Amoxiclav Quiktab dispersible tablets 875+125 mg 14 pcs. in Moscow
Amoxiclav®
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.
Amoxiclav® is recommended to be taken at the beginning of a meal for optimal absorption and to reduce possible side effects from the digestive system.
The course of treatment is 5–14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without repeated medical examination.
Children under 12 years old
The dose is prescribed depending on age and body weight. The recommended dosage regimen is 40 mg/kg/day in 3 divided doses.
Children weighing 40 kg or more should be prescribed the same doses as adults. For children aged ≤6 years, it is preferable to take a suspension of the drug Amoxiclav®.
Adults and children over 12 years of age (or >40 kg body weight)
The usual dose in case of mild to moderate infection is 1 table. 250+125 mg every 8 hours or 1 tablet. 500+125 mg every 12 hours, in case of severe infection and respiratory tract infections - 1 table. 500+125 mg every 8 hours or 1 tablet. 875+125 mg every 12 hours.
Since amoxicillin and clavulanic acid combination tablets of 250+125 mg and 500+125 mg contain the same amount of clavulanic acid - 125 mg, then 2 tablets. 250+125 mg are not equivalent to 1 tablet. 500+125 mg.
Dosage for odontogenic infections
1 table 250+125 mg every 8 hours or 1 tablet. 500+125 mg every 12 hours for 5 days.
Patients with impaired renal function
Dose adjustments are based on the maximum recommended dose of amoxicillin and are carried out taking into account creatinine Cl values:
- adults and children over 12 years of age (or ≥40 kg body weight) (Table 2);
- for anuria, the interval between dosing should be increased to 48 hours or more;
- 875+125 mg tablets should be used only in patients with creatinine Cl >30 ml/min.
table 2
| Creatinine clearance | Amoxiclav® dosage regimen |
| >30 ml/min | No dose adjustment required |
| 10–30 ml/min | 1 table 50+125 mg 2 times a day or 1 tablet. 250+125 mg (for mild to moderate infection) 2 times a day |
| <10 ml/min | 1 table 500+125 mg 1 time per day or 1 tablet. 250+125 mg (for mild to moderate infection) 1 time per day |
| Hemodialysis | 1 table 500+125 mg or 2 tablets. 250+125 mg every 24 hours + 1 tablet. 500+125 mg or 2 tablets. 250+125 mg during dialysis and at the end of the dialysis session (due to decreased serum concentrations of amoxicillin and clavulanic acid) |
Patients with liver dysfunction
Amoxiclav® should be taken with caution. It is necessary to regularly monitor liver function.
Powder for suspension for oral administration
Inside
Daily dose of suspensions 125+31.25 mg/5 ml and 250+62.5 mg/5 ml
(to facilitate correct dosing, each package of suspensions 125 + 31.25 mg/5 ml and 250 + 62.5 mg/5 ml includes a dosing pipette, graduated to 5 ml, with a division scale of 0.1 ml or a dosing spoon with a capacity of 5 ml, with ring marks in the cavity at 2.5 and 5 ml).
Newborns and children up to 3 months
- 30 mg/kg/day (for amoxicillin), divided into 2 doses (every 12 hours).
Dosing of the drug Amoxiclav® with a dosage pipette - calculation of single doses for the treatment of infections in newborns and children up to 3 months (Table 3).
Table 3
| Body weight, kg | 2 | 2,2 | 2,4 | 2,6 | 2,8 | 3 | 3,2 | 3,4 | 3,6 | 3,8 | 4 | 4,2 | 4,4 | 4,6 | 4.8 |
| Suspension 156.25, ml (2 times a day) | 1,2 | 1,3 | 1,4 | 1,6 | 1,7 | 1,8 | 1,9 | 2 | 2,2 | 2,3 | 2,4 | 2,5 | 2,6 | 2,8 | 2,9 |
| Suspension 312.5, ml (2 times a day) | 0,6 | 0,7 | 0,7 | 0,8 | 0,8 | 0,9 | 1 | 1 | 1,1 | 1,1 | 1,2 | 1,3 | 1,3 | 1,4 | 1,4 |
Children over 3 months
- from 20 mg/kg for mild and moderate infections to 40 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis (according to amoxicillin) per day, divided into 3 doses (every 8 hours).
Dosing of the drug Amoxiclav® with a dosage pipette - calculation of single doses for the treatment of mild and moderate infections in children over 3 months (at the rate of 20 mg/kg/day (for amoxicillin) (Table 4).
Table 4
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Suspension 312.5, ml (3 times a day) | 0,7 | 0,8 | 0,9 | 1,1 | 1,2 | 1,3 | 1,5 | 1,6 | 1,7 | 1,9 | 2 | 2,1 | 2,3 | 2,4 | 2,5 | 2,7 | 2,8 | 2,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 | |
| Suspension 312.5, ml (3 times a day) | 3,1 | 3,2 | 3,3 | 3,5 | 3,6 | 3,7 | 3,9 | 4 | 4,1 | 4,3 | 4,4 | 4,5 | 4,7 | 4,8 | 4,9 | 5,1 | 5,2 |
Dosing of the drug Amoxiclav® with a dosage pipette - calculation of single doses for the treatment of severe infections in children over 3 months (at the rate of 40 mg/kg/day (for amoxicillin) (Table 5).
Table 5
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 2,7 | 3,2 | 3,7 | 4,3 | 4,8 | 5,3 | 5,9 | 6,4 | 6,9 | 7,5 | 8 | 8,5 | 9,1 | 9,6 | 10,1 | 10,7 | 11,2 | 11,7 |
| Suspension 312.5, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 12,3 | 12,8 | 13,3 | 13,9 | 14,4 | 14,9 | 15,5 | 16 | 16,5 | 17,1 | 17,6 | 18,1 | 18,7 | 19,2 | 19,7 | 20,3 | 20,8 | |
| Suspension 312.5, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 |
Dosing of the drug Amoxiclav® with a dosing spoon (in the absence of a dosing pipette) - recommended doses of suspensions depending on the child’s body weight and the severity of the infection (Table 6).
Table 6
| Body weight, kg | Age (approx.) | Mild/moderate course | Severe course | ||
| 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | ||
| 5–10 | 3–12 months | 3 × 2.5 ml (½ spoon) | 3 × 1.25 ml | 3 × 3.75 ml | 3 × 2 ml |
| 10–12 | 1–2 years | 3 × 3.75 ml | 3 × 2 ml | 3 × 6.25 ml | 3 × 3 ml |
| 12–15 | 2–4 years | 3 × 5 ml (1 spoon) | 3 × 2.5 ml (½ spoon) | 3 × 7.5 ml (1½ spoons) | 3 × 3.75 ml |
| 15–20 | 4–6 years | 3 × 6.25 ml | 3 × 3 ml | 3 × 9.5 ml | 3 × 5 ml (1 spoon) |
| 20–30 | 6–10 years | 3 × 8.75 ml | 3 × 4.5 ml | — | 3 × 7 ml |
| 30–40 | 10–12 years | — | 3 × 6.5 ml | — | 3 × 9.5 ml |
| ≥40 | ≥12 years | Amoxiclav® tablets | |||
Daily dose of suspension 400 mg+57 mg/5 ml
The dose is calculated per kg of body weight depending on the severity of the infection. From 25 mg/kg - for mild and moderate infections to 45 mg/kg - for severe infections and lower respiratory tract infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses.
To facilitate correct dosing, a dosage pipette is inserted into each package of the 400 mg + 57 mg/5 ml suspension, graduated simultaneously into 1, 2, 3, 4, 5 ml and into 4 equal parts.
Suspension 400 mg+57 mg/5 ml is used in children over 3 months.
Table 7
Recommended dose of suspension depending on the child’s body weight and severity of infection
| Body weight, kg | Age (approx.) | Recommended dose, ml | |
| Severe course | Moderate course | ||
| 5–10 | 3–12 months | 2×2,5 | 2×1,25 |
| 10–15 | 1–2 years | 2×3,75 | 2×2,5 |
| 15–20 | 2–4 years | 2×5 | 2×3,75 |
| 20–30 | 4 years - 6 years | 2×7,5 | 2×5 |
| 30–40 | 6–10 years | 2×10 | 2×6,5 |
Exact daily doses are calculated based on the child's body weight, not his age.
The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg for children.
The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg for children.
In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin.
Patients with creatinine Cl >30 ml/min do not require any dose adjustment.
Adults and children weighing more than 40 kg (the indicated dosage regimen is used for moderate and severe infections)
For patients with creatinine Cl 10-30 ml/min - 500/125 mg 2 times a day.
For creatinine Cl <10 ml/min, the recommended dose is 500/125 mg once a day.
For patients on hemodialysis, the recommended dose is 500/125 mg every 24 hours, plus 500/125 mg during dialysis and another dose at the end of dialysis (since serum concentrations of amoxicillin and clavulanic acid are reduced).
Children weighing less than 40 kg
With creatinine Cl 10–30 ml/min, the recommended dose is 15/3.75 mg/kg 2 times a day (maximum 500/125 mg 2 times a day).
For creatinine Cl <10 ml/min, the recommended dose is 15/3.75 mg/kg once a day (maximum 500/125 mg).
For hemodialysis, the recommended dose is 15/3.75 mg/kg once a day. Before hemodialysis - 15/3.75 mg/kg. To restore appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15/3.75 mg/kg after hemodialysis.
The course of treatment is 5–14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without repeated medical examination.
Instructions for preparing the suspension
Powder for suspension 125+31.25 mg/5ml
— shake the bottle vigorously, add 86 ml of water in two doses (to the mark), shaking well each time until the powder is completely dissolved.
Powder for suspension 250+62.5 mg/5 ml
— shake the bottle vigorously, add 85 ml of water in two doses (to the mark), shaking well each time until the powder is completely dissolved.
Powder for suspension 400 mg+57 mg/5 ml
- shake the bottle vigorously, add water in two additions (to the mark) in the amount indicated on the label and given in the table, shaking well each time until the powder is completely dissolved.
Table 8
| Volume of finished suspension, ml | Required amount of water, ml |
| 35 | 29,5 |
| 50 | 42 |
| 70 | 59 |
| 140 | 118 |
Shake vigorously before use!
To prepare the suspension, it is recommended to dilute the powder with boiled water at room temperature. It is recommended to place the finished suspension in the refrigerator.
It is not recommended to heat the suspension before use (it is necessary to bring the suspension to room temperature).
After taking the drug, it is recommended to rinse the dosage pipette with boiled water.
Powder for the preparation of a solution for intravenous administration
IV.
Children:
with body weight less than 40 kg - the dose is calculated depending on body weight.
Younger than 3 months and weighing less than 4 kg
- 30 mg/kg (calculated for the entire Amoxiclav® drug) every 12 hours.
Under 3 months and weighing more than 4 kg
- 30 mg/kg (calculated for the entire Amoxiclav® drug) every 8 hours.
In children under 3 months of age, Amoxiclav® should be administered only by slow infusion over 30–40 minutes.
Children from 3 months to 12 years
- 30 mg/kg (in terms of the entire drug Amoxiclav®) with an interval of 8 hours, in case of severe infection - with an interval of 6 hours.
Children with impaired renal function
Dose adjustments are based on the maximum recommended dose of amoxicillin. For patients with creatinine Cl levels above 30 ml/min, dose adjustment is not necessary.
Children weighing <40 kg:
| Creatinine Cl 10–30 ml/min | 25 mg/5 mg per 1 kg every 12 hours |
| Creatinine Cl <10 ml/min | 25 mg/5 mg per 1 kg every 24 hours |
| Hemodialysis | 25 mg/5 mg per 1 kg every 24 hours plus a dose of 12.5 mg/2.5 mg per 1 kg at the end of the dialysis session (due to a decrease in serum concentrations of amoxicillin and clavulanic acid) |
Every 30 mg of Amoxiclav® contains 25 mg of amoxicillin and 5 mg of clavulanic acid.
Adults and children over 12 years of age or weighing more than 40 kg
- 1.2 g of the drug (1000+200 mg) with an interval of 8 hours, in case of severe infection - with an interval of 6 hours.
Prophylactic doses for surgical interventions: 1.2 g during induction anesthesia (if the operation lasts less than 2 hours). For longer operations - 1.2 g up to 4 times a day.
For patients with renal insufficiency, the dose and/or interval between doses of the drug should be adjusted depending on the degree of insufficiency:
| Creatinine Cl | Dose and/or interval between administrations |
| >0.5 ml/s (30 ml/min) | No dose adjustment required |
| 0.166–0.5 ml/s (10–30 ml/min) | The first dose is 1.2 g (1000+200 mg), and then 600 mg (500+100 mg) IV every 12 hours |
| <0.166 ml/s (less than 10 ml/min) | The first dose is 1.2 g (1000+200 mg), and then 600 mg (500+100 mg) IV every 24 hours |
| Anuria | The dosing interval should be increased to 48 hours or more. |
Since 85% of the drug is removed by hemodialysis, the usual dose of Amoxiclav® must be administered at the end of each hemodialysis procedure. For peritoneal dialysis, no dose adjustment is required.
The course of treatment is 5–14 days. The duration of treatment is determined by the attending physician. When the severity of symptoms decreases, it is recommended to switch to oral forms of the drug Amoxiclav® to continue therapy.
Preparation of solutions for intravenous injections.
Dissolve the contents of the bottle in water for injection: 600 mg (500+100 mg) - in 10 ml of water for injection or 1.2 g (1000+200 mg) - in 20 ml of water for injection. Inject intravenously slowly (over 3–4 minutes).
The drug Amoxiclav® should be administered within 20 minutes after preparing solutions for intravenous administration.
Preparation of solutions for intravenous infusion.
For infusion administration of the drug Amoxiclav®, further dilution is necessary: prepared solutions containing 600 mg (500+100 mg) or 1.2 g (1000+200 mg) of the drug must be diluted in 50 or 100 ml of infusion solution, respectively. Infusion duration is 30–40 minutes.
When using the following liquids in the recommended volumes, the required antibiotic concentrations are maintained in the infusion solutions:
| Liquids used | Stability period, h | |
| at 25 °C | at 5 °C | |
| Water for injections | 4 | 8 |
| Sodium chloride solution 0.9% for intravenous infusion | 4 | 8 |
| Lactated Ringer's solution for intravenous infusion | 3 | |
| Solution of calcium chloride and sodium chloride for intravenous infusion | 3 | |
Amoxiclav® solution should not be mixed with solutions of dextrose, dextran or sodium bicarbonate.
Only clear solutions should be used. Prepared solutions should not be frozen.
Amoxiclav® Quiktab
Inside.
The dosage regimen is set individually depending on the age, body weight, kidney function of the patient and the severity of the infection.
The tablets must be dissolved in half a glass of water (minimum 30 ml) and mixed thoroughly, then drink or hold the tablets in your mouth until completely dissolved, then swallow.
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of meals.
Dispersible tablets of the drug Amoxiclav®Quiktab 500 mg/125 mg:
Adults and children over 12 years of age weighing ≥40 kg
For the treatment of mild to moderate infections - 1 table. (500 mg/125 mg) every 12 hours (2 times a day).
For the treatment of severe infections and respiratory infections - 1 table. (500 mg/125 mg) every 8 hours (3 times a day).
The maximum daily dose of Amoxiclav®Quictab is 1500 mg amoxicillin/375 mg clavulanic acid.
Patients with impaired renal function.
In patients with creatinine Cl above 30 ml/min, there is no need for dose adjustment.
Adults and children over 12 years of age weighing ≥40 kg (the indicated dosage regimen is used for moderate and severe infections):
| Creatinine Cl, ml/min | Dose |
| 10–30 | 500 mg/125 mg 2 times a day (for moderate to severe infection) |
| <10 | 500 mg/125 mg 1 time per day (for moderate to severe infection) |
| Hemodialysis | 500 mg/125 mg every 24 hours, plus 500 mg/125 mg during the dialysis session, repeated at the end of the dialysis session (as plasma concentrations of amoxicillin and clavulanic acid decrease) |
Dispersible tablets of the drug Amoxiclav®Quiktab 875 mg/125 mg:
Adults and children over 12 years of age weighing ≥40 kg
For severe infections and respiratory infections - 1 table. (875 mg/125 mg) every 12 hours (2 times a day).
The daily dose of Amoxiclav®Quictab when used 2 times a day is 1750 mg amoxicillin/250 mg clavulanic acid.
Patients with impaired renal function.
In patients with creatinine Cl more than 30 ml/min, there is no need for dose adjustment.
For patients with creatinine Cl less than 30 ml/min, the use of dispersible tablets of the drug Amoxiclav®Quiktab, 875 mg/125 mg is contraindicated.
Such patients should take the drug at a dosage of 500 mg/125 mg after dose adjustment appropriate to the creatinine Cl level.
Patients with impaired liver function.
Caution should be exercised when taking Amoxiclav® Quiktab. It is necessary to regularly monitor liver function. If treatment is started with parenteral administration of the drug, therapy can be continued by taking Amoxiclav® Quiktab tablets.
The duration of the course of treatment is determined by the attending physician!
The minimum course of antibacterial therapy is 5 days. Treatment should not continue for more than 14 days without reviewing the clinical situation.
AMOXICLAW KVIKTAB
Pharmacokinetics
Absorption
The active ingredients of the drug are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of active ingredients is optimal when the drug is taken with food.
The following are the pharmacokinetic parameters of amoxicillin and clavulanic acid after administration at a dose of 875 mg/125 mg and 500 mg/125 mg twice daily in healthy volunteers.
| Mean (±SD) pharmacokinetics | indicators | ||||
| Active | Dose | Cmax | Tmax (hour) | AUC (0-24h) | T„2 |
| substances | (mg) | (µg/ml) | (mcg*hour/ml) | (hour) | |
| Amoxicillin/Clav | |||||
| ulanic acid | |||||
| Amoxicillin | |||||
| 875 mg/125 mg | 875 | 11,64 | 1.50(1.0-2.5) | 53,52 | 1.19 |
| ±2,78 | ±12,31 | ±0.21 | |||
| 500 mg/125 mg | 500 | 7,19 | 1.5 (1.0-2.5) | 53,52 | 1.15 |
| ±2,26 | ±8,37 | ±0.20 | |||
| Clavulanic acid | |||||
| 875 mg/125 mg | 125 | 2,18 | 1.25 (1.0-2.0) | 10,16 | 0.96 |
| ±0,99 | ±3,04 | ±0.12 | |||
| 500 mg/125 mg | 125 | 2,40 | 1.5 (1.0-2.0) | 15,72 | 0.98 |
| ±0,83 | ±3,86 | ±0.12 | |||
Cmax - maximum concentration in blood plasma;
Tmax is the time to reach the maximum concentration in the blood plasma; AUC—area under the concentration-time curve;
T1/2 - half-life
Metabolism
About 10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1//-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butane-2 -it is excreted by the kidneys, through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.
Distribution
As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) .
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.
The volume of distribution is approximately 0.3-0.4 L/kg for amoxicillin and approximately 0.2 L/kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed. Amoxicillin (like most penicillins) is excreted in breast milk.
Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, diarrhea and candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants.
Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.
Removal
Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of 875 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged by the kidneys during the first 6 hours. The average half-life (T1/2) of amoxicillin/clavulanic acid is approximately 1 hour, and the average total clearance is approximately 25 L/h in healthy patients. In various studies, it was found that amoxicillin excretion by the kidneys within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration.
The pharmacokinetics of amoxicillin/clavulanic acid does not depend on the gender of the patient.
Patients with impaired renal function
The total clearance of amoxicillin/clavulanic acid decreases in proportion to the decrease in renal function. The decrease in clearance is more pronounced for amoxicillin than for clavulanic acid, because Most amoxicillin is excreted by the kidneys. Doses of the drug for renal failure should be selected taking into account the undesirability of amoxicillin accumulation while maintaining normal levels of clavulanic acid.
Patients with liver dysfunction
In patients with impaired liver function, the drug is used with caution; continuous monitoring of liver function is necessary.
Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.
Amoxiclav Quiktab tablet disperg 500 mg+125 mg pack cont cell/pack card x14
Latin name Amoksiсlav® Quicktab Active ingredient Amoxicillin* + Clavulanic acid* (Amoxicillin* + Clavulanic acid*) ATX J01CR02 Amoxicillin in combination with enzyme inhibitors Pharmacological group • Penicillins in combinations Nosological classification (ICD-10) • A49.8 Other bacterial infections of unspecified localization • H66.9 Otitis media, unspecified •J01 Acute sinusitis •J02 Acute pharyngitis •J03 Acute tonsillitis [sore throat] •J18.9 Pneumonia, unspecified •J20 Acute bronchitis •J31.2 Chronic pharyngitis •J32 Chronic sinusitis •J35.0 Chronic tonsillitis •J39. 0 Retropharyngeal and parapharyngeal abscess •J39.9 Upper respiratory tract disease, unspecified •J42 Chronic bronchitis, unspecified •J44.9 Chronic obstructive pulmonary disease, unspecified •K05.6 Periodontal disease, unspecified •K81 Cholecystitis •K83.0 Cholangitis •L08.8 Other specified local infections of the skin and subcutaneous tissue •L08.9 Local infection of the skin and subcutaneous tissue, unspecified •M00.9 Pyogenic arthritis, unspecified (infectious) •M73.8 Other soft tissue lesions in diseases classified elsewhere •M86 Osteomyelitis •N39.0 Urinary tract infection paths without established localization •N73.9 Inflammatory diseases of the female pelvic organs, unspecified Composition Dispersible tablets 1 table. active ingredients: amoxicillin trihydrate 574 mg 1004.5 mg (equivalent to 500 or 875 mg amoxicillin, respectively) potassium clavulanate 148.87 mg (equivalent to 125 mg clavulanic acid for both dosages) excipients: “Tropical Blend” flavor, “Sweet Orange” flavor , aspartame, colloidal anhydrous silicon dioxide, yellow iron (III) oxide E172, talc, hydrogenated castor oil, silicon-containing MCC Description of the dosage form Oblong octagonal tablets of light yellow color interspersed with brown color, with a fruity odor. Pharmacological action Pharmacological action - broad-spectrum antibacterial. Pharmacodynamics Amoxiclav® Quiktab is a combination of amoxicillin - a semi-synthetic penicillin with a wide spectrum of antibacterial activity and clavulanic acid - an irreversible inhibitor of beta-lactamases. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of beta-lactamases produced by microorganisms.
Clavulanic acid, similar in structure to beta-lactam antibiotics, has weak intrinsic antibacterial activity.
Amoxiclav® Quiktab has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive strains, including strains producing beta-lactamases:
- gram-positive aerobes - Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp., Enterococcus spp.,
- gram-negative aerobes - Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Helicobacter pylori, Eikenella corrodens,
- gram-positive anaerobes - Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelli, Fusobacterium spp., Prevotella spp.,
— gram-negative anaerobes — Bacteroides spp.
Pharmacokinetics The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration; food intake does not affect the degree of absorption. The bioavailability of amoxicillin and clavulanic acid when taken orally is 90 and 70%, respectively.
Peak plasma concentrations are reached approximately 1 hour after administration. Cmax values are 3–12 μg/ml for amoxicillin (depending on the dose), and about 2 μg/ml for clavulanic acid. T1/2 of amoxicillin is 78 minutes, clavulanic acid - 60–70 minutes.
Both components are characterized by good Vd in body fluids and tissues (secretion of the paranasal sinuses, synovial fluid, tonsils, middle ear, pleural fluid, saliva and bronchial secretions, lungs, uterus, ovaries, liver, prostate gland, muscle tissue, gall bladder, peritoneal fluid.) The drug is present in urine in high concentrations.
Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed.
Amoxicillin and clavulanic acid penetrate the placental barrier and are excreted in trace concentrations into breast milk.
Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins.
Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism.
Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts may be excreted through the intestines and lungs. T1/2 of amoxicillin is extended to 7.5 hours in patients with severe renal failure. T1/2 of clavulanate can be prolonged to 4.5 hours in patients with severe renal failure.
Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.
Indications of the drug Amoxiclav® Quiktab Infections caused by sensitive strains of microorganisms:
infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis),
infections of the lower respiratory tract (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia),
urinary tract infections,
infections in gynecology,
infections of the skin and soft tissues, including human and animal bites,
infections of bone and connective tissue,
biliary tract infections (cholecystitis, cholangitis),
odontogenic infections.
Contraindications: hypersensitivity to any of the components of the drug,
history of hypersensitivity to any antibiotic from the group of penicillins, cephalosporins, other beta-lactam antibiotics,
a history of indications of cholestatic jaundice and/or other liver dysfunction caused by taking amoxicillin/clavulanic acid,
children under 12 years of age or with body weight With caution: history of pseudomembranous colitis, liver failure, severe renal impairment, lactation period.
Due to the fact that an erythematous rash was observed in a large number of patients suffering from infectious mononucleosis and lymphocytic leukemia who received ampicillin, the use of ampicillin antibiotics in such patients is not recommended.
Use during pregnancy and breastfeeding Amoxiclav® Quiktab can be prescribed during pregnancy if there are clear indications.
Amoxicillin and clavulanic acid pass into breast milk in small quantities.
Side effects Side effects are in most cases mild and transient.
From the digestive system: loss of appetite, nausea, vomiting, diarrhea, rarely - impaired liver function, increased ALT or AST activity, increased alkaline phosphatase levels, in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis.
Allergic reactions: itching, urticaria, erythematous rashes, very rarely - exudative erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis, in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis.
From the nervous system: dizziness, headache, very rarely - convulsions (may occur in patients with impaired renal function when taking high doses of the drug).
From the hematopoietic and lymphatic system: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia, very rarely - hemolytic anemia, reversible increase in PT.
From the urinary system: very rarely - interstitial nephritis, crystalluria.
Other: rarely - candidiasis and other types of superinfection.
Interaction Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
The simultaneous use of Amoxiclav® Quiktab and methotrexate increases the toxicity of methotrexate.
Prescription together with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided.
In some cases, taking the drug may increase PT; therefore, caution should be exercised when prescribing anticoagulants and Amoxiclav® Quiktab simultaneously.
When combined with rifampicin, there is a mutual weakening of the antibacterial effect. Amoxiclav® Quiktab should be used several hours before taking bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides.
Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Amoxiclav® Quiktab reduces the effectiveness of oral contraceptives.
Directions for use and dosage: Inside. The tablets must be dissolved in half a glass of water (at least 30 ml) and mixed thoroughly, then drink or hold the tablets in your mouth until completely dissolved, then swallow.
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of meals.
Adults and children over 12 years of age (or body weight >40 kg): in case of mild to moderate infection - 1 table. (625 mg) every 12 hours, in case of respiratory tract infections and severe infections - 1 table. (625 mg) every 8 hours or 1 tablet. (1000 mg) every 12 hours.
If treatment is started with parenteral administration of the drug, it can be continued by taking oral tablets Amoxiclav® Quiktab.
The duration of treatment is up to 14 days.
Dosages for renal failure
In accordance with the severity of renal functional disorders, it is necessary to reduce the dose of the drug and/or increase the dosing interval.
For patients with moderate renal failure (creatinine clearance from 10 to 30 ml/min), 1 table is recommended. (625 mg) every 12 hours.
Patients with severe renal failure (Cl creatinine In cases of anuria, the interval between taking the drug should be increased to 48 hours (or more).
Overdose There are no reports of death or life-threatening side effects due to an overdose of the drug.
Symptoms: in most cases, include gastrointestinal disorders (abdominal pain, diarrhea, vomiting); anxiety, insomnia, dizziness are also possible, and in isolated cases, seizures.
Treatment: symptomatic. In case of overdose, the patient should be under medical supervision.
In case of recent use (less than 4 hours), it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/potassium clavulanate is removed by hemodialysis.
Special instructions During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys.
In patients with severe renal impairment, adequate dose adjustment or increased intervals between dosing are required.
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.
Laboratory indicators: High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucosidase.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. There is no data on the negative effect of Amoxiclav® Quiktab in recommended doses on the ability to drive a car or operate machinery.
Release form Dispersible tablets, 500 mg + 125 mg or 875 mg + 125 mg. 2 tables each in a blister. 5 or 7 blisters in a cardboard pack.
Manufacturer: Lek d.d.
Verovškova 57, Ljubljana, Slovenia.
Consumer complaints should be sent to Sandoz CJSC:
123317, Moscow, Presnenskaya embankment, 8, building 1.
Tel., fax.
Conditions for dispensing from pharmacies By prescription.
Storage conditions for Amoxiclav® Quiktab: Protected from moisture, at a temperature not exceeding 25 °C. Keep out of the reach of children.
The shelf life of Amoxiclav® Quiktab is 3 years.
