Amoxicillin, clavulanic acid | Augmentin EU suspension 600 + 42, 9 mg / 5 ml bottle 100 (23.13 g)

Release form

Powder for oral suspension.

Packing

Bottle 100 ml.

Pharmacological action

Amoxicillin is a semi-synthetic broad-spectrum antibiotic with activity against many gram-positive and gram-negative microorganisms.

Clavulanic acid is an -lactamase inhibitor. -lactamases are produced by many gram-negative and gram-positive bacteria. The action of β-lactamase can lead to the destruction of some antibacterial drugs even before they begin to affect bacteria. Clavulanic acid blocks the action of -Lactamase, restoring the sensitivity of bacteria to amoxicillin.

Clavulanic acid does not have antibacterial activity, but its combination with amoxicillin allows to obtain a broad-spectrum antibiotic that is insensitive to -lactamases.

Augmentin ® EC has a bactericidal effect on the following microorganisms:

Sensitive gram-positive aerobic microorganisms: Staphylococcus aureus. Streptococcus pneumoniae. Streptococcus pyogenes. Sensitive gram-negative aerobic microorganisms: Haemophilus influenzae. Moraxella catarrhalis. Escherichia coli. Klebsiella spp. Proteus mirabilis. Proteus vulgaris.

Sensitive anaerobic microorganisms: Bacteroides fragilis.

Some strains of these types of bacteria produce beta-lactamases, which makes them insensitive to amoxicillin monotherapy.

Cross-resistance

The development of cross-resistance to unprotected amoxicillin with other beta-lactam antibiotics, a combination of a beta-lactam antibiotic and a beta-lactamase inhibitor and cephalosporins has been shown.

Resistance mechanisms

Clavulanic acid restores the sensitivity of beta-lactamase producing strains. Slow release improves efficacy against strains whose resistance is due to the modification of penicillin-binding proteins.

Indications

Augmentin ® EC is used for the short-term treatment of infections caused by susceptible microorganisms in children:

Upper respiratory tract infections: recurrent or persistent acute otitis media, caused by Streptococcus pneumoniae (minimum inhibitory concentration 2 μg / ml), Haemophilus influenzae and Moraxella catarrhalis. Tonsillo-pharyngitis and sinusitis, usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.

Lower respiratory tract infections: lobar pneumonia and bronchopneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis.

Infections of the skin and soft tissues, usually caused by Staphylococcus aureus and Streptococcus pyogenes.

Some strains of these types of bacteria produce beta-lactamases, which makes them insensitive to amoxicillin monotherapy.

Contraindications

Hypersensitivity to beta-lactam antibiotics (penicillins and cephalosporins).

Jaundice or impaired liver function that has developed with beta-lactam antibiotics.

Children under 3 months of age (due to insufficient clinical trial data for this age group).

Chronic renal failure (creatinine clearance <30 ml / min).

Use during pregnancy and lactation

Fertility: in studies of reproductive functions in animals when taking the drug Augmentin ® EC, it was shown that oral and parenteral administration of this drug did not cause teratogenic effects.

Pregnancy: in a single study in women with premature rupture of the membranes, it was found that prophylactic therapy with Augmentin ® EC may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all medicines, the Augmentin ® EU drug is not recommended for use during pregnancy, except in cases when the expected benefit to the mother exceeds the potential risk of using the drug for the fetus.

Lactation: Amoxicillin, like most penicillins, passes into breast milk. Traces of clavulanic acid have also been found in breast milk. With the exception of the risk of sensitization, no other adverse effects of amoxicillin and clavulanic acid on the health of breast-fed children are known.

Special instructions

Before starting treatment with Augmentin В® EC, a detailed medical history should be collected regarding previous hypersensitivity reactions to penicillins and cephalosporins.

Serious, and sometimes fatal, hypersensitivity reactions to penicillins are described.

The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In case of an allergic reaction, it is necessary to discontinue treatment with the Augmentin В® EC drug. In case of serious hypersensitivity reactions, appropriate measures should be taken immediately. Oxygen therapy, intravenous administration of glucocorticosteroids, and airway management, including intubation, may also be required.

It is not recommended to prescribe the drug Augmentin В® EC in cases of suspected infectious mononucleosis, as in patients with this disease, amoxicillin can cause a skin rash, which complicates the diagnosis of the disease.

Long-term treatment with Augmentin В® EC sometimes leads to excessive reproduction of insensitive microorganisms.

In general, the drug Augmentin В® EC is well tolerated and has low toxicity characteristic of all penicillins. During long-term therapy with Augmentin В® EC, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis.

The drug is not recommended for patients with creatinine clearance below 30 ml / min. In patients with reduced diuresis in very rare cases, the development of crystalluria was reported, mainly with parenteral use of the drug. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of liquid and maintain adequate diuresis to reduce the likelihood of formation of amoxicillin crystals.

There is no experience with patients weighing more than 40 kg, as well as sufficient experience with children under 3 months of age.

Augmentin В® EC Suspension and other Augmentin В® Suspensions are not interchangeable due to the different ratios of amoxicillin: clavulanic acid.

In the medical literature there is no evidence of abuse of the drug Augmentin В® EU and the development of dependence on this drug.

Influence on the ability to drive vehicles and control mechanisms

The drug Augmentin В® EU does not affect the ability to drive a car and other mechanisms.

Composition of

5 ml of the finished suspension contain:

Active substances:

amoxicillin (in the form of trihydrate) - 600 mg

clavulanic acid (in the form of potassium salt) - 42.9 mg.

Excipients:

xanthan gum,

aspartame,

silicon dioxide,

silicon dioxide colloid,

carmellose sodium,

strawberry flavor.

Dosage and administration of

To optimize absorption, the drug should be taken orally at the beginning of a meal. Treatment should not be continued for longer than 14 days without a review of the clinical situation.

If necessary, it is possible to carry out stepwise therapy (at the beginning of the intravenous administration of the Augmentin ® preparation (powder for the preparation of a solution for intravenous administration) with subsequent transition to oral administration).

Children

Augmentin ® EU is recommended for children aged 3 months and older. The recommended daily dose is 90 mg / 6.4 mg / kg body weight, divided into two doses every 12 hours for 10 days:

Weight (kg) 8 - 3 ml 2 times / day (volume of Augmentin ® EC suspension (ml) at the rate of 90 mg / kg / day).

Weight (kg) 12 - 4.5 ml 2 times / day (volume of suspension "Augmentin ® EC" (ml) at the rate of 90 mg / kg / day).

Weight (kg) 16 - 6 ml 2 times / day (suspension volume of Augmentin ® EC (ml) based on 90 mg / kg / day).

Weight (kg) 20 - 7.5 ml 2 times / day (volume of suspension "Augmentin ® EC" (ml) at the rate of 90 mg / kg / day).

Weight (kg) 24 - 9 ml 2 times / day (volume of suspension "Augmentin ® EC" (ml) at the rate of 90 mg / kg / day).

Weight (kg) 28 - 10.5 ml 2 times / day (volume of Augmentin ® EC suspension (ml) based on 90 mg / kg / day).

Weight (kg) 32 - 12.5 ml 2 times / day (volume of Augmentin ® EC suspension (ml) based on 90 mg / kg / day).

Weight (kg) 36 - 13.5 ml 2 times / day (volume of Augmentin ® EC suspension (ml) based on 90 mg / kg / day).

In patients with impaired renal function

No dosage adjustment required for creatinine clearance> 30 ml / min. Not recommended for creatinine clearance <30 ml / min.

In patients with impaired liver function

Caution is advised when monitoring liver function.

Method of preparing a suspension

A suspension is prepared immediately before the first use.

Add approximately 2/3 of the volume of boiled water cooled to room temperature to Table 2, then close the vial with a lid and shake it until the powder is completely diluted, let the vial stand for 5 minutes to ensure complete dilution. Then add water to the mark on the bottle and shake the bottle again.

The vial should be shaken well before each use. For accurate dosing of the drug should use a measuring spoon, which must be washed well with water after each use. After dilution, the suspension should be stored for no more than 10 days in the refrigerator, but do not freeze

Approximate volume of water for suspension:

50 ml vial volume - water volume for 45 ml suspension.

100 ml vial volume - water volume for suspension preparation 90 ml.

Side effects

Adverse events are listed below, depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows:

Very often (? 1/10).

Often (? 1/100 and less than 1/10).

Not often (? 1/1000 and <1/100).

Rarely (? 1/10 000 and <1/1000).

Very rare (<1/10 000).

Frequency categories were based on the absolute frequency of occurrence during the clinical trial program of the drug.

Superinfection: often - candidiasis of the skin and mucous membranes.

From the hemopoietic system and lymphatic system: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia very rarely - reversible agranulocytosis and hemolytic anemia, lengthening of prothrombin time and bleeding time, eosinophilia, thrombocytosis, anemia.

From the side of the immune system: not often - skin rash, itching, urticaria rarely - erythema multiforme very rare - angioedema, anaphylactic reactions, syndrome, similar to serum sickness, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

From the nervous system: not often - dizziness, headache very rarely - reversible hyperactivity, convulsions (can occur in patients with impaired renal function when taking high doses of the drug) insomnia, agitation, anxiety, behavior change.

From the gastrointestinal tract: very often - diarrhea often - nausea, vomiting, dyspeptic disorders very rarely - colitis (including pseudomembranous colitis and hemorrhagic), gastritis, stomatitis, black “hairy” tongue, discoloration of the surface layer of tooth enamel . Oral care helps prevent discoloration of the teeth, because it’s enough to brush your teeth.

From the liver and biliary tract: not often - a moderate increase in the activity of aspartate aminotransferase and alanine aminotransferase (AST and ALT) is very rare - hepatitis and cholestatic jaundice (noted with concomitant therapy with other penicillins and cephalosporins), increased activity of alkaline phosphatase and / or b. Usually, side effects from the liver are reversible. It is extremely rare in patients with severe previous illnesses or those who have received potentially hepatotoxic drugs, they can be quite severe up to death.

From the kidneys and urinary tract: very rarely - interstitial nephritis, crystalluria, hematuria. With the development of any symptoms of hypersensitivity, you should stop using the drug.

Drug Interactions

Probenicid is not recommended at the same timebut with the drug Augmentin ® EC. Probenicide reduces the tubular secretion of amoxicillin, and therefore, the simultaneous use of the drug Augmentin ® EC and probenicide can lead to a steady and long-term increase in the blood concentration of amoxicillin, but not clavulanic acid.

The combined use of allopurinol and amoxicillin increases the risk of allergic reactions. Currently, there is no data in the literature on the combined use of the drug Augmentin ® EC and allopurinol.

Like other broad-spectrum antibiotics, the Augmentin ® EC drug can reduce the effectiveness of oral contraceptives, and patients should be informed about this.

The literature describes rare cases of increasing international normalized ratio (MHO) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous administration of the drug Augmentin ® EC with indirect anticoagulants, prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the drug Augmentin ® EC.

Overdose

Symptoms: Gastrointestinal disorders and disorders of water and electrolyte balance, abdominal pain, vomiting, diarrhea, rash, hyperactivity or drowsiness may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure.

Treatment: conducting symptomatic therapy, paying particular attention to the normalization of the water-electrolyte balance. Amoxicillin and clavulanic acid are eliminated from the blood by hemodialysis.

Storage conditions

Do not store above 25 РC.

The reconstituted suspension should be stored in the refrigerator at 2 ° to 8 РC.

Keep out of the reach and sight of children.

Shelf life

2 years. The prepared suspension is 10 days in a tightly closed bottle.

Deystvuyushtee substance

amoxicillin, Klavulanovaya Chisloth

Terms and conditions

prescription

Prescription

For

For children as prescribed by a doctor, Ber mennym prescribed by a doctor for adults appointment doctor

Glakso SmithKlyan, United Kingdom