Amoxiclav - instructions for use, dose, side effects, contraindications

active substances: amoxicillin (in the form of trihydrate) in terms of the active substance - 400 mg; clavulanic acid (in the form of potassium salt) in terms of the active substance - 57 mg; Excipients: citric acid (anhydrous) - 2,694 mg; sodium citrate (anhydrous) - 8.335 mg; cellulose microcrystalline and carmellose sodium - 28.1 mg; gum xanthan - 10.0 mg; silicon dioxide colloidal - 16.667 mg; silicon dioxide - 0.217 g; flavor of wild cherry - 4,000 mg; flavoring lemon - 4,000 mg; sodium saccharinate - 5,500 mg; Mannitol up to 1250 mg.

Each 5 ml of a suspension of 250 mg + 62.5 mg / 5 ml contains:

active substances: amoxicillin (in the form of trihydrate) in terms of the active substance - 250 mg; Clavulanic acid (in the form of potassium salt) in terms of the active substance - 62,5 mg; Excipients: citric acid (anhydrous) - 2,167 mg; sodium citrate (anhydrous) - 8,335 mg; sodium benzoate - 2,085 mg; cellulose microcrystalline and carmellose sodium - 28,1 mg; gum xanthan - 10,0 mg; Silica colloidal dioxide - 16,667 mg; silicon dioxide - 0,217 g; flavor of wild cherry - 4,000 mg; sodium saccharinate - 5,500 mg; mannitol to 1250 mg.

Each 5 ml of a suspension of 125 mg + 31.25 mg / 5 ml contains: active ingredients: amoxicillin (in the form of trihydrate) in terms of the active substance - 125 mg; Clavulanic acid (in the form of potassium salt) in terms of the active substance - 31,25 mg; Excipients: citric acid (anhydrous) - 2,167 mg; sodium citrate (anhydrous) - 8,335 mg; sodium benzoate - 2,085 mg; cellulose microcrystalline and carmellose sodium - 28,1 mg; gum xanthan - 10,0 mg; Silica colloidal dioxide - 16,667 mg; silicon dioxide - 0,217 g; strawberry flavor - 15,000 mg; sodium saccharinate - 5,500 mg; mannitol to 1250 mg.

Description:

powder: from white to yellowish white.

Suspension: from almost white to yellow, a homogeneous suspension.

Pharmacotherapeutic group:antibiotic - penicillin semisynthetic + beta-lactamase inhibitor.

ATX: & nbsp

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic, It has activity against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is subject to destruction by beta-lactamases, and therefore the spectrum of activity Amoxicillin does not apply to microorganisms that produce this enzyme.

Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide spectrum of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficacy against plasmid beta-lactamases, which most often determine the resistance of bacteria, and is not effective against type I chromosomal beta-lactamases that are not inhibited by clavulanic acid.

The presence of clavulanic acid in the preparation protects amoxicillin from destruction by enzymes - beta-lactamases, which allows to expand the antibacterial spectrum of amoxicillin.

The activity of a combination of amoxicillin with clavulanic acid in vitro.

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes^1,2, Streptococcus agalactiae^1,2, other beta-hemolytic streptococci^1,2, Staphylococcus aureus (sensitive to methicillin)¹, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae¹, Helicobacter pylori, Moraxella catarrhalis¹, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: kinds kind Clostridium, Peptococcus niger, Peptostrepiococcus magnus, Peptostreptococcus micros, kinds kind Pepto streptococcus.

Gram-negative anaerobes: Bcicteroides fragilis, kinds kind Bacteroides, kinds kind Capnocytophaga, Eikenella corrodens, Fusobacterium nucleatum, kinds kind Fusobacterium, kinds kind Porphyromonas, kinds kind Prevotella.

Bacteria for which the acquired resistance to a combination of amoxicillin and clavulanic acid is probable

Gram-negative aerobes: Escherichia coli¹, Klebsiella oxytoca, Klebsiella pneumoniae, species of genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of genus Proteus, species of genus Salmonella, species of genus Shigella. Streptococcus pneumoniae^1,2, group streptococci Viridans.

Gram-positive aerobes: kinds kind Corynebacterium, Enterococcus faecium.

Bacteria, possessing natural sustainability to combinations amoxicillin from clavulanate acid

Gram-negative aerobes: species of genus Acinetobacter, Citrobacter freundii, species of genus Enterobacter, Hafhia alvei, Legionella pneumophila, Morganella morganii, species of genus Providencia, species of genus Pseudomonas, species of genus Serratia, Stenotrophomonas maltophilia, Yersinia enterocolitica.

Other: Chlamydia pneumoniae, Chlamydia psittaci, kinds kind Chlamydia, Coxiella burnetii, kinds kind Mycoplasma.

For these bacteria, the clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

²strains of these bacteria do not produce beta-lactamases. Sensitivity to monotherapy with amoxicillin suggests a similar sensitivity to the combination of amoxicillin and clavulanic acid.

Pharmacokinetics:

Suction

The active substances of the preparation are quickly and completely absorbed from the gastrointestinal tract (GIT) after ingestion. Absorption of active substances is optimal in case of application of the preparation together with food.

Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid after taking a dose of 45 mg / 6.4 mg / kg divided into two doses by patients under 12 years of age.

Mean value of pharmacokinetic parameters

FROMmOh

(mg / ml)

T max

(h)

AUC (mg in h / l)

T1/2 (h)

Amoxicillin

11,99±3,28

1,0

(1,0-2,0)

35,2±5,0

1,22±0,28

Clavulanic acid

5,49±2,71

1,0

(1,0-2,0)

13,26±5,88

0,99±0,14

FROM_m_Oh - maximum concentration in blood plasma;

T_m_Oh - time to reach the maximum concentration in the blood plasma;

AUC - area under the curve "concentration-time";

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-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxybutan-2-one and 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, the therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (in the gall bladder, abdominal tissues, skin, fat and muscle tissues, synovial and peritoneal fluids, bile secretion) .

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount is associated with plasma proteins clavulanic acid and 18% amoxicillin in blood plasma.

The distribution volume is about 0.3-0.4 l / kg for amoxicillin and about 0.2 l / kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate hematoencephalic barrier in non-inflamed meninges. Amoxicillin (like most penicillins) is excreted in breast milk.

Traces of clavulanic acid can also be detected in breast milk. With the exception of the possibility of development sensitization, diarrhea and mucosal candidiasis of the oral cavity,There are no other negative effects of amoxicillin and clavulanic acid on the health of infants fed by breast milk.

Studies of reproductive function in animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no adverse effect on the fetus.

Excretion

Amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is through both renal and extrarenal mechanisms. After a single oral intake of 875 mg / 125 mg or 500 mg / 125 mg of approximately 60-70% amoxicillin and 40-65% clavulanic acid for the first 6 hours is excreted unchanged in the kidneys. The mean half-life (T_1/2) amoxicillin / clavulanic acid is approximately 1 hour, the average total clearance is approximately 25 l / h in healthy patients. In various studies, it was found that excretion of amoxicillin by the kidneys within 24 hours is approximately 50-85%, clavulanic acid 27-60%. The greatest amount of clavulanic acid is excreted within the first 2 hours after administration.

The pharmacokinetics of amoxicillin / clavulanic acid does not depend on the patient's sex.

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 of the amoxicillin is excreted by the kidneys. Doses of the drug for renal failure should be selected taking into account the undesirability of cumulation of amoxicillin against the background of maintaining a normal level of clavulanic acid.

Patients with impaired hepatic function

In patients with impaired liver function, the drug is used with caution. It is necessary to carry out constant monitoring of liver function.

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

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to amoxicillin + clavulanic acid:

- infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, zaglugal abscess, tonsillitis, pharyngitis);

- infection of the lower respiratory tract (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);

- urinary tract infections (eg, cystitis, urethritis, pyelonephritis);

- infection in gynecology;

- skin and soft tissue infections, including animal and human bites;

- infections of bone and connective tissues;

- infection of the biliary tract (cholecystitis, cholangitis);

- odontogenic infections.

Contraindications:

- hypersensitivity to any of the components of the drug;

- increased sensitivity in the anamnesis to penicillins, cephalosporins and other β-lactam antibiotics;

- the presence in the anamnesis of indications of cholestatic jaundice and / or a violation of the liver function caused by the intake of amoxicillin / clavulanic acid;

- Infectious mononucleosis;

- lymphocytic leukemia.

Carefully:

at a pseudomembranous colitis in the anamnesis, diseases of the gastrointestinal tract, liver failure, severe impairment of kidney function, pregnancy, lactation, with simultaneous use with anticoagulants.

Pregnancy and lactation:

Studies in animals have not revealed data on the dangers of taking the drug during pregnancy and its effect on embryonic development of the fetus.

In one study, in women with premature rupture of amniotic membranes,that preventive therapy with amoxicillin / clavulanic acid may be associated with an increased risk of developing necrotizing enterocolitis in newborns.

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

Amoxicillin and clavulanic acid penetrate into breast milk in small amounts, so taking the drug during breastfeeding should be continued only if there are clear indications.

In infants receiving breastfeeding, it is possible to develop sensitization, diarrhea, candidiasis of the mucous membranes of the oral cavity. In such cases, breastfeeding should be discontinued.

Dosing and Administration:

Inside.

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

The daily dose of suspensions 125 mg + 31.25 mg / 5 ml and 250 mg + 62.5 mg / 5 ml (to facilitate the correct dispensing of 125 mg + 31.25 mg / 5 ml and 250 mg + 62.5 mg / 5 ml suspensions into each package, a measuring pipette graduated 5 ml with a scale of 0.1 ml or a dosage spoon with a capacity of 5 ml, with annular marks in the cavity of 2.5 ml and 5 ml).

Newborns and children under 3 months:

30 mg / kg (per amoxicillin) per day, divided into 2 doses (every 12 hours).

Dosage of Amoxiclav® with a dosage pipette: calculation single doses for the treatment of infections in newborns and children up to 3 months:

Weight

bodies

(kg)

2,0

2,2

2,4

2,6

2,8

3,0

3,2

3,4

3,6

3,8

4,0

4,2

4,4

4,6

4,8

156.25 cps, ml (2 times a day)

1,2

1,3

1,4

1,6

1,7

1,8

1,9

2,0

2,2

2,3

2,4

2,5

2,6

2,8

2,9

312.5 cps, ml (2 times a day)

0,6

0,7

0,8

0,9

1,0

1,1

1,2

1,3

1,4

Children older than 3 months:

From 20 mg / kg for infections of mild to moderate severity up to 40 mg / kg in severe infections and lower respiratory infections, otitis media, sinusitis (per amoxicillin) per day, divided into 3 doses (every 8 hours).

Dosage of Amoxiclav® with a dosage 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 body weight per day (for amoxicillin):

Light and middle-aged heavy infection and
Body weight, kg	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22
156.25 cps, 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	4,0	4,3	4,5	4,8	5,1	5,3	5,6	5,9
312,5 casp, 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	2,0	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
156.25 cps, ml (3 times a day)	6,1	6,4	6,7	6,9	7,2	7,5	7,7	8,0	8,3	8,5	8,8	9,1	9,3	9,6	9,9	10, 1	10, 4
312,5 casp, ml (3 times a day)	3,1	3,2	3,3	3,5	3,6	3,7	3,9	4,0	4,1	4,3	4,4	4,5	4,7	4,8	4,9	5,1	5,2

Dosage of Amoxiclav® with a dosage pipette: calculation

single doses for the treatment of severe infections in children older than 3 months (from calculation of 40 mg / kg body weight per day (for amoxicillin):

Heavy infection and
Body weight, kg	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22
156.25 cps, 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	8,0	8,5	9,1	9,6	10, 1	10, 7	11, 2	11, 7
312.5 cps, 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	4,0	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
156.25 cps, ml	12, 0	12, 8	13, 0	13, 9	14, 4	14, 9	15, 5	16, 0	16, 5	17, 1	17, 6	18, 1	18, 7	19, 2	19, 7	20, 3	20, 8
(3 times a day)
312.5 cps, ml (3 times a day)	6,1	6,4	6,7	6,9	7,2	7,5	7,7	8,0	8,3	8,5	8,8	9,1	9,3	9,6	9,9	10, 1	10, 4

Dosage of Amoxiclav® with a dosage spoon (in the absence of a dosage pipette): recommended doses of suspensions depending on the weight of the child and the severity of the infection

Weight bodies (kg)	Age (approx.)	*The course of light / medium gravity*		*Heavy current*
Weight bodies (kg)	Age (approx.)	125mg + 31.25mg / 5ml	250mg + 62.5 mg / 5ml	125mg + 31.25mg / 5ml	250mg + 62.5 mg / 5ml
5-10	3-12 months.	3 x 2.5ml (1/2 a spoon)	3 x 1.25 ml	3 x 3.75 ml	3 x 2 ml
10- 12	1 - 2 years.	3 x 3.75 ml	3 x 2 ml	3 x 6.25 ml	3 x 3 ml
12-15	2-4 yr	3 x 5 ml (1 spoonful)	3 x 2.5 ml (1/2 a spoon.)	3 x 7.5 ml (1 1/2 a spoon.)	3 x 3.75 ml
15-20	4-6 years old	3 x 6.25 ml	3 x 3 ml	3 х9.5	3 x 5 ml (1 spoon.)
20-30	6-10 years	3 x 8.75 ml	3 x 4.5 ml	-	3 x 7 ml
30-40	10-12 years	-	3 x 6.5 ml	-	3 x 9.5 ml
>40	> 12 years	Preparation Amoxiclav® tablets

The daily dose of the suspension is 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 infections of mild to moderate severity up to 45 mg / kg in severe infections and lower respiratory infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses.

To facilitate correct dosing, a metering pipette, calibrated simultaneously into 1,2, 3, 4, 5 ml and 4 equal parts - is inserted in each packing of the suspension of 400 mg + 57 mg / 5 ml.

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

The recommended dose of the suspension, depending on the weight of the child and the severity of the infection

Body mass (kg)	Age (approx.)	*Heavy current*	*The course of medium gravity*
5 - 10	3-12 months.	2 x 2.5 ml	2 x 1.25 ml
10-15	1 - 2 years.	2 x 3.75 ml	2 x 2.5 ml
15-20	2-4 yr	2 x 5 ml	2 x 3.75 ml
20-30	4-6 years old	2 x 7.5 ml	2 x 5 ml
30-40	6-10 years	2 x 10 ml	2 x 6.5 ml

Exact daily doses are calculated on the basis of the child's body weight, not his age.

The maximum daily dose of amoxicillin is 6 g for adults, 45 mg / kg for children.

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults, 10 mg / kg for children.

Have patients with impaired renal function The dose should be adjusted based on the maximum recommended dose of amoxicillin.

Patients with QC greater than 30 mL / min do not require any dose adjustment.

Adults and children weighing more than 40 kg (this dosing regimen is used for infections of medium and severe course)

Patients with a creatinine clearance of 10-30 ml / min 500 mg / 125 mg twice daily.

With SC less than 10 ml / min, the recommended dose is 500 mg / 125 mg once daily. Patients on hemodialysis have a recommended dose of 500 mg / 125 mg every 24 hours plus 500 mg / 125 mg during the dialysis session and another dose at the end of the dialysis session (since concentrations of amoxicillin and clavulanic acid in the serum are reduced).

Children weighing less than 40 kg

With QC 10-30 ml / min, the recommended dose is 15 mg / 3.75 mg / kg twice daily (maximum 500 mg / 125 mg twice daily).

With SC less than 10 ml / min, the recommended dose is 15 mg / 3.75 mg / kg once daily (maximum 500 mg / 125 mg).

With hemodialysis, the recommended dose is 15 mg / 3.75 mg / kg once daily. Before hemodialysis 15 mg / 3.75 mg / kg. To restore the appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15 mg / 3.75 mg / kg after hemodialysis.

A course of treatment is 5-14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not last more than 14 days without reviewing the clinical situation.

Instructions for preparing a suspension

Powder for the preparation of the suspension 125 mg + 31.25 mg / 5 ml: vigorously shake the bottle, add 86 ml of water in two batches (until the mark), each time shaking well until the powder is completely dissolved.

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

Powder for the preparation of suspension 400 mg + 57 mg / 5 ml: vigorously shake the bottle, add water in two batches (up to the mark) in the amount indicated on the label and given in the table,each time shaking well until the powder is completely dissolved.

The volume of the finished suspension	Required amount of water
35 ml	29.5 ml
50 ml	42 ml
70 ml	59 ml
140 ml	118 ml

Vigorously shake 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 ready 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.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very frequent (> 1/10), frequent (> 1/100, <1/10), not frequent (> 1/1000, <1/100), rare (> 1/10000, <1/1000) and very rare (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

On the part of the organs of hematopoiesis and lymphatic system

rarely: reversible leukopenia (including neutropenia), thrombocytopenia; rarely: eosinophilia, thrombocytosis, reversible agranulocytosis, increased bleeding time and a reversible increase in prothrombin time, anemia, including reversible hemolytic anemia.

From the immune system

rarely: angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.

From the nervous system

infrequently: dizziness, headache;

rarely: insomnia, agitation, anxiety, behavior change, reversible hyperactivity, convulsions; seizures can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug.

From the gastrointestinal tract

often: loss of appetite, nausea, vomiting, diarrhea;

Nausea is more often observed with ingestion of high doses. If violations of the GI tract are confirmed, they can be eliminated if you take the drug at the beginning of the meal. infrequently: indigestion disorder;

rarely: antibiotic-associated colitis, induced reception of antibiotics (including pseudomembranous and hemorrhagic colitis), black hairy tongue, gastritis, stomatitis.

In children, the discoloration of the surface layer of tooth enamel was very rare. Oral care helps prevent discoloration of tooth enamel.

From the skin infrequently: skin rash, itching, urticaria; rarely: multiforme exudative erythema;

rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

From the urinary system

rarely: crystalluria, interstitial nephritis, hematuria.

From the liver and biliary tract

infrequently: increased activity of alanine aminotransferase (ALT) and / or aspartate aminotransferase (ACT); (this phenomenon is observed in patients receiving beta-lactam antibiotic therapy, but its clinical significance is unknown).

Undesirable liver side effects were observed mainly in men and elderly patients and may be associated with long-term therapy. These undesirable phenomena are very rare in children. These signs and symptoms usually occur in the process or immediately after the end of therapy, but in some cases may not appear for several weeks after the completion of therapy. Undesirable phenomena, as a rule, are reversible.Undesirable phenomena from the liver can be severe, in extremely rare cases there have been reports of lethal outcomes. In almost all cases, these were persons with serious concomitant pathology or persons receiving potentially hepatotoxic drugs at the same time. rarely: increased alkaline phosphatase, increased levels of bilirubin, hepatitis, cholestatic jaundice (noted with concomitant therapy with other penicillins and cephalosporins).

Other

often: Candidiasis of the skin and mucous membranes;

frequency is unknown: growth of insensitive microorganisms.

Overdose:

There are no reports of death or the occurrence of life-threatening side effects due to an overdose of Amoxiclav®. Symptoms of overdose include gastrointestinal disorders (abdominal pain, diarrhea, vomiting) and water-electrolyte balance disorders. Reports of crystalluria caused by amoxicillin have been reported, which, in some cases, led to the development of renal failure.

Possible development of seizures in patients with renal insufficiency or in patients receiving high doses of the drug.

In case of an overdose, the patient should be under the supervision of a physician, treatment - symptomatic.

When an overdose of the drug recommended gastric lavage and intake of adsorbents (Activated carbon).

Amoxicillin / clavulanic acid is excreted by hemodialysis.

Interaction:

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

Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion (probenecid), increase concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

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

Assignment together with allopurinol increases the frequency of development of exanthema. The simultaneous use of disulfiram. Reduces the effectiveness of drugs, in the process of metabolism of which forms para-aminobenzoic acid, ethinyl estradiol - risk of bleeding "breakthrough".

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). When taking anticoagulants simultaneously, you need to monitor indicators of blood clotting.

In the literature, rare cases of an increase in the international normalized relationship (INR) in patients with co-administration acenocoumarol or warfarin and amoxicillin. If necessary, simultaneous use with anticoagulants prothrombin time or INR should be carefully monitored when the drug is prescribed or withdrawn.

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

In patients who received mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed, before taking the next dose of the drug by approximately 50%.Changes in this concentration can not accurately reflect the overall changes in the exposure of mycophenolic acid.

Amoxiclav® reduces effectiveness oral contraceptives.

Special instructions:

Before starting treatment, it is necessary to interview the patient to identify in a history of hypersensitivity reactions to penicillins, cephalosporins or other β-lactam antibiotics.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics. In course treatment it is necessary to monitor the status of the function of the organs of hematopoiesis, liver, kidneys.

Patients with severe renal dysfunction require adequate dose adjustment or an increase in the intervals between doses.

To reduce the risk of side effects from the gastrointestinal tract should take the drug during meals. Perhaps the development of superinfection due to the growth of microflora insensitive to amoxicillin, which requires a corresponding change in antibacterial therapy.

If antibiotic-associated colitis occurs, Amoxiclav® should be immediately discontinued,contact a doctor and begin appropriate treatment. Drugs that inhibit peristalsis are contraindicated in such situations.

Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease. With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, other additional methods of contraception should be used whenever possible. Amoxicillin and clavulanic acid may provoke non-specific binding of immunoglobulins and albumins to the erythrocyte membrane, which may be the cause of a false positive reaction in the Coombs sample.

In patients with reduced diuresis, crystalluria is very rare. During the administration of large doses of amoxicillin, it is recommended that

a sufficient amount of fluid and maintain an adequate diuresis to reduce the likelihood of amoxicillin crystals. The administration of the drug should be avoided in case of suspected infectious mononucleosis.

Lab tests: high concentrations of amoxicillin give a false positive reaction to urine glucose when using a Benedict reagent or Felling solution.

It is recommended to use enzymatic reactions with glucosidase.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions when destroying an unused Amoxiclav® preparation.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of Amoxiclav® in recommended doses on the ability to drive or work with mechanisms are not present. However, 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 and engaging in other activities that require concentration and speed of psychomotor reactions. When these undesirable phenomena appear, one should refrain from performing these activities.

Form release / dosage:

Powder for the preparation of a suspension for oral administration.

Packaging:For dosages of 125 mg + 31.25 mg / 5 ml and 250 mg + 62.5 mg / 5 ml:

Primary packaging: 25 g of powder (100 ml of finished suspension) in a vial of dark glass with a ring mark (100 ml).The bottle is closed with a screw cap of high-density polyethylene with a control ring and with a cone seal inside the lid or a screw-on metal cover with a control ring, inside the lid is a lining of low density polyethylene.

Secondary package: One bottle with a dosage spoon with ring marks in the cavity for 2.5 ml and 5 ml ("2.5 CC" and "5 CC"), a maximum filling mark of 6 ml ("6 SS") on the handle of the spoon and instructions for medical use in a cardboard box.

One bottle together with a dosage graduated pipette and instructions for medical use in a cardboard box.

For a dosage of 400 mg + 57 mg / 5 ml:

Primary packaging: 8.75 g (35 ml of the finished suspension), 12.50 g (50 ml of the finished suspension), 17.50 g (70 ml of the finished suspension) or 35.0 g (140 ml finished suspension) powder in a vial of dark glass with a screw cap of high-density polyethylene with a control ring and with a cone seal inside the lid.

For 17.50 g (70 ml of finished suspension) in a vial of dark glass with a ring mark (70 ml) with a screw cap of high-density polyethylene with a control ring and with a cone seal inside the lid.

Secondary packaging: One bottle together with a graduated graduated pipette and instructions for medical use in a cardboard pack.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C.

The finished suspension is stored at a temperature of 2-8 ° C in a tightly closed vial.

Keep out of the reach of children!

Shelf life:

2 years.

Finished suspension - 7 days.

Do not use the product after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:П N012124 / 03

Date of registration:29.06.2011

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp27.04.2015

Illustrated instructions

Instructions

Amoxiclav® (Amoksiklav®)