Ecoclav suspension powder for oral use 250+62.5mg/5ml bottle, 25g

Composition

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of 5 ml of the finished suspension (one dosage spoon) contains:  

Active ingredients:

amoxicillin trihydrate (in terms of amoxicillin) 250 mg,

potassium clavulanate (in terms of clavulanic acid) 62.5 mg;

Auxiliary substances:

lactulose, aspartame,

colloidal silicon dioxide (aerosil),

xanthan gum,

crospovidone (collidone CL-M),

citric acid anhydrous,

sodium citrate dihydrate,

sodium benzoate,

talc,

orange flavor,

mannitol (mannitol)

Pharmacological action

Antibacterial.

Indications

Infectious and inflammatory diseases caused by drug-sensitive pathogens:

• infections of the lower respiratory tract (bronchitis, pneumonia);
• infections of ENT organs (sinusitis, tonsillitis, otitis media);
• infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, oophoritis, endometritis, bacterial vaginitis, septic abortion, chancroid, gonorrhea);
• infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, cellulitis, wound infection);
• infections of bones and joints (osteomyelitis).

Use during pregnancy and lactation

Pregnancy

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

Breast-feeding

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

Contraindications

• Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics),
• Infectious mononucleosis.
• Episodes of jaundice or impaired liver function due to the use of amoxicillin/clavulanic acid in the anamnesis, phenylketonuria (contains aspartame).

Side effects

The drug is well tolerated. Side effects are rare, mostly mild, and 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 long-term therapy), colitis (including pseudomembranous), black “hairy” tongue, darkening of tooth enamel, increased activity of “liver” transaminases, increased bilirubin content and alkaline phosphatase activity.

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

Central nervous system disorders: dizziness, headache, hyperactivity, anxiety, behavior changes, seizures.

Allergic reactions: urticaria, erythematous rashes, erythema multiforme, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis.

Renal and urinary tract disorders: interstitial nephritis, crystalluria, hematuria.

Other: candidiasis, development of superinfection.

Interaction

It is not recommended to use a combined preparation of amoxicillin and clavulanic acid simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, so their combined use can lead to an increase and persistence of the concentration of amoxicillin in serum, while the serum concentration of clavulanic acid does not change.

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

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

Allopurinol increases the risk of skin rashes.

As with other broad-spectrum antibiotics, the combination of amoxicillin and clavulanic acid may reduce the effectiveness of oral contraceptives, and patients should be informed about this. The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin.

If concomitant use of the combined drug amoxicillin and clavulanic acid with indirect anticoagulants is necessary, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.

How to take, course of use and dosage

Inside. The dosage regimen is set individually depending on the patient’s body weight, the severity of the course and localization of the infectious process, as well as the sensitivity of the pathogen.

The minimum course of antibacterial therapy is from 5 days. Treatment should not be continued for more than 14 days without reviewing the clinical situation. The duration of treatment of acute uncomplicated otitis media is 5-7 days, in children under 2 years – 7-10 days.

A single dose is set depending on age and body weight (calculated according to amoxicillin):

• children under 3 months – 30 mg / kg / day in 2 divided doses;
• children from 3 months and older:

– low doses (for the treatment of skin and soft tissue infections, as well as chronic tonsillitis) – 20 mg / kg / day in 3 doses;

– high doses (for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections) – 40 mg/kg/day in 3 doses.

Children weighing 40 kg or more should be given doses similar to adults.

The suspension can be used in adults with difficulty swallowing.

Recommended dosage regimen for adults: 20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml 2-3 times a day.

The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age – 45 mg/kg of body weight.

The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age – 10 mg/kg of body weight.

Patients with impaired renal function:

Dose adjustment is based on the maximum recommended dose of amoxicillin and creatinine clearance.

Children

Creatinine clearance greater than 30 ml / min no dose adjustment is required.

Creatinine clearance 10-30 ml / min – 15 mg / 3.75 mg / kg 2 times a day, the maximum dose is 500 mg+125 mg (20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml) 2 times a day;

Creatinine clearance less than 10 ml / min – 15 mg / 3.75 mg / kg once a day, the maximum daily dose is 500 mg+125 mg (20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml);

Adults

Creatinine clearance greater than 30 ml / min no dose adjustment is required.

Creatinine clearance 10-30 ml / min – 500 mg+125 mg (20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml) 2 times a day;

Creatinine clearance less than 10 ml / min – 500 mg+125 mg (20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml) once a day;

Patients undergoing hemodialysis:

Dose adjustment is based on the maximum recommended dose of amoxicillin

• Children – 15 mg / 3.75 mg / kg 1 time per day.

Before the hemodialysis session, one additional dose of 15 mg/3.75 mg/kg should be taken. To restore the concentration of active components of the drug in the blood, a second additional dose of 15 mg/3.75 mg / kg should be taken after a hemodialysis session.

• Adults – 500 mg+125 mg (20 ml of suspension at a dosage of 125 mg+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250 mg+62.5 mg/5 ml) once every 24 hours.

An additional 1 dose during the dialysis session and another dose at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Overdose

Symptoms: violation of the function of the gastrointestinal tract and water-electrolyte balance.

Treatment: symptomatic. Hemodialysis is effective.

Special instructions

The severity of gastrointestinal symptoms decreases when taking the drug at the beginning of a meal.

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 selection of resistant forms of the pathogen.

False positive results may be detected when determining the glucose content in the urine. In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine.

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

If infectious mononucleosis is suspected, the drug should not be used, since in patients with this disease, amoxicillin can cause a crust-like skin rash, which makes it difficult to diagnose the disease.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Given the likelihood of developing side effects from the central nervous system, caution should be exercised when driving vehicles and working with moving mechanisms.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Children as prescribed by a doctor

Indications

Bronchitis, Pneumonia, Tonsillitis, Skin Infections, Sinusitis, Urinary Tract Infections, Cholecystitis, Otitis Media, Sore Throat, Pharyngitis, Osteomyelitis, Periodontitis