Antibacterial agent "Ampicillin trihydrate": instructions for use. An effective drug for widespread use, ampicillin trihydrate

**** *TYUMEN HFZ* Akrikhin KhFK JSC Barnaul Plant of Medical Preparations, LLC BELMEDPREPARATY, RUP Biosynthesis JSC BioFarm, LLC BIOPHARMA JSC Biokhimik, JSC Borisov Plant of Medical Preparations, RUE BRYNTSALOV BRYNTSALOV-A, CJSC Vertex (JSC) VOSTOK Dalkhimfarm O JSC IRBITSKY CHIMPHARMZAVOD, OJSC KIEVMEDPREPARET, OJSC Medisorb, JSC Moskhimfarmpreparaty FSUE im. Semashko Moskhimfarmpreparaty named after N.A. Semashko, JSC NOVOSIBIRSK MEDICAL FACTORY. PR-V Update of PFC ZAO Organika OJSC OTHERS North Star, ZAO Sintez AKO OAO STI-Vostok, ZAO Tatkhimfarmpreparaty OAO THFZ ICN URALBIOPHARM, OAO Pharmasintez OAO FEREIN

Country of origin

Republic of Belarus Russia

Product group

Antibacterial drugs

Antibiotic of the group of semisynthetic penicillins wide range actions

Release forms

  • 10 - cellless contour packages. 10 - cellless contour packages (1) - cardboard packs. 10 - cellless contour packages (2) - cardboard packs. 24 - contour cell packaging (1) - cardboard packs. tablets 250 mg - 20 pcs per pack.

Description of the dosage form

Pharmacological action

An antibiotic from the group of semisynthetic penicillins with a broad spectrum of action. Has a bactericidal effect by inhibiting synthesis cell wall bacteria. Active against aerobic gram-positive bacteria: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp., Enterococcus spp., Listeria monocytogenes; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae. Ampicillin is destroyed by penicillinase. Acid resistant.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Ampicillin is distributed in most organs and tissues. Penetrates the placental barrier, poorly penetrates the BBB. For inflammation meninges BBB permeability increases sharply. 30% of ampicillin is metabolized in the liver. Excreted in urine and bile.

Special conditions

During treatment with ampicillin, systematic monitoring of renal, liver and peripheral blood function is necessary. Patients with impaired renal function require adjustment of the dosage regimen in accordance with CC values. When used in high doses ah in patients with renal failure Possible toxic effect on the central nervous system. When ampicillin is used in patients with bacteremia (sepsis), a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

Compound

  • 1 tab. ampicillin (in trihydrate form) 250 mg excipients: starch, magnesium stearate, zinc Ampicillin trihydrate 250 mg; excipients (starch, magnesium stearate or calcium stearate, talc). Ampicillin trihydrate; excipients: starch, magnesium stearate or calcium stearate, talc

Ampicillin trihydrate indications for use

  • Infectious and inflammatory diseases caused by microorganisms sensitive to ampicillin: incl. ear, nose and throat infections, odontogenic infections, bronchopulmonary infections, sharp and chronic infections genitourinary tract, gastrointestinal infections (including salmonellosis, cholecystitis), gynecological infections, meningitis, endocarditis, septicemia, sepsis, rheumatism, erysipelas, scarlet fever, skin and soft tissue infections.

Ampicillin trihydrate contraindications

Ampicillin trihydrate dosage

  • 0.25 g 250 mg

Ampicillin trihydrate side effects

  • Allergic reactions: urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia; extremely rarely - anaphylactic shock. From the outside digestive system: nausea, vomiting. Effects caused by chemotherapy: oral candidiasis, vaginal candidiasis, intestinal dysbiosis, colitis caused by Clostridium difficile.

Drug interactions

Sulbactam, an irreversible inhibitor of β-lactamases, prevents the hydrolysis and destruction of ampicillin by β-lactamases of microorganisms. With the simultaneous use of ampicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism appears; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism. Ampicillin enhances the effect indirect anticoagulants, suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index. Ampicillin reduces the effect of drugs, during the metabolism of which PABA is formed. Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of ampicillin, which may be accompanied by an increase in its concentration in the blood plasma. Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of ampicillin. Ascorbic acid increases the absorption of ampicillin. Ampicillin reduces the effectiveness of oral contraceptives.

Storage conditions

  • store in a dry place
  • store at room temperature 15-25 degrees
  • keep away from children
  • store in a place protected from light
Information provided by the State Register of Medicines.

Synonyms

  • Ampiside, Ampic, Ampirex, Ampicillin, Ampicillin Innotek, Ampicillin trihydrate, Ampicillin-AKOS, Ampicillin-Akos, Ampicillin-Teva, Ampicillin sodium salt, Ampicillin sodium salt sterile, Amplital, Apo-Ampi, Decapen, Zetsil, Campicillin, Mescilli

Instructions for use present the drug "Ampicillin trihydrate" as a drug included in pharmacological group wide spectrum useful action. Taking this medicine has a pronounced bactericidal effect on the human body due to the suppression of wall synthesis pathogenic microorganisms. At the same time, pronounced activity this remedy possesses both aerobic gram-positive and gram-negative microbes. It should be especially noted that “Ampicillin trihydrate” (the instructions for use confirm this) is resistant to acids and is destroyed under the influence of penicillinase.

This semi-synthetic product is produced in the form of a white crystalline powder with a sweet taste and specific odor. As for its main characteristics, it is practically insoluble in alcohol and easily soluble in water, and also differs little in properties from a substance such as ampicillin.

This one is used medicinal powder, mainly for the preparation of capsules and special compositions for suspensions. In addition, you can find white or white-yellow tablets"Ampicillin trihydrate" containing 0.25 grams of ampicillin trihydrate. Additionally, they contain calcium stearate or magnesium stearate, corn or potato starch, and talc.

The instructions for use recommend using Ampicillin Trihydrate mainly for the treatment of bronchitis, peritonitis, tonsillitis and sepsis. Besides, good results demonstrates this antibacterial drug during the treatment of gastrointestinal infections caused by salmonella or shigella, infectious diseases of the urinary and biliary tract.

For example, it is very effective to use this semi-synthetic drug for cystitis, pyelitis, cholangitis, pyelonephritis and cholecystitis. The drug "Ampicillin trihydrate" is also ideal for the treatment of patients who are carriers of salmonella. Instructions for use advise using it for treatment various kinds infections of joints, bones and soft tissues, treatment of diseases such as streptococcal pharyngitis, gonorrhea, otitis media, sinusitis or meningitis. In addition, this can be successfully prescribed to prevent postoperative complications.

The use of this semi-synthetic drug is strictly not recommended if the patient has allergic reaction for penicillins, severe form liver failure or diseases causing infectious nature and provoked by microorganisms insensitive to it. People with individual intolerance cephalosporins should also be avoided from using Ampicillin Trihydrate. Reviews from doctors also indicate that its use is undesirable in cases of bronchial asthma or pregnancy.

Ampicillin trihydrate is a broad-spectrum antibiotic. It belongs to the group of semisynthetic penicillins, and, like other representatives of this group, has bactericidal properties. The drug is active against gram-positive and gram-negative strains, and also effectively destroys intracellular harmful microorganisms.

The drug can be purchased at the pharmacy, where it is presented in the form of a water-soluble powder. Or in the form of granules, from which a suspension is then prepared independently. You can purchase ampoules for injection. Ampicillin trihydrate is often prescribed to take in the form of capsules and tablets of 250 mg. It is about the tablet form of the drug that we will talk to you today.

When and to whom ampicillin trihydrate is prescribed, instructions for use, what are the indications for use of the drug? Does the medicine have contraindications, and what are they? To learn more about this antibiotic, you should study detailed instructions. I suggest you read the description of the drug compiled on its basis.

But you should not consider the information below as a reason for self-medication. The antibiotic ampicillin trihydrate can only be prescribed by a doctor. Self-medication with antibiotics is a frivolous and dangerous activity!

What are the indications for use of Ampicillin trihydrate?

This drug is included in the complex of therapeutic measures for various infectious diseases caused by pathogenic microflora. In particular, Ampicillin trihydrate is prescribed for infections:

Respiratory system organs: sinusitis, tonsillitis and pharyngitis. Prescribed for otitis media, bronchitis, pneumonia. The drug is effective in the treatment of lung abscess.
- Urinary system: pyelonephritis, pyelitis, as well as cystitis and urethritis.
- Infection of the biliary system: diseases such as cholangitis and cholecystitis.
- For chlamydial infections found in pregnant women, if there is intolerance to another drug - erythromycin.

The drug is also recommended when prescribing the combined treatment of cervicitis, infectious diseases skin, soft tissues. Prescribed for bacterial infections affecting the musculoskeletal system. Used in the treatment of pasteurellosis and listeriosis.

The drug has proven itself effective means during treatment severe infections Gastrointestinal tract (typhoid, dysentery, salmonellosis, etc.), in the treatment of endocarditis, meningitis, bacterial septicemia.

What are the uses and dosage of Ampicillin trihydrate?

Adults

Usually prescribed: 0.25 g 4 times a day. Take 40-60 minutes before. before meals, with a small volume clean water. According to indications, it is possible to increase the dosage. But you cannot exceed 3 grams per day.

For infections of the digestive system, as well as genitourinary system: 0.5 g up to 4 times per day.
For the treatment of gonococcal urethritis: 3.5 g once a day. More often prescribed intramuscular injections 0.5 g 2 times a day. When treating uncomplicated gonorrheal urethritis - 0.5 g tablets as a single dose.

Treatment of listeriosis is best done with intramuscular or intravenous administration. Injections: 50 mg of medication per 1 kg of body weight, every 6 hours.
In case of infectious diseases moderate severity: IM 0.25-0.5 g. Administration - every 6-8 hours.

In case severe course infectious diseases: tablets - 1.2 g 3-4 times a day. More often, 0.5 g of medication is administered intravenously every 6 hours.

For the treatment of meningitis: 14 g of the drug per day. The dose should be divided into 6-8 parts.

Children:

Usually prescribed:

From 4 years - 1.2 g/day.
From 1 to 4 years - 100-150 mg/kg.
Up to 1 year - at the rate of 100 mg/kg.
Newborn babies (from 1 month) - 150 mg/kg.
The specified daily dosage medications are divided into 4-6 doses.

If infectious disease occurs in an uncomplicated form, the medicine is usually prescribed in the form of a suspension. If the infection is moderate or severe, it is indicated intramuscular injection: administer 25-50 mg per 1 kg of body weight, 4 times a day.

When treating meningitis, the recommended daily dose is: 100-200 mg per 1 kg of body weight, 6-8 injections in total.

The total duration of treatment is 5-10 days, or can be extended up to 3 weeks. It depends on the diagnosis and its severity. In cases chronic course treatment is carried out for several months.

What are the contraindications for Ampicillin trihydrate? What do the instructions say?

For Ampicillin trihydrate, the instructions for use indicate a number of health conditions when the drug is contraindicated for use. So it should not be prescribed if the patient has infectious mononucleosis, liver failure, as well as acute diseases Gastrointestinal tract, for example, with colitis, which developed from long-term use antibiotics.

There are contraindications for taking the drug by pregnant women. This antibiotic is not prescribed to nursing mothers. This medicine is not prescribed to babies under 1 month of age. The drug should not be prescribed if the body is particularly sensitive to penicillins, cephalosporins, or carbapenems.

There are contraindications for exacerbation of bronchial asthma and manifestations of allergies. For hay fever, all kinds of bleeding.

During treatment, regular monitoring of the state of the hematopoietic system, liver, and kidneys is required. If superinfection develops, antibacterial therapy should be adjusted.

Ampicillin trihydrate is an antibiotic of the semisynthetic penicillin group. Has an antibacterial (bactericidal) effect. Active against a wide range of gram-positive (alpha- and beta-hemolytic streptococci, Streptococcus pneumoniae, Starhylococcus spp., with the exception of penicillinase-producing strains, Bacillus anthracis, Clostridium spp., Enterococcus spp.) and gram-negative (Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Salmonella spp., Proteus mirabilis, Listeria monocytogenes, Shigella spp., Escherichia coli, Bordetella pertussis) microorganisms. It is destroyed by penicillinase and therefore has no effect on penicillinase-producing strains of pathogens.

Pharmacokinetics

40-60% is absorbed in the gastrointestinal tract dose taken. The maximum concentration in the blood is achieved 1.5-2 hours after administration. Penetrates into tissues and biological fluids body. Does not collapse in acidic environment stomach. It is excreted mainly by the kidneys unchanged. are created in urine high concentrations unchanged antibiotic. Partially excreted with bile, in nursing mothers - with milk. At repeated administrations does not accumulate, which makes it possible to use ampicillin trihydrate for a long time.

Indications for use

Bacterial infections caused by sensitive pathogens: ENT infections, bronchitis, pneumonia, infections urinary tract, gonorrhea, gynecological infections, septicemia, peritonitis, endocarditis, meningitis, typhoid fever, gastrointestinal infections.

If oral administration is not possible, the use of parenteral dosage form.

Contraindications

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), infectious mononucleosis, lymphocytic leukemia, liver failure, diseases gastrointestinal tract history (especially colitis associated with the use of antibiotics), lactation period, children under 6 years of age.

With caution: bronchial asthma, hay fever and others allergic diseases, renal failure, history of bleeding, pregnancy.

Pregnancy and lactation

Use during lactation is contraindicated. Use during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

Directions for use and doses

Inside, 0.5-1 hour before meals.

Adults (including elderly patients):

For infections of the ENT organs: 250 mg 4 times a day.

For bronchitis: standard mode therapy: 250 mg 4 times a day, high-dose therapy regimen: 1 g 4 times a day.

For pneumonia: 500 mg 4 times a day.

For urinary tract infections: 500 mg 3 times a day.

For gonorrhea: 2 g ampicillin trihydrate in combination with 1 g probenecid once orally. For the treatment of women, multiple doses are recommended.

For gastrointestinal infections: 500-750 mg 3-4 times a day.

For typhoid fever: in the acute period: 1-2 g 4 times a day for 2 weeks, when carrying bacteria: 1-2 g 4 times daily for 4-12 weeks.

Children from 6 years of age: the drug is prescribed at a dose of 100 mg/kg body weight. The daily dose is divided into 4-6 doses.

Patients with renal failure:

If the patient has severe renal failure (creatinine clearance less than 10 ml/min.), the need to reduce the dose or increase the time interval between doses of the drug should be considered. After the dialysis procedure, it is necessary to prescribe an additional dose of the drug.

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Side effect

Hypersensitivity reactions:

If a hypersensitivity reaction occurs, the drug should be discontinued.

Rarely, it has been reported that skin rash, itching and urticaria. The likelihood of these reactions occurring is higher in patients with infectious mononucleosis and acute or chronic leukemia of lymphoid origin. Purpura has also been reported. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and epidermal necrolysis.

IN in rare cases anaphylactic reactions occurred.

From the genitourinary system: in rare cases, interstitial nephritis may occur.

From the gastrointestinal tract: Nausea, vomiting, and diarrhea may occur. Pseudomembranous and hemorrhagic colitis have been rarely reported .

From the hepatobiliary system: about cases of hepatitis, cholestatic jaundice has been reported rarely. A moderate transient increase in the activity of “liver” transaminases is possible.

Laboratory values: Transient leukopenia, thrombocytopenia and hemolytic anemia, increasing bleeding time and prothrombin time.

Overdose

Symptoms: manifests itself toxic effect to 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 carbon, saline laxatives, medicines to maintain water and electrolyte balance and symptomatic therapy. Eliminated by hemodialysis.

Interaction with other drugs

Pharmaceutically incompatible with aminoglycosides. 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 medications oral contraceptives(need to use additional methods contraception), ethinyl estradiol (in the latter case, the risk of breakthrough bleeding increases). Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, low molecular weight polysaccharides high density and other 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.

Precautions

Before starting treatment, it is necessary to ensure that the patient does not have hypersensitivity to beta-lactam antibiotics. Cases of severe hypersensitivity reactions, sometimes fatal (cases of anaphylaxis), have been reported in patients receiving beta-lactam antibiotics. Although cases of anaphylaxis are more common after use of the parenteral dosage form, there are reports of cases of anaphylaxis occurring after oral administration of the drug. Such reactions occur more often in patients with a history of hypersensitivity to beta-lactam antibiotics.

Avoid taking the drug if you suspect infectious mononucleosis and/or acute or chronic leukemia of lymphoid origin. Cases of skin rash have been associated with these conditions after taking the drug.

At long-term use ampicillin trihydrate may develop superinfection due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibacterial therapy.

In patients with renal failure, dose adjustment of the drug is necessary.

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. When prescribed to patients with sepsis, the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.

At treatment of mild diarrhea in the background course 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. Treatment must be continued for another 48-72 hours after disappearance clinical signs diseases.

Storage conditions

Store in a place protected from moisture and light at a temperature not exceeding 25 0 C.

Keep out of the reach of children.

Best before date

Do not use after the expiration date stated on the packaging.

Name:

Ampicillin trihydrate

INN:

Ampicillin
Analogues:

None
Pharmacotherapeutic group

Antibiotic, semi-synthetic penicillin.

Pharmacological action

An antibiotic from the group of semisynthetic penicillins with a broad spectrum of action. It has a bactericidal effect by inhibiting the synthesis of bacterial cell walls.

Active against aerobic gram-positive bacteria: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp., Enterococcus spp., Listeria monocytogenes; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Bordetella pertussis, some strains of Haemophilus influenzae.

Destroyed by bacterial β-lactamases.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Ampicillin is distributed in most organs and tissues. Penetrates the placental barrier, poorly penetrates the BBB. With inflammation of the meninges, the permeability of the BBB increases sharply. 30% of ampicillin is metabolized in the liver. Excreted in urine and bile.

Compound

1 tablet contains

Active substances :

250 mg ampicillin trihydrate.


Indications for use

Ampicillin trihydrate is used for:

  • pneumonia,
  • bronchopneumonia,
  • lung abscesses;
  • peritonitis; sepsis;
  • sore throat;

Infections, including mixed ones,

  • urinary and biliary tract (pyelitis, pyelonephritis, cystitis, cholangitis, cholecystitis);
  • infections of the gastrointestinal tract, including salmonella carriage;
  • soft tissue infections and other diseases caused by antibiotic-sensitive microorganisms.

Directions for use and doses

Ampicillin trihydrate is administered orally, regardless of food intake.

A single dose for adults is 0.5 g, a daily dose is 2-3 g. Children over 1 month of age are prescribed at daily dose 100 mg/kg.

The daily dose is divided into 4-6 doses.

The duration of treatment is determined individually depending on the severity and form of the disease (from 5-10 days to 2-3 weeks or more).
Special instructions

During treatment with ampicillin trihydrate, systematic monitoring of liver, kidney and peripheral blood function is necessary. Patients with impaired renal function require adjustment of the dosage regimen in accordance with creatinine clearance values. When using high doses of the drug in patients with renal failure, toxic effects on the central nervous system are possible.

At bronchial asthma, hay fever and other allergic conditions, desensitizing agents are prescribed at the same time. In case of liver failure, ampicillin trihydrate is used under supervision. functional state liver.

Side effects

  • Allergic reactions (urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis, rarely - fever, joint pain, eosinophilia, extremely rarely - anaphylactic shock),
  • Nausea, vomiting, intestinal dysbiosis, colitis caused by C. difficale,
  • Oral candidiasis, vaginal candidiasis.


Contraindications

  • Increased individual sensitivity (including to other penicillins, cephalosporins, carbapenems);
  • Infectious mononucleosis;
  • Severe violations liver functions;
  • Breast-feeding(needs to be suspended for the duration of treatment).

Interaction with other drugs

Ampicillin trihydrate reduces the effect of oral contraceptives and increases the effect of anticoagulants and aminoglycoside antibiotics. Allopurinol increases the likelihood of skin rashes. Probenecid, when used simultaneously with ampicillin, reduces the tubular secretion of the latter, resulting in an increase in the concentration of ampicillin in the blood plasma and an increased risk of developing toxic effects.
Overdose

Symptoms:

It has a toxic effect on the central nervous system (especially in patients with renal failure).

Treatment:

Symptomatic (maintaining vital functions).
Release form

Tablets of 250 mg in package No. 20 (No. 10x2 in contour-free packaging).

Manufacturer:

Belmedpreparaty