Description
Capsule-shaped tablets of white or almost white color with a score.
Pharmacotherapeutic group:
antibiotic - semisynthetic penicillin
ATX code:
J01CA04
Pharmacological properties
Pharmacodynamics
Amoxicillin is an aminobenzyl penicillin, a semisynthetic broad-spectrum antibiotic that has a bactericidal effect due to inhibition of bacterial cell wall synthesis. Minimum inhibitory concentration (MIC) thresholds for different sensitive microorganisms vary. The prevalence of resistant strains varies geographically and over time, so it is advisable to rely on local resistance information, especially when treating severe infections.
Pharmacokinetics
Suction
Absorption is fast, high (93%), food intake does not affect absorption, and is not destroyed in the acidic environment of the stomach. When taken orally at a dose of 250 mg and 500 mg, the maximum concentration in blood plasma is 5 mcg/ml and 10 mcg/ml, respectively. The time to reach maximum concentration after oral administration is 1-2 hours.
Distribution
It has a large volume of distribution - high concentrations are found in blood plasma, bronchial secretions (in purulent bronchial secretions the distribution is weak), liver, lymph nodes, uterus, ovaries, paranasal sinuses, pleural and peritoneal fluid, saliva and tear fluid, urine, contents of skin blisters , lung tissue, intestinal mucosa, middle ear fluid and paranasal sinuses, bones, adipose tissue, gall bladder (the concentration in bile is 10 times higher than the concentration in blood plasma - with normal patency of the bile ducts), fetal tissues. When the dose is doubled, the concentration also doubles. In the amniotic fluid and umbilical cord vessels, the concentration of amoxicillin is about 50% of the concentration in the blood plasma of a pregnant woman. It penetrates poorly through the blood-brain barrier; with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid increases to 20% of the concentration in the blood plasma. Bonding with blood plasma proteins is 15-25%.
Metabolism
Partially (10-20%) is metabolized to form inactive metabolites.
Removal
The half-life (T1/2) is 1-1.5 hours. It is excreted 50-70% unchanged by the kidneys through tubular excretion (80%) and glomerular filtration (20%), and 10-20% by the liver. A small amount is excreted in breast milk. If renal function is impaired (creatinine clearance [CC] ≤ 15 ml/min), T1/2 is extended to 8.5 hours.
Amoxicillin is removed by hemodialysis.
Special patient groups
Age
T1/2 of amoxicillin in children aged 3 months to 2 years is similar to T1/2 in older children and adults.
Since in elderly patients the likelihood of decreased renal function increases, dose selection is carried out with caution, and monitoring of renal function is also necessary.
Floor
When administered orally to healthy men and women, the gender of the patients does not have a significant effect on the pharmacokinetics of amoxicillin.
Kidney failure
The total serum clearance of amoxicillin increases in proportion to the decrease in renal function. If renal function is impaired (creatinine clearance < 15 ml/min), T1/2 lengthens and can reach 8.5 hours in anuria.
Liver failure
In patients with impaired liver function, dose selection should be carried out with caution, and regular monitoring of liver function is necessary.
Contraindications and side effects
During breastfeeding, a young mother needs to be especially careful about the use of medications. This drug, like any other, has contraindications and side effects. The first include:
- individual intolerance to the active component;
- mononucleosis of infectious origin;
- renal, liver failure;
- presence of bronchial asthma;
- seasonal allergic manifestations.
The antibiotic medicine in question is considered the safest for nursing women and infants, and is highly effective against infections of bacterial origin. However, in some cases it can provoke the occurrence of side effects, the impact of which negatively affects the health of the baby during breastfeeding.
In the process of antibiotic therapy, as a rule, the intestinal microflora is disrupted, resulting in abdominal problems. Therefore, taking this, although safe, drug should be combined with the use of probiotics, for example, Linex, Eubicor, Bifidumbacterin.
The negative effects of antibiotics include:
- The occurrence of an allergic reaction, accompanied by conjunctivitis, itchy skin rashes, inflammation of the nasal mucosa.
- Decreased hemoglobin levels, deterioration of blood quality, development of anemia, thrombocytopenia.
- Indigestion, diarrhea, feelings of nausea, changes in taste.
- Increased heart rate, breathing problems.
- Development of candidiasis, stomatitis.
- Termination of lactation in a nursing mother.
- Deterioration of the nervous system (anxiety, restlessness, dizziness, convulsions).
As a rule, if the prescribed dosage and duration of treatment are observed, negative phenomena are observed extremely rarely. It is strongly not recommended to take medications on your own (without medical prescription), which can cause significant harm to the health of a nursing woman or baby. If painful symptoms occur in an infant, you must stop using the antibiotic and immediately contact your pediatrician for help.
We recommend reading: Eco Slim: real reviews about eco slim for weight loss, price in the pharmacy, instructions for use, where to buy effervescent tablets, how much do analogues cost?
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- upper respiratory tract infections (tonsillopharyngitis, sinusitis, acute otitis media);
- lower respiratory tract infections (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia);
- infections of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, endometritis, cervicitis, gonorrhea);
- abdominal infections (cholangitis, cholecystitis);
- eradication of Helicobacter pylori
in patients with duodenal or gastric ulcers (always in combination with other drugs); - infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
- leptospirosis, listeriosis;
- Lyme disease;
- infections of the gastrointestinal tract (enterocolitis, typhoid fever, dysentery, salmonellosis (caused by Salmonella typhi
, sensitive to ampicillin), salmonella carriage; - prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract.
Use during pregnancy and breastfeeding
Results from animal studies do not indicate direct or indirect effects on reproductive toxicity. Limited data on the use of amoxicillin during human pregnancy do not indicate an increased risk of congenital malformations. Amoxicillin can be used during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
Amoxicillin is excreted into breast milk in small quantities; if necessary, the drug can be used during breastfeeding. A breastfed baby may develop diarrhea, sensitization and fungal infection of the mucous membranes, so it may be necessary to stop breastfeeding. Amoxicillin should be used during breastfeeding only after the attending physician has assessed the benefit/risk ratio.
Use during breastfeeding
Many breastfeeding women wonder whether Amoxicillin can be taken while breastfeeding, because everything that a nursing mother consumes enters the child's body through breast milk. Experts say that taking the medicine does not affect the production of breast milk and does not harm the baby’s health. In this case, you must follow the prescribed dosage and duration of the therapeutic course.
After consuming the antibiotic in question, only 1% of the medication enters the mother’s milk, which does not pose a threat to the baby’s body. 1.5 - 2 hours after taking the drug, the maximum concentration of the antibiotic in the blood of a nursing woman is observed. Elimination from the body takes about 6 hours.
The health of a nursing mother during lactation is especially important, which affects the condition of the baby. The doctor prescribing the medicine must establish the appropriate dosage, duration of treatment, and give important recommendations.
Directions for use and doses
Inside, before or after meals.
The dose of Amoxicillin depends on the sensitivity of the infectious agent, the severity of the disease and the localization of the infectious process.
Adults and children over 13 years of age and/or weighing more than 40 kg
Usually prescribed 250 mg - 500 mg 3 times a day or 500 mg - 1000 mg 2 times a day. For sinusitis, community-acquired pneumonia and other severe infections, it is recommended to prescribe 500 mg - 1000 mg 3 times a day. The maximum daily dose is 6 g.
Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg
Usually prescribed 250 mg 2 times a day. In cases where there is a high likelihood of infection caused by resistant Streptococcus
pneumoniae
, higher doses of 500 mg 2-3 times daily are recommended.
Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg
Usually recommended is 250 mg 3 times a day. In cases where there is a high likelihood of infection caused by resistant Streptococcus
pneumoniae
, higher doses are recommended - 500-1000 mg 3 times a day.
The maximum daily dose for children is 100 mg/kg/day.
Lyme disease (borreliosis)
—
early stage
Adults and children over 13 years of age and/or weighing more than 40 kg
500 mg - 1000 mg 3 times a day up to a maximum daily dose of 4 g, divided into several doses, for 14 days (10-21 days).
Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg
250 mg 3 times a day.
Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg
500 mg 2-3 times a day (at the rate of 50 mg/kg/day, divided into 3 doses).
Eradication of
Helicobacter pylori in patients with duodenal or gastric ulcers
(always in combination with other drugs)
Adults: 1000 mg twice daily in combination with a proton pump inhibitor (eg, omeprazole, lansoprazole) and another antibiotic (eg, clarithrominin, metronidazole) for 7 days.
Children over 13 years old and/or weighing more than 40 kg -
1000 mg 2 times as part of combination therapy.
Children from 3 to 5 years old and/or weighing from 15 kg to 19 kg
250-500 mg 2 times a day.
Children from 5 to 13 years old and/or weighing from 19 kg to 40 kg
500-1000 mg 2 times a day (at the rate of 50 mg/kg/day, divided into 2 doses).
Prevention of bacterial endocarditis
Adults and children over 13 years of age and/or weighing more than 40 kg
It is recommended 2 g (or at the rate of 50 mg/kg/day) 0.5-1 hour before surgery.
Children from 3 to 5 years old
u /or body weight from 15 kg to 19 kg
750-1000 mg (at the rate of 50 mg/kg/day) before the procedure.
Children from 5 to 13 years old and/or with a body weight of 19 kg and up to 40 kg
1000-2000 mg (at the rate of 50 mg/kg/day) before the procedure.
For renal failure
In patients with CC > 30 ml/min, there is no need for dose adjustment. When CC < 30 ml/min, it is recommended to increase the interval between doses or reduce subsequent doses.
Dosage
Amoxicillin during breastfeeding is taken 500 mg (1 tablet) three times a day, regardless of meals. The therapeutic course can last from 3 to 10 days. (depending on the pathogen, the form of the disease, the increase in leukocytes). While using the antibiotic Amoxicillin, you should not stop breastfeeding. The baby should be fed as usual. To prevent the development of dysbiosis, it is recommended to take probiotics during treatment.
We recommend reading: Is it possible to tattoo eyebrows while breastfeeding?
The dosage of an antibiotic, as well as other medications for hepatitis B, should be determined only by a doctor after examining the patient; self-medication is unacceptable. The capsule/tablet should be taken with plenty of liquid.
