Amoxicillin, clavulanic acid | Ecoclave tablets coated.pl.ob. 500 mg + 125 mg 15 pcs.

release form

film-coated tablets

Packing

15 tablets.

Pharmacological action

Antibacterial.

Indications

Infectious and inflammatory diseases caused by drug-sensitive pathogens:

lower respiratory tract infections (bronchitis, pneumonia)

infections of the ENT organs (sinusitis, tonsillitis, otitis media)

infections of the urinary tract, pyelitis and pyelitis and pyelitis cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, septic abortion, soft chancre, gonorrhea)

infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscesses, phlegmon, wound infections)

infections osteomyelitis).

Contraindications

hypersensitivity (including to cephalosporins and other beta-lactam antibiotics)

infectious mononucleosis

episodes of jaundice or impaired hepatic function as a result of the use of amoxicillin / clavulanic acid in children under 12 years old 40 kg (for this dosage form)

With caution: severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure Residual.

Use during pregnancy and lactation

The combined preparation of amoxicillin and clavulanic acid during pregnancy is recommended only in cases where the expected benefits of taking it for the mother outweigh the potential risk to the fetus.

The drug can be used during breastfeeding. With the exception of the risk of sensitization associated with the penetration into breast milk of trace amounts of the active ingredients of this drug, no other adverse effects were detected in breast-fed infants.

Composition

1 film-coated tablet contains:

active ingredients: amoxicillin trihydrate (in terms of amoxicillin) 500 mg, potassium clavulanate (in terms of clavulanic acid) 125 mg,

excipients: lactulose, crospovidone (collidone CL), croscarmellose sodium, talc, magnesium stearate crystalline cellulose cellulose cellulose : Insta Moistskold film coating mixture (hypromellose - 54%, ethyl cellulose - 5%, diethyl phthalate - 12%, titanium dioxide - 25%, talc - 4%)

Dosage and administration of

Ecoclave taken orally. The dosage regimen is set individually depending on the age and body weight of the patient, the severity of the course and localization of the infectious process, as well as the sensitivity of the pathogen.

The minimum course of antibiotic therapy is from 5 days. Treatment should not be continued for longer than 14 days without a review of the clinical situation.

Adults and children over 12 years of age or weighing more than 40 kg: Mild and moderate infections - 1 tablet of 500 mg + 125 mg 2 times a day.

Severe infections or lower respiratory tract infections - 1 tablet of 500 mg + 125 mg 3 times a day.

Since tablets contain the same amount of clavulanic acid (125 mg), it should be borne in mind that 2 tablets of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg.

The maximum daily dose of amoxicillin for adults and children over 12 years old is 6 g, clavulanic acid is 600 mg.

In chronic renal failure, dose and dose rates are adjusted depending on creatinine clearance (QC): - for QC over 30 ml / min dose adjustment is not required

- for QC 10-30 ml / min: 1 tablet of 250 mg + 125 mg 2 times / day (for mild and moderate infections) or 1 tablet of 500 mg + 125 mg 2 times / day (for severe infections or lower respiratory tract infections)

- with CC less than 10 ml / min: 1 tablet of 250 mg +125 mg 1 time / day (for mild and moderate infections) or 1 tablet of 500 mg + 125 mg 1 time / day (for severe infections or lower respiratory tract infections)

Hemodialysis patients: 1 tablet of 500 mg + 125 mg or 2 tablets of 250 mg + 125 mg every 24 hours in combination with 1 dose during hemodialysis and 1 dose after hemodialysis, as the concentration of amoxicillin and clavulanic acid decreases.

Side effects

The drug is well tolerated. Side effects rarely occur, they are mostly mild and are transient in nature.

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with prolonged therapy), colitis (including pseudomembranous), black hairy tongue, darkening of tooth enamel , increased activity of hepatic transaminases, increased bilirubin content and alkaline phosphatase activity.

Hematopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

From the central nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.

Allergic reactions: urticaria, erythematous rashes, multiforme exudative erythema, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, syndrome, similar to acute osteoarthritis

From the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria.

Other: candidiasis, development of superinfection.

Drug Interaction

It is not recommended to use a combination preparation of amoxicillin and clavulanic acid with probenecid. Probenecid reduces tubular secretion of amoxicillin, so their co-administration can lead to increased and persistent serum concentrations of amoxicillin, whereby the serum concentration of clavulanic acid does not change.

Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is eliminated mainly by glomerular filtration).

Antacids, glucosamine, laxatives slow down and reduce the absorption of amoxicillin ascorbic acid - increases.

Allopurinol increases the risk of skin rash.

Like other broad-spectrum antibiotics, a combination drug of amoxicillin and clavulanic acid may reduce the effectiveness of oral contraceptives, and patients should be informed.

The literature describes rare cases of increased international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. When concurrent use of the combination drug amoxicillin and clavulanic acid with indirect anticoagulants, prothrombin time or MNO should be carefully monitored when prescribing or discontinuing the drug.

Overdose

Symptoms: impaired gastrointestinal function and water-electrolyte balance.

Treatment: symptomatic. Hemodialysis is effective.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 РC.

Expiration

2 years.

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ABBA RUS, Russia