Название документа

Powder is applied to oral Augmentin™suspension at treatment at adults and children of the bacterial infections caused by microorganisms, sensitive to drug:

  • sharp bacterial sinusitis (confirmed);
  • sharp average otitis;
  • confirmed exacerbation of chronic bronchitis;
  • community-acquired pneumonia;
  • cystitis;
  • pyelonephritises;
  • an infection of leather and soft tissues, including cellulitis, stings of animals, heavy dentoalveolyarny abscesses with widespread cellulitis;
  • an infection of bones and joints, including osteomyelitis.

Structure

5 ml of suspension contain (active ingredients):

  • amoxicillin (in the form of trihydrate amoxicillin) - 200 mg;
  • clavulanic acid (in the form of clavulanate potassium) - 28.5 mg.

Excipients: xanthane gum, aspartame (E 951), succinic acid, silicon dioxide colloidal waterless, hydroksipropilmetiltsellyuloza, fragrances dry orange (1 and 2), fragrance dry crimson, fragrance dry "Light treacle", silicon dioxide.

Contraindication

  • hypersensitivity to medicine components, to any antibacterial agents of group of penicillin;
  • existence in the anamnesis of the heavy reactions of hypersensitivity (including an anaphylaxis) connected with application of others beta laktamnykh agents (including cephalosporins, karbapenem or monobaktam);
  • existence in the anamnesis of jaundice or the dysfunction of a liver connected with use of amoxicillin/clavulanate.

Route of administration

Drug should be used according to the official recommendations about antibiotic treatment and data of local sensitivity to an antibiotic in the presence. The sensitivity to amoxicillin/clavulanate differs in different regions and can change over time. In case of need it is necessary to carry out determination of sensitivity of a microorganism to an antibiotic.

Dose of medicine is appointed by the doctor depending on the expected microorganisms and their sensitivity to antibacterial drugs, disease severity and localization of an infection, age, body weight and function of kidneys of the patient.

In case of need should consider the possibility of application of alternative forms of production of the medicine "Augmentin™" (that is, providing high doses of amoxicillin and/or various ratios of content of amoxicillin and clavulanic acid).

For children with a weight <40 kg this dosage form of the medicine "Augmentin™" provides the maximum daily dose of 1000-2800 mg of amoxicillin / 143-400 to clavulanic acid mg on condition of reception as it is recommended below. If the raised amoxicillin dose is considered necessary, it is recommended to choose other dosage form of the medicine "Augmentin™" in order to avoid reception of excessively high daily doses of clavulanic acid.

Duration of treatment is determined by the clinical response of the patient to treatment. Some infections (for example osteomyelitis) demand long-term treatment. Treatment should not continue more than 14 days without revision.

Adults and children with body weight ≥ 40 kg should apply other forms of the medicine "Augmentin™".

Children with body weight <40 kg

Recommended daily doses from 25/3.6 mg/kg of body weight to 45/6.4 mg/kg of body weight divided into 2 receptions.

For children with body weight <40 kg medicine appoint in the maximum daily dose 1000-2800 mg of amoxicillin / 143-400 clavulanic acid mg at application, as shown below.

Approximate calculation of Augmentin™suspension (ml) a day (on amoxicillin):

  • body weight of the child is 5 kg:
    • a dose of 25 mg/kg/days - 2.5 ml;
    • a dose of 45 mg/kg/days - 5 ml;
  • body weight of the child is 7 kg:
    • a dose of 25 mg/kg/days - 5 ml;
    • a dose of 45 mg/kg/days - 7.5 ml;
  • body weight of the child is 10 kg:
    • a dose of 25 mg/kg/days - 7.5 ml;
    • a dose of 45 mg/kg/days - 10 ml;
  • body weight of the child is 12 kg:
    • a dose of 25 mg/kg/days - 7.5 ml;
    • a dose of 45 mg/kg/days - 12.5 ml;
  • body weight of the child is 15 kg:
    • a dose of 25 mg/kg/days - 10 ml;
    • a dose of 45 mg/kg/days - 15 ml;
  • body weight of the child is 17 kg:
    • a dose of 25 mg/kg/days - 10 ml;
    • a dose of 45 mg/kg/days - 20 ml;
  • body weight of the child is 20 kg:
    • a dose of 25 mg/kg/days - 12.5 ml;
    • a dose of 45 mg/kg/days - 22.5 ml;
  • body weight of the child is 22 kg:
    • a dose of 25 mg/kg/days - 15 ml;
    • a dose of 45 mg/kg/days - 25 ml;
  • body weight of the child is 25 kg:
    • a dose of 25 mg/kg/days - 15 ml;
    • a dose of 45 mg/kg/days - 27.5 ml;
  • body weight of the child is 27 kg:
    • a dose of 25 mg/kg/days - 17.5 ml;
    • a dose of 45 mg/kg/days - 30 ml;
  • body weight of the child is 30 kg:
    • a dose of 25 mg/kg/days - 20 ml;
    • a dose of 45 mg/kg/days - 32.5 ml.

For treatment of some infections, such as average otitis and sinusitis, lower respiratory tract infections, to children of 2 years it is possible to apply daily doses to 70 mg / 10 the body weight mg/kg divided into 2 receptions.

If for treatment needs to appoint by

high doses of amoxicillin, it is necessary to apply other forms of the medicine "Augmentin™" to avoid purpose of excess high doses of clavulanic acid.

Way of use is intended to

"Augmentin™" by

for oral administration.

should take the Drug at meal time to minimize potential gastrointestinal intolerance.

can Begin with

treatment with parenteral administration of medicine, and to continue by a medicine form for oral administration.

Instruction for suspension preparation. The powder which is contained in a bottle should be dissolved before formation of suspension:

  1. Check a bottle lid concerning its preliminary opening.
  2. Turn
  3. and stir up a bottle for loosening of powder in it.
  4. Pour into a bottle with powder boiled water to lower, designated by the red line with an arrow, level.
  5. Close
  6. a cover and stir up a bottle before formation of suspension.
  7. Add residue of water to the top level designated by the black line with an arrow and stir up again.
  8. Suspension should allow to stand within 5 minutes before full dispersion of powder.
  9. Carefully shake up suspension before each reception.

should apply a measured cap or a measured spoon or the measured syringe which need to be washed after each use with water To exact measuring off of a dose of medicine.

Feature of application

Pregnant women

Reproductive researches on animals of oral and parenteral forms of the medicine "Augmentin™" did not reveal any teratogenic action. During one research with participation of women with a premature rupture of covers of a fruit it was reported that preventive use of the medicine "Augmentin™" can be connected with increase in risk of a necrotizing coloenteritis at newborns. As well as at use of other medicines, it is necessary to avoid use of medicine during pregnancy, especially in the first trimester, except cases when, according to the doctor, such application is necessary.

active components of medicine are excreted by

Both in breast milk (there is no information concerning influence of clavulanic acid on the baby who is on breastfeeding). Respectively, at the baby who is on breastfeeding the appearance of diarrhea and fungal infection of mucous membranes is possible therefore feeding by a breast should be stopped. It is necessary to take possibility of allergic reactions into account. "Augmentin™" during feeding by a breast it is possible to apply only when, according to the doctor, the advantage of application prevails over risk.

Drivers

were not carried out by

Research on ability of medicine to influence speed of response at control of motor transport and to work with mechanisms. However emergence of undesirable effects (such as allergic reactions, dizziness, spasms) is possible which can affect ability to drive the car and to work with other mechanisms.

Overdose

Symptoms

Can be observed by

symptoms characteristic of disorder of digestive tract and violation of balance of liquid and electrolytes. The crystalluria connected with intake of amoxicillin that in some cases led to development of a renal failure was observed.

At patients with a renal failure and at the patients accepting high doses of medicine the developing of spasms is possible

.

to

It was reported about amoxicillin precipitation in bladder catheters, mainly after introduction in high doses. It is necessary to check passability of catheters regularly.

Treatment

Disturbance from digestive tract can treat symptomatically, paying attention to balance of liquids/electrolytes. Amoxicillin/clavulanic acid can be removed from a blood-groove by means of a hemodialysis.

to

Side effects

by

it was Most often reported about such side reactions on medicine (PR) as diarrhea, nausea and vomiting.

Storage conditions

Original packings to store

closed at a temperature below 25 °C in the dry place.

Prepared suspension to store

in the fridge at a temperature from 2 °C to 8 °C within 7 days. To store out of children's reach.

Expiration date - 2 years.

Characteristics
Active ingredients Amoxicillin, clavulanic acid
Amount of active ingredient 40 mg + 5.7 mg
Applicant GSK
Code of automatic telephone exchange J01CR02 Amoxicillin and inhibitor of enzyme
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Original
Origin Chemical
Prescription status According to the prescription
Primary packing bottle
Producer SMITH KLEIN TO FARMASYUTIKALS SCOURGES
Quantity in packing 70 ml
Release form powder for internal use
Route of administration Oral
Sign Import
Storage temperature from 5 °C to 25 °C
Trade name Augmentin

Reviews Augmentin time. for shouted. susp. 200mg/28.5mg/5ml fl. 70 ml

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Augmentin time. for shouted. susp. 200mg/28.5mg/5ml fl. 70 ml

  • Product Code: 179324
  • In Stock

  • Ready to ship
  • $23.20


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