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
| QC | Tablets 500 mg+125 mg or 250 mg+125 mg | Suspension 4:1 (125 mg/31.25 mg in 5 ml) |
| >30 ml/min | No dose adjustment required | No dose adjustment required |
| 10-30 ml/min | 1 tab. 500 mg+125 mg 2 times a day or 1 tablet. 250 mg+125 mg (for mild to moderate infection) 2 times a day | 500 mg/125 mg (20 ml suspension at a dose of 125 mg/31.25 mg in 5 ml) 2 times a day |
| <10 ml/min | 1 tab. 500 mg+125 mg 1 time/day or 1 tablet. 250 mg+125 mg (for mild to moderate infection) 1 time/day | 500 mg/125 mg (20 ml suspension at a dose of 125 mg/31.25 mg in 5 ml) 1 time/day |
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)
| Frequency of administration: 3 times/day Suspension 4:1 (125 mg/31.25 mg in 5 ml) | Frequency of administration: 2 times/day Suspension 7:1 (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml) | |
| Low doses | 20 mg/kg/day | 25 mg/kg/day |
| High doses | 40 mg/kg/day | 45 mg/kg/day |
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
| QC | Augmentin dosage regimen |
| >30 ml/min | No dose adjustment required |
| 10-30 ml/min | 15 mg/3.75 mg/kg 2 times/day, maximum dose 500 mg/125 mg (20 ml suspension at a dose of 125 mg/31.25 mg in 5 ml) 2 times/day |
| <10 ml/min | 15 mg/3.75 mg/kg 1 time/day, maximum daily dose 500 mg/125 mg (20 ml suspension at a dose of 125 mg/31.25 mg in 5 ml). |
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®
Before starting treatment with Augmentin®, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam drugs or other substances that cause an allergic reaction in the patient.
Serious and in some cases fatal hypersensitivity reactions (including anaphylactoid and severe skin adverse reactions) to penicillins have been reported. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in individuals with atopy. If an allergic reaction occurs, treatment with Augmentin® should be discontinued and appropriate alternative therapy should be initiated.
If the infection is proven to be caused by microorganisms sensitive to amoxicillin, the possibility of replacing the combination of amoxicillin with clavulanic acid with amoxicillin should be considered in accordance with official recommendations.
The combination of amoxicillin and clavulanic acid is not suitable for use in cases where there is a high risk that the suspected pathogens have beta-lactam resistance that is not due to beta-lactamases susceptible to inhibition by clavulanic acid.
The combination of amoxicillin and clavulanic acid should not be used to treat infections caused by penicillin-resistant Streptococcus pneumoniae.
If infectious mononucleosis is suspected, Augmentin® should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.
The occurrence of generalized erythema with fever accompanied by pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. This reaction requires discontinuation of treatment with Augmentin® and is a contraindication for its further use in any situation.
Concomitant use of allopurinol during amoxicillin therapy may increase the likelihood of allergic skin reactions.
Long-term treatment with Augmentin® may lead to excessive proliferation of insensitive microorganisms. Cases of pseudomembranous colitis have been described when taking antibiotics, the severity of which can vary from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is prolonged or severe, or the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined. If pseudomembranous colitis develops, appropriate treatment must be started. The use of drugs that inhibit intestinal motility is contraindicated.
During long-term therapy with Augmentin®, it is recommended to periodically evaluate renal, liver and hematopoietic function.
Convulsions may occur in patients with impaired renal function or in patients receiving high doses of the drug (see section "Side effects").
The combination of amoxicillin with clavulanic acid should be used with caution in patients with signs of liver dysfunction (see section "Side effects").
In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in INR) 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 amoxicillin with clavulanic acid should be reduced according to the degree of impairment.
In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. When administering high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation (see section "Overdose"). In patients with a catheterized bladder, it is necessary to regularly check the patency of the catheter, since according to the data obtained, amoxicillin deposits in bladder catheters mainly when administered intravenously in high doses.
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.
Clavulanic acid may cause nonspecific binding of immunoglobulins G and albumin to red blood cell membranes, leading to false-positive Coombs test results.
Positive results from a study using the Platelia Aspergillus ELISA diagnostic kit (Bio-Rad Laboratories) have been reported in patients receiving a combination of amoxicillin and clavulanic acid who were subsequently free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfurans have been reported when tested using the Platelia Aspergillus ELISA diagnostic kit (Bio-Rad Laboratories). Therefore, positive test results in patients receiving a combination of amoxicillin and clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
The laminated aluminum foil package contains a desiccant pouch that is not intended for ingestion.
Augmentin® 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®.
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.
