Augmentin powder for suspension 200mg + 28.5mg \ 5ml bottle 70ml

Active ingredient and dosage form

Coated Tablets from white to almost white, oval, with indented and "AUGMENTIN and" on one side; on a kink - from almost white to yellowish-white.
1 pill contains Amoxicillin (in the form of trihydrate) - 250 mg, clavulanic acid (in the form of potassium salt) - 125 mg;
auxiliary substances: Magnesium stearate, sodium starch glycolate type A, anhydrous colloidal silicon, microcrystalline cellulose;
Shell composition: titanium dioxide, hydroxypropylmethylcellulose (5 cps), hydroxypropylmethylcellulose (15 cps), polyethylene glycol 4000, polyethylene glycol 6000, dimethicone (silicone oil).
10 pieces. in aluminum foil blister, 2 blisters in a carton box.

Coated tablets: 1 pill contains amoxicillin (in the form of trihydrate) - 500 mg, clavulanic acid (in the form of potassium salt) - 125 mg;
7 or 10 pieces in aluminum foil blister, 2 blisters in a carton box.

Coated Tablets from white to almost white color, oval, with the letters and "А and" and and "С and" on both sides of the pill and the fault line on one side; on a kink - from almost white to yellowish-white.
 1 pill contains amoxicillin (in the form of trihydrate) - 875 mg, clavulanic acid (in the form of potassium salt) - 125 mg;
7 pieces in aluminum foil blister, 2 blisters in a carton box.

Powder for suspension for oral administration white or almost white in color, with a characteristic odor; prepared suspension of white or almost white color.
5 ml of the prepared suspension contains amoxicillin (in the form of trihydrate) - 125 mg, clavulanic acid (in the form of potassium salt) - 31.25 mg;
Excipients: Xanthan gum, aspartame, succinic acid, colloidal silicon, hydroxypropylmethylcellulose, silicon dioxide, dry orange flavoring 610271E (Tastemaker) and 9/027108 (Dragoco), dry raspberry flavoring NN07943 (Quest), dry flavoring and Light chimes and and ny; Firmenich);
11.5 g of powder in a 100 ml vial, 1 vial complete with a measuring cap in a cardboard box.

Powder for suspension for oral administration: 5 ml of the prepared suspension contains amoxicillin (in the form of trihydrate) - 200 mg, clavulanic acid (in the form of potassium salt) - 28.5 mg;
7.7 g of powder in a 70 ml vial, 1 vial complete with a measuring cap in a cardboard box.

Powder for suspension for oral administration: 5 ml of the prepared suspension contains amoxicillin (in the form of trihydrate) - 400 mg, clavulanic acid (in the form of potassium salt) - 57 mg;
12.6 g of powder in a bottle of 70 ml, 1 bottle complete with a measuring cap in a cardboard box.

Powder for solution for intravenous administration from white to almost white.
1 bottle contains amoxicillin (in the form of trihydrate) - 500 or 1000 mg, clavulanic acid (in the form of potassium salt) - 100 or 200 mg, respectively;
10 bottles in a carton box.

Mechanism of action

Combined broad-spectrum antibiotic, resistant to the action of b-lactamase, containing amoxicillin and clavulanic acid.
Amoxicillin is a semi-synthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. Amoxicillin is destroyed by b-lactamases, therefore microorganisms producing b-lactamase are not included in the spectrum of its antibacterial activity.
Clavulanic acid, a b-lactam compound, has the ability to inactivate a wide range of b-lactamases, enzymes that usually produce microorganisms that are resistant to penicillins and cephalosporins.
The presence of clavulanic acid in Augmentin composition protects amoxicillin from the destructive action of b-lactamase and expands the spectrum of its antibacterial activity with the inclusion of microorganisms, usually resistant to other penicillins and cephalosporins.
Augmentin effective against gram-positive aerobic microorganisms: Bacillis anthracis^*, Corynebacterium spp., Enterococcus faecalis^*, Enterococcus faecium^*, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus^*, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus spp. (including Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans); for gram-positive anaerobic microorganisms: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; for gram-negative aerobic microorganisms: Bordetella pertussis, Brucella spp., Escherichia coli^*, Gardnerella vaginalis, Haemophilus influenzae^*, Helicobacter pylori, Klebsiella spp.^*, Legionella spp., Moraxella catarrhalis^* (Branhamella catarrhalis), Neisseria gonorrhoeae^*, Neisseria meningitidis^*, Pasteurella multocida, Proteus mirabilis^*Proteus vulgaris^*, Salmonella spp.^*, Shigella spp.^*, Vibrio cholerae, Yersinia enterocolitica^*; for gram-negative anaerobic microorganisms: Bacteroides spp^*. (including Bacteroides fragilis), Fusobacterium spp.^*; for other microorganisms: Borrelia burgdorferi, Chlamydiae, Leptospira icterohaemorrhagiae, Treponema pallidum.
* Some strains of these types of bacteria produce b-lactamase, which causes resistance to amoxicillin monotherapy.

Indications and usage

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and upper respiratory tract (including recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis and Streptococcus pyogenes;
- lower respiratory tract infections: exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis;
- infections of the urinary tract: cystitis, urethritis, pyelonephritis, infections of the female genital organs, usually caused by species of the family Enterobacteriaceae (mainly Escherichia coli), Staphylococcus saprophyticus and species of the genus Enterococcus, as well as gonorrhea caused by Neisseria gonorrhoeae;
- infections of the skin and soft tissues, usually caused by Staphylococcus aureus, Streptococcus pyogenes and species of the genus Bacteroides;
- infections of bones and joints: osteomyelitis, usually caused by Staphylococcus aureus, with the need for long-term therapy;
- other mixed infections, such as septic abortion, obstetric sepsis, intra-abdominal infections.

Contraindications

- jaundice or abnormal liver function in the history of Augmentin's use;
- Hypersensitivity to beta-lactam antibiotics (includingpenicillins and cephalosporins).
Carefully should be used for infectious mononucleosis, pregnancy, lactation, gastrointestinal diseases (including if there is a history of indications of transferred colitis associated with the use of penicillins), chronic renal failure.

The dosage regimen is set individually depending on the age, body weight, renal function of the patient, as well as the severity of the infection.
For optimal absorption and reduction of possible side effects from the digestive system, Augmentin is recommended to be taken at the beginning of a meal.
Treatment should not be continued for more than 14 days without revising the clinical situation.
If necessary, it is possible to conduct stepwise therapy (at the beginning of the intravenous injection of the drug with the subsequent transition to oral administration).
Adults and children over 12 years old or with a body weight of more than 40 kg
1 pill (875 mg + 125 mg) 2 times / day or 1 pill (500 mg + 125 mg) 3 times / day.
Children under 12 years old
The dose, depending on age and body weight, is indicated in mg / kg of body weight per day, or in ml of suspension.
The recommended dosing regimen: 45 mg / kg / day in 2 doses or 40 mg / kg / day in 3 doses. The multiplicity of reception depends on the form of release.
Children weighing 40 kg or more the drug should be prescribed in the same doses as adults.
Single doses of the drug Augmentin, depending on age and body weight are presented in the table.

* Amoxicillin
Two tablets of Augmentin (250 mg + 125 mg) are not equivalent to one pill (500 mg + 125 mg), since the content of clavulanic acid in them is 2 times higher.
For the correct dosing volume of suspension at children under 3 months It is recommended to use a syringe with a graduation.
For the convenience of receiving children under 2 years the suspension can be diluted twice with water.
At treatment of infections of the skin and soft tissues, as well as recurrent tonsillitis the drug can be administered at a dose of 20 mg / kg / day in 3 doses (suspension 4: 1) and 25 mg / kg / day in 2 doses (suspension 7: 1).
If the frequency of excretion of pneumococcus with a high level of penicillin resistance (with penicillin BMD 2-4 mg / l) in the region (or closed institution) exceeds 10%, amoxicillin / clavulanate (Augmentin) should be used in a dose of 80-90 mg / kg / day, divided for 3 doses.
Optimum dosage form Augmentina for children from 6 to 12 years Tablets are 500 mg + 125 mg taken 2 times / day.
Patients with impaired renal function
Dose adjustment is based on the maximum recommended dose of amoxicillin and is based on the values ​​of QC.
Adults

Tablets of 875 mg + 125 mg should be used only in patients with QA and> 30 ml / min.
Children

In most cases, if possible, preference should be given to parenteral therapy.
Hemodialysis patients
Dose adjustment is based on the maximum recommended dose of amoxicillin.
For adults appoint 1 tab. (500 mg + 125 mg) or 2 tab. (250 mg + 125 mg) every 24 hours
Additionally, 1 dose is prescribed during the dialysis session and 1 more dose at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).
Tablets (875 mg + 125 mg) should be used only in patients with QA and> 30 ml / min.
For children appoint 15 mg + 3.75 mg / kg 1 time / day.
Before a hemodialysis session, one additional dose of 15 mg + 3.75 mg / kg should be administered. To restore the concentration of Augmentin active ingredients in the blood, a second additional dose of 15 mg + 3.75 mg / kg should be administered after a hemodialysis session.
Patients with impaired liver function
The treatment is carried out with caution; monitor liver function regularly. Not enough data to correct the dosage regimen for this category of patients.
Elderly patients
Reduce the dose Augmentina not required; doses are the same as for adults. Have elderly patients with impaired renal function dose should be adjusted as described above for adults with impaired renal function.
Suspension method
Suspension is prepared immediately before the first application. The powder should be dissolved with boiled water, cooled to room temperature, gradually shaking and adding water to the mark on the bottle. Then let stand for about 5 minutes to ensure complete dissolution. The bottle should be shaken well before each use. For the exact dosage of the drug, use a measuring cap-cap, which should be rinsed 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.

IN / INJECTION
The dose depends on age, body weight, kidney function and the severity of the infection.
Doses Augmentina expressed as the content of amoxicillin to the content of clavulanic acid.
Adults
Standard dose: 1000/200 mg every 8 hours
Severe infections: 1000/200 mg every 4-6 hours.
Prevention of surgical infections for operations lasting less than 1 hour: 1000/200 mg during induction anesthesia. For operations lasting more than 1 hour: 1000/200 mg during induction anesthesia in combination with the introduction of up to 4 doses of 1000/200 mg per 24 hours.
Obvious signs of infection during surgery require the appointment of a standard course of Augment therapy in the postoperative period, either in the form of intravenous injection or for oral administration.
At renal dysfunction Augmentin dosing regimen set on the basis of the maximum dose of amoxicillin, which can be used to reduce renal function in each case. Correction of the dosing regimen is carried out depending on the CC.

When conducting hemodialysis 1000/200 mg initial dose, then 500/100 mg 1 time / day and an additional 500/100 mg at the end of dialysis, since the concentration of amoxicillin and clavulanic acid is reduced.
For elderly patients dosing regimen is the same as in adults.
Children
In children with a body weight less than 40 kg, the dose is established depending on the body weight.
Children under 3 months and weighing less than 4 kg Augmentin is prescribed at the rate of 25/5 mg / kg or 50/5 mg / kg every 12 hours.
Children under 3 months and weighing more than 4 kg the drug is prescribed at the rate of up to 25/5 mg / kg or 50/5 mg / kg every 8 hours, depending on the severity of the infection.
Children aged 3 months to 12 years the drug is prescribed at the rate of 25/5 mg / kg or 50/5 mg / kg every 6-8 hours, depending on the severity of the infection.
If kidney damage carry out the correction of the dosage depending on the QC.

Augmentin is used at the rate of 25/5 mg / kg 1 time / day and additionally 12.5 / 2.5 mg / kg at the end of dialysis, then 25/5 mg / kg / day,since the daily concentration of amoxicillin and clavulanic acid is reduced.
Augmentin should not be prescribed for more than 14 days without evaluating the feasibility of continuing therapy.
Terms of preparation and administration of the solution for intravenous injection
Augmentin can be administered as a slow intravenous injection for 3-4 minutes directly into the vein.
Augmentin can not be entered in / m.

The solvent is water for injection. During breeding, a temporary pink color may appear. The finished solution has a light yellow color. Augmentin can not be entered within 20 minutes after dilution.
Terms of preparation and administration of the solution for intravenous infusion
Augmentin can be administered as an intravenous infusion over 30–40 minutes.
Augmentin's solution for intravenous infusion at a dose of 500/100 mg and 1000/200 mg is immediately added to 50 ml and 100 ml of the fluid for infusion, respectively. For the preparation of Augmentin solutions for IV infusions, various standard solutions can be used for IV infusions. A sufficient concentration of antibiotics is maintained at 5 ° and 25 ° C in the recommended volumes of the infusion solutions listed below. If dilution and storage occurs at room temperature, infusions should be made within the prescribed time.

The stability of Augmentin solutions for iv administration depends on the concentration. If it is necessary to use more concentrated solutions, the period of stability is adjusted accordingly to a given concentration.
At a temperature of 5 ° C, the prepared solutions of Augmentin 500/100 mg and 1000/200 mg can be stored for up to 8 hours by adding them to the pre-cooled infusion bags, after which, immediately when the solution reaches room temperature, it should be administered to the patient.

Augmentin is less stable in infusion solutions containing dextrose, dextran or sodium bicarbonate. The prepared Augmentin solution can be administered through an IV drip within 3-4 minutes.
Do not use the remnants of the antibiotic solution.
Augmentin bottles are not intended for repeated use.

Determination of the incidence of side effects: very often (and> 10%), often (and> 1% and and <10%), sometimes (and> 0.1% and and <1%), rarely (and> 0.01% and and < 0.1%), very rarely (and <0.01%).
From the hemopoietic system: rarely, reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - reversible agranulocytosis and hemolytic anemia, an increase in bleeding time and prothrombin time.
Allergic reactions: very rarely - angioedema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematic pustus.
In case of any form of atopic dermatitis, treatment with Augmentin should be stopped.
Dermatological reactions: sometimes - skin rash, urticaria; rarely erythema multiforme.
From the side of the central nervous system: sometimes - dizziness, headache; very rarely - reversible hyperactivity and convulsions. Seizures can occur in patients with impaired renal function and in patients receiving the drug in high doses.
From the digestive system: very often - diarrhea (in adults); often - diarrhea (in children), nausea (more often when taking the drug in high doses), vomiting; sometimes dyspepsia ; very rarely - discoloration of the surface layer of tooth enamel (in children taking the suspension).
Liver: sometimes with beta-lactam antibiotics, a moderate increase in ACT and / or ALT levels is observed (clinical significance not established); very rarely - hepatitis, cholestatic jaundice. These side effects are observed when taking other penicillins or cephalosporins.
The side effects of the liver are reversible, occurring during or shortly after the end of treatment. Children develop very rarely.Occur predominantly in men and elderly patients, and may be associated with long-term therapy.
In extremely rare cases, in patients with serious previous illnesses or in those who have received potentially hepatotoxic drugs, side effects can be severe and fatal.
From the urinary system: very rarely - interstitial nephritis, crystalluria.
Effects due to microbiological effects: often - mucosal candidiasis; very rarely, pseudomembranous and hemorrhagic colitis.
When taking Augmentina side effects occur rarely and are predominantly light and transient.

In studies of reproductive functions in animals when Augmentin was taken, it was shown that oral and parenteral administration of this drug did not cause teratogenic effects.
In a single study in women with premature rupture of the membranes, it was found that Augmentin preventive therapy may be associated with an increased risk of necrotizing enterocolitis in the newborn. Augmentin is not recommended for use during pregnancy, except in cases where, according to the doctor, it is necessary.
Augmentin can be used during breastfeeding. With the exception of the risk of sensitization associated with the release into the breast milk of the active substances of the drug in trace amounts, no other adverse effects were observed in breastfed babies.

Before starting treatment with Augmentin, a detailed history should be collected regarding previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and sometimes lethal hypersensitivity reactions (anaphylactic reactions) to penicillins are described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to antibiotics in this group. In the event of an allergic reaction, it is necessary to discontinue treatment with Augmentin and initiate an alternative therapy. For serious hypersensitivity reactions, epinephrine (epinephrine) should be injected immediately. Oxygen therapy, intravenous steroids and airway management, including intubation, may also be required.
Augmentin should be avoided if infectious mononucleosis is suspected, since in such cases amoxicillin can cause a skin rash, which makes it difficult to diagnose the disease.
Use caution Augmentin in patients with impaired liver function.
The severity of side effects from the digestive system can be reduced by taking Augmentin at the beginning of a meal.
Oral care helps to prevent discoloration of teeth, because it is enough to brush your teeth.
In patients receiving Augmentin, an increase in prothrombin time is rarely observed, and therefore, with the simultaneous use of Augmentin and anticoagulants, it is necessary to conduct appropriate monitoring.
In patients with reduced diuresis, crystalluria occurs very rarely, mainly during parenteral therapy. When taking amoxicillin in high doses, it is recommended to take a sufficient amount of liquid and maintain adequate diuresis to reduce the likelihood of the formation of amoxicillin crystals.
Prolonged treatment with Augmentin may be accompanied by excessive growth of insensitive microorganisms.
In general, Augmentin is well tolerated and has a low toxicity peculiar to all penicillins. During prolonged therapy with Augmentin, it is recommended to periodically monitor the function of the kidneys, liver, blood formation.
Suspension contains aspartame, which is a source of phenylalanine, and therefore these dosage forms should be used with caution in patients with phenylketonuria.
In the medical literature there is no evidence of augmentin abuse and dependence on this drug.
Influence on ability to drive motor transport and control mechanisms
Augmentin does not adversely affect the ability to drive vehicles and work with machinery.

Symptoms: gastrointestinal disturbances and water-electrolyte imbalance are possible. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure.
Treatment: conducting symptomatic therapy, correction of water and electrolyte balance.Augmentin is eliminated from the blood through hemodialysis.

It is not recommended to apply Augmentin along with probenecid. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of Augmentin and probenecid can lead to an increase and persistence in the blood levels of amoxicillin, but not clavulanic acid.
With the simultaneous use of Allopurinol and amoxicillin may increase the risk of allergic reactions. Data on the simultaneous use of Augmentin and allopurinol are currently not available.
Like other broad-spectrum antibiotics, Augmentin can reduce the effectiveness of oral contraceptives (this is necessary to inform patients).

List B. The drug should be stored in a dry place inaccessible to children at a temperature not higher than 25 ° C. Shelf life of tablets (250 mg + 125 mg) and (875 mg + 125 mg) - 2 years, tablets (500 mg + 125 mg) - 3 years. The shelf life of the powder for the preparation of suspensions is 2 years.
The prepared suspension should be stored in a refrigerator at a temperature of 2 ° to 8 ° C for 7 days.
Pharmacy sales terms
The drug is available on prescription.