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.
Adverse drug reactions (ADRs)
AMO/CC is well tolerated. ADRs include diarrhea (9%), nausea (3%) and vomiting (1%), as well as skin rash (3%). Reducing the daily dose of clavulanate reduces the risk of developing adverse reactions from the gastrointestinal tract. Thus, the frequency of diarrhea in adults when administered orally with AMO/CC at a dose of 875/125 mg 2 times a day is 60% lower than when using a dosage form of 500/125 mg 3 times a day [13]. In terms of the risk of use during pregnancy, amoxicillin/clavulanate is classified as category B (according to the gradings of the Food and Drug Administration; FDA, USA), that is, studies in animals did not reveal a risk of adverse effects of the drug on the fetus [14]. There are also no reports of toxic effects of amoxicillin/clavulanate on the human fetus. In 2004, a prospective study was conducted in Israel to evaluate the safety of the use of amoxicillin/clavulanate in the first trimester of pregnancy in 382 women, according to the results of which the drug was safe for the fetus [15].
