Amoxiclave 625mg tbl p / p about N15

Prescription drug

Manufacturer: Лек д.д.
Рецептурный препарат
амоксиклав  625мг тбл п/п об n15
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Brief information

Производитель

Лек д.д.

Действующее вещество

Амоксициллин + Клавулановая кислота
There are contraindications, specialist advice is required

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Amoxiclav

Film-coated tablets1 table.
the active substance (core): 
amoxicillin (in the form of a trihydrate) 250 mg
clavulanic acid (in the form of potassium salt)125 mg
excipients: silicon dioxide colloidal-5.4 mg; crospovidone-27.4 mg; croscarmellose sodium-27.4 mg; magnesium stearate-12 mg; talc-13.4 mg; MCC - up to 650 mg 
film shell: hypromellose-14.378 mg; ethylcellulose 0.702 mg; Polysorbate 80-0.78 mg; triethylcitrate-0.793 mg; titanium dioxide-7.605 mg; talc-1.742 mg 
Film-coated tablets1 table.
the active substance (core): 
amoxicillin (in the form of a trihydrate)500 mg
clavulanic acid (in the form of potassium salt)125 mg
excipients: silicon dioxide colloidal-9 mg; crospovidone-45 mg; croscarmellose sodium-35 mg; magnesium stearate-20 mg; MCC-up to 1060 mg 
film shell: hypromellose-17.696 mg; ethylcellulose-0.864 mg; Polysorbate 80-0.96 mg; triethylcitrate-0.976 mg; titanium dioxide-9.36 mg; talc-2.144 mg 
Film-coated tablets1 table.
the active substance (core): 
amoxicillin (in the form of a trihydrate)875 mg
clavulanic acid (in the form of potassium salt)125 mg
excipients: silicon dioxide colloidal-12 mg; crospovidone-61 mg; croscarmellose sodium-47 mg; magnesium stearate-17.22 mg; MCC-up to 1435 mg 
film shell: hypromellose-23.226 mg; ethylcellulose-1.134 mg; Polysorbate 80-1.26 mg; triethylcitrate-1.28 mg; titanium dioxide-12.286 mg; talc-2.814 mg 
Powder for preparing a suspension for oral administration5 ml of suspension
active substance: 
amoxicillin (in the form of a trihydrate)125 mg
clavulanic acid (in the form of potassium salt)31.25 mg
excipients: citric acid (anhydrous) — 2,167 mg; sodium citrate (anhydrous) — 8,335 mg; sodium benzoate — 2,085 mg; MCC and carmellose sodium — 28,1 mg; xanthan gum — 10 mg; silicon dioxide colloidal — 16,667 mg; silicon dioxide — 0,217 g; sodium saccharin — 5.5 mg; mannitol — 1250 mg; strawberry flavor 15 mg 
Powder for preparing a suspension for oral administration5 ml of suspension
active substance: 
amoxicillin (in the form of a trihydrate)250 mg
clavulanic acid (in the form of potassium salt)62.5 mg
excipients: citric acid (anhydrous) — 2,167 mg; sodium citrate (anhydrous) — 8,335 mg; sodium benzoate — 2,085 mg; MCC and carmellose sodium — 28,1 mg; xanthan gum — 10 mg; silicon dioxide colloidal — 16,667 mg; silicon dioxide — 0,217 g; sodium saccharin — 5.5 mg; mannitol — 1250 mg; flavor wild cherry — 4 mg 
Powder for preparing a suspension for oral administration5 ml of suspension
active substance: 
amoxicillin (in the form of a trihydrate)400 mg
clavulanic acid (in the form of potassium salt)57 mg
excipients: citric acid (anhydrous) — 2,694 mg; sodium citrate (anhydrous) — 8,335 mg; MCC and carmellose sodium — 28,1 mg; xanthan gum — 10 mg; silicon dioxide colloidal — 16,667 mg; silicon dioxide — 0,217 g; flavor wild cherry — 4 mg; lemon flavor — 4 mg; sodium saccharin — 5.5 mg; mannitol — 1250 mg 
Powder for preparation of intravenous solution1 FL.
active substance: 
amoxicillin (in the form of sodium salt)500 mg
clavulanic acid (in the form of potassium salt)100 mg
Powder for preparation of intravenous solution1 FL.
active substance: 
amoxicillin (in the form of sodium salt)1000 mg
clavulanic acid (in the form of potassium salt).200 mg

Amoxiclav Of Quicktab

Dispersible tablets1 table.
active substance: 
amoxicillin trihydrate 574 mg
(equivalent to 500 mg of amoxicillin) 
potassium clavulanate148.87 mg
(equivalent to 125 mg of clavulanic acid) 
excipients: flavor reminiscent of the tropics — 26 mg; flavor sweet orange — 26 mg; aspartame — 6.5 mg; silicon dioxide colloidal anhydrous — 13 mg; iron (III) oxide yellow (E172) — 3.5 mg; talc — 13 mg; castor oil hydrogenated — 26 mg; microcrystalline silicon-containing up to 1300 mg 
Dispersible tablets1 table.
active substance: 
amoxicillin trihydrate 1004.50 mg
(equivalent to 875 mg of amoxicillin) 
potassium clavulanate148.87 mg
(equivalent to 125 mg of clavulanic acid) 
excipients: flavor reminiscent of the tropics — 38 mg; flavor sweet orange — 38 mg; aspartame — 9.5 mg; silicon dioxide colloidal anhydrous — 18 mg; iron (III) oxide yellow (E172) — 5,13 mg; talc — 18 mg; castor oil hydrogenated — 36 mg; microcrystalline silicon, up to 1940 mg 

Description of the dosage form

Amoxiclav

250+125 mg tablets: white or almost white, oblong, octagonal, biconvex, film-coated, with 250/125 impressions on one side and AMC on the other side.

Tablets 500 + 125 mg: white or almost white, oval, biconvex, covered with a film shell.

875+125 mg tablets: white or almost white, oblong, biconvex, film-coated, with a notch and impressions of 875 and 125 on one side and AMC on the other side.

View of the fracture: yellowish mass.

Powder for preparing a suspension for oral administration: white to yellowish-white powder. Ready-made suspension-from almost white to yellow homogeneous suspension.

Powder for preparation of the solution for intravenous administration: from white to yellowish-white.

Amoxiclav Of Quicktab

Dispersible tablets: oblong, octagonal, light yellow with brown inclusions, with a fruity smell.

Pharmacokinetics

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid are well soluble in aqueous solutions with a physiological pH value and after taking Amoxiclav inside, they are quickly and completely absorbed from the gastrointestinal tract. The absorption of active substances-amoxicillin and clavulanic acid-is optimal if the drug is taken at the beginning of a meal.

The bioavailability of amoxicillin and clavulanic acid after oral administration is about 70%.

Peak plasma concentrations are reached approximately 1 hour after administration. The C max values are 3-12 mcg / ml for amoxicillin (depending on the dose), and about 2 mcg/ml for clavulanic acid.

The C max in blood plasma after bolus injection at a dose of 1.2 g (1000+200 mg) of the drug is 105.4 mg / l for amoxicillin and 28.5 mg / l for clavulanic acid.

When using Amoxiclav, plasma concentrations of amoxicillin/clavulanic acid are similar to those of oral administration of the corresponding doses of amoxicillin or clavulanic acid separately in equivalent doses.

Both components are characterized by sufficient V d in various organs, tissues, and body fluids (including lungs, abdominal organs; fat, bone, and muscle tissues; pleural, synovial, and peritoneal fluids; skin, bile, urine, purulent discharge, sputum, and interstitial fluid).

Plasma protein binding is moderate-25% for clavulanic acid and 18% for amoxicillin.

V d 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 in non-inflamed meninges.

Amoxicillin (like most penicillins) is excreted in breast milk. Trace amounts of clavulanic acid were also found in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier.

Amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted by both renal and extrarenal mechanisms. After a single oral administration of one tablet 250 + 125 mg or 500 + 125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid is excreted unchanged in the urine for the first 6 hours. About 10-25% of the initial dose of amoxicillin is excreted in the urine as inactive penicillic acid. Clavulanic acid in the human body undergoes intensive metabolism to form 2,5-dihydro-4-(2-hydroxyethyl) - 5-oxo-1H-pyrrol-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-it and is excreted in the urine and feces.

The average T 1/2 of amoxicillin/clavulanic acid is approximately 1 h, the average total clearance is approximately 25 l / h in healthy patients. In various studies, it was found that the excretion of amoxicillin in the urine for 24 hours is approximately 50-85%, clavulanic acid-27-60%. The largest amount of clavulanic acid is excreted within the first 2 hours after administration.

Pharmacokinetic parameters of amoxicillin and clavulanic acid are summarized in table 1.

Table 1

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Average (±SD) pharmacokinetic parameters
Active ingredients Amoxicillin/clavulanic acidDose, mgC max, mcg / mlT max, hAUC (0-24), mcg * h / mlT 1/2, h
Amoxicillin
875 mg/125 mgEight hundred seventy five11.64±2.781.5 (1-2, 5)53.52±12.311.19±0.21
500 mg/125 mgFive hundred7.19±2.261.5 (1-2, 5)53.52±8.371.15±0.2
Clavulanic acid
875 mg/125 mgOne hundred twenty five2.18±0.991.25 (1-2)10.16±3.040.96±0.12
500 mg/125 mgOne hundred twenty five2.4±0.831.5 (1-2)15.52±3.860.98±0.12

Patients with impaired liver function

In patients with severe renal failure, T 1/2 increases to 7.5 h for amoxicillin and 4.5 h for clavulanic acid.

For patients with impaired liver function, the dose of the drug should be selected with caution: constant monitoring of the liver condition is necessary.

Both components are removed by hemodialysis and minor amounts are removed by peritoneal dialysis.

Pharmacodynamics

Amoxiclav is a combination of amoxicillin and clavulanic acid.

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PSBs) on the pathway of the biosynthesis of peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to loss of cell wall strength, which usually causes lysis and death of microbial cells.

Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of amoxicillin activity does not include microorganisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits certain beta-lactamases, thereby preventing inactivation of amoxicillin and expanding the spectrum of its activity, including bacteria that are usually resistant to amoxicillin, as well as other penicillins and cephalosporins. Clavulanic acid itself does not have a clinically significant antibacterial effect.

The drug Amoxiclav has a bactericidal effect in vivo on the following microorganisms:

- gram-positive microbes-Staphylococcus aureus*, Streptococcus pneumoniae, Streptococcus pyogenes;

- gram-negative aerobes-Enterobacter spp.** , Escherichia coli*, Haemophilus influenzae*, species of the genus Klebsiella*, Moraxella catarrhalis* (Branhamella catarrhalis).

The drug Amoxiclav has a bactericidal effect in vitro on the following microorganisms (however, the clinical significance is still unknown):

— gram-positive microbes-Bacillis anthracis* , species of the genus Corynebacterium, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides , coagulase-negative staphylococci* (including Staphylococcus epidermidis ), Streptococcus agalactiae , other species of the genus Streptococcus, Streptococcus Viridans;

- gram-positive anaerobes-Clostridium species, Peptococcus species , Peptostreptococcus species;

- gram-negative microbes-Bordetella pertussis, species of the genus Brucella, Gardnerella vaginalis, Helicobacter pylori, species of the genus Legionella, Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, species of the genus Salmonella*, species of the genus Shigella*, Vibrio cholerae, Yersinia enterocolitica — ;

- gram-negative anaerobes-species of the genus Bacteroides* (including Bacteroides fragilis ), species of the genus Fusobacterium*;

- other — Borrelia burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum.

* Some strains of these types of bacteria produce beta-lactamases, which contributes to their insensitivity to amoxicillin monotherapy.

** Most strains of these bacteria are resistant to the amoxicillin/clavulanic acid combination in vitro, but the clinical efficacy of this combination has been demonstrated in the treatment of urinary tract infections caused by these strains.

Indications of the drug

For all dosage forms

Infections caused by sensitive strains of microorganisms:

upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, swallowing abscess, tonsillitis, pharyngitis);

lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);

urinary tract (e.g. cystitis, urethritis, pyelonephritis);

in gynecology;

skin and soft tissue, including human and animal bites;

bone and connective tissue;

biliary tract (cholecystitis, cholangitis);

odontogenic.

Amoxiclav

For powder for preparation of solution for intravenous administration in addition

infection of the abdominal cavity;

sexually transmitted infections (gonorrhea, soft chancre);

prevention of infections after surgery.

Contraindications

hypersensitivity to the drug components;

hypersensitivity to penicillins, cephalosporins, and other beta-lactam antibiotics in the history;

history of cholestatic jaundice and / or other liver disorders caused by amoxicillin / clavulanic acid;

infectious mononucleosis and lymphocytic leukemia;

For tablets dispersible Amoxiclav Quicktab additionally

children under 12 years of age or weighing less than 40 kg.

phenylketonuria;

renal failure (with creatinine Levels <30 ml / min) (for dispersible tablets 875 mg+125 mg)

With caution: a history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal impairment, pregnancy, lactation, and concomitant use of anticoagulants.

Use during pregnancy and lactation

During pregnancy and lactation, Amoxiclav is used only if the intended benefit to the mother exceeds the potential risk to the fetus and child.

Amoxiclav Quicktab can be prescribed during pregnancy if there are clear indications.

Amoxicillin and clavulanic acid in small amounts penetrate into breast milk.

Dosage and administration

Amoxiclav

Film-coated tablets

Inside. The dosage regimen is set individually, depending on the patient's age, body weight, kidney function, and 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 a second medical examination.

Children under 12

The dose is prescribed depending on age and body weight. The recommended dosage regimen is 40 mg / kg / day in 3 doses.

Children with a body weight of 40 kg or more should be given the same doses as adults. For children less than 6 years of age, Amoxiclav suspension is more preferable .

Adults and children over 12 years of age (or >40 kg of body weight)

The usual dose in the case of mild to moderate infection is 1 table. 250+125 mg every 8 hours or 1 table. 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 table. 875 + 125 mg every 12 hours.

Since the combination of amoxicillin and clavulanic acid tablets of 250 + 125 mg and 500+125 mg contain the same amount of clavulanic acid-125 mg, then 2 table. 250 + 125 mg is not equivalent to 1 table. 500+125 mg.

Dosage for odontogenic infections

1 table. 250+125 mg every 8 hours or 1 table. 500+125 mg every 12 hours for 5 days.

Patients with impaired renal function

Dose adjustment is based on the maximum recommended dose of amoxicillin and is based on creatinine Cl values:

- adults and children over 12 years of age (or ≥40 kg of body weight) (table. Two);

- in anuria, the interval between dosing should be increased to 48 hours or more;

- 875+125 mg tablets should only be used in patients with creatinine Cl >30 ml/min.

Table 2

Creatinine clearance The dosage regimen of the drug Amoxiclav
>30 ml / min Dose adjustment is not required
10-30 ml / min 1 table. 50 + 125 mg 2 times a day or 1 table. 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 table. 250+125 mg (for mild to moderate infection) 1 time per day
Hemodialysis 1 table. 500+125 mg or 2 table. 250+125 mg every 24 hours + 1 table. 500+125 mg or 2 table. 250+125 mg during dialysis and at the end of the dialysis session (due to lower serum concentrations of amoxicillin and clavulanic acid)

Patients with impaired liver function

Amoxiclav should be taken with caution. It is necessary to conduct regular monitoring of liver function.

Powder for preparing a suspension for oral administration

Inside

Daily dose suspensions 125+31,25 mg/5 ml and 250+62.5 mg/5 ml (to facilitate proper dosing in each package suspensions 125+31,25 mg/5 ml and 250+62.5 mg/5 ml is embedded metering pipette, graduated 5 ml, scale division 0.1 ml or dosing spoon capacity 5 ml, with ring marks in the cavity on 2.5 and 5 ml).

Newborns and children up to 3 months — 30 mg / kg / day (amoxicillin), divided into 2 doses (every 12 hours).

Dosing of Amoxiclav with a dosing 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 Two 2.2 2.4 2.6 2.8 Three 3.2 3,4 3.6 3.8 Four 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 Two 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 One One 1.1 1.1 1,2 1.3 1.3 1.4 1.4

Children older than 3 months — from 20 mg / kg for mild and moderate infections to 40 mg/kg for severe infection and lower respiratory tract infections, otitis media, sinusitis (amoxicillin) per day, divided into 3 doses (every 8 hours).

Dosing of Amoxiclav with a dosing pipette-calculation of single doses for the treatment of mild and moderate infections in children older than 3 months (at the rate of 20 mg / kg / day (according to amoxicillin) (table. 4).

Table 4

Body weight, kg Five Six Seven Eight Nine Ten Eleven Twelve Thirteen Fourteen Fifteen Sixteen Seventeen Eighteen Nineteen Twenty Twenty one Twenty two
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 Four 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 Two 2.1 2.3 2.4 2.5 2.7 2.8 2.9
                                     
Body weight, kg Twenty three Twenty four Twenty five Twenty six Twenty seven Twenty eight Twenty nine Thirty Thirty one Thirty two Thirty three Thirty four Thirty five Thirty six Thirty seven Thirty eight Thirty nine  
Suspension 156.25, ml (3 times a day) 6.1 6,4 6.7 6.9 7.2 7.5 7.7 Eight 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 Four 4.1 4.3 4.4 4.5 4.7 4.8 4.9 5.1 5.2  

Dosing of Amoxiclav with a dosing pipette-calculation of single doses for the treatment of severe infections in children older than 3 months (at the rate of 40 mg / kg / day (according to amoxicillin) (table. 5).

Table 5

Body weight, kg Five Six Seven Eight Nine Ten Eleven Twelve Thirteen Fourteen Fifteen Sixteen Seventeen Eighteen Nineteen Twenty Twenty one Twenty two
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 Eight 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 Four 4.3 4.5 4.8 5.1 5.3 5,6 5.9
                                     
Body weight, kg Twenty three Twenty four Twenty five Twenty six Twenty seven Twenty eight Twenty nine Thirty Thirty one Thirty two Thirty three Thirty four Thirty five Thirty six Thirty seven Thirty eight Thirty nine  
Suspension 156.25, ml (3 times a day) 12.3 12.8 13.3 13.9 14.4 14.9 15.5 Sixteen 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 Eight 8.3 8.5 8.8 9.1 9.3 9.6 9.9 10.1 10.4  

Dosing of Amoxiclav with a dosage spoon (if there is no dosage 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 (approximately) Light/moderate current 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 teaspoon) 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 teaspoon) 3 × 7.5 ml (1½ spoons) 3 × 3.75 ml
15-20 4-6 years old 3 × 6.25 ml 3 × 3 ml 3 × 9.5 ml 3 × 5 ml (1 spoon)
20-30 6-10 years old 3 × 8.75 ml 3 × 4.5 ml - 3 × 7 ml
30-40 10-12 years old - 3 × 6.5 ml - 3 × 9.5 ml
≥40 ≥12 years Drug Amoxiclav tablets

The daily dose of the 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 infection and lower respiratory tract infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses.

To facilitate correct dosing, a dosing pipette is inserted into each 400 mg+57 mg/5 ml suspension package, graduated simultaneously by 1, 2, 3, 4, 5 ml and 4 equal parts.

Suspension of 400 mg+57 mg/5 ml is used in children older than 3 months.

Table 7

The recommended dose of the suspension depends on the child's body weight and the severity of the infection

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Body weight, kgAge (approximately)Recommended dose, ml
Severe courseModerate severity
5-103-12 months2×2.52×1.25
10-151-2 years2×3.75 2×2.5
15-202-4 years2×5 2×3.75
20-304 years — 6 years2×7.52×5
30-406-10 years old2×102×6.5

The exact daily doses are calculated based on the child's body weight, not their 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 need any dose adjustment.

Adults and children weighing more than 40 kg (the specified dosage mode is used for infections of medium and severe course)

Patients with creatinine Cl 10-30 ml / min-500/125 mg 2 times a day.

With CL creatinine <10 ml/min the recommended dose of 500/125 mg 1 time per 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

For Cl creatinine 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).

With CL creatinine <10 ml / min recommended dose-15/3, 75 mg / kg 1 time per 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 the 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 a second medical examination.

Instructions for preparing the suspension

Powder for preparing a suspension of 125 + 31.25 mg/5ml-shake the bottle vigorously, add 86 ml of water in two doses (up to the mark), each time shaking well until the powder is completely dissolved.

Powder for suspension preparation 250+62.5 mg/5ml-shake the bottle vigorously, add 85 ml of water in two doses (up to the mark), shaking well each time until the powder is completely dissolved.

Powder for preparing a suspension of 400 mg+57 mg/5 ml-shake the bottle vigorously, add water in two doses (before the label) in the amount indicated on the label and given in the table, each time shaking well until the powder is completely dissolved.

Table 8

Volume of the finished suspension, ml Required amount of water, ml
Thirty five 29.5
Fifty Forty two
Seventy Fifty nine
One hundred forty One hundred eighteen

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 wash the dosage pipette with boiled water.

Powder for preparation of solution for intravenous administration

In/in.

Children: with a body weight of less than 40 kg-the dose is calculated depending on the body weight.

Younger than 3 months with a body weight of less than 4 kg-30 mg/kg (in terms of the entire drug Amoxiclav) every 12 hours.

Younger than 3 months with a body weight of more than 4 kg-30 mg/kg (in terms of the entire drug Amoxiclav) every 8 hours.

In children younger than 3 months the drug Amoxiclav should be administered only slowly by infusion for 30-40 minutes.

Children from 3 months to 12 years — 30 mg / kg (based on the entire drug Amoxiclav ) at an interval of 8 hours, in case of severe infection - at an interval of 6 hours.

Children with impaired kidney function

Dose adjustment is based on the maximum recommended dose of amoxicillin. Patients with creatinine CL values above 30 ml/min do not need to adjust the dose.

Children. <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 older than 12 years or weighing more than 40 kg-1.2 g of the drug (1000 + 200 mg) at an interval of 8 hours, in case of severe infection - at an interval of 6 hours.

Prophylactic doses for surgical interventions: 1.2 g for introductory anesthesia (if the duration of the operation is less than 2 hours). For longer operations-1.2 g up to 4 times during the day.

For patients with renal insufficiency, the dose and / or interval between administration of the drug should be adjusted depending on the degree of insufficiency:

\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t
Creatinine ClDose and / or interval between injections
>0.5 ml / s (30 ml / min)Dose adjustment is not required
0.166–0.5 ml / s (10-30 ml / min)The first dose is 1.2 g (1000 + 200 mg), followed by 600 mg (500+100 mg) in/in every 12 hours
<0.166 ml / s (less than 10 ml / min)The first dose is 1.2 g (1000 + 200 mg), followed by 600 mg (500+100 mg) in/in every 24 hours
AnuriaThe dosing interval should be increased to 48 hours or more

Since 85% of the drug is removed by hemodialysis, the usual dose of Amoxiclav should be administered at the end of each hemodialysis procedure . In peritoneal dialysis, dose adjustment is not required.

The course of treatment is 5-14 days. The duration of treatment is determined by the attending physician. If the severity of symptoms decreases, it is recommended to switch to oral forms of the drug Amoxiclav in order to continue therapy .

Preparation of solutions for intravenous injections. Dissolve the contents of the vial 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. In/in enter slowly (within 3-4 minutes).

The drug Amoxiclav should be administered within 20 minutes after the preparation of solutions for intravenous administration.

Preparation of solutions for intravenous infusions. For infusion administration of Amoxiclav, further dilution is necessary: prepared solutions containing 600 mg (500 + 100 mg) or 1.2 g (1000+200 mg) of the drug should be diluted in 50 or 100 ml of the infusion solution, respectively. The duration of the infusion is 30-40 minutes.

When using the following fluids in the recommended volumes in infusion solutions the necessary concentrations of the antibiotic are maintained:

\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t
Used liquidsA period of stability, h
at 25 °Cat 5 °C
Water for injectionFourEight
0.9% sodium chloride solution for intravenous infusionsFour Eight
Normal saline and ringer's lactate for on/in infusionsThree  
Solution of calcium chloride and sodium chloride for intravenous infusionsThree 

The solution of the drug Amoxiclav 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 Of Quicktab

Inside. The dosage regimen is set individually depending on the patient's age, body weight, kidney function, and the severity of the infection.

The tablets should be dissolved in half a glass of water (at least 30 ml) and thoroughly mixed, 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, you should take the drug at the beginning of a meal.

Dispersible tablets of Amoxiclav Quicktab 500 mg / 125 mg:

Adults and children over 12 years of age with a body weight of ≥40 kg

For the treatment of mild and 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 Quicktab is 1500 mg of amoxicillin/375 mg of 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 with a body weight of ≥40 kg (this dosage regimen is used for moderate and severe infections):

\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t
Creatinine Cl, ml / minDose 
10-30500 mg / 125 mg 2 times a day (for medium and\t \ t severe infection) 
<Ten500 mg / 125 mg 1 time per day (for medium and\t \ t severe infection) 
Hemodialysis500 mg / 125 mg every 24 hours, plus 500 mg / 125 mg during a dialysis session, with repeated use at the end of the dialysis session (since plasma concentrations of amoxicillin and clavulanic acid are reduced) 

Dispersible tablets of Amoxiclav Quicktab 875 mg / 125 mg:

Adults and children over 12 years of age with a body weight of ≥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 Quicktab when used 2 times a day is 1750 mg of amoxicillin/250 mg of clavulanic acid.

Patients with impaired renal function. Patients with creatinine Cl greater than 30 ml / min do not need to adjust the dose.

Patients with creatinine Cl less than 30 ml / min are contraindicated using dispersible tablets of Amoxiclav Quicktab, 875 mg/125 mg.

These patients should take the drug at a dosage of 500 mg / 125 mg after the appropriate level of CL creatinine dose adjustment.

Patients with impaired liver function. Caution should be exercised when taking Amoxiclav Quicktab. It is necessary to conduct regular monitoring of liver function. If treatment begins with parenteral administration of the drug, therapy may be continued by taking tablets of the drug Amoxiclav Quicktab.

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.

Side effect

Amoxiclave film-coated tablets and powder for preparing a solution for intravenous administration

From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black hairy tongue, darkening of the tooth enamel, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomembranous colitis, impaired liver function, increased activity of ALT, AST, alkaline phosphatase and/or bilirubin in plasma, liver failure (more often in elderly men with long-term therapy), cholestatic jaundice, hepatitis.

Allergic reactions: itching, urticaria, erythematous rashes, multiform exudative erythema, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustules, a syndrome similar to serum sickness, toxic epidermal necrolysis.

From the hematopoietic system and lymphatic system: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PV (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis.

From the Central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug).

From the urinary system: interstitial nephritis, crystalluria, hematuria.

Other: candidiasis and other types of superinfection.

Amoxiclav

For film-coated tablets, powder for preparing a suspension for oral administration, powder for preparing a solution for intravenous administration.

CNS: hyperactivity. Anxiety, insomnia, behavior changes, arousal.

Amoxiclav

Amoxiclav Of Quicktab

Amoxiclave Quicktab and amoxiclave powder for preparing a suspension for oral administration

From the hematopoietic and lymphatic system: rarely-reversible leukopenia (including neutropenia), thrombocytopenia; very rarely-eosinophilia, thrombocytosis, reversible agranulocytosis, increased bleeding time and reversible increase in PV, anemia, including reversible hemolytic anemia.

On the part of the immune system: the frequency is unknown-angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.

On the part of the nervous system: infrequently-dizziness, headache; very rarely-insomnia, agitation, anxiety, behavior changes, reversible hyperactivity, convulsions; convulsions can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug.

From the digestive tract: often-loss of appetite, nausea, vomiting, diarrhea. Nausea is more frequently observed with the ingestion of high doses. If gastrointestinal disorders are confirmed, they can be eliminated if you take the drug at the beginning of a meal; infrequently-digestive disorders; very rarely-antibiotic-associated colitis induced by taking antibiotics (including pseudomembranous and hemorrhagic colitis), black hairy tongue, gastritis, stomatitis. In children, a change in the color of the surface layer of tooth enamel was very rarely observed. Care for the oral cavity helps to prevent discoloration of the tooth enamel.

From the skin: infrequently-skin rash, itching, urticaria; rarely-multiform exudative erythema; frequency unknown-Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustules.

From the urinary system: very rarely — crystalluria, interstitial nephritis, hematuria.

Liver and biliary tract: infrequently-increased ALT and/or AST activity (this phenomenon is observed in patients receiving beta-lactam antibiotics, but its clinical significance is unknown); Adverse liver events have been observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rarely observed in children.

These signs and symptoms usually occur during or immediately after the end of therapy, but in some cases may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, and in extremely rare cases, there have been reports of fatal outcomes. In almost all cases, these were patients with serious comorbidities or patients receiving potentially hepatotoxic drugs at the same time. Very rarely - increased activity of schf, increased bilirubin levels, hepatitis, cholestatic jaundice (observed with concomitant therapy with other penicillins and cephalosporins).

Other: often-candidiasis of the skin and mucous membranes; frequency unknown-growth of insensitive microorganisms.

Interaction

For all dosage forms

Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion (probenecid), increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Simultaneous use of Amoxiclav and methotrexate increases the toxicity of methotrexate.

Administration together with allopurinol increases the frequency of exanthema. Simultaneous use with disulfiram should be avoided.

Reduces the effectiveness of drugs, in the process of metabolism of which pabc is formed; ethinylestradiol — the risk of bleeding breakthrough.

The literature describes rare cases of increased INR in patients with the combined use of acenocumarol or warfarin and amoxicillin. If concomitant use with anticoagulants is necessary, PV or INR should be carefully monitored when prescribing or discontinuing the drug.

The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides because of the possible decrease in the effectiveness of the drug Amoxiclav .

Amoxiclav reduces the effectiveness of oral contraceptives.

For dispersible tablets and powder for preparing a suspension for oral administration in addition

Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). In some cases, taking the drug may lengthen the PV, so caution should be exercised when using anticoagulants and the drug Amoxiclav Quicktab.

Probenecid reduces the excretion of amoxicillin, increasing its serum concentration.

In patients receiving mycophenolate mofetil, after starting the combination of amoxicillin with clavulanic acid, there was a decrease in the concentration of the active metabolite — mycophenolic acid, before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect the overall changes in mycophenolic acid exposure.

For powder for preparation of solution for intravenous administration in addition

Amoxiclav and aminoglycoside antibiotics are chemically incompatible.

Do not mix Amoxiclav in a syringe or infusion bottle with other drugs.

Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate, as well as with solutions containing blood, proteins, lipids.

Overdose

There are no reports of fatal or life-threatening side effects due to an overdose of the drug.

Symptoms: in most cases — disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), may also be anxiety, insomnia, dizziness, in rare cases — convulsive seizures.

Treatment: in case of overdose, the patient should be under the supervision of a doctor, treatment is symptomatic.

In the case of a recent intake (less than 4 hours) of the drug, gastric lavage should be performed and activated charcoal should be prescribed to reduce absorption. Amoxicillin / potassium clavulanate is removed by hemodialysis.

Special instruction

For all dosage forms

During the course of treatment, it is necessary to monitor the state of the function of the blood-forming organs, liver, and kidneys.

In patients with severely impaired renal function requires adequate correction of the dose or interval between doses.

It is possible to develop superinfection due to the growth of non-sensitive microflora, which requires appropriate changes in antibacterial therapy.

Patients who are hypersensitive to penicillins may have cross-allergic reactions with cephalosporin antibiotics.

In women with premature rupture of fetal membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of developing necrotizing colitis in newborns.

In patients with reduced diuresis, crystalluria is very rare. When using high doses of amoxicillin, it is recommended to take enough liquid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals forming.

Laboratory analysis. High concentrations of amoxicillin give a false positive reaction to urine glucose when using a Benedict reagent or a Fehling solution. It is recommended to use enzymatic reactions with glucosidase.

For dispersible tablets and powder for preparing a suspension for oral administration in addition

Before starting treatment, the patient should be interviewed for a history of hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam antibiotics.

In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug before or during meals.

With the use of high doses of the drug Amoxiclavquicktab of patients with crystalluria it is necessary to adequately compensate for the loss of liquid.

If antibiotic-associated colitis occurs, immediately discontinue Amoxiclav Quicktab, consult a doctor and start appropriate treatment. Drugs that inhibit peristalsis are contraindicated in such situations.

Treatment must continue for another 48-72 hours after the disappearance of clinical signs of the disease. When using estrogens-containing oral contraceptives and amoxicillin at the same time, other or additional methods of contraception should be used if possible.

Amoxicillin and clavulanic acid may provoke nonspecific binding of immunoglobulins and albumins to the red blood cell membrane, which may cause a false positive reaction in the Coombs test.

The use of amoxicillin and clavulanic acid is contraindicated in infectious mononucleosis, since it can provoke the appearance of a bark-like rash.

Special precautions for disposal of unused medicinal product. There is no need for special precautions when destroying unused Amoxiclav .

Influence on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Due to the possibility of developing side effects from the Central nervous system, such as dizziness, headache, convulsions, during treatment, care should be taken when driving a car and other activities that require concentration and speed of psychomotor reactions.

Amoxiclav

Amoxiclav Of Quicktab

For film-coated tablets, dispersible tablets, powder for preparing a suspension for oral administration.

In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug with a meal.

For powder for preparation of solution for intravenous administration in addition

Amoxicillin and clavulanic acid may provoke nonspecific binding of immunoglobulins and albumins to the red blood cell membrane, which may be the cause of a false positive Coombs sample.

Information for patients who follow a low-sodium diet: each 600 mg (500+100 mg) vial contains 29.7 mg of sodium. Each 1.2 g vial (1000+200 mg) contains 59.3 mg of sodium. The amount of sodium in the maximum daily dose exceeds 200 mg.

Form release

Amoxiclav

Film-coated tablets, 250 mg + 125 mg. 15, 20 or 21 table. and 2 desiccants (silica gel) in a round red container with the inscription inedible in a dark glass bottle, capped with a metal screw-on lid with a control ring with a perforation and a gasket made of HDPE inside. 1 FL. in a cardboard.

Film-coated tablets, 500 mg + 125 mg. 15 or 21 table. and 2 desiccants (silica gel) in a round red container with the inscription inedible in a dark glass bottle, capped with a metal screw-on lid with a control ring with a perforation and a gasket made of HDPE inside. 1 FL. in a cardboard.

5 or 7 table. in a blister of varnished hard aluminum / soft aluminum foil. On 2, 3 or 4 blisters on 5 table. or 2 blisters of 7 table. in a cardboard.

Film-coated tablets, 875 mg + 125 mg. 5 or 7 table. in a blister of varnished hard aluminum / soft aluminum foil. 2 or 4 blisters of 5 table. or 2 blisters of 7 table. in a cardboard.

Powder for preparing a suspension for oral administration, 125 mg + 31.25 mg/5 ml or 250 mg + 62.5 mg/5 ml. Primary packaging — 25 g of powder (100 ml of the finished suspension) in a dark glass bottle with a ring mark (100 ml). The bottle is closed with a screw-on metal cover with a control ring, and a penp gasket is inside the cover.

Secondary packaging-1 FL. with a dosing spoon with ring marks in the cavity for 2.5 and 5 ml (2.5 CC and 5 CC), a maximum filling mark of 6 ml (6 CC) on the handle of the spoon in a cardboard package. Or 1 FL. together with a graduated pipette in a cardboard box.

Powder for preparation of suspension for oral administration, 400 mg + 57 mg/5 ml. the Primary package of 8.75 g (35 ml of the prepared suspension), of 12.50 g (50 ml of the prepared suspension), of 17.50 g (70 ml suspension) or 35.0 g (140 ml suspension) of the powder in a bottle of dark glass with a screw cap of HDPE with a control ring and gasket inside the lid. Or 17.5 g (70 ml of the finished suspension) in a dark glass bottle with a ring mark (70 ml) with a screw-on HDPE lid with a control ring and a gasket inside the lid.

Secondary packaging-1 FL. together with a graduated pipette in a cardboard box.

Powder for preparation of intravenous solution, 500 mg + 100 mg or 1000 mg + 200 mg . 500 mg of amoxicillin and 100 mg of clavulanic acid or 1000 mg of amoxicillin and 200 mg of clavulanic acid in a colorless glass bottle closed with a rubber stopper and a compressed aluminum cap with a plastic lid. 5 FL. placed in a cardboard box.

Amoxiclav Of Quicktab

Dispersible tablets, 500 mg + 125 mg or 875 mg + 125 mg.2 table. blistere. 5 or 7 blisters are placed in a cardboard pack.

Conditions of supply of pharmacies

By prescription.

Manufacturer

Lek D. D. Verovskova 57, Ljubljana, Slovenia.

For powder for preparation of solution for intravenous administration in addition

Generated

1. Lek D. D., Verovskova 57, Ljubljana, Slovenia.

2. Sandoz GmbH, Biohemishtrasse 10 A-6250, Kundl, Austria.

Send consumer complaints to Sandoz CJSC: 125317, Moscow, Presnenskaya nab, 8, p. 1.

Tel.: (495) 660-75-09; Fax: (495) 660-75-10.

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

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