
Gram-negative aerobic bacteria (the strains which are not developing some beta lactamazu): Bordetella pertussis, Neisseria meningitidis, Proteus mirabilis, Yersinia multocida (before Pasteurella), many types of Salmonella spp., Shigella spp., Escherichia coli, anaerobe bacterias: Clostridium spp.
It is not active concerning penitsillinazoprodutsiruyushchy strains of Staphylococcus spp., all strains of Pseudomonas aeruginoza, Proteus vulgaris, the majority of strains of Klebsiella spp. and Enterobacter spp., some strains of Escherichia coli, mycoplasmas, chlamydias, rickettsiae.
– bronchitis, pneumonia, lung abscess
– sinusitis, tonsillitis, average otitis
– pyelonephritis, a pyelitis, cystitis, an urethritis
– a cholangitis, cholecystitis
– the ugly face, impetigo which are again infected a dermatosis
– musculoskeletal system infections
– a typhoid and a paratyphoid, dysentery, salmonellosis (including carriage)
– an endocarditis (prevention and treatment)
– gonorrhea (including a gonorrheal urethritis, a gonorrheal cervicitis)
the Route of administration and doses
Intravenously (in / c) struyno and by drop infusion, intramusculary (in oil).
Doses and duration of treatment establish individually depending on weight, localization of an infection and sensitivity of a contagium. In infections of a medium-weight course to adults and children with body weight over 20 kg enter intravenously or intramusculary 250-500 mg each 6 h, at heavy treatment – 1000-2000 mg each 3-4 h.
Listeriosis – on 50 mg/kg each 6 h.
Typhus fever – on 25 mg/kg each 6 h.
In a gonococcal urethritis – 3.5 g once.
Maximum daily dose of 14 g/days.
In a renal failure the dose adjustment depending on glomerular filtration rate is required:
– at clearance of creatinine of 20-30 ml/min. – 2/3 usual doses
– at clearance of creatinine less than 20 ml/min. – 1/3 usual doses.
In the profound renal failure the ampicillin dose in 8 hours should not exceed 1 g.
To children (in meningitis): the newborn with body weight to 2 kg – each 12 h, in oil on 25-50 mg/kg, in the first week of life, then 50 mg/kg each 8 h, newborn with the body weight of 2 kg and above – 50 mg/kg each 8 h in the first week of life, then 50 mg/kg each 6 h. At other indications in oil to children with body weight to 20 kg – 12.5-25 mg/kg each 6 h.
Duration of treatment depends on disease severity (of 5-10 days to 2-3 weeks, and at chronic processes – from 1 to 3 months).
Solution for intramuscular introduction is prepared, adding to bottle contents water for injections in quantity: 2 ml on a bottle of 500 mg, 4 ml – on a bottle of 1000 mg and 6 ml – on a bottle of 2 g.
For intravenous jet administration the single dose of drug (no more than 2 g) is dissolved in 5-10 ml of water for injections or 0.9% of solution of sodium of chloride and entered slowly within 3-5 min. At the single dose exceeding 2 g, the drug is administered only intravenously by drop infusion.
For intravenous drop administration the single dose of drug (2-4 g) is dissolved in the small volume of water for injections (7.5-15 ml respectively), then the received solution of an antibiotic add 0.9% of solution of sodium of chloride to 125-250 ml or 5-10% of solution of a dextrose enter with a speed of 60-80 thaws a minute.
At drop introduction to children as solvent use 5-10% dextrose solution (30-50 ml depending on age).
Solutions use right after preparation.
Before prescribing of ampicillin it is necessary to define sensitivity of an infestant to drug.
– peeling of skin, an itching, urticaria, rhinitis, conjunctivitis, a Quincke’s edema
– dysbacteriosis, an abdominal pain, nausea, vomiting
– fever, an arthralgia, an eosinophilia, erythematic and makulopapulezny rash, exfoliative dermatitis, a multiformny exudative erythema, including Stephens-Johnson, the reactions similar to a serum disease
– stomatitis, gastritis, dryness in a mouth, change of taste, diarrhea, stomatitis, a glossitis, an abnormal liver function, moderate increase in level of hepatic transaminases, a pseudomembranous coloenteritis
– the excited state, aggression, uneasiness, confusion of consciousness, change of behavior
– a leukopenia, a neutropenia, thrombocytopenia
– acute anaphylaxis.
– a depression, spasms (at therapy by high doses)
– an agranulocytosis, anemia
Other side reactions
– a candidiasis of a vagina
it is rare:
– interstitial nephrite, a nephropathy, superinfection (especially at patients with chronic diseases or reduced resistance of an organism)
Local reactions: pain in the injection site,
– hypersensitivity to drug (including to penicillin, cephalosporins, karbapenema)
– an infectious mononucleosis
– a lymphoid leukosis
– a liver failure
– digestive tract diseases in the anamnesis (especially the colitis connected with use of antibiotics)
– the lactation period
Pharmaceutical is incompatible with aminoglycosides.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, Cycloserinum, Vancomycinum, rifampicin) – have sinergidny effect, bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) – antagonistic.
Ampicillin 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 paraaminobenzoic acid is formed, ethinylestradiol (in the latter case risk of developing bleedings of break increases).
Diuretics, Allopyrinolum, oksifenbutazon, the phenylbutazone, non-steroidal anti-inflammatory drugs and other medicines blocking canalicular secretion increase concentration of Ampicillin in plasma (due to decrease in canalicular secretion).
Allopyrinolum increases risk of developing skin rash.
Reduces clearance and increases toxicity of a methotrexate.
Synergism of antibacterial action is observed at co-administration with aminoglikozidny antibiotics (but not mixing in one syringe!).
With care: bronchial asthma, a pollinosis and other allergic diseases, a renal failure, bleedings in the anamnesis, children’s age up to 1 month.
At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys.
Development of superinfection due to growth of microflora, insensitive to it, is possible that demands corresponding change of antibacterial therapy.
At treatment of patients with bacteremia (sepsis) development of reaction of a bacteriolysis (Yarisha-Gerksgeymer’s reactions) is possible.
At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.
At treatment of the slight diarrhea arising against the background of course treatment it is necessary to avoid prescribing of the antidiarrheal drugs reducing an intestines vermicular movement, it is possible to use a kaolin or attapulgitsoderzhashchy antidiarrheal means.
In heavy diarrhea it is necessary to see a doctor.
Treatment has to continue surely for 48-72 more h after disappearance of clinical signs of a disease.
At not heavy course of infections at children it is more preferable to appoint drug in the form of suspension.
Pregnancy and the period of a lactation
Use of drug during pregnancy is possible only when the expected advantage for mother exceeds potential risk for a fruit. At intake of ampicillin the development of decrease in a tone of a uterus and weakness of labor pains is possible.
In need of prescribing of drug in the period of a lactation it is necessary to stop breastfeeding.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment needs to abstain from control of motor transport and occupation potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Symptoms: nausea, vomiting, diarrhea, disturbance of water and electrolytic balance (as a result of vomiting and diarrhea), strengthening of side effects.
Treatment: symptomatic. It is removed by means of a hemodialysis.
A form of release and packing
On 500 mg, 1000 mg and 2.0 g of active agent in the bottles with a capacity of 10 ml hermetically corked by the rubber bungs which are pressed out by caps aluminum or the caps combined aluminum with plastic covers.
On a plastic cover the trademark of the enterprise executed by a casting method under pressure is put.
On 1 bottle of 1000 mg or 2 g with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
On 50 bottles of 500 mg or 1000 mg with 5 iinstruktion on medical use in the state and Russian languages place in a box of cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not above 20 °C.
To store out of children’s reach!
not to use a period of storage after an expiration date.
According to the prescription
JSC Sintez Producer,
Russia 640008. Barrow, Konstitutsii Avenue, 7.
ph./fax (3522) 48-16-89
the Owner of the registration certificate
of JSC Sintez, Russia
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of STOFARM LLP,
000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14
ph. 714 228 01 79
To Develop email@example.com