Instructions for use Ampicillin tablets 250 mg No. 20
Composition
active ingredient: ampicillin;
1 tablet contains ampicillin trihydrate equivalent to ampicillin 250 mg;
excipients: potato starch, talc, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or almost white color, round shape with a flat surface, with a bevel and a score.
Pharmacotherapeutic group
Beta-lactam antibiotics, penicillins. Broad-spectrum penicillins. ATX code J01C A01.
Pharmacological properties
Pharmacodynamics
Ampicillin trihydrate has a broad spectrum of antimicrobial activity. It is active against gram-positive microorganisms (Streptococcus spp., including S. pneumoniae, Enterococcus spp., etc.) and a number of gram-negative microorganisms (Neisseria meningitidis, N. gonorrhoeae, Escherichia coli, Shigella spp., Salmonella spp., Proteus spp., Bordetella pertussis, some strains of Haemophilus influenzae, etc.). The drug is destroyed by penicillinase and therefore does not act on penicillinase-producing strains of microbes (for example, Staphylococcus spp.).
Pharmacokinetics
It is well absorbed when taken orally, penetrating into the tissues and biological fluids of the body. The drug is not destroyed in the acidic environment of the stomach. When taken orally, the maximum concentration of the drug in the blood is determined after 1.5-2 hours. The time for the concentration of the drug in the blood to decrease by half is 60-120 minutes. It is excreted mainly by the kidneys, with high concentrations of unchanged antibiotic formed in the urine, and a large amount also enters the bile. Approximately 30% of the applied dose is excreted within 6-8 hours, approximately 60% within 24 hours. Ampicillin trihydrate does not accumulate with repeated use, which allows it to be used for a long time in large doses.
Indication
Infections caused by microorganisms sensitive to the drug:
biliary system infections (cholangitis, cholecystitis); respiratory tract and ENT infections (pneumonia, bronchitis, lung abscess, sinusitis, pharyngitis, otitis, tonsillitis); meningitis; gastroenteritis caused by Shigella or Salmonella, typhoid and paratyphoid fever; bacterial endocarditis; genitourinary system infections (pyelitis, pyelonephritis, cystitis, urethritis, gonorrhea); peritonitis; septicemia; skin and soft tissue infections.
Contraindication
Hypersensitivity to ampicillin and other β-lactam antibiotics (penicillins, cephalosporins, carbapenems), as well as to any auxiliary components of the drug. Severe liver dysfunction. Infectious mononucleosis. Leukemia. HIV infections.
Interaction with other medicinal products and other types of interactions
Ampicillin enhances the effect of anticoagulants, aminoglycoside antibiotics, reduces the effect of oral contraceptives. With the simultaneous use of ampicillin with oral estrogen-containing drugs, a decrease in their effectiveness is noted due to the weakening of the hepatic circulation of estrogens.
Probenecid reduces the tubular secretion of ampicillin, which increases the risk of its toxic effects.
Allopurinol increases the likelihood of skin rash.
High doses of ampicillin reduce the level of atenolol in the blood plasma, so it is recommended to use these drugs separately, taking atenolol first, and then ampicillin.
Ampicillin reduces the clearance and increases the toxicity of methotrexate, and enhances the absorption of digoxin.
When used simultaneously with chloroquine, the absorption of ampicillin is reduced.
When ampicillin interacts with macrolides, paromomycin, tetracyclines, chloramphenicol, the effect of both drugs is reduced. Ampicillin may reduce the effect of sodium benzoate.
The drug is pharmaceutically incompatible with tetracyclines, chloramphenicol (chloramphenicol), amphotericin, clindamycin, erythromycin, lincomycin, metronidazole, polymyxin B, acetylcysteine, chlorpromazine, hydralazine, dopamine, heparin, metoclopramide.
Application features
Before starting therapy, it is necessary to exclude the presence of hypersensitivity in the patient to ampicillin and other β-lactam antibiotics.
During treatment, systematic monitoring of kidney and liver function and peripheral blood picture is required. In case of bronchial asthma, hay fever and other allergic diseases, the drug should be used simultaneously with desensitizing agents. If signs of anaphylactic shock appear, urgent measures should be taken to remove the patient from this condition.
When using high doses in patients with impaired renal function, a toxic effect on the central nervous system is possible.
It is necessary to stop taking the drug if a skin rash occurs.
Patients with lymphocytic leukemia have an increased risk of developing a skin rash.
Prolonged or repeated use may lead to the rapid growth of resistant microflora and the development of superinfections.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, some patients may experience adverse reactions from the central nervous system (see the "Adverse Reactions" section), therefore caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
No teratogenic effect of ampicillin has been identified. However, the use of ampicillin during pregnancy is possible only if the expected benefit to the woman outweighs the potential risk to the fetus.
Ampicillin passes into breast milk in low concentrations. Breastfeeding should be discontinued during treatment with the drug.
Method of administration and doses
The drug should be used as prescribed by a doctor. Ampicillin should be administered orally 30 minutes before or 2 hours after a meal. The duration of treatment with ampicillin is set individually (from 5 days to 3 weeks or more), depending on the characteristics of the disease, the patient's age, the effectiveness of therapy and the state of kidney function. After the disappearance of clinical signs of the disease, ampicillin should be taken for another 2-3 days.
The recommended single standard dose for adults and children over 14 years of age is 250-1000 mg every 6 hours. The dosage regimen is established by the doctor.
Urinary tract infections: 500 mg every 8 hours.
Typhoid and paratyphoid fever: 1000-2000 mg every 6 hours. In acute disease – for 2 weeks, if the patient is a carrier – for 4-12 weeks.
Uncomplicated gonorrhea: a single dose of 2000 mg of ampicillin in combination with 1000 mg of probenecid. It is recommended that the course of treatment be repeated in women.
Respiratory tract and ENT infections: 250 mg every 6 hours.
Pneumonia: 500 mg every 6 hours.
Children over 6 years of age should be prescribed the drug in a daily dose of 100 mg/kg of body weight. The daily dose should be divided into 4-6 doses.
Patients with severe renal impairment (creatinine clearance less than 10 ml/min) require correction of the dosing regimen: the dose of the drug should be reduced or the interval between doses should be increased.
Children
This dosage form of ampicillin should not be used in children under 6 years of age.
Overdose
In case of overdose, toxic effects on the central nervous system (dizziness, headache), dyspeptic phenomena (nausea, vomiting, loose stools), allergic reactions in the form of skin rash are possible. In case of symptoms of overdose, the drug should be immediately discontinued and, if necessary, symptomatic treatment should be carried out: gastric lavage, use of activated charcoal, saline laxatives, correction of water and electrolyte balance, hemodialysis. In case of allergies, antihistamines and desensitizing agents are indicated.
Adverse reactions
On the part of the immune system: allergic reactions, including rashes (urticaria, maculopapular), itching, hyperemia, urticaria, rhinitis, conjunctivitis, fever, joint pain, eosinophilia, exfoliative dermatitis, purpura, erythema multiforme exudative, Stevens-Johnson syndrome, Quincke's edema, anaphylactic shock.
Gastrointestinal: nausea, vomiting, diarrhea, taste changes, abdominal pain, stomatitis, glossitis, dry mouth, intestinal dysbacteriosis, gastritis, enterocolitis, hemorrhagic colitis. During treatment or for several weeks after the end of antibiotic therapy, there is a possibility of developing pseudomembranous colitis.
From the liver and hepatobiliary system: hepatitis, cholestatic jaundice.
From the side of the central and peripheral nervous system: when using high doses in patients with renal failure - tremor, convulsions, headache, neuropathy.
Laboratory indicators: moderate increase in the activity of "liver" transaminases, lactate dehydrogenase, alkaline phosphatase, creatinine, pseudopositive results of non-enzymatic glucosuric tests and Coombs' reaction.
Others: reversible disorders of hematopoiesis (leukopenia, thrombocytopenia, hemolytic anemia, agranulocytosis), interstitial nephritis, superinfection, candidiasis. When using Ampicillin in patients with bacteremia (sepsis), a bacteriolysis reaction (Jarish-Herxheimer reaction) is possible.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
250 mg tablets: 10 tablets in a blister; 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat", Ukraine.
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
