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An effective, widely used drug is ampicillin trihydrate. An effective widely used drug ampicillin trihydrate Country of origin of the manufacturer

Ampicillin trihydrate

International nonproprietary name

Ampicillin

Dosage form

Tablets, 250 mg

Compound

One tablet contains

active substance- ampicillin trihydrate 290.0 mg

(in terms of 100% substance 250.0 mg),

excipients: potato starch, talc, sodium starch glycolate, calcium stearate.

Description

White, flat-cylindrical tablets. On one side of the tablet there is a chamfer and a mark, on the other there is a chamfer and a corporate logo in the form of a cross.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Ampicillin

ATX code J01CA01

Pharmacological properties

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract, bioavailability is 30-40%. The maximum concentration is reached after 1.5-2 hours. In the blood, it reversibly binds to plasma proteins (about 20%). Easily penetrates histohematic barriers into all organs and tissues. It is found in high concentrations in pleural, peritoneal and synovial fluid. It penetrates the blood-brain barrier poorly (permeability increases with inflammation of the meninges).

About 30% of the drug is metabolized in the liver. The half-life is 1-2 hours. It is excreted by the kidneys through tubular secretion unchanged (75-80%), while high concentrations of ampicillin are created in the urine. To a lesser extent, it is excreted with bile into the intestines. In case of renal failure, the excretion of ampicillin slows down. In persons over 60 years of age, the half-life of the drug is 4.9-6.7 hours.

Pharmacodynamics

Ampicillin trihydrate is a broad-spectrum semisynthetic penicillin antibiotic. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls. Inhibits peptidoglycan polymerase and transpeptidase, prevents the formation of peptide bonds and disrupts the late stages of cell wall synthesis of a dividing microorganism. The resulting defects in the membrane reduce the osmotic stability of the bacterial cell and cause its death (lysis). Ampicillin is active against most aerobic gram-positive bacteria: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp., Enterococcus spp., Listeria monocytogenes; gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae. Does not affect penicillinase-forming staphylococci. Acid resistant.

Indications for use

Infections of the ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media)

Upper and lower respiratory tract infections (bronchitis, pneumonia)

Acute and chronic urinary tract infections (pyelonephritis,

pyelitis, cystitis, urethritis)

Gastrointestinal tract infections (salmonellosis,

salmonella carriage, typhoid fever, cholangitis, cholecystitis)

Gonorrhea

Directions for use and doses

The drug is taken orally, 30 minutes before or 2 hours after meals.

The course of treatment is 5-10 days. The dosage and duration of treatment are determined individually depending on the severity of the disease, the location of the infection and the sensitivity of the pathogen.

For adult patients

Infections of ENT organs,upper and lower respiratory tract

A single dose is 250 mg - 500 mg, 1-2 tablets 4 times a day.

Urinary tract infections andgastrointestinal tract infections (cholangitis, cholecystitis, salmonellosis)

A single dose is 500 mg, 2 tablets 4 times a day.

Typhoid fever

Acute course: daily dose - 1-2 g, 1-2 tablets 4 times a day, for 2 weeks.

Carriage: daily dose - 1-2 g, 1-2 tablets 4 times a day, for 4-12 weeks, under the control of the results of bacteriological examination of stool.

Acute gonorrhea

The drug is prescribed once, 3 g (12 tablets) once a day.

Elderly patients

There is no need for dose adjustment.

Renal dysfunction

Dose reduction should be considered if renal function is impaired.

With creatinine clearance > 30 ml/min: daily dose - 1 g, interval between doses of the drug is 6-8 hours.

With creatinine clearance< 30 мл/мин: суточная доза - 1 г, интервал между приемами препарата составляет 12 часов.

For children over 6 years old

The dosage is selected individually, depending on the child’s weight and the severity of the disease.

The daily dose is divided into 4 doses.

Side effects

Often

Nausea, vomiting, flatulence, diarrhea

Uncommon

Candidiasis, dysbacteriosis

Itching, urticaria, Quincke's edema, rhinitis, conjunctivitis

Rarely

Fever, arthralgia, eosinophilia, erythematous and maculopapular

rash, exfoliative dermatitis, exudative erythema multiforme,

incl. Stevens-Johnson, reactions similar to serum sickness

Stomatitis, glossitis, dry mouth, change in taste, gastritis, disorder

liver function, increased levels of “liver” transaminases,

pseudomembranous colitis

Agitation or aggressiveness, anxiety, confusion,

behavior change

Leukopenia, neutropenia, thrombocytopenia

Interstitial nephritis, nephropathy

Superinfection (especially in patients with chronic diseases

or reduced body resistance)

Very rarely

Anaphylactic shock

Depression

Seizures (with high dose therapy)

Agranulocytosis, anemia

Contraindications

Hypersensitivity to ampicillin, cephalosporins, other

penicillin drugs and auxiliary components

drug

Infectious mononucleosis, lymphocytic leukemia

Liver dysfunction

History of gastrointestinal tract diseases (especially colitis,

associated with the use of antibiotics)

Children under 6 years old

Lactation period

Drug interactions

With the simultaneous use of Ampicillin trihydrate with bactericidal antibiotics, including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin, synergism appears; with bacteriostatic antibiotics, including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides - antagonism.

When used simultaneously with anticoagulants and aminoglycoside antibiotics, their effectiveness increases.

Ampicillin trihydrate reduces the effectiveness of estrogen-containing oral contraceptives.

Probenecid, diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs reduce the tubular secretion of Ampicillin trihydrate, which may be accompanied by an increase in its concentration in the blood plasma.

Ampicillin trihydrate reduces the excretion of methotrexate, which may increase the toxicity of the latter.

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce, and ascorbic acid increases the absorption of Ampicillin trihydrate.

With simultaneous use of Ampicillin trihydrate with allopurinol, the likelihood of skin rash increases, especially in patients with hyperuricemia.

Special instructions

Caution should be exercised when prescribing Ampicillin trihydrate to patients with allergic diseases (hay fever, allergic conjunctivitis, bronchial asthma), due to the possible development of an anaphylactic reaction.

If allergic reactions occur, the drug should be discontinued and desensitizing therapy should be prescribed.

During treatment, systematic monitoring of kidney function, liver function and general blood tests is necessary.

Patients with impaired renal function require dose adjustment according to creatinine clearance values.

When used in high doses in patients with renal failure, the drug may have a toxic effect on the central nervous system.

Long-term use of antibiotics can lead to the development of superinfection, overgrowth of Candida and Pseudomonas.

To prevent the development of candidiasis, antifungal drugs should be prescribed simultaneously with Ampicillin trihydrate.

Pregnancy and lactation

Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Ampicillin trihydrate is excreted into breast milk in low concentrations. If necessary, use during lactation should stop breastfeeding.

Features of the effect of the drug on the ability to drive vehicles or potentially dangerous mechanisms

Caution should be exercised when driving vehicles or working with potentially dangerous machinery.

Overdose

Symptoms: nausea, vomiting, diarrhea, cramps, increased side effects.

Treatment: drug withdrawal, gastric lavage, taking activated charcoal and saline laxatives, hemodialysis, hemoperfusion, symptomatic therapy. There is no specific antidote.

Release form and packaging

10 tablets in a blister pack made of polyvinyl chloride film and aluminum foil.

Outline packages are placed in cardboard boxes.

Each box contains approved instructions for medical use in the state and Russian languages.

Storage conditions

Store in a dry place, protected from light, at a temperature of 2 to 30°C.

Keep out of the reach of children!

Shelf life

After the expiration date, do not use the drug.

Conditions for dispensing from pharmacies

By prescription

Manufacturer

JSC "Khimpharm", Kazakhstan

Registration Certificate Holder

JSC "Khimpharm", Kazakhstan

Address of the hosting organization on the territory of the Republic of Kazakhstan complaints from consumers regarding product (product) quality

JSC "Khimpharm", Shymkent, KAZAKHSTAN,

st. Rashidova, w/n, t/f: 560882

Phone number 7252 (561342)

Fax number 7252 (561342)

Email address [email protected]

Ampicillin Trihydrate: instructions for use and reviews

Latin name: Ampicillin trihydrate

ATX code: J01CA01

Active ingredient: ampicillin

Manufacturer: Biosintez, JSC (Russia), Biokhimik, JSC (Russia), Uralbiofarm, JSC (Russia), Moskhimfarmpreparaty im. N. A. Semashko (Russia)

Updating the description and photo: 23.11.2018

Ampicillin Trihydrate is a semi-synthetic antibiotic of the penicillin series with a broad spectrum of action with bactericidal activity.

Release form and composition

Dosage forms of Ampicillin Trihydrate:

  • tablets: white, depending on the manufacturer, either round with biconvex surfaces and a score, or round flat-cylindrical with a chamfer and a score, or a flat-cylindrical shape with a chamfer and a score (10, 20, 24 or 30 pcs. in a blister pack, in a cardboard a pack of 1 or 2 packages; 10 pcs. in a contour-free package, in a cardboard pack 1 or 2 packages, for hospitals - in a cardboard box of 10, 20, 500, 600, 800 or 1000 pcs. in a glass jar, 10, 20, 30, 40 or 50 pcs. in a polymer jar, 1 jar in a cardboard pack);
  • capsules: white (10 pieces in a blister, 1 or 2 blisters in a cardboard box).

1 tablet contains:

  • additional components: depending on the manufacturer – potato starch, magnesium/calcium stearate, talc; additionally – povidone (low molecular weight medical polyvinylpyrrolidone with a molecular weight of 12,600 + 2700).

1 capsule contains:

  • active substance: ampicillin (in the form of trihydrate) – 250 mg;
  • additional components: potato starch, powdered sugar.

Pharmacological properties

Pharmacodynamics

Ampicillin Trihydrate is a semi-synthetic penicillin with a broad spectrum of action, which has a bactericidal effect by inhibiting the synthesis of the bacterial cell wall. The drug is active against the following microorganisms:

  • gram-positive: Streptococcus pneumoniae, alpha and beta hemolytic streptococci, Bacillus anthracis, Staphylococcus spp., Clostridium spp.;
  • gram-negative: Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Yersinia multocida (formerly Pasteurella), Proteus mirabilis, Escherichia coli, many species of Salmonella spp., Shigella spp.;
  • aerobic non-spore-forming bacteria.

Ampicillin Trihydrate demonstrates moderate activity against Listeria spp., most Enterococcus spp., including Enterococcus faecalis.

The antibiotic is ineffective against penicillinase-producing strains of Staphylococcus spp., most strains of Klebsiella spp. and Enterobacter spp., all strains of Pseudomonas aeruginosa.

Pharmacokinetics

After oral administration, the active substance is quickly and effectively absorbed, but its bioavailability is 40%. When taking ampicillin at a dose of 500 mg, its maximum concentration in the blood (Cmax) can be 3-4 μg/ml, and the time to reach it (T Cmax) can be 2 hours. The drug binds to proteins by 20%, the half-life (T ½) is 1–2 hours.

Ampicillin trihydrate is characterized by uniform distribution in therapeutic concentrations in the following tissues and organs of the body: synovial, pleural, peritoneal and amniotic fluids, cerebrospinal fluid, urine (in high concentrations), contents of blisters, bile, intestinal mucosa, gall bladder, bones, lungs, tissues of the female genital organs, bronchial secretions (if purulent - slight accumulation), middle ear fluid (if it is inflamed), paranasal sinuses, saliva, fetal tissue.

The active substance does not pass well through the blood-brain barrier (permeability increases with inflammation of the meninges). It is excreted primarily by the kidneys (approximately 70-80%), while high concentrations of unchanged drug are formed in the urine. Partially excreted with bile, when used during lactation - with mother's milk.

Ampicillin trihydrate does not accumulate with repeated doses and is removed during hemodialysis.

Indications for use

According to the instructions, Ampicillin Trihydrate is recommended for the treatment of the following infectious and inflammatory lesions caused by microorganisms sensitive to its action:

  • pharyngitis, tonsillitis, sinusitis, otitis media, pneumonia, bronchitis, lung abscess;
  • cholecystitis, cholangitis;
  • urethritis, cystitis, pyelitis, pyelonephritis;
  • cervicitis;
  • gonorrhea;
  • impetigo, erysipelas, secondary infected dermatoses;
  • dysentery, typhoid fever, paratyphoid fever, salmonellosis (including carriage);
  • infections of the musculoskeletal system.

Additional indications (depending on manufacturer):

  • pasteurellosis, listeriosis;
  • chlamydial infections in pregnant women (in case of intolerance to erythromycin).

Contraindications

Absolute:

  • history of gastrointestinal diseases (especially colitis caused by taking antibiotics);
  • liver failure;
  • lymphocytic leukemia;
  • infectious mononucleosis;
  • age up to 3 years;
  • breastfeeding period;
  • hypersensitivity to any of the components of Ampicillin Trihydrate, as well as to other penicillins, carbapenems, cephalosporins.

Relative (ampicillin should be used with extreme caution):

  • history of bleeding;
  • renal failure;
  • hay fever, bronchial asthma and other allergic diseases (including a history);
  • pregnancy.

Instructions for use of Ampicillin Trihydrate: method and dosage

Ampicillin trihydrate is taken orally 30–60 minutes before meals with a small amount of water.

Adults and children over 3 years of age with a body weight of more than 20 kg are recommended to use an antibiotic every 6 hours at a dose of 250–500 mg. The maximum permissible daily dose is 4000 mg.

Children over 3 years old with a body weight of less than 20 kg are recommended to take the drug every 8 hours at 16.7–33.3 mg/kg or every 6 hours at 12.5–25 mg/kg.

When treating gonococcal urethritis, Ampicillin Trihydrate is taken once at a dose of 3500 mg.

The dosage regimen and course of treatment are determined by the attending physician individually, taking into account the sensitivity of the pathogen and the severity of the infection. The duration of drug therapy can vary from 5–10 to 14–20 days, and in chronic processes it can reach several months.

Side effects

  • digestive system: stomatitis, dry oral mucosa, dysbacteriosis, change in taste, glossitis, nausea, abdominal pain, vomiting, diarrhea, gastritis, moderate increase in the activity of liver transaminases, pseudomembranous colitis;
  • allergic reactions: urticaria, itching, peeling of the skin, conjunctivitis, rhinitis, angioedema; rarely - arthralgia, fever, erythematous or maculopapular rash, exudative erythema, including Stevens-Johnson syndrome, exfoliative dermatitis, eosinophilia, reactions similar to serum sickness; isolated cases - anaphylactic shock;
  • nervous system: tremor, headache, anxiety, agitation/aggression, depression, behavior changes, confusion, convulsions (when using high doses);
  • laboratory parameters: anemia, thrombocytopenia, neutropenia, leukopenia, agranulocytosis;
  • other: vaginal candidiasis, nephropathy, interstitial nephritis, superinfection (mainly in the presence of chronic diseases or reduced body resistance), rash (may go away without discontinuing Ampicillin Trihydrate).

Overdose

Symptoms of an overdose of Ampicillin Trihydrate may include nausea, diarrhea, vomiting, water and electrolyte imbalance (caused by vomiting and diarrhea); manifestations of toxic effects on the nervous system (mainly in patients with renal failure).

In case of overdose, gastric lavage, activated charcoal, saline laxatives, drugs to maintain water and electrolyte balance, and symptomatic medications are prescribed. The drug is removed by hemodialysis.

Special instructions

During treatment, systematic monitoring of the functional state of the hematopoietic organs, kidneys and liver is required.

During therapy with the drug in patients with bacteremia (sepsis), there is a risk of developing a bacteriolysis reaction (Jarisch-Herxheimer reaction).

In the event of an allergy, at its first symptoms, it is necessary to stop using the antibiotic and carry out desensitizing treatment.

Due to the growth of microflora insensitive to Ampicillin Trihydrate, superinfection may occur; in such cases, appropriate adjustment of antibacterial therapy is required.

If there is an existing hypersensitivity to penicillins, the development of cross-allergic reactions with cephalosporin antibiotics may occur.

If mild diarrhea caused by Clostridium difficile occurs during a course of taking the drug, antidiarrheals that reduce intestinal motility should not be used to treat it. The use of kaolin- or attapulgite-containing antidiarrheal drugs is allowed; discontinuation of the antibiotic is possible. For severe diarrhea, consult a doctor.

Treatment with Ampicillin Trihydrate should be continued for another 48–72 hours after the clinical symptoms of the disease have resolved.

Impact on the ability to drive vehicles and complex mechanisms

During therapy, patients driving vehicles or other complex and potentially dangerous equipment should be careful.

Use during pregnancy and lactation

During pregnancy, ampicillin is allowed only if the expected benefit of therapy for the mother far outweighs the possible threat to the health of the fetus.

Since Ampicillin Trihydrate passes into breast milk in low concentrations, if it is necessary to administer it during lactation, the issue of stopping breastfeeding should be decided.

Use in childhood

Children under 3 years of age are contraindicated to take antibiotics.

For impaired renal function

In the presence of renal failure, Ampicillin Trihydrate should be used with caution, adjusting the dosage regimen taking into account creatinine clearance.

For liver dysfunction

The drug is contraindicated in patients with liver failure.

Drug interactions

  • ascorbic acid: increases the absorption of ampicillin;
  • bactericidal antibiotics, including cephalosporins, aminoglycosides, rifampicin, cycloserine, vancomycin: a synergistic effect is noted;
  • laxatives, antacids, aminoglycosides, glucosamine: absorption of ampicillin slows down and decreases;
  • sulfonamides, lincosamides, macrolides, tetracyclines, chloramphenicol: antagonistic phenomena are observed;
  • indirect anticoagulants: the effectiveness of these drugs increases due to the suppression of intestinal microflora, a decrease in the production of vitamin K and the prothrombin index;
  • drugs, in the process of metabolic transformation of which para-aminobenzoic acid is formed: the effect of these drugs is weakened;
  • ethinyl estradiol: its effect is weakened, the threat of breakthrough bleeding worsens;
  • estrogen-containing oral contraceptives: their effectiveness decreases (other methods of contraception should be used or additional ones should be used);
  • allopurinol: the likelihood of developing a skin rash increases;
  • non-steroidal anti-inflammatory drugs, phenylbutazone, oxyphenbutazone, allopurinol, diuretics and other drugs that block tubular secretion: the plasma level of ampicillin increases (as a result of a decrease in tubular secretion);
  • methotrexate: its clearance decreases and toxicity increases.

Analogs

Analogs of Ampicillin Trihydrate are: Ampicillin, Ampicillin sodium salt-Vial, Ampicillin-AKOS, Ampicillin-Ferein.

Terms and conditions of storage

Store in a place protected from light and moisture, out of reach of children, at a temperature not exceeding 20–25 °C.

The shelf life of tablets is 2 years, capsules are 3 years.

Active ingredient

Ampicillin

Dosage form

pills

Description

The tablets are white, biconvex, scored.

Pharmacotherapeutic group

Antibiotic, semi-synthetic penicillin

J.01.C.A Broad-spectrum penicillins

J.01.C.A.01 Ampicillin

Pharmacodynamics

Semi-synthetic penicillin, broad-spectrum, bactericidal. Acid resistant. Suppresses the synthesis of bacterial cell walls.

Active against gram-positive (alpha- and beta-hemolytic streptococci, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp.), Listeria spp., and gram negative ( Haemophilus influenzae, Neisseria meningitidis, Proteus mirabilis, Yersinia multocida(previously Pasteurella), many types Salmonella spp., Shigella spp., Escherichia coli) microorganisms, aerobic non-spore-forming bacteria.

Moderately active against most enterococci, incl. Enterococcus faecalis. Ineffective against penicillinase-producing strains Staphylococcus spp., all strains Pseudomonas aeruginosa, most strains Klebsiella spp. And Enterobacter spp.

Pharmacokinetics

Absorption when taken orally is high, bioavailability is 40%; time to reach maximum concentration when taking 500 mg orally is 2 hours, maximum concentration is 3-4 mcg/ml. Communication with plasma proteins - 20%. Evenly distributed in organs and tissues of the body, found in therapeutic concentrations in pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, the contents of blisters, urine (high concentrations), intestinal mucosa, bones, gall bladder, lungs, tissues of the female genital organs, bile , in bronchial secretions (in purulent bronchial secretions the accumulation is weak), paranasal sinuses, middle ear fluid (with inflammation), saliva, fetal tissues. It penetrates the blood-brain barrier poorly, its permeability increases with inflammation. The half-life is 1-2 hours. It is excreted mainly by the kidneys (70-80%), and very high concentrations of unchanged antibiotic are created in the urine; partially - with bile, in nursing mothers - with milk. Does not cumulate. Removed by hemodialysis.

Indications

Infectious inflammatory diseases caused by sensitive microorganisms: respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess), kidney and urinary tract infections (pyelonephritis, pyelitis, cystitis, urethritis), gonorrhea, infections biliary system (cholangitis, cholecystitis), chlamydial infections in pregnant women (with erythromycin intolerance), cervicitis, skin and soft tissue infections (erysipelas, impetigo, secondary infected dermatoses); infections of the musculoskeletal system; pasteurellosis, listeriosis, gastrointestinal tract infections (typhoid and paratyphoid, dysentery, salmonellosis, salmonellosis carriage).

Contraindications

Hypersensitivity to drugs of the penicillin group and other beta-lactam antibiotics, infectious mononucleosis, lymphocytic leukemia, liver failure, history of gastrointestinal diseases (especially colitis associated with the use of antibiotics), lactation period, children under 3 years of age and/or overweight less than 20 kg.

With caution

Bronchial asthma, hay fever and other allergic diseases, renal failure, history of bleeding.

Pregnancy and lactation

During pregnancy, ampicillin can be used if the benefit to the mother outweighs the potential risk to the fetus. Ampicillin is excreted in breast milk in low concentrations. If it is necessary to use ampicillin during lactation, the issue of stopping breastfeeding should be decided.

Side effects

From the digestive system: glossitis, stomatitis, gastritis, dry mouth, change in taste, nausea, vomiting, diarrhea, abdominal pain, pseudomembranous enterocolitis, increased activity of liver transaminases.

Laboratory indicators: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia.

From the central nervous system: headache, tremor, convulsions (with high dose therapy).

Allergic reactions: erythematous and maculopapular rash, exfoliative dermatitis, erythema multiforme, skin peeling, itching, urticaria, rhinitis, conjunctivitis, Quincke's edema, fever, arthralgia, eosinophilia; anaphylactic shock.

Others: interstitial nephritis, nephropathy, superinfection (especially in patients with chronic diseases or reduced body resistance), vaginal candidiasis.

Overdose

Symptoms: manifestations of toxic effects on the central nervous system (especially in patients with renal failure); nausea, vomiting, diarrhea, water and electrolyte imbalance (as a result of vomiting and diarrhea).

Treatment: gastric lavage, activated charcoal, saline laxatives, medications to maintain water-electrolyte balance and symptomatic. Eliminated by hemodialysis.

Interaction

Antacids, glucosamine, laxatives, food and aminoglycosides (when taken enterally) slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives (it is necessary to use additional methods of contraception), drugs whose metabolism produces para-aminobenzoic acid, ethinyl estradiol (in the latter case, the risk of breakthrough bleeding increases). Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion increase the concentration of ampicillin in plasma (by reducing tubular secretion). When taken together with allopurinol, the likelihood of skin rash increases.

Reduces clearance and increases toxicity of methotrexate. Enhances the absorption of digoxin.

Special instructions

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

When used in high doses in patients with renal failure, toxic effects on the central nervous system are possible.

When treating patients with bacteremia (sepsis), the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

When treating mild diarrhea during a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided; You can use kaolin- or attapulgite-containing antidiarrheal drugs; discontinuation of the drug is indicated. If diarrhea is severe, consult a doctor.

Storage conditions

List B. In a dry place, protected from light, at a temperature not exceeding 25° C.

Keep out of the reach of children.

Conditions for dispensing from pharmacies

in bottles 10 ml; in a cardboard pack 1 fl.


in bottles.


in bottles; in a cardboard pack 1 fl.


in bottles.


in polyethylene bottles of 150 or 250 ml, complete with a measuring cup; 1 bottle in a cardboard pack


in a blister pack 10 pcs.; in a cardboard pack or without it and in a contour-free packaging 10 pcs.


in aluminum cans; in a drum (2 kg) or plastic bags, 1 can.

Description of the dosage form

Powder for the preparation of a suspension for oral administration is white with a yellowish tint, with a specific odor. The finished suspension is a white suspension with a yellowish tint.

Tablets are white, flat-cylindrical in shape with a chamfer and a score.

The powder for preparing the injection solution is white and hygroscopic.

Pharmacodynamics

Active against gram-positive microorganisms, incl. Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp. (including Enterococcus spp.), gram-negative microorganisms, incl. Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae, Klebsiella pneumoniae, aerobic non-spore-forming bacteria - Listeria monocytogenes. Destroyed by penicillinase, acid-resistant.

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. When administered parenterally (i.m., i.v.), the concentration in the blood exceeds that created when administered orally. T 1/2 - 2 hours. Distributed in most organs and tissues, found in therapeutic concentrations in pleural, peritoneal and synovial fluids. It penetrates the BBB poorly; with inflammation of the meninges, the permeability of the BBB increases sharply. 30% of ampicillin is metabolized in the liver. It is excreted primarily in urine (70–80%) and bile; high concentrations of unchanged drug are created in the urine. Ampicillin trihydrate and ampicillin sodium salt do not accumulate with repeated administrations.

Ampicillin trihydrate: Indications

Infectious and inflammatory diseases caused by ampicillin-sensitive microorganisms, incl. infections of the ear, throat, nose, odontogenic infections, respiratory tract infections (pneumonia, bronchitis, bronchopneumonia, lung abscess), acute and chronic urinary and biliary tract infections (pyelitis, pyelonephritis, cholecystitis), gastrointestinal infections (including salmonellosis ), gynecological infections (including gonorrhea), meningitis, endocarditis, septicemia, sepsis, rheumatism, erysipelas, scarlet fever, skin and soft tissue infections.

Ampicillin trihydrate: Contraindications

Hypersensitivity (including to penicillins and other beta-lactam antibiotics), infectious mononucleosis, lymphocytic leukemia.

Use during pregnancy and breastfeeding

Directions for use and doses

Inside, the suspension is washed down with water. Tablets are taken regardless of meals. The dose is set individually depending on the severity of the disease, the location of the infection and the sensitivity of the pathogen.

Suspension: adults single dose - 0.25-0.5 g 4 times a day, children weighing up to 20 kg - 12.5-25 mg/kg every 6 hours. The duration of treatment depends on the location of the infection and the characteristics of the course of the disease. The maximum dose for adults is 4 g/day.

To prepare a suspension, 62 ml of distilled water is added to a bottle containing 5 g of the drug in a pharmacy (1 ml of the finished suspension contains 50 mg of ampicillin). The suspension is dosed with a dosing spoon having 2 marks: the lower one corresponds to 2.5 ml (125 mg), the upper one corresponds to 5 ml (250 mg). Shake the suspension before use.

Tablets: single dose for adults - 0.25-0.5 g, daily dose - 1-3 g. Children weighing more than 20 kg - 50-100 mg/kg/day, weighing up to 20 kg - 12.5-25 mg/day kg/day The daily dose is taken in 3-4 doses. The maximum daily dose is 4 g.

IM or IV. Before use, first prepare the solution by adding a solvent to the bottle with the powder. For moderate infections in adults - 0.25-0.5 g intramuscularly every 6-8 hours, for severe infections - 1-2 g intravenously 3-4 times a day. For listeriosis - IM or IV 50 mg/kg every 6 hours, for meningitis - 14 g/day (frequency of administration - 6-8 times). The maximum daily dose for adults is 14 g.

For children with severe and moderate infections - 25–50 mg/kg intramuscularly 4 times a day; for meningitis, the daily dose is 100–200 mg/kg for 6–8 administrations.

Ampicillin trihydrate: Side effects

From the cardiovascular system and blood (hematopoiesis, hemostasis): anemia, leukopenia, thrombocytopenia, agranulocytosis.

From the gastrointestinal tract: nausea, vomiting, diarrhea, dysbiosis, pseudomembranous colitis, glossitis, stomatitis, increased activity of liver transaminases.

Allergic reactions: skin rash, itching, urticaria, rhinitis, conjunctivitis, fever, joint pain, eosinophilia, Quincke's edema, exfoliative dermatitis, erythema multiforme, anaphylactic shock, etc.

Use with caution for bronchial asthma, hay fever and other allergic diseases, and desensitizing agents are prescribed at the same time. If allergic reactions occur, the drug is discontinued and desensitizing therapy is prescribed. If signs of anaphylactic shock appear, urgent measures must be taken to remove the patient from this state. In weakened patients, during long-term treatment, superinfection caused by drug-resistant microorganisms (candidiasis) may develop; When treating such patients with the drug, it is advisable to prescribe B vitamins and vitamin C, and, if necessary, nystatin or levorin.

During treatment, systematic monitoring of renal function, liver function (especially in case of liver failure), and peripheral blood patterns is necessary. In patients with impaired renal function, adjustment of the dosage regimen is required in accordance with creatinine clearance values. The use of high doses in patients with renal failure can lead to toxic effects on the central nervous system.

When ampicillin is used in patients with bacteremia (sepsis), a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

Manufacturer

Joint Stock Kurgan Society of Medical Preparations and Products “Sintez”, Russia.

In this article you can read the instructions for use of the drug Ampicillin. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Ampicillin in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Ampicillin analogues in the presence of existing structural analogues. Use for the treatment of sore throat and other infectious diseases in adults, children, as well as during pregnancy and lactation.

Ampicillin- a broad-spectrum antibacterial bactericidal agent from the group of semi-synthetic penicillins, acid-resistant. Inhibits peptidoglycan polymerase and transpeptidase, prevents the formation of peptide bonds and disrupts the late stages of cell wall synthesis of a dividing microorganism, which leads to a decrease in the osmotic stability of the bacterial cell and causes its lysis.

Active against gram-positive and gram-negative microorganisms, aerobic non-spore-forming bacteria (Listeria spp.).

Not effective against penicillinase-producing strains of Staphylococcus spp., all strains of Pseudomonas aeruginosa, most strains of Klebsiella spp. and Enterobacter spp.

Compound

Ampicillin (in trihydrate form) + excipients.

Pharmacokinetics

Absorption after oral administration is fast, high, bioavailability is 40%. Evenly distributed in organs and tissues of the body, found in therapeutic concentrations in pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, the contents of blisters, urine (high concentrations), intestinal mucosa, bones, gall bladder, lungs, tissues of the female genital organs, bile , in bronchial secretions (in purulent bronchial secretions the accumulation is weak), paranasal sinuses, middle ear fluid, saliva, fetal tissues. It penetrates the blood-brain barrier poorly (permeability increases with inflammation).

It is excreted primarily by the kidneys (70-80%), and very high concentrations of unchanged antibiotic are created in the urine; partly with bile, in nursing mothers - with milk.

Does not cumulate. Removed by hemodialysis.

Indications

Bacterial infections caused by sensitive microflora:

  • respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess);
  • kidney and urinary tract infections (pyelonephritis, pyelitis, cystitis, urethritis);
  • infections of the biliary system (cholangitis, cholecystitis);
  • chlamydial infections in pregnant women (with intolerance to erythromycin);
  • cervicitis;
  • infections of the skin and soft tissues: erysipelas, impetigo, secondary infected dermatoses;
  • musculoskeletal infections;
  • pasteurellosis;
  • listeriosis;
  • gastrointestinal infections (typhoid fever and paratyphoid fever, dysentery, salmonellosis, salmonella carriage, peritonitis);
  • endocarditis (prevention and treatment);
  • meningitis;
  • bacterial septicemia.

Release forms

Tablets 250 mg.

Powder or granules for the preparation of suspension for oral administration.

Powder for the preparation of a solution for intravenous and intramuscular administration (injections in ampoules for injection).

Capsules 250 mg and 500 mg.

Instructions for use and dosage

Orally, adults - 250 mg 4 times a day 0.5-1 hour before meals with a small amount of water; if necessary, the dose is increased to 3 g per day.

Infections of the gastrointestinal tract and genitourinary system - 500 mg 4 times a day.

For gonococcal urethritis - 3.5 g orally once.

The suspension is recommended for children with mild infections: newborns from 1 month - 150 mg/kg body weight per day; up to 1 year - at the rate of 100 mg/kg body weight per day; from 1 to 4 years - 100-150 mg/kg body weight per day; Children over 4 years old are prescribed 1-2 g per day. The daily dose is divided into 4-6 doses.

The duration of treatment depends on the severity of the disease (from 5-10 days to 2-3 weeks, and in chronic processes - for several months).

The tablets are taken orally regardless of meals.

Preparation of the suspension: add water to the bottle up to the risk and shake well. The prepared suspension is stable at room temperature for 14 days. The suspension must be shaken before each use. 5 ml of the prepared suspension (1 measuring spoon) contains 250 mg of ampicillin.

For parenteral administration (intramuscular, intravenous stream or intravenous drip (dropper)), a single dose for adults is 250-500 mg, a daily dose is 1-3 g; for severe infections, the daily dose can be increased to 10 g or more.

For newborn children the drug is prescribed in a daily dose of 100 mg/kg, for children of other age groups - 50 mg/kg. In severe cases of infection, the indicated doses can be doubled.

The daily dose is divided into 4-6 injections with an interval of 4-6 hours. The duration of intramuscular administration is 7-14 days. The duration of intravenous administration is 5-7 days, followed by a transition (if necessary) to intramuscular administration.

A solution for intramuscular administration is prepared by adding 2 ml of water for injection to the contents of the bottle.

For intravenous jet administration, a single dose of the drug (no more than 2 g) is dissolved in 5-10 ml of water for injection or isotonic sodium chloride solution and administered slowly over 3-5 minutes (1-2 g over 10-15 minutes) . For a single dose exceeding 2 g, the drug is administered intravenously. To do this, a single dose of the drug (2-4 g) is dissolved in 7.5-15 ml of water for injection, then the resulting solution is added to 125-250 ml of isotonic sodium chloride solution or 5-10% glucose solution and administered at a rate of 60-80 drops. /min. When administered intravenously to children, a 5-10% glucose solution (30-50 ml depending on age) is used as a solvent.

Solutions are used immediately after preparation.

Side effect

  • peeling of the skin;
  • hives;
  • rhinitis;
  • conjunctivitis;
  • Quincke's edema;
  • fever;
  • anaphylactic shock;
  • dysbacteriosis;
  • stomatitis;
  • gastritis;
  • dry mouth;
  • change in taste;
  • abdominal pain;
  • vomiting, nausea;
  • diarrhea;
  • pseudomembranous enterocolitis;
  • aggressiveness;
  • anxiety;
  • confusion;
  • behavior change;
  • depression;
  • convulsions (with high dose therapy);
  • leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia;
  • interstitial nephritis;
  • nephropathy;
  • superinfection (especially in patients with chronic diseases or reduced body resistance);
  • vaginal candidiasis.

Contraindications

  • infectious mononucleosis;
  • lymphocytic leukemia;
  • liver failure;
  • history of gastrointestinal diseases (especially colitis associated with the use of antibiotics);
  • lactation period;
  • children's age (up to 1 month);
  • hypersensitivity (including to other penicillins, cephalosporins, carbapenems).

Use during pregnancy and breastfeeding

Use the drug with caution during pregnancy. Contraindicated during lactation.

Special instructions

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.

When treating patients with bacteremia (sepsis), the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

In patients who are hypersensitive to penicillins, cross-allergic reactions with other beta-lactam antibiotics are possible.

When treating mild diarrhea during a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided; You can use kaolin- or attapulgite-containing antidiarrheals, discontinue the drug. If diarrhea is severe, consult a doctor.

Treatment must be continued for another 48-72 hours after the disappearance of clinical signs of the disease.

Drug interactions

Antacids, glucosamine, laxatives, food slow down and reduce absorption; ascorbic acid increases absorption.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) - synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) antagonistic.

Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives (it is necessary to use additional methods of contraception), drugs whose metabolism produces para-aminobenzoic acid, ethinyl estradiol (in the latter case, the risk of breakthrough bleeding increases).

Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs, drugs that block tubular secretion, increase the concentration of ampicillin in plasma (by reducing tubular secretion).

Allopurinol increases the risk of developing skin rashes.

Reduces clearance and increases toxicity of methotrexate.

Enhances the absorption of digoxin.

Analogues of the drug Ampicillin

Structural analogues of the active substance:

  • Ampicillin AMP-KID;
  • Ampicillin AMP-Forte;
  • Ampicillin Innotec;
  • Ampicillin sodium;
  • Ampicillin-AKOS;
  • Ampicillin-Ferein;
  • Ampicillin sodium salt;
  • Ampicillin sodium salt, sterile;
  • Ampicillin trihydrate;
  • Zetsil;
  • Penodil;
  • Pentrexil;
  • Standacillin.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.