Augmentin por d/prig suspension 400mg+57mg/5ml fl 12.6g (Glaxo)

Augmentin

Use during pregnancy and breastfeeding

In studies of reproductive function in animals, oral and parenteral administration of Augmentin® did not cause teratogenic effects.
In a single study in women with premature rupture of membranes, it was found that prophylactic therapy with the drug may be associated with an increased risk of developing necrotizing enterocolitis in newborns. Like all medications, Augmentin® is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

Augmentin® can be used during breastfeeding. With the exception of the possibility of diarrhea or oral candidiasis associated with the passage of trace amounts of the active ingredients of this drug into breast milk, no other adverse effects have been observed in breastfed infants. If adverse effects occur in breastfed infants, breastfeeding should be discontinued.

Use for liver dysfunction

Treatment is carried out with caution; regularly monitor liver function. There is insufficient data to adjust the dosage regimen in this category of patients.

Use for renal impairment

Patients with impaired renal function

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

Adults

Tablets 875 mg + 125 mg should be used only in patients with CC >30 ml/min, and no dose adjustment is required.

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

Adults and children over 12 years of age or weighing more than 40 kg who are on hemodialysis

Dose adjustments are based on the maximum recommended dose of amoxicillin: 1 tablet. 500 mg + 125 mg in one dose every 24 hours or 2 tablets. 250 mg/125 mg in one dose every 24 hours, or 500 mg/125 mg (20 ml of suspension at a dose of 125 mg/31.25 mg in 5 ml) 1 time/day.

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

Use in children

Children under 12 years old

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

The dose is calculated depending on age and weight, indicated in mg/kg body weight per day (calculation for amoxicillin) or in milliliters of suspension.

Children weighing 40 kg or more should be prescribed the same doses as adults.

Children from birth to 3 months. Due to the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin® (calculated according to amoxicillin) is 30 mg/kg/day in 2 doses in the form of a 4:1 suspension.

The use of the 7:1 suspension is not recommended in this population.

Children aged from 3 months to 12 years. The recommended dosage regimen and frequency of administration are presented in the table below.

Augmentin® dosage regimen table (dose calculation based on amoxicillin)

Low doses of Augmentin® are used to treat skin and soft tissue infections, 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.

There is 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) or 45 mg/kg/day in 2 divided doses (7:1 suspension) in children under 2 years of age .

Children

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

Children on hemodialysis

Prescribe 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 concentrations of the active components of the drug Augmentin® in the blood, a second additional dose of 15 mg/3.75 mg/kg should be administered after a hemodialysis session.

special instructions

Before starting treatment with Augmentin®, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, treatment with Augmentin® should be discontinued and appropriate alternative therapy should be initiated. For severe hypersensitivity reactions, epinephrine should be administered immediately. Oxygen therapy, intravenous administration of corticosteroids, and airway management, including intubation, may also be required.

It is not recommended to prescribe Augmentin® for suspected infectious mononucleosis, since amoxicillin can cause a measles-like rash in patients with this disease, which makes diagnosing the disease difficult.

Long-term treatment with Augmentin® sometimes leads to excessive proliferation of insensitive microorganisms.

In general, Augmentin® is well tolerated and has the low toxicity characteristic of all penicillins.

During long-term therapy with Augmentin®, it is recommended to periodically evaluate renal, liver and hematopoietic function.

In order to reduce the risk of developing side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.

In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in MHO) has been reported in rare cases. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of relevant indicators is necessary. Dosage adjustments may be required to maintain the desired effect of oral anticoagulants.

In patients with impaired renal function, the dose of Augmentin® should be reduced according to the degree of impairment.

In patients with reduced diuresis, the development of crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation.

Taking Augmentin® orally leads to a high level of amoxicillin in the urine, which can lead to false-positive results when determining glucose in the urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in urine.

Oral care helps prevent tooth discoloration by simply brushing your teeth.

The tablets must be used within 30 days of opening the laminated aluminum foil package.

Drug abuse and dependence

There was no drug dependence, addiction, or euphoric reactions associated with the use of Augmentin®.

Impact on the ability to drive vehicles and operate machinery

Since the drug may cause dizziness, patients should be warned to take precautions when driving or operating moving machinery.

Augmentin por d/prig suspension 400mg+57mg/5ml fl 12.6g (Glaxo)

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection. For optimal absorption and to reduce possible side effects from the digestive system, Augmentin® is recommended to be taken at the beginning of a meal. The minimum course of antibacterial therapy is 5 days. Treatment should not continue for more than 14 days without reviewing the clinical situation. If necessary, it is possible to carry out stepwise therapy (at the beginning of therapy, parenteral administration of the drug followed by switching 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 a day (for mild to moderate infections), or 1 tablet 500 mg/125 mg 3 times a day, or 1 tablet 875 mg/125 mg 2 times/day, or 11 ml of suspension 400 mg/57 mg/5 ml 2 times/day (equivalent to 1 tablet 875 mg/125 mg). 2 tablets of 250 mg/125 mg are not equivalent to 1 tablet of 500 mg/125 mg. Children from 3 months to 12 years weighing less than 40 kg The drug is prescribed in the form of a suspension for oral administration. The dose is calculated depending on age and body weight, indicated in mg/kg body weight/day (calculation based on amoxicillin) or in ml of suspension. The frequency of taking the suspension is 125 mg/31.25 mg in 5 ml - 3 times a day every 8 hours. The frequency of taking the suspension is 200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml - 2 times a day every 12 hours. The recommended dosage regimen and frequency of administration are presented below: Frequency of administration - 3 times a day; suspension 4:1 (125 mg/31.25 mg in 5 ml): Frequency of administration - 2 times a day; suspension 7:1 (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml): Low doses of Augmentin® are used to treat skin and soft tissue infections, 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, bone and joint infections. There is 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 the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin® (calculated according to amoxicillin) is 30 mg/kg/day in 2 doses in the form of a 4:1 suspension. 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. Children born prematurely There are no recommendations regarding dosage regimen. Elderly patients No dose adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function. Patients with impaired renal function Dose adjustments are based on the maximum recommended dose of amoxicillin and are carried out taking into account QC values. Adults Tablets 250 mg+125 mg or 500 mg+125 mg: Suspension 4:1 (125 mg/31.25 mg in 5 ml): 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 no dose adjustment is required. In most cases, whenever possible, parenteral therapy should be preferred. Patients on hemodialysis Dose adjustments are based on the maximum recommended dose of amoxicillin: 2 tablets. 250 mg/125 mg in one dose every 24 hours, or 1 tablet. 500 mg/125 mg in one dose every 24 hours, or suspension at a dose of 15 mg/3.75 mg/kg 1 time/day. Tablets: during a 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: Before a hemodialysis session, one additional dose of 15 mg/3.75 mg/kg should be administered. To restore the concentrations of the active components of the drug Augmentin® 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 Treatment is carried out with caution; regularly monitor liver function. There is insufficient data to adjust the dosage regimen in this category of patients. Rules for preparing the suspension The suspension is prepared immediately before the first use. Suspension (125 mg / 31.25 mg in 5 ml): add approximately 60 ml of boiled water, cooled to room temperature, to the bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted, let the bottle stand for 5 minutes to ensuring complete dilution. Then add water up 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, you should use a measuring cap, which must 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. For children under 2 years of age, a measured single dose of Augmentin® suspension can be diluted by 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 bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted , allow the vial to stand for 5 minutes to ensure complete dilution. Then add water up 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 precise dosing of the drug, use a measuring cap or dosing syringe, which must 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. For children under 2 years of age, a measured single dose of Augmentin® suspension can be diluted with water in a ratio of 1:1.

Augmentin, 14 pcs., 875 mg+125 mg, film-coated tablets

Inside.

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

To reduce potential gastrointestinal disturbances and to optimize absorption, the drug should be taken at the beginning of a meal. The minimum course of antibacterial therapy is 5 days.

Treatment should not continue for more than 14 days without reviewing the clinical situation.

If necessary, it is possible to carry out stepwise therapy (initially, parenteral administration of the drug, followed by switching to oral administration).

It must be remembered that 2 tables. Augmentin® drug, 250 mg+125 mg is not equivalent to 1 tablet. Augmentin® drug, 500 mg + 125 mg.

Adults and children aged 12 years and older or weighing 40 kg or more.

It is recommended to use 11 ml of suspension at a dosage of 400 mg + 57 mg in 5 ml, which is equivalent to 1 tablet. Augmentin® drug, 875 mg + 125 mg.

1 table each 250 mg+125 mg 3 times a day for mild to moderate infections. For severe infections (including chronic and recurrent urinary tract infections, chronic and recurrent lower respiratory tract infections), other dosages of Augmentin® are recommended.

1 table each 500 mg+125 mg 3 times a day.

1 table each 875 mg+125 mg 2 times a day.

Children aged 3 months to 12 years weighing less than 40 kg.

The dose is calculated depending on age and body weight, indicated in mg/kg/day or in ml of suspension. The daily dose is divided into 3 doses every 8 hours (125 mg + 31.25 mg) or 2 doses every 12 hours (200 mg + 28.5 mg, 400 mg + 57 mg). The recommended dosage regimen and frequency of administration are presented in the table below.

Table 6

Augmentin® dosage regimen (dose calculation based on amoxicillin)

Low doses of Augmentin® are recommended for the treatment of skin and soft tissue infections, as well as recurrent tonsillitis.

High doses of Augmentin® are recommended for the treatment of diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, bone and joint infections.

There is insufficient clinical data to recommend the use of Augmentin® at a dose of more than 40 mg + 10 mg/kg in 3 doses (4:1 suspension) in children under 2 years of age.

Children from birth to 3 months.

Due to the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin® (calculated according to amoxicillin) is 30 mg/kg/day in 2 doses in the form of a 4:1 suspension.

Children born prematurely.

There are no recommendations regarding dosage regimen.

Special patient groups

Elderly patients.

No adjustment of the dosage regimen is required; the same dosage regimen is used as in younger patients. In elderly patients with impaired renal function, appropriate doses are prescribed for adult patients with impaired renal function.

Patients with impaired liver function.

Treatment is carried out with caution; regularly monitor liver function. There is insufficient data to change the dosage recommendations in these patients.

Patients with impaired renal function.

Correction of the dosage regimen is based on the maximum recommended dose of amoxicillin and the creatinine clearance value.

Table 7

Augmentin® dosage regimen

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

Patients on hemodialysis. Powder for oral solution:

15 mg+3.75 mg/kg/day.

Before a hemodialysis session, one additional dose of 15 mg + 3.75 mg/kg should be administered.

To restore the concentrations of the active components of the drug Augmentin® in the blood, a second additional dose of 15 mg + 3.75 mg/kg should be administered after a hemodialysis session.

Film-coated tablets, 250 mg+125 mg:

adjustment of the dosage regimen is based on the maximum recommended dose of amoxicillin.

2 tables 250 mg + 125 mg in 1 dose every 24 hours.

During a dialysis session, an additional 1 dose (1 tablet) and 1 more tablet. at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Film-coated tablets, 500 mg+125 mg:

adjustment of the dosage regimen is based on the maximum recommended dose of amoxicillin.

1 table 500 mg + 125 mg in 1 dose every 24 hours.

During a dialysis session, an additional 1 dose (1 tablet) and 1 more tablet. at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Method of preparing the suspension

The suspension is prepared immediately before the first use. Add approximately 60 ml of boiled water, cooled to room temperature, to the bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted, let the bottle stand for 5 minutes to ensure complete dilution. Then add water up to the mark on the bottle and shake the bottle again. In general, the suspension requires approximately 92 ml of water for the 125 mg + 31.25 mg dosage and 64 ml of water for the 200 mg + 28.5 mg and 400 mg + 57 mg dosages.

The bottle should be shaken well before each use. For accurate dosing of the drug, you should use a measuring cap, which must 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.

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