Амоксиклав®

General characteristics. Structure:

Tablets, film coated 1 table.
active agents (kernel):  
amoxicillin (in the form of trihydrate) 250 mg
clavulanic acid (in the form of potassium salt) 125 mg
excipients: silicon dioxide colloid — 5,4 mg; кросповидон — 27,4 mg; croscarmellose sodium — 27,4 mg; magnesium stearate — 12 mg; talc — 13,4 mg; MKTs — to 650 mg  
the cover is film: a gipromelloza — 14,378 mg; ethyl cellulose of 0,702 mg; polysorbate of 80 — 0,78 mg; triethyl citrate — 0,793 mg; titanium dioxide — 7,605 mg; talc of 1,742 mg  

Tablets, film coated 1 table.
active agents (kernel):  
amoxicillin (in the form of trihydrate) 500 mg
clavulanic acid (in the form of potassium salt) 125 mg
excipients: silicon dioxide colloid — 9 mg, кросповидон — 45 mg, croscarmellose sodium — 35 mg, magnesium stearate — 20 mg, MKTs — to 1060 mg  
the cover is film: a gipromelloza — 17,696 mg, ethyl cellulose — 0,864 mg, polysorbate of 80 — 0,96 mg, triethyl citrate — 0,976 mg, titanium dioxide — 9,36 mg, talc — 2,144 mg  

Tablets, film coated 1 table.
active agents (kernel):  
amoxicillin (in the form of trihydrate) 875 mg
clavulanic acid (in the form of potassium salt) 125 mg
excipients: silicon dioxide colloid — 12 mg; кросповидон — 61 mg; croscarmellose sodium — 47 mg; magnesium stearate — 17,22 mg; MKTs — to 1435 mg  
the cover is film: a gipromelloza — 23,226 mg; ethyl cellulose — 1,134 mg; polysorbate of 80 — 1,26 mg; triethyl citrate — 1,28 mg; titanium dioxide — 12,286 mg; talc of 2,814 mg  

Powder for preparation of suspension for intake of 5 ml of suspension
active agents:  
amoxicillin (in the form of trihydrate) 125 mg
clavulanic acid (in the form of potassium salt) 31,25 mg
ratio — 4:1  
excipients: citric acid (anhydrous) — 2,167 mg; sodium citrate (anhydrous) — 8,335 mg; Natrium benzoicum — 2,085 mg; MKTs and a karmelloza of sodium — 28,1 mg; gum xanthane — 10 mg; silicon dioxide colloid — 16,667 mg; silicon dioxide — 0,217 g; sodium saccharinate — 5,5 mg; Mannitolum — 1250 mg; fragrance strawberry — 15 mg  

Powder for preparation of suspension for intake of 5 ml of suspension
active agents:  
amoxicillin (in the form of trihydrate) 250 mg
clavulanic acid (in the form of potassium salt) 62,5 mg
ratio — 4:1  
excipients: citric acid (anhydrous) — 2,167 mg; sodium citrate (anhydrous) — 8,335 mg; Natrium benzoicum — 2,085 mg; MKTs and a karmelloza of sodium — 28,1 mg; gum xanthane — 10 mg; silicon dioxide colloid — 16,667 mg; silicon dioxide — 0,217 g; sodium saccharinate — 5,5 mg; Mannitolum — 1250 mg; fragrance of wild cherry — 4 mg  

Powder for preparation of suspension for intake of 5 ml of suspension
active agents:  
amoxicillin (in the form of trihydrate) 400 mg
clavulanic acid (in the form of potassium salt) 57 mg
ratio — 7:1  
excipients: citric acid (anhydrous) — 2,694 mg; sodium citrate (anhydrous); — 8,335 mg; MKTs and a karmelloza of sodium — 28,1 mg; gum xanthane — 10 mg; silicon dioxide colloid — 16,667 mg; silicon dioxide — 0,217 g; sodium saccharinate — 5,5 mg; Mannitolum — 1250 mg; fragrance of wild cherry — 4 mg; fragrance lemon — 4 mg  

Description of a dosage form

Tablets of 250+125 mg: white or almost white, oblong, octagonal, biconvex tablets, film coated, with prints "250/125" on one party and "AMC" on other party.

Tablets of 500+125 mg: white or almost white, oval, biconvex tablets, film coated.

Tablets of 875+125 mg: white or almost white, oblong, biconvex tablets, film coated, with a notch and prints "875" and "125" on one party and "AMC" on other party.

Look on a break: mass of yellowish color.

Powder for preparation of suspension for intake: powder from white till yellow-white color. Ready suspension — from almost white till yellow color homogeneous suspension.

Pharmacological properties:

Amoxiclav — an amoxicillin combination (a semi-synthetic antibiotic of a penicillinic number of a broad spectrum of activity) and clavulanic acid (irreversible inhibitor β-лактамаз, the amoxicillin forming inactive complex connections with enzymes and preventing destruction). Clavulanate of potassium has weak antibacterial activity and does not influence the mechanism of effect of amoxicillin. As clavulanic acid suppresses β-lactamelements which usually inactivate amoxicillin, the combination of amoxicillin and clavulanic acid is effective many microorganisms steady against amoxicillin which are rather producing β-lactamelements.
Amoxiclav possesses a wide range of antibacterial activity. The combination is active as in vitro, and in case of clinical infections which are rather not producing and producing a penicillinase of gram-positive and gram-negative microorganisms:
• gram-positive aerobes: strains of Streptococcus pneumonie, Streptococcus pyogenes, sensitive to penicillin, strains of Staphylococcus aureus, Listeria spp, sensitive to Methicillinum., Enterococcus faecalis, Enterococcus faecium, Corynebacterium spp.;
• gram-positive anaerobe bacterias: Peptococcus spp., Peptostreptococcus spp., Clostridium perfringens, Actinomyces israelli;
• gram-negative aerobes: Haemophillus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Neisseria meningitidіs, Pasteurella multocida, Salmonella spp., Shigella spp., Vibrio cholerae, Helicobacter pylori, Bordetella pertussis;
• gram-negative anaerobe bacterias: Bacteroides spp., Fusobacterium spp., Prevotella spp.

To Pseudomonas aeruginosa rezistentna Amoxiclav, strains of Staphylococcus aureus, Legionella spp are steady against Methicillinum., Chlamydia spp., Mycoplasma spp.
Pharmacokinetics. The key pharmacokinetic parameters of amoxicillin and clavulanic acid are similar; their combination does not influence pharmacokinetics of each other. Both components are well absorbed after oral administration; food slightly influences extent of absorption (if to use drug at the beginning of meal, absorption of clavulanic acid increases).
Cmax in plasma at use of the drug Amoxiclav in the form of powder for oral suspension is reached approximately in 1–2 h after administration of drug and makes for amoxicillin (depending on a dose) 3–12 mkg/ml, for clavulanic acid – about 2 mkg/ml.
Cmax in plasma after a bolyusny injection of the drug Amoxiclav (at use of the drug Amoxiclav in the form of powder for solution for injections) 1000 mg / 200 makes mg 105,4 mkg/ml for amoxicillin and 28,5 mkg/ml — for clavulanic acid.
Amoxiclav 2X: Cmax in a blood plasma is reached in 1–2,5 h after reception.
Amoxiclav Kviktab: Cmax in plasma is reached approximately in 1–2 h after administration of drug.
Both components are characterized by the large volume of distribution in liquids and body tissues (lungs, exudate of a middle ear, a secret of maxillary sine, a secret of okolonosovy bosoms, pleural and peritoneal liquid, a prostate, almonds, a phlegm, a bronchial secret, a liver, a gall bladder, a uterus, ovaries, synovial fluid), except for a brain and SMZh (amoxicillin and clavulanic acid do not get through GEB at an uninflammed meninx). High concentration of drug in urine is reached.
Both components get through a placental barrier and are present at a small amount in breast milk.
Amoxicillin and clavulanic acid are characterized by low linkng with proteins of plasma (17–20 and 22–30% respectively).
Both components are allocated with kidneys; amoxicillin is metabolized for 10–20%, and clavulanic acid — almost for 50%. A small amount can be removed through intestines and lungs. T½ of amoxicillin and clavulanic acid makes 78 and 60–70 min. according to, increasing respectively up to 7,5 and 4,5 h at patients with heavy renal failures. Both substances are well removed at a hemodialysis, however is insignificant — at peritoneal dialysis.

Indications to use:

treatment of the bacterial infections caused sensitive to a combination amoxicillin/clavulanic acid by strains of microorganisms:
• upper respiratory tract infections (including infections of ENT organs), including recurrent tonsillitis, sinusitis, average otitises;
• lower respiratory tract infections (bronchitis, pneumonia);
• infections of an urinary system (cystitis, urethritis, pyelonephritis);
• infections of female generative organs (septic abortion, postnatal sepsis, sepsis of pelvic bodies);
• abdominal infections and postoperative intraabdominal complications, including intraabdominal sepsis;
• infections of biliary tract (cholecystitis, cholangitis);
• infections of skin and soft tissues (burns, abscesses, inflammation of hypodermic cellulose, wound fevers);
• dontogenous infections, including dentoalveolyarny abscesses;
• infections of bones, joints and connecting fabric (including osteomyelites);
• prevention of infectious complications after surgical interventions on bodies of a digestive tract, a basin, the head and a neck, heart, kidneys, at amputation of extremities, replacement of joints.

Amoxiclav is applied to treatment of the multi-infections caused both by microorganisms, and the microorganisms, sensitive to amoxicillin, producing β-lactamelements.

Route of administration and doses:

Amoxiclav in the form of powder for oral suspension
Doses are specified in units amoxicillin/clavulanic acid.
At selection of a dose of Amoxiclav it is necessary to consider:
• the expected pathogenic microorganisms and their probable sensitivity to active ingredients;
• weight and localization of an infection;
• age, body weight and condition of function of kidneys of the patient.

In case of need it is necessary to consider expediency of use of alternative forms of Amoxiclav (for example those which contain higher doses of amoxicillin and/or various ratio of amoxicillin and clavulanic acid).
Duration of therapy depends on the course of a disease. It is not necessary to continue treatment more than 14 days without consultation of the doctor.
Adults and children with the body weight of ≥40 kg: a single dose of 500/125 mg 3 times a day.
Children with body weight <40 kg: from 20/5 mg on 1 kg of body weight a day (at infections easy and moderately severe) to 60/15 mg on 1 kg of body weight a day (at heavy infections) in the form of 3 separate doses.
Clinical data on use of Amoxiclav with a ratio of amoxicillin and clavulanic acid to 4:1 children to 2 years in a dose more than 40/10 mg/kg of body weight a day are absent.
There are no clinical data on use of Amoxiclav in the form of suspension for treatment of children up to 2 months therefore recommendations about a dosage do not exist. In this age group it is necessary to apply a parenteral form of Amoxiclav.
Recommendations concerning dosing to children are given in the table below.
                                                 2 months-2 of year
                                                 (5–12 kg)           on 1,7–4,0 ml of suspension 125/31,25 of mg 3 times a day
Moderately severe infections –  2–6 years
25/6,25 mg/kg/days                      (13–21 kg)         on 4,3–7,0 ml of suspension 125/31,25 of mg 3 times a day
                                                 7–12 years
                                                 (22–40 kg)         on 7,3–13,3 ml of suspension 125/31,25 of mg 3 times a day
                                                 
                                                  2–6 years
Heavy infections –               (13–21 kg)        on 7,8–12,6 ml of suspension 125/31,25 of mg 3 times a day
 45/11,25 mg/kg/days                    are 7–12 years old
                                                 (22–40 kg)        on 13,2–24,0 ml of suspension 125/31,25 of mg 3 times a day

For measuring off of suspension the piston pipette of 5 ml with scale interval of 0,1 ml is applied. Exact daily doses are calculated according to the body weight of the child, but not his age!
Patients of advanced age
Dose adjustment is not required.
Renal failure
Dose adjustment is based on the maximum recommended doses of amoxicillin and depends on a glomerular filtration rate. For patients with clearance of creatinine of 30 ml/min. of dose adjustment it is not required.
Adults and children with the body weight of ≥40 kg
Clearance of creatinine of 10-30            ml/min. 500/125 mg 2 times a day
Clearance of creatinine <10               ml/min. 500/125 mg in tablets of 1 times a day
Hemodialysis                                                of 500/125 mg of 1 times a day + 500/125 mg in time
                                                                      dialysis and after the end of a procedure
Children with body weight <40 kg
Clearance of creatinine of 10-30         ml/min. 15/3,75 mg/kg 2 times a day (at most 500/125 mg 2 times a day)
Clearance of creatinine <10                ml/min. 15/3,75 mg/kg of 1 times a day (at most 500/125 mg)
Hemodialysis                                               of 15/3,75 mg/kg of 1 times a day. Before and after the termination
                                                                  procedures of a hemodialysis — 15/3,75 mg/kg
Abnormal liver function
Drug is used with care. It is necessary to control function of a liver regularly.
Route of administration
For optimum absorption and reduction of possible side effects from a digestive tract drug should be accepted at the beginning of meal.
It is possible to begin treatment with parenteral administration of drug, and to continue by a drug form for oral administration.
Preparation of 100 ml of suspension: to stir up a bottle that powder separated from walls and a bottom. To add drinking water in two portions (at first to ⅔, and then to a tag on a bottle), stirring up every time. Before each reception it is good to shake up.
Amoxiclav in the form of powder for solution for injections
Before use of drug it is necessary to take samples on portability of amoxicillin and clavulanic acid.
The dose depends on age, body weight, function of kidneys of the patient, and also on severity of an infection. Doses are specified in units amoxicillin/clavulanate. Amoxiclav is entered in/in struyno (slowly, for 3–4 min.) or kapelno (the infusion period — 30–40 min.). This form of Amoxiclav is not applied to injections in oil. It is impossible to continue treatment more than 14 days without assessment of results of use and a clinical picture.
Adults
Standard dose: 1000/200 mg everyone 8 ​ч.
Heavy infections: 1000/200 mg each 4–6 h.
Prevention of complications at surgical interventions
Operation duration <1 h: 1 dose of 1000/200 mg is entered before administration of anesthesia.
Operation duration> 1 h: as it is stated above, and to 4 doses of 1000/200 mg are entered according to the instruction during 24 h.
The purpose of use of Amoxiclav at surgical interventions is protection of the patient for risk of a postoperative infectious complication.
Existence of accurate clinical signs of infectious complications demands a full course in/in or oral administration of Amoxiclav after operation.
Renal failure
Correction of dosing is based on the maximum recommended amoxicillin doses.
Clearance of creatinine> 30 ml/min.: dose adjustment is not required.
Clearance of creatinine of 10-30 ml/min.: 1000/200 mg, then 500/100 mg 2 times a day.
Clearance of creatinine <10 ml/min.: 1000/200 mg, then 500/100 mg each 24 h.
Hemodialysis
The first dose — 1000/200 mg, then — 500/100 mg each 24 h. As amoxicillin is removed by a hemodialysis, 1 more dose should be entered after the termination of a hemodialysis.
At peritoneal dialysis of dose adjustment it is not required.
Abnormal liver function
Care when dosing, continuous monitoring of function of a liver with regular intervals.
Patients of advanced age
Dose adjustment is not required.
Children
The dosage for children with body weight <40 kg depends on body weight.
Up to 3 months: the body weight of the child <4 kg — 25/5 mg/kg each 12 h; the body weight of the child> 4 kg — to 25/5 mg/kg each 8 h depending on the course of a disease.
Children from 3 months to 12 years: 25/5 mg/kg each 6–8 h depending on the course of a disease.
Renal failure
Correction of dosing is based on the maximum recommended amoxicillin doses.
Clearance of creatinine> 30 ml/min.: dose adjustment is not required.
Clearance of creatinine of 10-30 ml/min.: 25/5 mg/kg 2 times a day.
Clearance of creatinine <10 ml/min.: 25/5 mg/kg of 1 times a day.
Hemodialysis
Enter 25/5 mg/kg of 1 times a day. Considering need of recovery of effective concentration, 1 more dose should be entered after the termination of a hemodialysis.
Abnormal liver function
The available data are not enough for recommendations concerning dosing therefore it is necessary to be careful when dosing; continuous monitoring of function of a liver with regular intervals.
Preparation of solution and feature of introduction
Amoxiclav is entered in the way in/in injections (struyno) or by periodic infusions (kapelno). Amoxiclav it is impossible to enter in oil.
Bottle of 500/100 mg: to dissolve contents in 10 ml of water for injections (the final volume of 10,5 ml).
Bottle of 1000/200 mg: to dissolve contents in 20 ml of water for injections (the final volume of 20,9 ml).
The recovered solutions have yellowish (pale straw) color. Use only transparent solutions.
In/in an injection. Solution of Amoxiclav should be applied within 20 min. after recovery and to enter slowly within 3–4 min. Amoxiclav can be entered directly into a vein or through a catheter kapelno.
In/in infusion. Amoxiclav can be entered in/in in the form of infusion. To add the recovered solution of Amoxiclav 500/100 of mg to 50 ml of infusional liquid or to add the recovered solution of Amoxiclav 1000/200 of mg to 100 ml of infusional liquid (better to apply a mini-container or the burette). To carry out infusion within 30–40 min.
Stability of the prepared solution. For in/in infusions it is possible to apply various solutions. Satisfactory concentration of an antibiotic remains at 5 °C and at the room temperature (25 °C) in the recommended volumes of the infusional solutions provided below. At dissolution of drug and its stay at the room temperature of infusion it is necessary to carry out during the time provided below.

Solution for in/in infusions                              the stability Period at 25 °C, h
Water for injections                                                        4
0,9%                                               chloride 4 sodium solution
Ringer's solution with a lactate                                                 3
Solution of potassium of chloride and sodium                            of chloride 3

 

At storage in the conditions of 5 °C solutions 1000/200 of mg and 500/100 mg can be added to previously cooled solution for infusions (in a plastic sterile container) and the received drug can be stored at the specified temperature to 8 h.

Solution for in/in infusions                            the stability Period at 5 °C, h
Water for injections                                                    8
0,9%                                           chloride 8 sodium solution

 

When heating to room temperature solution should be used immediately.
Amoxiclav is less stable in solutions of glucose, a dextran and bicarbonate therefore solutions on this basis need to be used within 3–4 min. after dissolution.
Any unused solution should be destroyed.
Amoxiclav should not be mixed in the syringe or an infusional bottle with other drugs.
Amoxiclav 2X, Amoxiclav Kviktab
Adults and children are more senior than 12 years with body weight> 40 kg: the recommended dose — 875/125 mg 2 times a day or 500/125 mg 2–3 times a day (at slight or moderate infections — 500/125 mg in each 12 h, at heavy infections — 500/125 mg everyone 8 ​​ h).
Renal failure
At slight disturbance (clearance of creatinine> of 30 ml/min.) dose adjustment is not required.
At moderate disturbance (clearance of creatinine of 10-30 ml/min.) — on 500/125 mg 2 times a day.
At heavy disturbance (clearance of creatinine <10 ml/min.) the drug Amoxiclav 2X is not used, Amoxiclav Kviktab — 500/125 mg of 1 times a day.
Amoxiclav Kviktab, dosing at a hemodialysis. 500/125 mg of 1 times a day + on 500/125 mg during dialysis and at the end of the procedure (considering decrease in concentration of amoxicillin and clavulanic acid in blood serum).
Abnormal liver function
Such patients have not enough recommendations about dosing made relatively. To apply carefully, it is necessary to carry out monitoring of hepatic function through regular periods.
Patients of advanced age. Dose adjustment is not required.
For optimum absorption and reduction of possible side effects from a digestive tract drug should be accepted at the beginning of meal. The tablet Amoxiclav Kviktab needs to be dissolved in ½ glasses of water (not less than 100 ml), to mix carefully before reception or to chew before swallowing.
Duration of a course of treatment depends on indications, is defined individually and should not exceed 14 days without assessment of a condition of the patient. It is recommended to continue treatment at least within 3–4 days after disappearance of acute symptoms of a disease and improvement of a condition of the patient. At infection with beta and hemolitic streptococci for prevention of late complications (for example rheumatism, a glomerulonephritis), it is necessary to accept drug not less than 10 days.

Features of use:

Before therapy by Amoxiclav it is necessary to exclude existence in the anamnesis of reactions of hypersensitivity to penicillin, cephalosporins or other allergens. Heavy allergic reactions (including anaphylactoid) arise at patients with existence of hypersensitivity to penicillin in the anamnesis more often. In case of allergic reactions it is necessary to stop therapy by Amoxiclav and to begin the corresponding alternative therapy.
In case it is proved that the infection is caused by the microorganisms sensitive to amoxicillin, it is necessary to reconsider a possibility of transition from a combination amoxicillin/clavulanic acid on amoxicillin according to official recommendations.
Prolonged use of drug can cause the excess growth of microflora, insensitive to Amoxiclav. Drug should not be used for treatment of S. pneumoniae steady against penicillin.
Patients with renal failures or at those who received high doses of drug can have spasms.
Development of a generalized erythema in an initiation of treatment can be a symptom of an acute generalized exanthematous pustulez. In that case it is necessary to stop Amoxiclav use.
Amoxiclav needs to be cancelled at suspicion on an infectious mononucleosis and a lymphocytic leukosis as emergence at this disease of korepodobny rash can be connected with amoxicillin reception.
Occasionally at the patients accepting Amoxiclav increase in a prothrombin time can be observed. At a concomitant use of anticoagulants the corresponding monitoring is necessary.
Patients should appoint Amoxiclav with care with liver dysfunction. Undesirable reactions from a liver arise preferential at men and patients of advanced age, their emergence can be connected with prolonged use of drug. Signs and symptoms of a disease arise in time or right after treatment, but in certain cases can arise in several weeks after the end of treatment. These phenomena usually have reversible character. Extremely seldom lethal cases at patients with a serious basic disease or at such which were at the same time treated by the drugs having a negative impact on a liver took place.
Use of antibiotics can cause development of pseudomembranous colitis of various degree of manifestation. In the presence of heavy persistent diarrhea after use of antimicrobic means it is important to be convinced that it is not connected with the specified pathology. The drugs suppressing a peristaltics are contraindicated.
In case of prolonged treatment regular checks of renal and hepatic function and carrying out hematologic researches are shown.
For patients with a renal failure it is necessary to korrigirovat a dose according to extent of disturbance. Patients with reduction of amount of the emitted urine very seldom can have a crystalluria, mainly at parenteral administration of drug. Therefore at use of high doses of amoxicillin adequate reception of liquid and control of the corresponding removal of urine for the purpose of decrease in risk of emergence of a crystalluria of amoxicillin is recommended (see OVERDOSE).
At treatment amoxicillin for determination of level of glucose in blood recommends to use enzymatic reactions with glucose oxydas as other methods can yield false positive results.
Availability of clavulanic acid in drug can cause nonspecific binding of IgG and albumine on membranes of erythrocytes therefore the false positive result at test of Koombs is as a result possible.
The patients receiving amoxicillin/clavulanic acid have messages on false positive results of tests for existence of Aspergillus.
In case of need parenteral administration of high doses of drug it is necessary to pay attention to the content of sodium in solutions at treatment of the patients who are on a natriykontroliruyemy diet.
Use during pregnancy and feeding by a breast
Effect of drug is not present data on teratogenic (amoxicillin and clavulanic acid belong to the category B according to FDA classification). It is necessary to avoid use of drug during pregnancy, especially in the I trimester, except cases when the advantage of use of drug exceeds potential risk.
Amoxicillin and clavulanic acid in a small amount get into breast milk therefore it is impossible to exclude risk of development of hypersensitivity in the child who is on breastfeeding. Use Amoxiclav in the period of a lactation perhaps only after careful assessment of a ratio advantage/risk.
Children. Drug in the form of suspension is appointed to children aged from 2 months. To children up to 2 months apply a parenteral form of Amoxiclav. Amoxiclav 2X and Amoxiclav Kviktab are not recommended to children up to 12 years with body weight to 40 kg.
Ability to influence speed of response at control of vehicles or work with mechanisms. The negative impact on speed of response at control of vehicles or work with mechanisms was not observed, but it is necessary to consider probability of such side effect as dizziness.

Side effects:

Standard classification of side reactions by frequency: very often (≥1/10), it is frequent (≥1/100, <1/10), infrequently (≥1/1000, <1/100), is rare (≥1/10 000, <1/1000), is very rare (<1/10 000), it is unknown (it cannot be estimated due to the lack of data).
Infections and invasions: often — candidiasis of generative organs, skin and mucous membranes; it is unknown — development of superinfection.
From hemopoietic and lymphatic system: seldom — a reversible leukopenia (including a neutropenia) and thrombocytopenia; very seldom — a reversible agranulocytosis and hemolitic anemia, an eosinophilia, a pancytopenia, a miyelosupressiya, increase in a bleeding time and a prothrombin ratio.
From immune system: very seldom — a Quincke's disease, an anaphylaxis, a serumal syndrome, an allergic vasculitis.
From a nervous system: often — dizziness, a headache, sleeplessness, excitement; very seldom — a reversible hyperactivity and spasms. Spasms can arise at patients with an impaired renal function or at those who receive high doses of drug.
Mental disorders: very seldom — a hyperactivity, an alarming condition, sleeplessness, confusion of consciousness, an agressive behavior.
From a GIT: often — diarrhea, nausea, vomiting, a proctal itch; seldom — digestion disturbances, an abdominal pain, stomatitis, antibiotikoassotsiirovanny colitis (including hemorrhagic and pseudomembranous colitis); very seldom — coloring of language in black color, change of coloring of teeth that can be eliminated by means of toothbrushing.
From gepatobiliarny system of system: infrequently — moderate increase in the ASAT and/or ALAT, LDG and ShchF level; very seldom — hepatitis and cholestatic jaundice.
Skin and hypodermic fabrics: infrequently — skin rash, an itch, a small tortoiseshell; seldom — a polymorphic erythema; very seldom — Stephens's syndrome — Johnson, a toxic epidermal necrolysis, violent exfoliative dermatitis, acute generalized exanthematous пустулез. In case of any allergic dermatitis treatment should be stopped.
From an urinary system: very seldom — intersticial nephrite, a crystalluria, a hamaturia.
Amoxiclav in the form of powder for solution for injections
Local reactions: seldom — thrombophlebitis, pain, reddening in the place of an injection.

Interaction with other medicines:

Drug should not be used together with bacteriostatic chemotherapeutic means / antibiotics (chloramphenicol, macroleads, tetracyclines or streptocides) as in reactions of in vitro at such combinations the antagonistic effect was observed.
At simultaneous use with Allopyrinolum the risk of an enanthesis increases.
Simultaneous use of Amoxiclav and methotrexate can increase toxicity of the last (a leukopenia, thrombocytopenia, a yazvoobrazovaniye on skin).
Probenetsid reduces canalicular secretion of amoxicillin therefore at simultaneous use of a probenetsid with Amoxiclav increase in content of drug in blood is possible. The increased level of amoxicillin can remain for a long time. It does not concern clavulanic acid.
As well as efficiency of peroral contraceptives can reduce other antibiotics of a broad spectrum of activity, Amoxiclav.
In certain cases at reception of Amoxiclav with peroral anticoagulants increase in a prothrombin time therefore their simultaneous use demands care is possible. Amoxicillin can reduce concentration of Sulfasalazinum in a blood plasma.
At simultaneous use with digoxin increase in extent of absorption of the last is possible.
Amoxiclav should not be applied together with Disulfiramum.
Influence on results of diagnostic laboratory testings: at oral administration of drug its content in urine can be rather high that, in turn, can lead to false positive reactions in the analysis to the content of glucose with use of a reactant of Benedict or solution of Felinga. In that case for determination of content of glucose it is recommended to use an enzymatic glyukozooksidazny method.
Reception of Amoxiclav can affect also results of definition of urobilinigen. The false positive result at test of Koombs is possible.
At purpose of ampicillin to pregnant women perhaps passing decrease in content of the general conjugated estriol, estriol glucuronide, the conjugated estrone and oestradiol in a blood plasma. The similar effect can cause amoxicillin.

Contraindications:

Hypersensitivity to amoxicillin, clavulanic acid, to other β-laktamny antibiotics, including to penicillin and cephalosporins.
Existence in the anamnesis of the heavy abnormal liver functions, cholestatic jaundice connected using drug; contraindicated sick infectious mononucleosis and a lymphoid leukosis (see. Special INSTRUCTIONS).
For Amoxiclav 2X also: children up to 12 years with body weight to 40 kg.

Overdose:

The overdose can be followed by symptoms from a GIT and disorder of water and electrolytic balance. These phenomena treat symptomatic, paying attention to correction of water and electrolytic balance. Sometimes at overdose an enanthesis, hypersensitivity reactions, drowsiness, spasms, a short-term loss of consciousness, involuntary muscular contractions, clonic spasms, a coma, hemolitic reactions, a renal failure and acidosis are possible. In exceptional cases in 20–40 min. there can be shock.
It was reported about crystalluria cases which sometimes led to a renal failure. There are messages on amoxicillin precipitation in an uric catheter at use of intravenous Amoxiclav in high doses.
Developing of spasms at patients with a renal failure or receiving high doses of drug is possible.
Treatment: drug phase-out; symptomatic therapy. The patient has to be under observation of the doctor.
Amoxiclav can be removed from a blood-groove with a hemodialysis method.

Storage conditions:

To store at a temperature not above 25 °C in the place, unavailable to children. A period of validity - 2 years. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 250 mg + 125 mg. On 15, 20 or 21 tab. and 2 dehumidifiers (silica gel) in a container of a round form of red color with a text "is inedible" in the bottle of dark glass corked by the metal screw-on cover with a control ring with perforation and laying from PENP inside. 1 фл. in a cardboard pack.

Tablets, film coated, 500 mg + 125 mg. On 15 or 21 tab. and 2 dehumidifiers (silica gel) in a container of a round form of red color with a text "is inedible" in the bottle of dark glass corked by the metal screw-on cover with a control ring with perforation and laying from PENP inside. 1 фл. in a cardboard pack.

According to 5 or 7 tab. in the blister from the varnished rigid aluminum/soft aluminum foil. On 2, 3 or 4 blisters on 5 tab. or 2 blisters according to 7 tab. in a cardboard pack.

Tablets, film coated, 875 mg + 125 mg. According to 5 or 7 tab. in the blister from the varnished rigid aluminum/soft aluminum foil. On 2 or 4 blisters on 5 tab. or 2 blisters according to 7 tab. in a cardboard pack.

Powder for preparation of suspension for intake

For dosages of 125 mg +31,25 mg / 5 ml and 250 mg +62,5 mg / 5 ml

Primary packaging — on 25 g of powder (100 ml of ready suspension) in a bottle of dark glass with a ring tag (100 ml). The bottle is closed by the screw-on metal cover with a control ring, in a cover — laying from PENP.

Secondary packaging — on 1 фл. with a dosing spoon with ring marks in a cavity on 2,5 and 5 ml ("2,5 CC" and "5 CC"), a mark of the maximum filling of 6 ml ("6 CC") in the spoon handle in a cardboard pack. Or on 1 фл. together with the dosing graduated pipette in a cardboard pack.

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

Primary packaging — on 8,75 g (35 ml of ready suspension), 12,5 g (50 ml of ready suspension), 17,5 g (70 ml of ready suspension) or 35 g (140 ml of ready suspension) of powder in a bottle of dark glass with the screw-on cover from PEVP with a control ring and with laying in a cover. Or on 17,5 g (70 ml of ready suspension) in a bottle of dark glass with a ring tag (70 ml) with the screw-on cover from PEVP with a control ring and with laying in a cover.

Secondary packaging — on 1 фл. together with the dosing graduated pipette in a cardboard pack.