Amoxicillin, capsules 250mg, 16pcs

Composition

1 capsule contains:

Active ingredient:  

Amoxicillin – 250 mg (in the form of trihydrate).

Auxiliary substances:  

Magnesium stearate

Microcrystalline Cellulose PH 102

Composition of the 250 mg capsule:  

Titanium dioxide E 171

Quinoline yellow dye E 104

Dye Azorubin E 122

Dye Blue patent V E 131

Dye Black shiny E 151

Gelatin

Pharmacological action

Amoxicillin is a broad-spectrum antibacterial acid-resistant bactericidal agent from the group of semi-synthetic penicillins.

It inhibits transpeptidase, disrupts the synthesis of peptidoglycan (a cell wall support protein) during division and growth, and causes bacterial lysis.

Due to the wide spectrum of action, the drug is active against both gram-positive and gram-negative microorganisms.

Clinically significant gram-negative microorganisms sensitive to amoxicillin include Escherichia coli, Proteus mirabilis, Salmonella, Shigella, CamPylobacter, Haemophilus influenzae, Bordetella pertussis, Leptospira, Chlamydia.

In addition, amoxicillin is active against all microorganisms sensitive to penicillin G, for example, Streptococcus groups A, B, C, G, H, I, M, Streptococcus pneumoniae, staphylococci and Neisseria spp. not

producing penicillinase, Erysipelothrix rhysiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, Streptobacilli, Spirillium minus, Pastereulla multocida, Listeria, Spirochaeta (Leptospira, Treponema, Borrelia) and others,

and various anaerobic microorganisms (including peptococci, Peptostreptococcus, Clostridium, and fuzobakterii).

Pharmacokinetics

Absorption – fast, high (93%), food intake does not affect absorption, does not break down in the acidic environment of the stomach.

When taken orally at a dose of 125 and 250 mg, the maximum concentration is 1.5-3 mcg / ml and 3.5-5 mcg/ml, respectively.

The action develops in 15-30 minutes after application and lasts 8 hours. The time to reach the maximum concentration after oral use is 1-2 hours.

Has a large volume of high concentrations found in plasma, sputum, bronchial secretions (in purulent bronchial secretion distribution weak), pleural and peritoneal fluid, urine,

content, skin blisters, lung tissue, intestinal mucosa, female genitals, and the prostate gland, middle ear fluid, bone, fat tissue, gall bladder (normal liver), fetal tissues.

When the dose is increased by 2 times, the concentration also increases by 2 times. The concentration in bile exceeds the concentration in plasma by 2-4 times.

In the amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the level in the plasma of a pregnant woman.

Poorly penetrates the blood-brain barrier, with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid is about 20%. Binding to plasma proteins is 17%.

Partially metabolized to form inactive metabolites. The elimination half-life is 1-1.5 hours.

It is excreted by 50-70% by the kidneys in unchanged form by tubular excretion (80%) and glomerular filtration (20%), by the liver – 10-20%.

It is excreted in small amounts in breast milk. If renal function is impaired (creatinine clearance is less than or equal to 15 ml / min), the elimination half-life increases to 8.5 hours.

Amoxicillin is removed during hemodialysis.

Active ingredients

Amoxicillin

Indications

Bacterial infections caused by sensitive microflora:

• infection of the respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia),
• urogenital system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis),
• gastrointestinal tract (peritonitis, enterocolitis, typhoid fever, cholangitis, cholecystitis),
• infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses),
• leptospirosis,
• listeriosis,
• Lyme disease (borreliosis),
• dysentery,
• salmonellosis,
• salmonellosis,
• meningitis,
• endocarditis (prevention),
• sepsis.

Use during pregnancy and lactation

It is possible to use amoxicillin during pregnancy if the benefit to the mother exceeds the potential risk to the fetus.

Amoxicillin is excreted in breast milk in low concentrations.

If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be decided.

Contraindications

• Hypersensitivity to product components (including other penicillins, cephalosporins, carbapenems),
• allergic diseases (including in history),
• bronchial asthma,
• hay fever,
• infectious mononucleosis,
• lymphatic leukemia,
• liver failure,
• colitis associated with antibiotic use, including history,
• lactation,
• children’s age up to 10 years with body weight less than 40 kg.

With caution

With caution – pregnancy, allergic reactions (including in the anamnesis), diseases of the gastrointestinal tract in the anamnesis, renal failure, as well as if there is a history of bleeding.

Side effects

Allergic reactions:  

skin rash, hyperemia, pruritus, urticaria, erythema, angioedema, rhinitis, conjunctivitis; fever, joint pain, eosinophilia, exfoliative dermatitis, erythema multiforme,

Stevens – Johnson syndrome; serum-like reactions, toxic epidermal necrolysis, generalized exanthematous pustulosis, allergic vasculitis, anaphylactic shock.

From the digestive system:  

dysbiosis, taste changes, vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the activity of “hepatic” transaminases, cholestatic jaundice, hepatic cholestasis, acute cytolytic hepatitis, pseudomembranous colitis.

Nervous system disorders:  

agitation, anxiety, insomnia, ataxia, confusion, behavior changes, depression, peripheral neuropathy, headache, dizziness, seizures.

Laboratory parameters:  

leukopenia, neutropenia, thrombocytopenic purpura, anemia.

Other services:  

shortness of breath, tachycardia, interstitial nephritis, crystalluria, eosinophilia, agranulocytosis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced body resistance).

Interaction

Pharmacologically incompatible with aminoglycosides (to avoid mutual inactivation, do not mix).

Antacids, glucosamine, laxatives, food, aminoglycosides-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) have an antagonistic effect.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives,

drugs that produce paroaminobenzoic acid in the process of metabolism, ethinyl estradiol – the risk of breakthrough bleeding.

Diuretics, allopurinol, oxifenbutazone, phenylbutazone, nonsteroidal anti-inflammatory drugs; drugs that block tubular secretion-reducing tubular secretion, increase the concentration.

Allopurinol increases the risk of developing a skin rash.

Reduces the clearance and increases the toxicity of methotrexate.

Increases digoxin absorption.

How to take, course of use and dosage

Inside, before or after a meal.

Adults and children over 10 years of age (with a body weight of more than 40 kg) are prescribed 500 mg 3 times a day; in severe cases of infection-750 mg-1 g 3 times a day.

In acute uncomplicated gonorrhea,3 g is prescribed once; in the treatment of women, repeated use of the indicated dose is recommended.

For acute infectious diseases of the gastrointestinal tract (paratyphoid, typhoid fever) and biliary tract, for gynecological infectious diseases for adults-1.5-2 g 3 times a day or 1-1.5 g 4 times a day.

For leptospirosis adults – 0.5-0.75 g 4 times a day for 6-12 days.

In case of Salmonella transmission to adults-1.5-2 g 3 times a day for 2-4 weeks.

For the prevention of endocarditis with minor surgical interventions, adults – 3-4 g 1 hour before the procedure. If necessary, a second dose is prescribed after 8-9 hours. In children, the dose is reduced by 2 times.

In patients with impaired renal function with a creatinine clearance of 15-40 ml / min, the interval between doses is increased to 12 hours; with a creatinine clearance below 10 ml/min, the dose is reduced by 15-50%; with anuria, the maximum dose is 2 g / day.

Overdose

Symptoms: nausea, vomiting, diarrhea, impaired water and electrolyte balance (as a result of vomiting and diarrhea).

Treatment: gastric lavage, activated charcoal, saline laxatives, medications to maintain water and electrolyte balance; hemodialysis.

Purpose

Antibiotic-penicillin

Special instructions

Special instructions

During the course of treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver and kidneys.It is possible to develop superinfection due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.

When prescribed to patients with bacteremia, a bacteriolysis reaction (Yarish-Gerksheimer reaction) may develop.

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

In the treatment of mild diarrhea during the course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided; kaolin-or attapulgite-containing antidiarrheal agents can be used. If you have severe diarrhea, you should consult a doctor.

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

When using estrogen-containing oral contraceptives and amoxicillin at the same time, other or additional methods of contraception should be used if possible.

Form of production

Capsules

Storage conditions

Store in a dry place protected from light at a temperature of 15 to 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Amoxicillin

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Sore Throat, Bronchitis, Otitis Media, Urinary Tract Infections, Intestinal Infections, Respiratory Tract Infections, Skin Infections, Pharyngitis