ALO (Included in the Free Outpatient Drug Supply List)

Manufacturer: Lek Pharmaceuticals d.d.

Anatomical-therapeutic-chemical classification: Amoxicillin in combination with beta-lactamase inhibitors

Registration number: No. RK-LS-5 No. 016456

Date of registration: 14.10.2015 - 14.10.2020

Instruction

• Russian

Tradename

Amoxiclav 2X

International non-proprietary name

Dosage form

Film-coated tablets 500 mg/125 mg, 875 mg/125 mg

Compound

One film-coated tablet contains

active substances: amoxicillin (as amoxicillin trihydrate) 500 mg and clavulanic acid (as clavulanate potassium) 125 mg (for a 500 mg/125 mg dosage) or amoxicillin (as amoxicillin trihydrate) 875 mg and clavulanic acid (as clavulanate potassium) 125 mg (for a dosage of 875mg/125mg).

Excipients: colloidal silicon dioxide, anhydrous crospovidone, sodium carboxymethylcellulose, magnesium stearate, dried microcrystalline cellulose.

film composition: hydroxypropyl cellulose, ethyl cellulose, polysorbate, triethyl citrate, titanium dioxide (E 171), talc.

Description

White or almost white film-coated tablets, oblong, chamfered, debossed with "875/125" and a notch on one side and engraved with "AMC" on the other side (for a dosage of 875 mg / 125 mg).

Farmacotherapeutic group

Antibacterial drugs for systemic use. Beta-lactam antibiotics - Penicillins. Penicillins in combination with beta-lactamase inhibitors. Clavulanic acid + amoxicillin.

ATX code J01CR02

Pharmacological properties

Pharmacokinetics

Amoxicillin and clavulanic acid are completely soluble in aqueous solution at physiological pH values ​​of the body. Both components are well absorbed after oral administration. It is optimal to take amoxicillin/clavulanic acid during or at the beginning of a meal. After oral administration, the bioavailability of amoxicillin and clavulanic acid is approximately 70%. The dynamics of the concentration of the drug in the plasma of both components is similar. Peak serum concentrations are reached 1 hour after ingestion.

Serum concentrations of amoxicillin and clavulanic acid when taking a combination of amoxicillin/clavulanic acid preparations are similar to those observed when an equivalent dose of amoxicillin and clavulanic acid is taken orally separately.

About 25% of the total amount of clavulanic acid and 18% of amoxicillin bind to proteins in the blood plasma. The volume of distribution for oral administration of the drug is approximately 0.3-0.4 l / kg of amoxicillin and 0.2 l / kg of clavulanic acid.

After intravenous administration, both amoxicillin and clavulanic acid have been found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, synovial and peritoneal fluids, bile, and pus. Amoxicillin does not penetrate well into the cerebrospinal fluid.

Amoxicillin and clavulanic acid cross the placental barrier. Both components also pass into breast milk.

Amoxicillin is partially excreted in the urine as inactive penicillic acid in amounts equivalent to 10-25% of the initial dose. Clavulanic acid is metabolized in the body and excreted in the urine and feces, as well as in the form of carbon dioxide with exhaled air.

The mean half-life of amoxicillin/clavulanic acid is approximately 1 hour and the mean total clearance is about 25 l/h. Approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours after taking a single dose of amoxicillin/clavulanic acid tablets. During various studies, it was found that 50-85% of amoxicillin and 27-60% of clavulanic acid are excreted in the urine within 24 hours. The greatest amount of clavulanic acid is excreted during the first 2 hours after application.

The simultaneous use of probenecid slows down the release of amoxicillin, but this drug does not affect the excretion of clavulanic acid through the kidneys.

The half-life of amoxicillin is similar in children aged 3 months to 2 years, as well as in older children and adults. When prescribing the drug to very young children (including premature newborns) in the first weeks of life, the drug should not be administered more than twice a day, which is associated with the immaturity of the renal excretion pathway in children. Due to the fact that elderly patients are more likely to suffer from renal dysfunction, Amoxiclav 2X should be used with caution in this group of patients, but if necessary, renal function should be monitored.

The total clearance of amoxicillin / clavulanic acid in plasma decreases in direct proportion to the decrease in kidney function. The decrease in the clearance of amoxicillin is more pronounced compared with clavulanic acid, since more amoxicillin is excreted through the kidneys. Therefore, when prescribing the drug to patients with renal insufficiency, dose adjustment is necessary to prevent excessive accumulation of amoxicillin and maintain the desired level of clavulanic acid.

When prescribing the drug to patients with hepatic insufficiency, care should be taken when choosing a dose and regularly monitor liver function.

Pharmacodynamics

Amoxicillin is a semi-synthetic antibiotic from the penicillin group (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins) involved in the biosynthesis of peptidoglycan, which is an important structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

Amoxicillin is degraded by beta-lactamases produced by resistant bacteria, and therefore the spectrum of activity of amoxicillin alone does not include microorganisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits some beta-lactamase, thereby preventing the inactivation of amoxicillin, and expands its spectrum of activity. By itself, clavulanic acid does not have a clinically significant antibacterial effect.

The time to exceed the minimum inhibitory concentration (T > MIC) is considered the main determinant of the effectiveness of amoxicillin.

The two main mechanisms of resistance to amoxicillin and clavulanic acid are:

inactivation by bacterial beta-lactamases that are not inhibited by clavulanic acid, including classes B, C and D.

change in penicillin-binding proteins, which reduces the affinity of the antibacterial agent to the target pathogen.

Bacterial impermeability or efflux pump mechanisms (transport systems) can cause or maintain bacterial resistance, especially Gram-negative bacteria.

The MIC breakpoints for amoxicillin/clavulanic acid are those defined by the European Committee for Antimicrobial Susceptibility Testing (EUCAST).

	Limits of sensitivity (µg/ml)
	Sensitive	moderately resistant	resistive
haemophilus influenzae1
Moraxella catarrhalis1
Staphylococcus aureus2
Coagulase-negative staphylococci2
Enterococcus1
StreptococcusA, B, C, G5
Streptococcus pneumoniae3
Enterobacteriaceae5
Gram-negative anaerobes1
Gram-positive anaerobes1
Breakpoint without specific association1

sensitivity, the concentration of clavulanic acid is fixed at 2 mg/l.

3 Breakpoint values ​​in the table are based on breakpoints

ampicillin.

4 The resistance breakpoint R > 8 mg/l ensures that all strains with

resistance mechanisms are reported as resistant.

5 Breakpoint values ​​in the table are based on breakpoints

benzylpenicillin.

The prevalence of resistance may vary geographically and over time for selected species, and local information on resistance is desirable, especially when treating severe infections.

Sensitive strains

: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (methicillin sensitive), Streptococcus agalacticae, Streptococcus pneumoniae, Streptococcus pyogenes and other beta-hemolytic streptococci, Streptococcus viridans group

Aerobic gram negative microorganisms: Capnocyptophaga spp., Eikenella corrodens, Haemophilus influenzae, Moraxella catarrhalis, Pasteurella multocida

Anaerobic microorganisms: Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp.

Strains whose acquired resistance may cause problems

Aerobic gram-positive microorganisms: Enterococcus faecium

: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris

Resistant strains

Aerobic gram-negative microorganisms: Acinetobacter sp., Citrobacter freundii, Enterobacter sp., Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia

Other strains

Chlamydophila pneumoniae, Chlamydophila psitacci, Coxiella burnetti, Mycoplasma pneumoniae

Indications for use

acute bacterial sinusitis

acute otitis media

exacerbation of chronic bronchitis

community-acquired pneumonia

• pyelonephritis

  infections of the skin and soft tissues (including phlegmon, animal bites, severe periodontal abscess, phlegmon of the maxillofacial region)

  bone and joint infections (particularly osteomyelitis)

Dosage and administration

Doses are calculated taking into account the content of amoxicillin / clavulanic acid. When choosing a dose of Amoxiclav 2X for the treatment of individual infections, the following should be considered:

susceptibility of pathogen to antibiotic

the severity and location of the infection

age, weight and kidney function of the patient as shown below.

It is also necessary to consider other ways of using the drug Amoxiclav 2X, for example, using higher doses of amoxicillin and / or prescribing amoxicillin and clavulanic acid in different ratios.

Tablets should be taken orally before meals to reduce possible gastrointestinal disturbances and increase the absorption of amoxicillin/clavulanic acid.

Adults and children over 12 years oldor with body weight over 40 kg

Assign 1 tablet 500 mg / 125 mg 3 times a day or 1 tablet 875 mg / 125 mg twice a day.

In severe cases, with infections of the lower respiratory tract, urinary tract, otitis media and sinusitis, 1 tablet of 875 mg / 125 mg is prescribed 2 times a day.

The duration of treatment depends on the response of the patient. Some infections (such as osteomyelitis) require a longer period of treatment. The maximum therapy time should not exceed 14 days.

The maximum daily dose for a dosage of 500 mg / 125 mg is 1500 mg of amoxicillin / 375 mg of clavulanic acid, for a dosage of 875 mg / 125 mg it is 1750 mg of amoxicillin / 250 mg of clavulanic acid.

Children under 12 years of age or weighing less than 40 kg

This dosage form is not intended for children under 12 years of age or children weighing less than 40 kg. Such children are prescribed the drug Amoxiclav 2X in the form of a suspension for oral administration.

Elderly patients dose adjustment is not required.

With kidney failure Dose adjustments are made based on the maximum recommended level of amoxicillin. Dose adjustment is not required when prescribing the drug to patients with a creatinine clearance (CrCl) of more than 30 ml / min.

In patients whose creatinine level is less than 30 ml / min, the use of amoxicillin and clavulanic acid at a dose of 875/125 mg is not recommended, since there are no recommendations for dosage adjustment.

Adults and children weighing over 40 kg

With liver failure apply with caution. Necessary

check liver function regularly.

Side effects

Classification of side effects by frequency of occurrence:

"very often" -  1/10, "often" - from  1/100 to  1/10, "infrequently" - from  1/1000 to  1/100, "rarely" - from  1/10000 to  1/1000, "very rarely" -  1/10000, the frequency is unknown (there is not enough data to make an estimate).

Often:

Often:

candidiasis (skin and mucous membranes)

Infrequently:

dizziness, headache

indigestion

increased AST and/or ALT5 levels

skin rash7, itching7, urticaria7

Rarely:

transient leukopenia (including neutropenia), thrombocytopenia

erythema multiforme7

Frequency unknown:

growth of non-susceptible organisms

transient agranulocytosis, hemolytic anemia, increased bleeding time and prothrombin time1

angioedema10, anaphylaxis10, serum-like syndrome10, allergic vasculitis10

transient hyperactivity, convulsions2

antibiotic-associated colitis4, black hairy tongue, discoloration of teeth11

hepatitis6, cholestatic jaundice6

Stevens-Johnson syndrome7, toxic epidermal necrolysis7, bullous exfoliative dermatitis7, acute generalized exanthematous pustulosis (AGEP)9

interstitial nephritis, crystalluria8

1 see section Special instructions.

2 see section Special instructions.

3 Nausea more frequent with higher oral doses. Can be reduced

gastrointestinal reactions while taking amoxicillin/clavulanic acid in

the beginning of a meal.

4 Including pseudomembranous colitis and hemorrhagic colitis (see Special

instructions).

5 Moderate increases in AST and/or ALT levels have been noted in patients

treated with beta-lactam antibiotics, but the significance of these results is unknown.

6 These complications have been noted when the drug is used in combination with other

penicillins and cephalosporins (see section Special Instructions).

7 If any skin hypersensitivity reaction occurs, treatment should be

stop (see section Special Instructions).

8 see section Special instructions.

9 see section Contraindications.

10 see section Special instructions.

Contraindications

hypersensitivity to the active substance or any auxiliary component of the drug

history of severe hypersensitivity reaction to other beta-

lactam drugs (eg, cephalosporins, carbapenems, or

monobactam)

cholestatic jaundice or other history of liver failure (due to the use of amoxicillin/clavulanic acid)

children under 12 years of age (weighing less than 40 kg)

Drug Interactions

Oral anticoagulants

Oral anticoagulants and antibiotics of the penicillin group are widely used in practice without interaction reports. However, in the literature, an increase in the international normalized ratio was noted in patients taking acenocoumarol or warfarin together with amoxicillin. If the simultaneous use of drugs is necessary, the prothrombin time or international normalized ratio should be carefully monitored when prescribing and canceling amoxicillin. Moreover, a change in the dosage of oral anticoagulants may be required.

Methotrexate

Drugs of the penicillin group can reduce the excretion of methotrexate, which causes a potential increase in toxicity.

probenecid

Co-administration of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Co-administration with Amoxiclav 2X may result in increased blood levels of amoxicillin but not clavulanic acid.

The simultaneous use of allopurinol and the drug Amoxiclav 2X may increase the risk of allergic reactions. Data on the simultaneous use of allopurinol and the drug Amoxiclav 2X are currently not available.

In patients taking mycophenolate mofetil, when combined with the drug Amoxiclav 2X, the concentration of the active metabolite of mycophenolic acid at the initial dose is reduced by approximately 50%. The change in the initial dose level may not correspond to the change in the total concentration of mycophenolic acid.

special instructions

Before starting therapy with amoxicillin/clavulanic acid, it is necessary to carefully study the patient's hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam substances.

Serious and sometimes fatal (anaphylactic) hypersensitivity reactions have been reported in patients treated with penicillin. These reactions are more common in people with a penicillin hypersensitivity reaction and a history of atopy. If an allergic reaction to amoxicillin/clavulanic acid develops, discontinue therapy with this drug and switch to another alternative treatment.

If the infection is resistant to amoxicillin, consideration should be given to using amoxicillin/clavulanic acid instead of amoxicillin.

At a high risk of pathogen resistance to beta-lactam antibiotics, Amoxiclav 2X should not be used. It is not recommended to use the drug for the treatment of penicillin-resistant S. pneumoniae.

Patients with impaired renal function and taking a high dose of the drug may develop convulsions.

Amoxicillin/clavulanic acid should not be prescribed for infectious mononucleosis, as a measles-like rash (for amoxicillin) may occur.

The simultaneous use of allopurinol during treatment with amoxicillin may increase the likelihood of skin allergic reactions. Data on the simultaneous use of allopurinol and the drug Amoxiclav 2X are currently not available.

Prolonged use of the drug may cause overgrowth of non-susceptible microorganisms.

The appearance at the beginning of treatment of generalized erythema with pustular rashes and fever may be a symptom of the development of acute generalized exanthematous pustulosis. With the development of this reaction, it is required to stop using the drug Amoxiclav 2X and no longer use amoxicillin in the future.

The drug should be used with caution in patients with hepatic impairment.

Cases of liver dysfunction have been reported mainly in men and elderly patients, and are quite rare in children who have taken the drug for a long period of time. Signs and symptoms usually develop during or immediately after the start of treatment, but in some cases may not appear until a few weeks after stopping therapy. These symptoms are usually reversible. Complications from the liver can be severe and in extremely rare cases be fatal. They almost always develop in patients with serious comorbidities or in patients taking other drugs that affect the liver.

The development of antibiotic-associated colitis is characteristic of any antibacterial drugs, including amoxicillin, and can vary in severity from moderate to life-threatening. Therefore, it is important to consider this diagnosis when prescribing the drug to patients suffering from diarrhea during or after the use of any antibiotics. If antibiotic-associated colitis occurs, use of Amoxiclav 2X should be discontinued immediately. After consulting a doctor, appropriate therapy should be prescribed. Drugs that reduce peristalsis are contraindicated in this situation. During long-term therapy, it is recommended to regularly evaluate the function of organ systems, including kidney, liver and hematopoietic function. It is necessary to adjust the dose of oral anticoagulants to maintain the desired level of blood clotting.

In patients with impaired renal function, dose adjustment is required depending on the severity of the impairment.

In patients with reduced diuresis, crystalluria was observed very rarely, mainly during parenteral therapy. During treatment, the patient is advised to drink plenty of fluids to avoid the possible development of crystalluria. According to the data obtained, amoxicillin settles in the bladder catheters (mainly with intravenous administration of large doses), in this case it is necessary to regularly monitor the patency of the catheter.

During treatment with amoxicillin, glucose oxidase enzymatic methods should be used when testing for the presence of glucose in the urine, since false positive results are possible when using non-enzymatic methods.

The presence of clavulanic acid in Amoxiclav 2X can lead to non-specific binding of immunoglobulin G and albumin to erythrocyte membranes and false positive Coombs test results. were not infected with Aspergillus infection, but there are no data on cross-reactions with non-Aspergillus polysaccharides and polyfuranoses. Thus, positive test results in patients treated with amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods. Pregnancy

Animal studies do not indicate direct or indirect harmful effects in relation to pregnancy, embryonic/fetal development, parturition or postnatal development.

Currently, there is a limited amount of data on the use of the drug Amoxiclav 2X during pregnancy in humans, which did not reveal an increased risk of congenital malformations. In a clinical study in women with premature rupture of the membranes, a causal relationship was documented between prophylactic treatment with amoxicillin/clavulanic acid and an increased risk of necrotizing enterocolitis in the newborn. It is not recommended to use the drug Amoxiclav 2X during pregnancy, the use is possible only in case of emergency, as directed by a doctor.

Lactation

Both active substances are excreted in breast milk (there is no data on the effect of clavulanic acid on breastfeeding). Therefore, breastfeeding may cause symptoms such as diarrhea and fungal infections of the mucous membranes, in which case breastfeeding should be discontinued. The drug Amoxiclav 2X is allowed to be used during breastfeeding only after a benefit / risk assessment by the attending physician.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Studies to identify effects that affect the ability to drive a car and machinery have not been conducted. However, the drug Amoxiclav 2X can cause side effects such as allergic reactions, convulsions, which can affect the ability to drive a car and move machinery.

Overdose

Symptoms: Gastrointestinal symptoms and fluid and electrolyte disturbances are possible. Crystalluria of amoxicillin in some cases leads to renal failure. Convulsions may occur in patients with impaired renal function or in patients taking high doses of the drug.

Treatment: symptomatic treatment, taking into account the water and electrolyte balance. Amoxicillin/clavulanic acid can be removed from the body by hemodialysis.

Release form and packaging

7 tablets in a blister pack of aluminum foil.

2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack.

Storage conditions

Store in a dry place at a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

Do not use after the expiry date stated on the packaging.

Terms of dispensing from pharmacies

On prescription

Manufacturer/Packer

Perzonali 47, SI - 2391 Prevalje, Slovenia

Registration certificate holder

Lek Pharmaceuticals d.d., Slovenia

Verovskova, 57, 1526 Ljubljana, Slovenia

Address of the organization that accepts claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Representative office of Sandoz Pharmaceuticals d.d. JSC in the Republic of Kazakhstan, Almaty, st. Luganskogo 96,

Phone number: +7 727 258 10 48, fax: +7 727 258 10 47

e-mail: [email protected]

8 800 080 0066 - free dial-up number within Kazakhstan

Attached files

555814661477976394_en.doc	147 kb
792323641477977600_kz.doc	158 kb

Amoxiclav (Amoksiklav)

Compound

Amoxiclav tablets 250 mg/125 mg
Active substances: amoxicillin (in the form of trihydrate) - 250 mg, clavulanic acid (in the form of potassium salt) - 125 mg.
Inactive substances: microcrystalline cellulose, croscarmellose sodium.

Powder for suspension Amoxiclav 156.25 mg / 5 ml
Active substances: amoxicillin (in the form of trihydrate) - 125 mg / 5 ml, clavulanic acid (in the form of potassium salt) - 31.25 mg / 5 ml.

Powder for suspension Amoxiclav 312.5 mg/5 ml
Active substances: amoxicillin (in the form of trihydrate) - 250 mg / 5 ml, clavulanic acid (in the form of potassium salt) - 62.5 mg / 5 ml.
Inactive substances: sodium citrate, microcrystalline cellulose, sodium benzoate, sodium saccharin, mannitol.

Powder for intravenous infusion Amoxiclav 600 mg
Active substances: amoxicillin (in the form of sodium salt) - 500 mg, clavulanic acid (in the form of potassium salt) - 100 mg.

Powder for intravenous infusion Amoxiclav 1200 mg
Active substances: amoxicillin (in the form of sodium salt) - 1000 mg, clavulanic acid (in the form of potassium salt) - 200 mg.

Tablets Amoxiclav 2X 500 mg/125 mg

Tablets Amoxiclav 2X 875 mg / 125 mg

Inactive ingredients: colloidal anhydrous silica, aspartame, orange flavor, tropical blend flavor, iron oxide yellow (E172), hydrogenated castor oil, talc, silicified microcrystalline cellulose.

Tablets Amoxiclav Quiktab 500 mg/125 mg
Active substances: amoxicillin (in the form of trihydrate) - 500 mg, clavulanic acid (in the form of potassium salt) - 125 mg.
Inactive ingredients: colloidal anhydrous silica, aspartame, orange flavor, tropical blend flavor, iron oxide yellow (E172), hydrogenated castor oil, talc, silicified microcrystalline cellulose.

Amoxiclav Quiktab 875 mg/125 mg tablets
Active substances: amoxicillin (in the form of trihydrate) - 875 mg, clavulanic acid (in the form of potassium salt) - 125 mg.
Inactive ingredients: colloidal anhydrous silica, aspartame, orange flavor, tropical blend flavor, iron oxide yellow (E172), hydrogenated castor oil, talc, silicified microcrystalline cellulose.

pharmachologic effect

Amoxiclav is an antibacterial combination drug. Active ingredients: amoxicillin (a broad-spectrum penicillin antibiotic) and an inhibitor of beta-lactamase microorganisms (clavulanic acid). Clavulanic acid prevents the destruction of amoxicillin due to the formation of stable complexes with beta-lactamases: in this case, the resulting complexes are pharmacologically inactive.

Amoxicillin is effective against bacteria that are sensitive to it. Due to the inclusion of a beta-lactamase inhibitor (clavulanic acid) in the preparation, the agent can also be prescribed for infections resistant to the action of amoxicillin. Amoxicillin in combination with clavulanic acid is active against: Streptococcus pneumoniae, Str. bovis, Str. pyogenes, Listeria spp., Staphylococcus aureus, S. epidermidis, Enterococcus spp. (gram-positive aerobic microorganisms), Moraxella catarrhalis, N. meningitidis, H. influenzae, E. coli, Klebsiella spp., Proteus spp., N. gonorrhoeae, Pasteurella multocida (gram-negative aerobic microorganisms), as well as against anaerobic infectants (Bacteroides spp ., Peptococcus spp., Clostridium spp., Actinomyces israelii, Peptostreptococcus spp.).

In general, the pharmacokinetic parameters of clavulanic acid and amoxicillin are similar when used in combination, therefore they do not have a mutual effect on the pharmacokinetic properties of each individual substance. After oral administration, both ingredients are well absorbed. Their maximum plasma concentrations are reached after about 60 minutes. The use of Amoxiclav during meals does not affect the absorption of clavulanic acid and amoxicillin. The half-life for clavulanic acid is 60-70 minutes, for amoxicillin - 78 minutes. Both substances penetrate into the tissues and fluids of the body easily, especially accumulate in the secretion of the maxillary sinuses, lungs, middle ear cavity, peritoneal and pleural fluids, ovaries and uterus. With meningitis, the components of Amoxiclav penetrate the blood-brain barrier. They also penetrate the placental barrier and are determined in trace amounts in breast milk.

With the bolus administration of Amoxiclav at a dosage of 1.2 g, the maximum plasma concentration of clavulanic acid is 28.5 mg / l, amoxicillin - 105.4 mg / ml. After 60 minutes, the peak concentration of these substances in body fluids is determined. Clavulanic acid and amoxicillin bind to plasma proteins, respectively, by 22-30% and 17-20%.

Clavulanic acid is extensively metabolized in the liver tissue. It is excreted partially with exhaled air and feces, mainly by the kidneys. Amoxicillin is predominantly excreted unchanged in the urine.

Indications for use

The indications are:
acute and chronic sinusitis;
pharyngeal abscess;
otitis media;
· pneumonia ;
· Chronical bronchitis;
· urinary tract infections;
· odontogenic infections, including periodontitis;
gynecological infections;
gonorrhea (including those caused by gonococci that produce beta-lactamase;
Infections of the skin and soft tissues (including wound infections);
· chancroid;
infections of the bones and joints;
prevention of purulent-septic complications during surgical interventions on the pelvic organs, abdominal cavity, kidneys, heart, bile ducts;
Therapy of mixed infections caused by gram-positive and gram-negative microorganisms, as well as anaerobic pathogens (biliary tract infections, ENT infections and postoperative abdominal infections, aspiration pneumonia, breast abscess);
· Maxillofacial Surgery;
orthopedic practice.

Mode of application

Tablets Amoxiclav
It is taken orally at the beginning of a meal, swallowing whole, without chewing and drinking plenty of water. The dosage regimen is set on an individual basis, taking into account the severity of the disease and the response to therapy. The duration of therapy is from 5 to 14 days.

Amoxiclav in the form of film-coated tablets is prescribed for adults and children over 6 years of age. Children under 6 years of age are recommended to use Amoxiclav suspension.
Recommended doses of the drug:
children from 6 to 12 years old - an average of 40 mg / kg / day. in 3 doses;
children (weighing more than 40 kg) and adults - with diseases of mild and moderate severity - 1 table. 250 + 125 mg every 8 hours (3 rubles / day) or 1 tab. 500+125 mg every 12 hours (2 r./day); with a severe form of diseases - 1 table. 500 + 125 mg every 8 hours (3 rubles / day) or 1 tab. 875+125 mg every 12 hours (2 r./day).

Tablets Amoxiclav 2X
It is taken orally at the beginning of a meal, swallowing whole, without chewing and drinking plenty of water. Appointed only for adult patients with severe respiratory diseases or severe infections, 1000 mg (1 tablet) twice a day.

The maximum daily dosage for adults is 6000 mg of amoxicillin. The maximum daily dose of clavulanic acid in the form of potassium salt is 600 mg.

Patients with renal insufficiency
In case of insufficiency of kidney function with a creatinine clearance level of 10 ml / min or less, the dosage of Amoxiclav is adjusted or the interval between taking the drug is increased. With anuria, the interval between doses can be 48 hours.
With a creatinine clearance of 80 ml / min or more, the interval between taking Amoxiclav is 8 hours, with a clearance of 80-50 ml / min - 8 hours, with a clearance of 50-10 ml / min - 12 hours, with a clearance of 10 ml / min or less - 24 hours.

Amoxiclav-suspension
Before preparing the suspension of the drug, the vial is shaken well until the powder particles are separated from the bottom and walls of the vessel. 86 ml of water is added to the vial in 2 doses, after each addition of water, the vial is thoroughly shaken. 1 measuring spoon for taking Amoxiclav suspension contains 5 ml of the drug; half - 2.5 ml; ¾ - 3.75 ml.
The exact dose of Amoxiclav suspension for pediatric patients is calculated only taking into account body weight.

Children from the first days of life up to the age of 3 months are prescribed at a dose of 30 mg / kg / day (in terms of amoxicillin), the daily dose is divided equally, taken at regular intervals.
Amoxiclav is prescribed from the age of 3 months or more or with a body weight of less than 40 kg at a dose of 25 mg / kg / day (divided into 2 injections every 12 hours); or 20 mg / kg / day (divided into 3 injections every 8 hours) - for moderate infectious diseases. In severe infections, Amoxiclav is used at 45 mg / kg / day (dose divided into 2 doses every 12 hours); or 40 mg/kg/day (divided into 3 doses every 8 hours).

The maximum daily dosage for children is 45 mg per 1 kg of body weight. The maximum daily dose of clavulanic acid in the form of potassium salt is 10 mg per 1 kg of body weight.

Amoxiclav for parenteral use
30 mg Amoxiclav for intravenous administration contains 5 mg of clavulanic acid and 25 mg of amoxicillin.
Preparation of Amoxiclav solution for intravenous administration: the contents of the vial are dissolved in water for injection (for Amoxiclav 600 mg - 10 ml of water; for Amoxiclav 1.2 g - 20 ml of water). The resulting solution should be administered intravenously slowly over 3-4 minutes. If the drug is administered as an intravenous infusion, then 600 mg of Amoxiclav is dissolved in 10 ml of water for injection, and then added to the infusion solution (50 ml). Amoxiclav - 1.2 g is dissolved in 20 ml of water for injection and added to 100 ml of infusion solution. Infusion is carried out intravenously for 30-40 minutes. Intravenous administration of Amoxiclav should begin no more than 20 minutes after the preparation of the solution. Freezing of Amoxiclav solution is not allowed.

Assign to children over 12 years old (or weighing 40 kg or more) and adults (intravenously) 1.2 g every 8 hours. In pediatrics, children from 3 months to 12 years old - 30 mg / kg every 8 hours. In severe cases of the disease, the drug is administered every 6 hours (for children under 3 months - 30 mg / kg every 8 hours). For children of the first days of life, including premature babies, Amoxiclav is prescribed 30 mg / kg every 12 hours. After achieving a therapeutic effect with the bolus administration of Amoxiclav, you can switch to oral administration. Amoxiclav treatment of children and adults continues for 14 days.

Application for the prevention of purulent-septic complications before surgical operations
It is prescribed before anesthesia, 1.2 g intravenously: in case of short interventions - once, for long-term (more than 60 minutes) additional administration of the solution is necessary - 1.2 g (maximum - up to 4 times a day). With a high risk of developing infectious complications, Amoxiclav continues to be administered intravenously or orally in the postoperative period, especially if there were obvious signs of an infectious process during the operation (in this case, intravenous use is continued after surgery).

With kidney failure
In case of renal insufficiency, the dose for intravenous administration of the drug is calculated based on creatinine clearance: with a clearance of 30 ml / min or more, the dosage is not adjusted; with a clearance of 10-30 ml / min, therapy begins with intravenous administration of 1.2 g, then 600 mg is prescribed every 12 hours; with a clearance of 10 ml / min or less, treatment begins with intravenous administration of 1.2 g, then 600 mg intravenously are prescribed with an interval of 24 hours. In case of renal failure in children, dose adjustment is also carried out. If the patient undergoes hemodialysis, then approximately 85% of the drug is excreted from the body. After hemodialysis, Amoxiclav is prescribed at a dosage of 600 mg intravenously. Peritoneal dialysis does not remove the drug, so dose adjustment is not needed.

Amoxiclav Quiktab
Before use, the tablets are dissolved in half a glass of water (at least 100 ml). After that, the resulting suspension is thoroughly stirred and drunk. It is also allowed to chew the tablet and drink it with water.
They are prescribed orally for children over 12 years old with a body weight of 40 kg or more, as well as for adults. The average daily dosage of the drug Amoxiclav Quiktab 500 mg / 125 mg varies within 2-3 tablets per day at regular intervals (depending on the severity of the infectious process). Amoxiclav Quiktab is best taken at the beginning of a meal.
In severe cases of the disease - 875 mg / 125 mg 2 rubles / day every 12 hours. The duration of the course of treatment depends on the indications, which is individually determined by the doctor, but should not exceed 2 weeks.

With kidney failure
The excretion of clavulanic acid and amoxicillin in renal failure is delayed, so the dosage of the drug is reduced depending on the severity of functional disorders. You can increase the interval between taking the drug. In mild renal failure with a creatinine clearance of 0.166-0.5 ml / s, Amoxiclav Quiktab is prescribed 500 mg / 125 mg (1 tablet) 2 times a day every 12 hours. With a clearance of less than 0.166 ml / s, a dose of 500 mg / 125 mg (1 tablet) is used 1 p. / Day (every 24 hours).

Side effects

Side effects are usually temporary and mild in severity.
From the digestive system: nausea (3%), diarrhea (4.1%), dyspepsia (1.6%) and vomiting (1.8%); rarely - flatulence, anorexia, gastritis, glossitis, enterocolitis, stomatitis or discoloration of the tongue. During or after discontinuation of Amoxiclav therapy, pseudomembranous colitis may develop, caused by the formation of Clostridium difficile toxins.
From the side of the skin: angioedema, rash, urticaria, rarely - erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the nervous system: rarely - agitation, anxiety, headache, dizziness, inappropriate behavior, insomnia, convulsions, confusion, hyperactivity.
From the blood system: thrombocytopenia, anemia (including cases of hemolytic anemia), leukopenia, eosinophilia, agranulocytosis.
Hepatobiliary disorders: it is possible to increase the parameters of liver function tests, including an increase in the activity (asymptomatic) of ALT and / or AST, alkaline phosphatase and serum bilirubin. Liver dysfunction usually develops in elderly patients or in patients who are prescribed long-term drug therapy. Hepatitis and cholestatic jaundice develop quite rarely. Signs and symptoms usually occur during treatment or immediately after the end of the course, but sometimes they may not appear for several weeks after the end of therapy.
From the urinary system: hematuria and interstitial nephritis (rare).
Others: vulvovaginal candidiasis (1%) and fever; taking for a long time can provoke oral candidiasis.

Contraindications

Hepatitis or cholestatic jaundice, provoked by the use of antibacterial agents of the penicillin group in history;
Individual hypersensitivity to clavulanic acid and amoxicillin, as well as other components of Amoxiclav or penicillin preparations.

Pregnancy

There is no information about the teratogenic effect of the active components of Amoxiclav, therefore, according to strict indications, the drug can be prescribed during pregnancy and lactation.

drug interaction

Amoxiclav for intravenous use is compatible with water for injection, Ringer's lactate solution, isotonic sodium chloride solution, potassium chloride solution. Amoxiclav is less stable in media that contain glucose or dextran. The drug must not be mixed with other means for parenteral administration in the same volume.

Overdose

Exceeding the dose is unlikely, however, taking Amoxiclav in a large dose can cause the following symptoms: insomnia, agitation, dizziness, and rarely, convulsions. In case of overdose, hemodialysis is possible, treatment is symptomatic.

Release form

Tablets Amoxiclav- 250 mg amoxicillin / 125 mg clavulanic acid; film-coated, 15 pieces per pack.

Tablets Amoxiclav 2X- 500 mg / 125 mg; 875 mg / 125 mg, film-coated, (pack of 10 or 14 pieces).

Amoxiclav Quiktab tablets- 500 mg / 125 mg; 875 mg/125 mg, dispersed tablets, pack of 10.

Powder for suspension for oral administration Amoxiclav- 312.5 mg / 5 ml (250 mg of amoxicillin per 5 ml of suspension / 62.5 mg of clavulanic acid per 5 ml of suspension); 156.25 mg / 5 ml (125 mg of amoxicillin per 5 ml of suspension / 31.25 mg of clavulanic acid per 5 ml of suspension) - a bottle for the preparation of 100 ml of a suspension, in a package - 1 bottle.

Amoxiclav for parenteral administration- powder for solution for injection into a vein, 600 mg in a vial (500 mg of amoxicillin and 100 mg of clavulanic acid) or 1.2 g in a vial (1000 mg of amoxicillin and 200 mg of clavulanic acid), in a package of 5 vials.

Storage conditions

In a dry place. Store at 25°C.

Nosological classification (ICD-10)

Gonococcal infection (A54)

Shankroid (A57)

Suppurative and unspecified otitis media (H66)

Acute sinusitis (J01)

Acute pharyngitis (J02)

Acute tonsillitis (J03)

Acute laryngitis and tracheitis (J04)

Bacterial pneumonia, not elsewhere classified (J15)

Acute bronchitis (J20)

Chronic rhinitis, nasopharyngitis and pharyngitis (J31)

ATH:

J01CR02

Manufacturer:

Sandoz

Additional information about the manufacturer

Country of origin - Switzerland.

Additionally

With caution, Amoxiclav is prescribed to patients with an indication of allergic reactions in the past. There is a possibility of cross-allergy between penicillins and antibiotics of the cephalosporin group, therefore Amoxiclav is prescribed with caution to those who have experienced allergic reactions to cephalosporins.
In case of violations of the functional activity of the liver, periodic monitoring of liver tests is necessary.

In 95% of patients with lymphocytic leukemia and infectious mononucleosis, the use of Amoxiclav is accompanied by the development of a skin rash, such patients are not recommended to use the drug.
In patients with severe damage to kidney function, the dosage is selected individually, an increase in the interval between injections of the drug is allowed.

When treating with the drug, it is recommended to drink plenty of water or other liquids.
Amoxiclav provokes false positive results of the Coombs test and Benedict's test (to determine the level of glucose in the urine). Therefore, it is recommended to use glucose tests that are based on an enzymatic oxidation reaction.

Authors

Attention!
Description of the drug Amoxiclav" on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult a doctor and read the annotation approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the dose and methods of its use.

Amoxiclav and Linex (bifiform), Essentiale

04.04.2018 18:27:48

Expert answer

Hello. Preparations - probiotics ("Linex", "Bifiform", etc.) should be taken together with antibiotics. The fact is that antibiotics destroy not only pathogenic microbes that caused suppuration, but, in general, all microorganisms without a choice. i.e., and those that form the normal intestinal microflora. Therefore, probiotics are prescribed, which will restore the dead microflora and prevent dysbacteriosis. At the same time, you can take sorbents ("Activated carbon", "Enterosgel", etc.), which will help cleanse the body and liver, including from decay products (toxins). It is also necessary to drink at least 2 liters of clean water per day (to prevent constipation and the fastest cleansing of the body). For the fastest restoration of normal microflora, it is also advisable to drink 1-2 glasses of freshly prepared kefir or yogurt daily at home. "Essentiale" can also be taken, this drug restores liver cells. But, it is desirable to take longer, from 2 to 6 months, 1-2 capsules 3 times a day (in this case, the more the better).

Amoxiclav is a unique antibiotic to strong drugs widely used to rid the human body of bacterial infections. The active ingredients in the composition of the drug are easily tolerated by patients, side effects are rare, so the drug is recommended for widespread use by all age categories.

The destructive effect of amoxiclav tablets is due to the clavulanic acid included in its composition. The substance helps amoxocillin not to react to the action of lactamases produced by the affected cells.

Dynamics in the body

The first component is amoxicillin, which is semi-synthetic antibiotic extended action. It actively destroys bacteria that react to the action of the drug, but does not act on those that secrete a harmful enzyme. Amoxicillin destroys the walls of bacteria, which leads to the death of pathogens.

The second constituent substance that is part of the drug is clavulanic acid, which is a beta-lactamate, similar to penicillin in chemical action. It inhibits beta-lactamases, which are resistant to penicillins and cephalosporins. Some types of gram-positive and gram-negative microorganisms produce lactamases, which leads to the destruction of amoxicillin before it has begun to act on bacteria and viruses.

Clavulanate acts as a blocker of harmful enzymes and restores sensitivity bacterial pathogens to penicillins, while significantly reducing the resistance of the drug antibiotic. The effect of the antibiotic is less pronounced for bacteria producing beta-lactamase of the first chromosomal type. Clavulanic acid is not used separately from amoxicillin, it expands the action of amoxiclav only when paired with penicillin antibiotics.

Reasons for the development of resistance

Increase in indicator occurs according to the following criteria:

The use of amoxiclav

Antibiotic treats inflammatory diseases caused by microorganisms that are sensitive to the drug:

• diseases of the ear, throat, nose of infectious origin (these include tonsillitis, otitis media, pharyngeal abscesses, pharyngitis, sinusitis, rhinitis, etc.);
• diseases of the ureters (prostatitis, cystitis) of an infectious nature;
• inflammation of the organs of the female genital area;
• lower respiratory diseases (chronic and acute bronchitis, pneumonia);
• infectious infections of bone tissue and connective cartilage;
• bacteriological inflammation of the skin and tissues;
• inflammation of the gallbladder and ducts (cholecystitis);
• odontogenic infections.

Existing contraindications for taking amoxiclav tablets

Not all patients can be treated with the drug, some diseases not suitable for antibiotic treatment:

In severe liver and kidney diseases and developing insufficiency of these organs, amoxiclav administered with caution and under medical supervision.

Concomitant side effects when taking

Amoxiclav, if it causes unpleasant effects, then they are short-lived and do not cause persistent deviations in the body:

• on the part of the circulatory system, reversible leukemia is observed, the formation of blood clots, in isolated cases, symptoms of pancytopenia and eosinophilia are observed;
• the digestive system responds with side effects in the form of nausea and vomiting, decreased appetite, diarrhea, pain in the abdomen, impaired liver function, in some cases jaundice, hepatitis, colitis occurs;
• allergic reactions cause rash, itching, urticaria, in single manifestations there is swelling, vasculitis, anaphylactic shock, pustulosis, dermatitis;
• the nervous system responds to the action of the antibiotic with dizziness, sometimes convulsive pain in the limbs, high arousal and hyperactivity, sleep disturbance and anxiety;
• on the part of the urinary system, interstitial nephritis develops, symptoms of crystalluria are observed;
• superinfection of secondary manifestation sometimes develops.

Forms of production and sale of the antibiotic amoxicillin clavunate

The usual forms of sale are presented in the form:

• tablets;
• powder for solution preparation;
• powder for injections (solution preparation).

Pills vary by the number of components contained:

• tablets 375 include 125 mg of clavulanate and 250 mg of amoxicillin;
• tablets 625 include 125 mg of clavulanate and 500 mg of amoxicillin;
• 1000 tablets include 125 mg of clavulanate and 850 mg of amoxicillin.

Powders for solution:

• powders 125 contain 125 mg of antibiotic, clavulanate - 31.2 mg;
• powders 250 contain 250 mg of antibiotic, clavulanate - 62.5 mg:
• powders 400 contain 400 mg of antibiotic, clavulanate - 57 mg.

In powders, sodium citrate, silicon dioxide, sodium saccharinate, citric acid, flavors are used as additional components. Powders are prepared according to the instructions, adding the indicated amount of liquid and bringing the mixture to the dissolution of all dry particles.

Powders for injection solution:

• preparation 500 contains 500 mg of an antibiotic produced as a sodium salt and 100 mg of clavulanic acid;
• preparation 1000 consists of an antibiotic 1000 mg and 200 mg of clavulanic acid.

A solution for intravenous administration is prepared by diluting the dry mixture in a special solution for infusion.

Pharmacological action in the body

After using the tablets inside, the active ingredients of the drug are actively absorbed from the stomach and intestines, regardless of food intake. Both components are absorbed in approximately the same period of time, the largest amount of the drug in the blood is detected after an hour after consumption.

Amoxicillin and clavulanate enter the tissues and body fluids, the first accumulates in the liver, prostate, tonsils, muscle tissue, saliva, bronchial mucus, synovial fluid. The BBB barrier is not overcome by the drug if the meninges are not subject to inflammatory processes, but the placenta does not serve as an obstacle for it, and an insignificant amount of the substance can be found in breast milk.

Amoxicillin is not fully involved in metabolic processes, but clavulanic acid is metabolized more intensively. Weak connection with blood proteins, to a small extent. From the human body, the drug is excreted by the kidneys, a very small part of the drug is removed with the contents of the intestine and lung secretions. After an hour and a half, the drug is half excreted from the body.

How to use amoxiclav?

Children under 12 years of age are not prescribed + amoxiclav. The dosage for the daily dose of clavulanate in adults is 600 mg, children take 10 mg per kilogram of body. Amoxicillin is dosed at a daily rate of 6 g for adult patients and 45 mg per kilogram of a child's body.

For parenteral administration dissolve the dry mix from a vial in a special liquid for injections:

• for 600 mg of the mixture you need 10 ml of water;
• 1.2 g of the mixture will require 20 ml of liquid.

The solution is injected intramuscularly slowly, spending about 4 minutes on a full infusion, the time of an intravenous dropper is about 40 minutes. The resulting solution is not subject to freezing.

Intensity of taking pills

In medium and light standard cases, they are prescribed every 8 hours on a tablet 375. Sometimes they change the regimen to take a tablet 500 after 12 hours. Severe forms of the course of the disease require taking one tablet 500 or 875 every 8 hours after 12 hours. The duration of admission is 6 to 15 days, this time is determined individually.

Patients suffering from odontogenic infections use the drug according to the system of 1 tablet 250 after 8 hours, or tablets 500 after 12 hours, the treatment is carried out for 5-6 days.

If the patient has a concomitant disease in the form of renal or hepatic insufficiency, then the interval between taking the tablets is increased to a day.

Use of suspension for children

For children, the drug is prescribed taking into account their weight and age. Babies up to 3 months per kilogram of body are prescribed 30 mg of medication (daily dose), which is divided into equal parts and given at the same time. Measuring spoon contains 5 ml of medicine.

After three months, the drug is prescribed at 25 mg per kilogram of body, the daily rate is divided into two doses. If the infection is not severe, then the medicine is given at 20 mg per kilogram of body, and the dose is divided into three doses.

Severe cases of infectious infection of the body require the use of a medicinal dose of 30 mg per kilogram of the child's body for two daily intervals.

Using Amoxiclav Quiktab

The tablet is dissolved in water (half a glass), thoroughly stirred and drunk. If you have to chew the medicine, then it is better to do it before eating. Children from 12 years old and adult patients accept 625 tablet several times a day, recommended 2 or 3 times. The severe course of the disease requires replacing the tablet with a stronger one (1000 mg) taken twice a day, but such treatment is not recommended for more than 14 days.

The use of amoxiclav in the treatment of certain diseases

Angina

Adults are given to drink a tablet of 325 mg three times a day. If the course of the disease is not complicated, then you can limit yourself to taking one tablet with a break of 12 hours. At the discretion of the doctor, the dose of the drug may be increased if he sees the need.

For children, treatment is prescribed in the form suspensions per spoon (5 ml), and the intervals between doses are prescribed by the doctor, while it is important for the child not to violate the sequence of the chosen therapy. The doctor can increase or decrease the rate.

Sinusitis

For the treatment of the disease, the dosage is 500 tablets three times a day. The duration of treatment depends on the condition of the patient, but the medicine must be drunk for at least 5 days.

Is there an overdose?

It can be easily avoided if you follow the norm prescribed by the doctor, this applies to adult patients and pediatric patients. In order not to take extra milligrams, you need to carefully read the instructions and learn how to dilute the solution and suspension. Unpleasant symptoms can manifest themselves if the weight of the prescribed pill is increased or the intake is carried out much more often. Main side effects when the dosage is exceeded:

• pain in the peritoneum;
• nausea and vomiting;
• diarrhea, upset stomach and intestines;
• excited state;
• convulsive pains and reflexes in the limbs (in severe cases).

If symptoms of overdose have been detected recently, then deep gastric lavage is done, then activated charcoal is prescribed depending on body weight. The patient is under the supervision of a doctor. If an overdose gives severe violations, then hemodialysis is indicated.

Mutual combination with other drugs

Unwanted Effects may occur when taking amoxiclav in combination with other drugs:

• slowing down the absorption of the drug occurs when taken simultaneously with antacids, glucosamine, aminoglycosides;
• the absorption of amoxiclav is accelerated with the combined use of ascorbic acid;
• the concentration of amoxicillin increases in the body in combination with allopurinol, phenylbutazone, diuretics, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion;
• the joint use of coagulants with amoxiclav leads to an increase in the prothrombin time, so this combination should be administered at the same time with caution;
• amoxicillin clavulanate increases the toxic effect of methotrexate;
• the drug, when used together with allopurinol, causes exanthema;
• the simultaneous use of the drug together with rifampicin makes their action mutually antagonistic and at the same time weakening the action against bacteria;
• reduce the effectiveness of amoxiclav simultaneous administration of macrolides, tetracyclines, sulfonamides and other drugs from the group of bacteriostatic antibiotics;
• the excretion of amoxicillin from the body slows down while taking probenecid, which increases its concentration in the body;
• oral contraceptives become less effective under the action of amoxiclav.

For people with infectious mononucleosis and lymphocytic leukemia, the use of amoxiclav containing amoxicillin, which causes a manifestation on the skin, is not recommended. erythematous rash.

If patients have a tendency to allergic reactions, then the drug should be prescribed carefully. In the process of taking a significant dosage of the drug, it is necessary to conduct a laboratory study of the functionality of the kidneys and liver. If violations are observed, then the norm is reduced or the intervals between doses are made longer.

To negate the side effects in the digestive tract and stomach, it is advisable to drink the drug during breakfast, lunch or dinner. False blood glucose readings may be detected when using amoxiclav in treatment.

There is no information that amoxiclav affects the work of the driver and work that requires special attention, so it can be taken without taking into account such circumstances. During treatment with the drug, you need to drink enough water. When prescribing to children, all the subtleties associated with age and body weight must be taken into account.

Amoxiclav analogs

For use in treatment, there are numerous analogues of the drug, for example, you can choose cheaper, but with the same efficiency. The price largely depends on the manufacturer. The list of medicines can be extended, but the main amoxiclav substitutes on the pharmaceutical market are:

For example, the drug Augmentin in tablets has a lower price, you can also pick up Russian manufacturers, in particular, amoxicillin.

Amoxiclav affects many types of pathogenic bacteria. The drug combines two active ingredients that exhibit antibacterial activity - amoxicillin and clavulanic acid. In the pharmacy network, the drug is available in various forms of release and dosage. How to take Amoxiclav and according to what scheme depends on the weight and age of the person, the nature of the disease and other related factors.

The action of the drug

Amoxiclav is a combined antibacterial agent of the penicillin group. It contains, in addition to amoxicillin, an inhibitor of β-lactamase. Due to this, the antibiotic Amoxiclav is more effective than its predecessors. The components of the drug act in a complex way:

• Amoxicillin disrupts protein synthesis in the cell walls of bacteria, thereby disrupting the process of division and growth, and ultimately causing death. But some microorganisms have adapted to resist the antibiotic with the help of beta-lactamase;
• Clavulanic acid inactivates the mentioned enzyme and restores the antimicrobial activity of the antibiotic. But, some strains of bacteria show resistance to Amoxiclav, even despite this.

The antibiotic has a high bioavailability and is rapidly absorbed when administered orally. It is excreted mainly in the urine. A small amount of the drug enters breast milk, so doctors often prescribe Amoxiclav during lactation.

Indications for appointment

Doctors prescribe Amoxiclav for the following diseases:

• respiratory diseases;
• ENT diseases (tonsillitis, sinusitis);
• inflammation of the urinary tract;
• conditions after surgery on the pelvic organs.

Amoxiclav is also indicated for pyoderma, inflammatory diseases of the skin and muscle tissue (helps with infected burns, wounds or bites).

Mode of application

The dosage of the drug is calculated based on the age and weight of the patient, the severity of the disease and the functional ability of the organs that excrete the drug and metabolites. Usually, adults are advised to take an antibiotic 2-3 times a day according to the scheme. The complicated course of the disease involves taking an antimicrobial agent in an amount of 1 g twice a day. The largest daily dose of medication for adults is 6 grams.

If the age of the child is more than 12 years, then the dosage is applied as for an adult. It should be borne in mind that self-medication is dangerous. The drug must be taken according to the recommendation of a specialist and following the indicated dosage. The admission scheme, designed for an adult, usually looks like this:

• 250/125 mg every 8 hours;
• 500/125 mg with an interval of 12 hours;
• 500/125 mg is prescribed for complicated course of the disease every 8 hours.

After 2-3 days of taking Amoxiclav tablets in adult patients, the severity of the symptoms of the disease decreases and the patient's condition improves. But you can not interrupt therapy, even if the sensations of the condition are completely normal. The duration of treatment for an adult should not be less than 5 days.

Application features

Eating does not affect the absorption of the drug, but in order to avoid nausea and irritation of the gastrointestinal mucosa, it is correct to take Amoxiclav at the beginning of a meal or immediately after it. The highest concentration of a substance in the blood is observed one hour after its ingestion. With prolonged treatment with the drug, the development of superinfection with bacteria and fungi resistant to the action of the antibiotic is possible, which requires its abolition and the appointment of appropriate treatment.

Tablets should be taken without chewing. If it is impossible to swallow a tablet, you can crush it and dilute it with a small amount of water. It is most convenient to use Amoxiclav in this way for the elderly. Amoxiclav for adults is allowed to be used in pediatric practice only after the child reaches 6 years of age. Preschoolers and young children should be given Amoxiclav in the form of a liquid suspension.

List of analogues of amoxiclav

According to doctors, analogues of the drug Amoxiclav produced in Switzerland (No. 15, 375 mg) - the price is from 190 rubles, are inexpensive and high-quality antibiotics:

• Oksamp - from 75 rubles;
• Augmentin - from 390 rubles;
• Ecoclave - from 175 rubles;
• Rapiclav - from 338 rubles;
• Arlet - 284 rubles.

In general, domestic counterparts are cheaper.

Contraindications and side effects

The drug Amoxiclav is well tolerated and rarely causes concomitant negative effects. As a rule, they occur if the patient exceeds the indicated dosage and regimen, or if the patient has contraindications or individual intolerance to the active components of the antibiotic. Side effects most often appear at the beginning of the intake and gradually disappear over time.

Possible side effects, which are described in the instructions for the drug Amoxiclav:

• nausea, vomiting, heartburn, bloating.
• peristalsis disorders.
• headache and disorientation.
• allergic reactions (rashes, hyperemia, itching).

In rare cases, symptoms of intoxication, sleep disturbances, pathological changes in the composition of the blood are possible. The likelihood of overdose when using large doses of the drug Amoxiclav is very low. In this case, symptomatic treatment is necessary.

Article verified
Anna Moschovis is a family doctor.

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From this medical article you can get acquainted with the drug Amoxiclav. Instructions for use will explain in which cases you can take an antibiotic, what it helps with, what are the indications for use, contraindications and side effects. The annotation presents the form of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Amoxiclav, from which you can find out if the medicine helped in the treatment of sinusitis, otitis media, tonsillitis, pharyngitis, bronchitis, pneumonia, cholecystitis, cholangitis in adults and children. The instructions list analogues of Amoxiclav, drug prices in pharmacies, as well as its use during pregnancy and breastfeeding.

Amoxiclav is a combined antibiotic.

Composition and form of release

The drug is produced in the form of tablets:

• Amoxiclav 250 mg / 125 mg.
• Amoxiclav 2X (500 mg/125 mg; 875 mg/125 mg).
• Amoxiclav Quiktab (500 mg/125 mg; 875 mg/125 mg) is available as dispersed tablets.

Also, the product is produced in the form of a powder, from which a suspension is made, the bottle contains a powder for preparing 100 ml of the product.

Produced powder for solution for intravenous injection. The bottle contains 600 mg of the product (500 mg, clavulanic acid 100 mg), 1.2 g bottles are also available (amoxicillin 1000 mg, clavulanic acid 200 mg), the package contains 5 vials.

Pharmacological properties

Amoxiclav is a combination of amoxicillin, a semi-synthetic penicillin with a wide spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor. Clavulanic acid forms a stable inactivated complex with these enzymes and provides amoxicillin resistance to the effects of beta-lactamases produced by microorganisms.

Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Amoxiclav, instructions for use confirms this, has a wide spectrum of antibacterial action.

The drug is active against strains sensitive to amoxicillin, including strains producing beta-lactamase, incl. aerobic gram-positive bacteria, aerobic gram-negative bacteria, anaerobic gram-positive bacteria, gram-negative anaerobes.

What helps Amoxiclav

Indications for use include diseases of an infectious and inflammatory nature, which develop as a result of the influence of microorganisms sensitive to this drug. The following indications for the use of Amoxiclav are determined:

• biliary tract infections (cholangitis, cholecystitis);
• odontogenic infections;
• infections of connective and bone tissues;
• infectious diseases of soft tissues, skin (including the consequences of bites);
• infectious diseases of the lower respiratory tract (pneumonia, acute and chronic bronchitis);
• gynecological diseases of an infectious nature;
• urinary tract infections (with cystitis, with prostatitis, etc.);
• infections of ENT organs, as well as infectious diseases of the upper respiratory tract (otitis media, pharyngeal abscess, sinusitis, pharyngitis, tonsillitis).

Instructions for use and dosage

Amoxiclav for adults and children over 12 years of age (or more than 40 kg of body weight):

• the usual dose in case of mild to moderate infection is 1 tablet 250 + 125 mg every 8 hours or 1 tablet 500 + 125 mg every 12 hours;
• in case of severe infection and respiratory tract infections - 1 tablet 500 + 125 mg every 8 hours or 1 table. 875 + 125 mg every 12 hours

Tablets are not prescribed for children under 12 years of age (less than 40 kg of body weight).

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg for children. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg for children.

The course of therapy is 5-14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without a second medical examination.

Dosage for renal insufficiency: for patients with moderate renal insufficiency (Cl creatinine - 10-30 ml / min), the dose is 1 table. 500 + 125 mg every 12 hours;

for patients with severe renal insufficiency (Cl creatinine less than 10 ml / min), the dose is 1 table. 500 + 125 mg every 24 hours

Dosage for odontogenic infections: 1 tab. 250 +125 mg every 8 hours or 1 tab. 500 + 125 mg every 12 hours for 5 days.

Contraindications

According to the instructions, Amoxiclav is contraindicated in the following cases:

• the presence of infectious lymphocytic leukemia or mononucleosis;
• high sensitivity of the patient to the main or additional components of the drug;
• high sensitivity to beta-lactam antibiotics, cephalosporins, penicillins;
• a history of liver dysfunction caused by the use of the drug (amoxicillin, clavulanic acid).

In addition, the use of Amoxiclav should be limited in severe renal impairment, liver failure, gastrointestinal diseases, history of pseudomembranous colitis. When taking anticoagulants, the drug must be used in the maximum permissible doses.

Side effect

• exfoliative dermatitis;
• dizziness, headache;
• convulsions (may occur in patients with impaired renal function when taking the drug in high doses);
• eosinophilia;
• thrombocytopenia;
• diarrhea;
• insomnia;
• loss of appetite;
• interstitial nephritis;
• anaphylactic shock;
• allergic vasculitis;
• nausea, vomiting;
• Stevens-Johnson syndrome;
• hemolytic anemia;
• crystalluria;
• itching, urticaria, erythematous rash;
• development of superinfection (including candidiasis);
• stomach ache;
• angioedema;
• reversible leukopenia (including neutropenia);
• sense of anxiety.

For kids

Children antibiotic Amoxiclav should be taken only after a doctor's prescription. It is important to adhere to the indicated dosage. Children under 12 years of age are usually prescribed a suspension. The dosage of Amoxiclav suspension for children depends on the severity of the disease and the diagnosis. As a rule, children under 2 years of age are prescribed a dose of 62.5 mg, at the age of 2 to 7 years - 125 mg, at the age of 7 to 12 years - 250 mg.

During pregnancy and lactation

Amoxiclav during pregnancy can be used if the expected effect outweighs the possible harm to the fetus. It is undesirable to use the drug in early pregnancy.

The 2nd trimester and 3rd trimester are more preferable, but even during this period, the dosage of Amoxiclav during pregnancy should be observed very accurately. When breastfeeding is not prescribed, since the active components of the drug penetrate into breast milk.

Interaction

Diuretics, phenylbutazone, allopurinol and non-steroidal anti-inflammatory drugs that block tubular secretion increase the concentration of the drug in the patient's body.

When Amoxiclav interacts with laxatives, antacids, aminoglycosides, glucosamine, the absorption of the drug slows down. When interacting with ascorbic acid, on the contrary, absorption increases.

Amoxiclav increases the toxicity of methotrexate. Simultaneous administration of the drug with allopurinol can lead to an increase in the incidence of exanthema. It is not recommended to take together with disulfiram.

The combined use of anticoagulants and Amoxiclav may increase the interval of prothrombosis. Interaction with rifampicin leads to a weakening of the antibacterial properties of drugs.

The effect of the drug is reduced when used together with bacteriostatic antibiotics (tetracyclines, macrolides) and sulfonamides. Probenecid reduces the excretion of the drug by increasing its serum concentration. Amoxiclav reduces the effectiveness of oral contraceptives.

special instructions

Taking Amoxiclav with meals reduces the likelihood of side effects from the gastrointestinal tract. During course therapy, it is necessary to control the functions of the liver, hematopoiesis and kidneys. Against the background of severe renal impairment, the doctor should adjust the dosing regimen or increase the interval between taking the medication.

Analogues of the drug Amoxiclav

Full analogues containing the same active substances are:

1. Arlet.
2. Amocomb.
3. Amoxiclav Quiktab.
4. Bactoclav.
5. Verclave.
6. Klamosar.
7. Liklav.
8. Medoklav.
9. Panklav.
10. Rapiclav.
11. ranclave.
12. Taromentin.
13. Flemoklav Solutab.
14. Ecoclave.

Price

In pharmacies, the price of Amoxiclav (Moscow) 250 mg + 125 mg tablets is 235 rubles. Powder for the preparation of an intravenous solution 1 g + 200 mg costs 845 rubles for 5 vials.