Amoxicillin tablets 250 mg
Broad-spectrum antibiotic for the treatment of respiratory and urinary tract infections, colienteritis, gonorrhea.
Description
Amoxicillin is one of the most popular and effective antibacterial bactericidal drugs. For 46 years, it has been successfully used to treat numerous bacterial infections. The active substance irreversibly destroys the cellular structure of harmful bacteria. As a result, the growth of pathogenic microflora slows down, leading to the rapid death of disease-causing microorganisms.
This antibiotic was developed in 1972 by specialists from the British company Beecham. It remains relevant today. According to the WHO, amoxicillin is included in the list of essential medicines that should be used within the healthcare system.
Release Form and Composition
Pharmacies offer amoxicillin in tablets and capsules of 250 and 500 mg. The oblong tablets are coated with a protective, yellowish-white shell. Each tablet has a convenient score line on both sides.
The main active substance is amoxicillin trihydrate. Excipients include magnesium stearate, povidone, sodium starch glycolate, and microcrystalline cellulose. The film coating consists of titanium dioxide, talc, and hypromellose.
Indications for Use
This broad-spectrum antibiotic helps eliminate various infections affecting different organs and systems. Typically, doctors recommend this drug for treating infectious diseases caused by streptococci. Among the most common diseases of this origin are:
- Infections of the upper respiratory tract and ENT organs (otitis media, sinusitis, tonsillitis, frontal sinusitis);
- Bacterial diseases of the lower respiratory tract (community-acquired pneumonia, acute bronchitis, and chronic bronchitis in the acute stage);
- Kidney and urinary tract diseases (cystitis, pyelonephritis);
- Intestinal infections (enteritis, colitis);
- Infectious lesions of the skin and soft tissues (phlegmon, abscess, erysipelas);
- All indications for use (instructions)
In combination with metronidazole, Amoxicillin tablets are effective in treating chronic gastritis, as well as peptic ulcers of the stomach and duodenum.
According to scientific data, the probability of successful treatment of respiratory tract infections with this antibiotic is 90%.
The instructions for use of Amoxicillin also indicate conditions for prophylactic use. It is prescribed to patients identified as having a high risk of endocarditis. The antibiotic is sometimes part of the medication arsenal of dentists (the bactericidal agent is relevant during prosthetics and tooth extraction).
Dosage and Administration
The optimal therapeutic dose is prescribed by the attending physician. Self-medication is very dangerous, as each infection requires a specific dosage regimen. The maximum daily amount of the drug is 3 g.
The instructions for use of amoxicillin state that adult patients, as well as children over 10 years old and weighing more than 40 kg, can take no more than 250-500 mg at a time. Typically, the antibiotic is taken three times a day with an eight-hour interval. For successful treatment, it is necessary to adhere to the established therapeutic regimen, without lengthening or shortening the interval. This helps maintain the optimal concentration of the antimicrobial agent in the body.
Young patients aged 5-10 years can be prescribed no more than 250 mg of the drug three times a day; the recommended dose for children aged 2-5 years is 125 mg. For infants, the daily dosage is established according to body weight: at a rate of 20 mg per kilogram. This amount of the drug should be divided into three doses.
The standard course of antibacterial therapy usually does not exceed 5-14 days. In severe cases of the disease, the dose is sometimes increased to 1000 mg.
When taking the tablets, you do not need to change your usual diet. Doctors allow the antibiotic to be taken either before meals or after breakfast, lunch, or dinner. It is recommended to take the drug with alkaline mineral water or milk, and a sufficient amount of liquid should be used. It is better to swallow the tablet whole, but in some cases, it can be split or crushed.
Main Advantages of Amoxicillin
Unlike similar drugs, such as ampicillin and benzylpenicillin, Amoxicillin tablets are absorbed into the bloodstream faster. As a result, the required concentration of the active component is achieved in a short period. Patients do not need to take the medicine frequently, which also saves money.
Another beneficial property identified through the use of Amoxicillin is its resistance to gastric acid. This makes the antibiotic well-suited for oral use.
Amoxicillin 500: Instructions for Use for Treatment and Prevention
It is strictly forbidden to determine the dosage for antibiotic treatment on your own. To exclude possible side effects and ensure treatment effectiveness, carefully read the instructions for use of Amoxicillin 500 tablets before taking. Typically, the instructions for Amoxicillin 500 clearly indicate the recommended duration of the course. If relief does not occur while following all conditions, it is necessary to consult the attending physician to adjust the antibacterial therapy.
Exceeding the treatment period set by the manufacturer, according to the instructions for Amoxicillin 500, is not recommended. This is fraught with the development of antibiotic resistance and reduced effectiveness. A repeat course of treatment with Amoxicillin 500, according to the instructions, is possible only after several months. To exclude the likelihood of resistance, the drug should be combined (alternated) with other antibiotic options.
When Should the Drug Not Be Taken?
The instructions for use of Amoxicillin indicate that it is a relatively safe antibiotic with few contraindications. Nevertheless, it should be completely avoided in case of individual intolerance to the main active substance. Hypersensitivity to the drug's components often manifests as an allergic reaction. The allergy can be relatively safe, like urticaria, but it can also cause angioedema and anaphylactic shock.
According to the instructions for use of Amoxicillin, other contraindications include complex liver and kidney dysfunction, phenylketonuria, and acute lymphoblastic leukemia.
Sometimes, against the background of taking the drug, abdominal pain occurs, frequent urges for defecation bother the patient, watery stools with blood appear, and temperature rises. These symptoms may indicate pseudomembranous colitis. In such a case, it is necessary to stop treatment with this antibiotic as soon as possible.
Amoxicillin in tablet form is not prescribed to children under three years of age (it is better to use a suspension). The drug is also not recommended for nursing mothers. The fact is that the drug easily passes into breast milk and can provoke allergies and disruption of the intestinal microflora.
Therapy During Pregnancy and Lactation
The instructions for use of amoxicillin 500 do not prohibit treatment with this drug during pregnancy, but extreme caution should be exercised. The antibiotic is allowed during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. A doctor may prescribe this antibacterial drug if a pregnant woman develops acute sinusitis, tonsillitis, otitis media, bronchitis, or pneumonia. Cystitis and pyelonephritis are also among the indications.
The use of amoxicillin during breastfeeding is highly discouraged.
Amoxicillin: Instructions for Use for Adults
Despite the minimal number of contraindications, the instructions for use of Amoxicillin for adults indicate that this antibiotic should be used cautiously. The specific regimen and dosage must be agreed upon with the attending physician. Deviating from the instructions for use of Amoxicillin for adults is not recommended to avoid the risk of possible complications and side effects.
Manifestations of Overdose
Exceeding the maximum daily amount of the drug usually occurs with self-medication. Overdose can also occur in patients with infectious diseases of the liver and kidneys. This is possible if such patients undergo a traditional course of treatment intended for people without nephrological and hepatological pathologies.
In case of overdose, the patient feels abdominal pain, experiences nausea and vomiting urges, and diarrhea often appears. The patient may develop convulsions. Salt crystals are found in the urine.
If an overdose occurs, it is necessary to stop using Amoxicillin and seek emergency medical help. Detoxification therapy may be carried out in a hospital. The patient undergoes gastric lavage, is given activated charcoal and laxatives. In severe cases, hemodialysis is performed.
Drug Interactions
The instructions for Amoxicillin indicate that it is often used as part of combination therapy. In combination with other medications, it can affect the condition of various organs and systems of the body.
Concomitant use of amoxicillin and oral anticoagulants, similar to warfarin, increases the likelihood of bleeding. The combination of the antibiotic with digoxin often leads to an overdose of both medications.
According to the instructions for Amoxicillin, its combination with other antibiotics (drugs of the tetracycline series, erythromycin, sulfonamide antimicrobials) reduces their effectiveness. Concurrent treatment with amoxicillin trihydrate and methotrexate increases the toxicity of the latter. Such therapy seriously impairs kidney health.
The popular bactericidal drug inhibits the action of oral contraceptives, which may lead to unplanned pregnancy.
It is important to remember that amoxicillin, according to the instructions, is incompatible with alcoholic beverages. The interaction of the antimicrobial agent with alcohol can cause an acute allergic reaction, which may be fatal. The toxic combination of ethyl alcohol and the antibiotic has a destructive effect on the liver and biliary tract. Alcoholic beverages can be consumed no earlier than 10 days after stopping the drug.
Specific Treatment Recommendations
Amoxicillin with clavulanic acid, like other antibiotics, is completely useless for treating infections caused by viruses, not bacteria. This includes influenza. If the disease requires long-term therapy, it makes sense to combine amoxicillin with antifungal drugs.
Particular attention should be paid to bactericidal treatment of infections in patients who have ever had bronchial asthma, hay fever, or allergic diathesis. If a doctor prescribes high-dose therapy, it is necessary to constantly monitor the condition of the liver and kidneys.
If amoxicillin is used as a component of a medication course to eliminate mild diarrhea, it is wise to avoid drugs that weaken intestinal peristalsis. It is better to use agents containing kaolin or attapulgite.
Antibiotic treatment should not be stopped even 2-3 days after the symptoms of the infectious lesion disappear.
Storage Conditions and Shelf Life
The drug should be stored in a dry, dark place at a temperature not exceeding +25°C. Exposure to direct sunlight can destroy the main bactericidal component.
The shelf life of amoxicillin is 3 years from the time of manufacture. Do not purchase expired medication. The antibiotic should be purchased only with a doctor's prescription.
For comprehensive information about the drug, please read the detailed instructions for amoxicillin 500 included in the packaging of this medicine. Our material is an accessible description of the main properties of this popular medication and does not replace the full pharmaceutical characteristics.
Prescription Status
By prescription.
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Our certificates:
Instructions for use Amoxicillin tablets 250 mg
Trade name: Amoxicillin
International nonproprietary or grouping name: amoxicillin
Dosage form: tablets
Composition per one tablet:
Active substance: amoxicillin trihydrate 287.0 mg / 574.0 mg (equivalent to amoxicillin) 250.0 mg / 500.0 mg
Excipients: talc 3.7 mg / 7.0 mg, magnesium stearate 3.7 mg / 7.0 mg, croscarmellose sodium 3.7 mg / 7.0 mg, potato starch - up to a tablet weight of 370.0 mg / 700.0 mg
Description
Capsule-shaped tablets, white or almost white, with a score line.
Pharmacotherapeutic group: antibiotic - semi-synthetic penicillin
ATC code: J01CA04
Pharmacological properties
Pharmacodynamics
Amoxicillin is an aminobenzyl penicillin, a broad-spectrum semi-synthetic antibiotic with a bactericidal effect resulting from the inhibition of bacterial cell wall synthesis. The minimum inhibitory concentration (MIC) thresholds for various susceptible microorganisms vary. The prevalence of resistant strains varies geographically and over time, so it is advisable to refer to local resistance information, especially when treating severe infections.
Pharmacokinetics
Absorption
Absorption is rapid, high (93%), food intake does not affect absorption, it is not destroyed in the acidic environment of the stomach. After oral administration of 250 mg and 500 mg doses, the maximum plasma concentration is 5 µg/ml and 10 µg/ml, respectively. 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 plasma, bronchial secretions (distribution is poor in purulent bronchial secretions), liver, lymph nodes, uterus, ovaries, paranasal sinuses, pleural and peritoneal fluid, saliva and tear fluid, urine, skin blister fluid, lung tissue, intestinal mucosa, middle ear fluid and paranasal sinuses, bones, adipose tissue, gallbladder (concentration in bile exceeds plasma concentration by 10 times - with normal bile duct patency), fetal tissues. When the dose is doubled, the concentration also doubles. In amniotic fluid and umbilical cord vessels, the concentration of amoxicillin is about 50% of the concentration in the maternal plasma. It penetrates the blood-brain barrier poorly; with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid increases to 20% of the plasma concentration. Plasma protein binding is 15-25%.
Metabolism
Partially (10-20%) metabolized to form inactive metabolites.
Excretion
Half-life (T1/2) - 1-1.5 hours. Excreted 50-70% by the kidneys unchanged via tubular secretion (80%) and glomerular filtration (20%), by the liver - 10-20%. A small amount is excreted in breast milk. In renal impairment (creatinine clearance [CrCl] ≤ 15 ml/min), T1/2 is prolonged to 8.5 hours.
Amoxicillin is removed by hemodialysis.
Special patient groups
Age
The T1/2 of amoxicillin in children aged 3 months to 2 years is similar to that in older children and adults.
As elderly patients have an increased likelihood of reduced renal function, dose selection should be cautious, and renal function monitoring is necessary.
Sex
When taken orally in healthy men and women, patient sex does not significantly affect the pharmacokinetics of amoxicillin.
Renal impairment
The total serum clearance of amoxicillin increases proportionally with decreasing renal function. In renal impairment (CrCl < 15 ml/min), T1/2 is prolonged and can reach 8.5 hours in anuria.
Hepatic impairment
In patients with impaired liver function, dose selection should be cautious, and regular monitoring of liver function is necessary.
Indications for use
Infectious and inflammatory diseases caused by microorganisms susceptible to the drug:
- Infections of the upper respiratory tract (tonsillopharyngitis, sinusitis, acute otitis media);
- Infections of the lower respiratory tract (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 peptic ulcer disease of the duodenum or stomach (always in combination with other drugs);
- Infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);
- Leptospirosis, listeriosis;
- Lyme disease;
- Infections of the gastrointestinal tract (enterocolitis, typhoid fever, dysentery, salmonellosis (caused by Salmonella typhi, susceptible to ampicillin), salmonella carriage;
- Prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract.
Contraindications
- Hypersensitivity to amoxicillin, other beta-lactam antibiotics (other penicillins, cephalosporins, monobactams, carbapenems) or any component of the drug;
- Infectious mononucleosis, lymphocytic leukemia;
- Children under 3 years of age (for this dosage form).
With caution
History of allergic reactions (including bronchial asthma, hay fever, hypersensitivity to acetylsalicylic acid), history of gastrointestinal diseases (especially antibiotic-associated colitis), renal failure, pregnancy and breastfeeding period.
Use during pregnancy and breastfeeding
Results from animal studies do not indicate a direct or indirect influence on reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. The drug Amoxicillin can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Amoxicillin is excreted in breast milk in small amounts; if necessary, the drug can be used during breastfeeding. A breastfed infant may develop diarrhea, sensitization, and fungal infections of the mucous membranes, so discontinuation of breastfeeding may be required. Amoxicillin should be used during breastfeeding only after assessment of the benefit/risk ratio by the attending physician.
Dosage and administration
Orally, before or after meals.
The dose of Amoxicillin depends on the sensitivity of the infectious agent, the severity of the disease, and the location of the infectious process.
Adults and children over 13 years and/or weighing more than 40 kg
Usually 250 mg - 500 mg three times daily or 500 mg - 1000 mg twice daily. For sinusitis, community-acquired pneumonia, and other severe infections, 500 mg - 1000 mg three times daily is recommended. Maximum daily dose is 6 g.
Children from 3 to 5 years and/or weighing from 15 kg to 19 kg
Usually 250 mg twice daily. In cases where there is a high probability of infection caused by resistant Streptococcus pneumoniae, higher doses of 500 mg 2-3 times daily are recommended.
Children from 5 to 13 years and/or weighing from 19 kg to 40 kg
Usually 250 mg three times daily is recommended. In cases where there is a high probability of infection caused by resistant Streptococcus pneumoniae, higher doses of 500-1000 mg three times daily are recommended.
Maximum daily dose for children is 100 mg/kg/day.
Lyme disease (borreliosis) - early stage
Adults and children over 13 years and/or weighing more than 40 kg
500 mg - 1000 mg three times daily 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 and/or weighing from 15 kg to 19 kg
250 mg three times daily.
Children from 5 to 13 years and/or weighing from 19 kg to 40 kg
500 mg 2-3 times daily (calculated as 50 mg/kg/day, divided into 3 doses).
Eradication of Helicobacter pylori in patients with peptic ulcer disease of the duodenum or stomach (always in combination with other drugs)
Adults 1000 mg twice daily in combination with a proton pump inhibitor (e.g., omeprazole, lansoprazole) and another antibiotic (e.g., clarithromycin, metronidazole) for 7 days.
Children over 13 years and/or weighing more than 40 kg - 1000 mg twice daily as part of combination therapy.
Children from 3 to 5 years and/or weighing from 15 kg to 19 kg
250-500 mg twice daily.
Children from 5 to 13 years and/or weighing from 19 kg to 40 kg
500-1000 mg twice daily (calculated as 50 mg/kg/day, divided into 2 doses).
Prevention of bacterial endocarditis
Adults and children over 13 years and/or weighing more than 40 kg
Recommended 2 g (or calculated as 50 mg/kg) 0.5-1 hour before surgical intervention.
Children from 3 to 5 years and/or weighing from 15 kg to 19 kg
750-1000 mg (calculated as 50 mg/kg) before the procedure.
Children from 5 to 13 years and/or weighing from 19 kg to 40 kg
1000-2000 mg (calculated as 50 mg/kg) before the procedure.
In renal failure
In patients with CrCl > 30 ml/min, no dose adjustment is necessary. For CrCl < 30 ml/min, increasing the interval between doses or reducing subsequent doses is recommended.
Dosage form
Tablets 250 mg, 500 mg.
10 tablets in a blister strip made of polyvinyl chloride film and printed lacquered aluminum foil. 1 or 2 blister packs, together with the instructions for use, are placed in a cardboard carton.
Storage conditions
In a dry place, protected from light and moisture, at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life
3 years. Do not use after the expiration date.
Prescription status
Dispensed by prescription.
Name and address of the legal entity in whose name the registration certificate is issued:
AVVA Pharmaceuticals Ltd., Cyprus 23A Spyrou Kyprianou, 4001 Mesa Geitonia, Limassol, Cyprus.
Manufacturer/Organization accepting claims:
JSC "AVVA RUS", Russia, 610044, Kirov region, Kirov, Luganskaya st., 53a.
Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.
avva-rus.ru
The full instruction can be found in the file "Instruction"
