Ampicillina Trihydrate - Instructions For Use, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ampicillin Trihydrate

Ampicillin Trihydrate: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ampicillin trihydrate

ATX code: J01CA01

Active ingredient: ampicillin (ampicillin)

Producer: Biosynthesis, OJSC (Russia), Biochemist, OJSC (Russia), Uralbiofarm, OJSC (Russia), Moskhimfarmpreparaty them. N. A. Semashko (Russia)

Description and photo updated: 2018-23-11

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 with a score, or round flat-cylindrical with a chamfer and a score, or flat-cylindrical shape with a chamfer and a score (10, 20, 24 or 30 pcs. in a blister strip packaging, in a cardboard a pack of 1 or 2 packages; 10 pcs. in a contoured non-cell package, in a cardboard box 1 or 2 packages, for hospitals - in a cardboard box 100, 200, 400, 500, 600, 800 or 1000 packages; 10, 20 or 24 pcs. in a glass jar, 10, 20, 30, 40 or 50 pcs. in a polymer jar, in a cardboard box 1 jar);
• capsules: white (10 pcs. in a blister, 1 or 2 blisters in a cardboard box).

1 tablet contains:

• active substance: ampicillin (in the form of trihydrate) - 250 mg;
• 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 suppressing 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.

Moderate activity of Ampicillin Trihydrate is shown 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 Pseudomonas aeruginosa strains.

Pharmacokinetics

After oral administration, the active substance is rapidly and efficiently absorbed, but its bioavailability is 40%. In the case of taking ampicillin at a dose of 500 mg, its maximum concentration in the blood (C _max) can be 3-4 μg / ml, and the time to reach it (T _{C max}) is 2 hours. The drug binds to proteins by 20%, the half-life (T _½) is 1–2 hours.

Ampicillin trihydrate is characterized by a 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 female genital organs, bronchial secretions (with purulent - weak accumulation), middle ear fluid (with inflammation), paranasal sinuses, saliva, fetal tissue.

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

Ampicillin Trihydrate does not accumulate with repeated doses, it 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, secondarily infected dermatoses;
• dysentery, typhoid fever, paratyphoid fever, salmonellosis (including carriage);
• infections of the musculoskeletal system.

Additional indications (depending on the manufacturer):

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

Contraindications

Absolute:

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

Relative (use ampicillin with extreme caution):

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

Instructions for the 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 old 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 of age with a body weight of less than 20 kg are recommended to take the agent every 8 hours at 16.7–33.3 mg / kg or every 6 hours at 12.5–25 mg / kg.

In the treatment of gonococcal urethritis, Ampicillin Trihydrate is taken once in 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 - up to several months.

Side effects

• digestive system: stomatitis, dryness of the oral mucosa, dysbiosis, change in taste, glossitis, nausea, abdominal pain, vomiting, diarrhea, gastritis, moderate increase in the activity of hepatic 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 / aggressiveness, depression, behavioral changes, confusion, seizures (when using high doses);
• laboratory parameters: anemia, thrombocytopenia, neutropenia, leukopenia, agranulocytosis;
• others: vaginal candidiasis, nephropathy, interstitial nephritis, superinfection (mainly in the presence of chronic diseases or reduced body resistance), rash (can disappear without discontinuation of Ampicillin Trihydrate).

Overdose

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

In case of an overdose, gastric lavage, intake of activated charcoal, saline laxatives, drugs to maintain water-electrolyte balance, symptomatic drugs are prescribed. The drug is excreted using hemodialysis.

special instructions

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

Against the background of drug therapy in patients with bacteremia (sepsis), there is a risk of developing a bacteriolysis reaction (Yarisch-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, an appropriate adjustment of antibiotic therapy is required.

With existing hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics may develop.

If mild diarrhea caused by Clostridium difficile occurs during the course of taking the drug, antidiarrheal drugs that reduce intestinal motility should not be used for its treatment. The use of kaolin- or attapulgite-containing antidiarrheal drugs is allowed, the antibiotic can be canceled. Severe diarrhea requires medical advice.

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

Influence on the ability to drive vehicles and complex mechanisms

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

Application during pregnancy and lactation

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

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

Pediatric use

Children under 3 years of age are contraindicated to take an antibiotic.

With 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 violations of liver function

Taking the drug in patients with hepatic impairment is contraindicated.

Drug interactions

• ascorbic acid: increased absorption of ampicillin;
• bactericidal antibiotics, including cephalosporins, aminoglycosides, rifampicin, cycloserine, vancomycin: synergistic action 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 agents 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 is aggravated;
• estrogen-containing oral contraceptives: their effectiveness decreases (you should use other methods of contraception or use additional ones);
• allopurinol: the likelihood of developing a skin rash increases;
• non-steroidal anti-inflammatory drugs, phenylbutazone, oxyfenbutazone, 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

Analogues 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.

Shelf life of tablets - 2 years, capsules - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Ampicillin Trihydrate

According to a large number of reviews, Ampicillina Trihydrate is a time-tested, effective and inexpensive antibiotic used most often for respiratory tract infections, ENT organs, cystitis and pyelonephritis. According to patients, it is necessary to use the drug at the first symptoms of infectious diseases, but only on the recommendation of a specialist. The drug quickly relieves fever and inflammation, is well tolerated.

At the same time, there are reviews that indicate a very weak effect of Ampicillin Trihydrate in the treatment of serious inflammations (in particular tonsillitis), as a result of which patients had to stop taking it and use more modern and strong antibiotics. The disadvantages of the drug include the presence of contraindications and side effects, as well as the bitter taste of the tablets.

According to many doctors, it is not worth prescribing this antibiotic, which has long been used in medicine, as a first-line treatment, since a very high resistance of pathogens has been revealed to it.

The price of Ampicillin Trihydrate in pharmacies

The price of Ampicillin Trihydrate can be 30–59 rubles per pack containing 20 tablets. Capsules can be purchased for about 47-60 rubles (20 per pack).

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!