Amoxicillin, clavulanic acid | Augmentin suspension 200 mg + 28.5 mg / 5 ml bottle 70 ml

Latin name

AUGMENTIN

Release form

Powder for oral suspension.

Packing

Bottle of 70 ml.

Pharmacological action

Amoxicillin is a semi-synthetic broad-spectrum antibiotic with activity against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by β-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms, that produce this enzyme.

Clavulanic acid, an -lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of -lactamases found in penicillin and cephalosporin resistant microorganisms.

Clavulanic acid has sufficient efficacy against plasmid -lactamases, which most often cause bacterial resistance, and is less effective against chromosomal -lactamases of type 1 that are not inhibited by clavulanic acid.

The presence of clavulanic acid in the Augmentin® preparation protects amoxicillin from destruction by enzymes -lactamases, which allows to expand the antibacterial spectrum of amoxicillin.

The following is the in vitro combination activity of amoxicillin with clavulanic acid.

bacteria, usually sensitive to a combination of amoxicillin with clavulanic acid

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus. (other beta hemolytic streptococci) 1,2, Staphylococcus aureus (methicillin sensitive) 1, Staphylococcus saprophyticus (methicillin sensitive), Staphylococcus spp. (coagulase-negative, sensitive to methicillin).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peplostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp.

Gram-negative anaerobes: Bacteroides fragilis, Bacteroides spp., Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp.

Bacteria for which the acquired resistance to a combination of amoxicillin with clavulanic acid is likely

Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, Streptococcus group Viridans2.

bacteria, possessing natural resistance to a combination of amoxicillin with clavulanic acid

Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonasiaphrophs. spp. .

Others: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, Mycoplasma spp.

1 - for these types of microorganisms, the clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 - strains of these types of bacteria do not produce -lactamases. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Indications

Bacterial infections caused by susceptible microorganisms:

Upper respiratory tract and ENT infections (e.g., recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis *, Streptococcus pyogenes

Lower respiratory tract infections: exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae * and Moraxella catarrhalis * urethritis, pyelonephritis, female genital infections, usually caused by species of the Enterobacteriaceae family (mainly Escherichia coli *), Staphylococcus saprophyticus and species of the genus Enterococcus

Gonorrhea caused by Neisseria gonorrhoeae * (except tablets 250 mg / 125 mg)

, skin infections and usually caused by Staphylococcus aureus *, Streptococcus pyogenes and species of the genus Bacteroides *

Bone and joint infections: osteomyelitis, usually caused by Staphylococcus aureus *, if long-term therapy is needed

Odontogenic infections, for example periodontitis, odontogenic, maxillary sinusitis, severe dental abscesses with spreading cellulite (for tablets 500 mg / 125 mg or 875 mg / 125 mg)

Other mixed infections (for example, septic abortion, postpartum sepsis, intraabdominal sepsis) in the framework of step therapy (for tablets 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg).

* - individual representatives of this type of microorganism, produce -lactamase, which makes them insensitive to amoxicillin.

Infections caused by microorganisms sensitive to amoxicillin can be treated with AugmentinВ® because amoxicillin is one of its active ingredients. AugmentinВ® is also indicated for the treatment of mixed infections, caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing ОІ-lactamase, sensitive to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies by region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (eg, penicillins, cephalosporins) in history.

Previous episodes of jaundice or impaired liver function with a history of amoxicillin and clavulanic acid.

Children under 12 years of age and body weight less than 40 kg (for tablets 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg).

Children under 3 months of age (for powder for oral suspension, 200 mg / 28.5 mg and 400 mg / 57 mg).

Impaired renal function (KK 30 ml / min) - (for tablets 875 mg / 125 mg, for powder for suspension for oral administration 200 mg / 28.5 mg and 400 mg / 57 mg).

Phenylketonuria (for powder for oral suspension).

Caution: impaired liver function.

Use in pregnancy and lactation

In studies of reproductive function in animals, oral and parenteral administration of AugmentinВ® did not cause teratogenic effects.

In a single study in women with premature rupture of the membranes, it was found that prophylactic drug therapy may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all medicines, AugmentinВ® is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

AugmentinВ® can be used while breastfeeding. Except for the possibility of developing diarrhea or candidiasis of the mucous membranes of the oral cavity, associated with the penetration into breast milk of trace amounts of the active substances of this drug, no other adverse effects were observed in breast-fed infants. In case of adverse effects in breast-fed infants, breast-feeding should be discontinued.

Composition of

5 ml of the prepared suspension contain:

Active ingredient:

amoxicillin (in the form of trihydrate) - 200 mg

clavulanic acid (in the form of potassium salt) - 28.5 mg.

Excipients:

xanthan gum - 12.5 mg,

aspartame - 12.5 mg,

succinic acid - 0.84 mg,

silicon dioxide colloidal - 25 mg,

hypromellose - 79.65 mg,

orange flavor - 15 mg,

flavoring orange 2 - 11.25 mg,

flavoring raspberry - 22.5 mg,

flavoring bright molasses - 23.75 mg,

silicon dioxide - up to 552 mg.

Dosage and administration of

The dosage regimen is set individually depending on the age, body weight, patient's kidney function, as well as the severity of the infection.

Augmentin® is recommended to be taken at the beginning of a meal to optimally absorb and reduce possible side effects from the digestive system.

The minimum course of antibiotic therapy is 5 days.

Treatment should not be continued for more than 14 days without a review of the clinical situation.

If necessary, it is possible to carry out stepwise therapy (at the beginning of therapy, parenteral administration of the drug with subsequent transition to oral administration).

Adults and children over 12 years of age or weighing 40 kg or more

1 tablet 250 mg / 125 mg 3 times / day (for infections of mild to moderate severity), or 1 tablet 500 mg / 125 mg 3 times / day, or 1 tablet of 875 mg / 125 mg 2 times / day, or 11 ml of a suspension of 400 mg / 57 mg / 5 ml 2 times / day (which is equivalent to 1 tablet of 875 mg / 125 mg).

2 tablets 250 mg / 125 mg are not equivalent to 1 tablet 500 mg / 125 mg.

Children from 3 months to 12 years old with body weight less than 40 kg

The drug is prescribed in the form of a suspension for oral administration.

Dose calculation is carried out depending on age and body weight, indicated in mg / kg body weight / day (calculation according to amoxicillin) or in ml of suspension.

Multiplicity of suspension 125 mg / 31.25 mg in 5 ml - 3 times / day every 8 hours.

Multiplicity of suspension 200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg 5 ml - 2 times / day every 12 hours

The recommended dosage regimen and frequency of administration are presented below:

Frequency of administration - 3 times / day, 4: 1 suspension (125 mg / 31.25 mg in 5 ml):

Low doses - 20 mg / kg / day .

High doses - 40 mg / kg / day.

Multiplicity of administration - 2 times / day, 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml):

Low doses - 25 mg / kg / day.

High doses - 45 mg / kg / day.

Low doses of Augmentin® are used to treat infections of the skin and soft tissues, as well as recurrent tonsillitis.

High doses of Augmentin® are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, and bone and joint infections.

Insufficient clinical data to recommend the use of Augmentin® at a dose of more than 40 mg / kg / day in 3 divided doses (4: 1 suspension) in children under 2 years of age.

Children from birth to 3 months

Due to immaturity of the excretory function of the kidneys, the recommended dose of Augmentin® (calculation for amoxicillin) is 30 mg / kg / day in 2 divided doses of 4: 1.

The use of a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) is not recommended in this population.

Premature birth

There are no recommendations regarding the dosage regimen.

Elderly patients

No dosage adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as follows for adults with impaired renal function.

Patients with impaired renal function

Dose adjustment is based on the maximum recommended dose of amoxicillin and is carried out taking into account QC values.

Adults

Tablets 250 mg + 125 mg or 500 mg + 125 mg:

KK> 30 ml / min - dosage adjustment is not required.

KK 10-30 ml / min - 1 tab. 250 mg + 125 mg 2 times / day or 1 tab. 500 mg + 125 mg (for mild to moderate infection) 2 times / day.

KK <10 ml / min - 1 tab. 250 mg + 125 mg 1 time / day or 1 tab. 500 mg + 125 mg (for mild to moderate infection) 1 time / day.

Suspension 4: 1 (125 mg / 31.25 mg in 5 ml):

KK> 30 ml / min - dosage adjustment is not required.

KK 10-30 ml / min - 15 mg / 3.75 mg / kg 2 times / day, maximum dose - 500 mg / 125 mg 2 times / day.

KK <10 ml / min - 15 mg / 3.75 mg / kg 1 time / day, the maximum daily dose is 500 mg / 125 mg.

Tablets 875 mg + 125 mg and suspension 7: 1 (200 mg / 28, 5 mg in 5 ml or 400 mg / 57 mg in 5 ml) should be used only in patients with CC> 30 ml / min, and dose adjustment is not required.

In most cases, parenteral therapy should be preferred if possible.

Hemodialysis patients

Dose adjustments are based on the maximum recommended dose of amoxicillin: 2 tab. 250 mg / 125 mg in one dose every 24 hours, or 1 tab. 500 mg / 125 mg in one dose every 24 hours, or a suspension at a dose of 15 mg / 3.75 mg / kg 1 time / day.

Tablets: during the hemodialysis session, an additional 1 dose (one tablet) and another 1 dose (one tablet) at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Suspension: one additional dose of 15 mg / 3.75 mg / kg should be administered before the hemodialysis session. To restore the concentration of the active components of the drug Augmentin® in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be introduced after a hemodialysis session.

Patients with impaired liver function

Treatment is carried out with caution regularly monitor liver function. There is not enough data to correct the dosing regimen in this category of patients.

Rules for the preparation of suspension

A suspension is prepared immediately before the first use.

Suspension (125 mg / 31.25 mg in 5 ml): approximately 60 ml of boiled water cooled to room temperature should be added to the powder bottle, then close the bottle with a lid and shake until the powder is completely diluted, allow the bottle to stand for 5 minutes to ensure complete breeding. Then add water to the mark on the bottle and shake the bottle again. In total, about 92 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For accurate dosing of the drug should use a measuring cap, which must be washed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years of age, a measured single dose of a suspension of Augmentin® can be diluted in half with water.

Suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml): add approximately 40 ml of boiled water cooled to room temperature to the powder bottle, then close the bottle with a lid and shake until diluted powder allow the vial to stand for 5 minutes to ensure complete dilution. Then add water to the mark on the bottle and shake the bottle again. In total, about 64 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For accurate dosing of the drug, use a measuring cap or a dosing syringe, which must be washed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years of age, a measured single dose of a suspension of Augmentin® can be diluted with water in a ratio of 1: 1.

Drug Interaction

Concomitant use of Augmentin® and probenecid is not recommended. Probenecid reduces tubular secretion of amoxicillin, and therefore concomitant administration of Augmentin® and probenecid may lead to increased and persistent blood concentrations of amoxicillin but not clavulanic acid.

The combined use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently, there are no data in the literature on the concomitant use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins are able to slow the excretion of methotrexate from the body by inhibiting its tubular secretion, therefore, concomitant administration of Augmentin® and methotrexate may increase the toxicity of methotrexate.

Like other antibacterials, Augmentin® can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of an increase in international normalized ratio (MHO) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If co-administration of Augmentin® with anticoagulants is required, prothrombin time or MHO should be closely monitored when prescribing or discontinuing Augmentin®, and dosage adjustment of anticoagulants may be required for oral administration.

Overdose

Symptoms: Gastrointestinal symptoms and impaired electrolyte balance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure.

Seizures may occur in patients with impaired renal function as well as in patients with who receives high doses of the drug.

Treatment: Gastrointestinal symptoms - symptomatic therapy, with special attention to normalization of water-electrolyte balance. In the event of an overdose, amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study with 51 children at a toxicology center showed that administration of amoxicillin at a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

Storage conditions

The drug should be stored in a dry place inaccessible to children at a temperature not exceeding 25 РC.

The prepared suspension should be stored in the refrigerator at a temperature of 2 ° to 8 РC.

Expiration

Expiration of tablets (250 mg + 125 mg) and (875 mg + 125 mg) - 2 years, tablets (500 mg + 125 mg) - 3 years.

The Expiration of the powder for suspension in an unopened vial is 2 years.

The reconstituted suspension should be stored for 7 days.

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dosage form

oral suspension

GlaxoSmithKline, UK