Amoksiklav (Pills)

Active material: Amoksiцillin, Clavulanic acid
When ATH: J01CR02
CCF: Antibiotics penicillin with a broad-spectrum beta-lactamase inhibitor
ICD-10 codes (testimony): A46, A54, A57, H66, J00, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, J47, J85, J86, J90, K05, K12, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, L30.3, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, N73.0, O08.0, O85, T14.0, T79.3, Z29.2
When CSF: 06.01.02.04.02
Manufacturer: LEK d.d. (Slovenia)

Amoksiklav – dosage form, composition and packaging

Pills, Film-coated white or nearly white, Oval, lenticular.

Excipients: colloidal silicon dioxide, krospovydon, sodium croscarmellose, magnesium stearate, talc, microcrystalline cellulose.

The composition of the coating film: gipromelloza, ethyl cellulose, diethyl phthalate, macrogol 6000, Titanium dioxide.

15 PC. – vials of dark glass (1) – packs cardboard.
20 PC. – vials of dark glass (1) – packs cardboard.
21 PC. – vials of dark glass (1) – packs cardboard.

Pills, Film-coated white or nearly white, Oval, lenticular.

Excipients: colloidal silicon dioxide, krospovydon, sodium croscarmellose, magnesium stearate, talc, microcrystalline cellulose.

The composition of the coating film: gipromelloza, ethyl cellulose, diethyl phthalate, macrogol 6000, Titanium dioxide.

15 PC. – bottles (1) – packs cardboard.
5 PC. – blisters (2) – packs cardboard.
5 PC. – blisters (3) – packs cardboard.
7 PC. – blisters (2) – packs cardboard.

Pills, Film-coated white or nearly white, oblong, lenticular, with print “AMC” on one side, with a notch and print “875” and “125” – another.

Excipients: colloidal silicon dioxide, krospovydon, sodium croscarmellose, magnesium stearate, talc, microcrystalline cellulose.

The composition of the coating film: gipromelloza, ethyl cellulose, povidone, triэtiltsitrat, Titanium dioxide, talc.

5 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (2) – packs cardboard.

Amoksiklav – pharmachologic effect

Broad-spectrum antibiotic; It contains a semisynthetic penicillin, amoxicillin and the β-lactamase inhibitor clavulanic acid. Clavulanic acid provides a stable complex with the inactivated enzymes and provides resistance to amoxicillin effects β-lactamases, produced by microorganisms.

Clavulanic acid, structurally similar β-lactam antibiotics, It has its own weak antibacterial activity.

Amoksiklav^® has a wide spectrum antibacterial action. It is active against sensitive strains to amoxicillin, including strains, продуцирующие b-лактамазы, incl. Aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except methicillin-resistant strains of), Staphylococcus epidermidis (except methicillin-resistant strains of), Staphylococcus saprophyticus, Listeria spp.; Aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; Gram anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., Gram-negative anaerobes: Bacteroides spp.

Amoksiklav – pharmacokinetics

Main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid in combination do not affect each other.

Absorption

After taking the drug inside the two components well absorbed from the digestive tract, eating does not affect the degree of suction. C_max in plasma achieved through 1 h after administration of the drug and make up (dose dependent) amoxicillin 3-12 ug / ml, for clavulanic acid – about 2 ug / ml.

Distribution

Both components are characterized by good volume distribution in body fluids and tissues (lungs, middle ear, plevralynaya and peritonealynaya zhidkosti, uterus, ovary). Amoxicillin penetrates well into the synovial fluid, liver, prostate, tonsils, muscle, gallbladder, the secret of the paranasal sinuses, spittle, bronchial secretion.

Amoxicillin and Clavulanic acid does not penetrate the BBB in the non-inflamed meninges.

Active substances penetrate the placenta and in trace concentrations excreted with breast milk. The degree of binding to plasma proteins is low.

Metabolism

Amoxicillin partially metabolized, Clavulanic acid is exposed, apparently, intensive metabolism.

Deduction

Amoxicillin appears kidneys virtually unchanged by tubular secretion and glomerular filtration rate. Clavulanic acid is eliminated by glomerular filtration, partly as metabolites. Small quantities can be derived through the intestines and lungs. T_1/2 amoxicillin and clavulanic acid is 1-1.5 no.

Pharmacokinetics in special clinical situations

In severe renal insufficiency T_1/2 increases to 7.5 h dlya amoksitsillina and 4.5 h for clavulanic acid. Both components are removed haemodialysis and minor amounts of peritoneal′nym dialysis.

Amoksiklav – Indications for use

Treatment of infectious and inflammatory diseases, caused by sensitive microorganisms:

• infections of the upper respiratory tract and ENT (incl. acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
• infections of the lower respiratory tract (incl. acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
• urinary tract infection;
• gynecological infections;
• infections of skin and soft tissue, including human and animal bites;
• Infection of bone and connective tissue;
• biliary tract infection (cholecystitis, kholangit);
• odontogyennyye infyektsii.

Amoksiklav – Dosage regimen

Adults and children over 12 years (or (c) weighing >40 kg) at light or moderate course of infection appoint 1 tab. (250 mg plus 125 mg) every 8 or h 1 tab. (500 mg plus 125 mg) every 12 no, when heavy course of infection and respiratory infections – by 1 tab. (500 mg plus 125 mg) every 8 or h 1 tab. (875 mg plus 125 mg) every 12 no.

The drug in pill form is not appointed children under 12 years (body weight <40 kg).
The maximum daily dose of clavulanic acid (in the form of potassium salt) It is for Adult – 600 mg, to children – 10 mg / kg body weight. The maximum daily dose of amoxicillin for Adult – 6 g, to children – 45 mg / kg body weight.

Course of treatment 5-14 days. Duration of treatment is determined by the attending physician. Treatment should not last more than 14 days without re-medical examination.

At odontogenic infections appoint 1 tab. (250 mg plus 125 mg) every 8 or h 1 tab. (500 mg plus 125 mg) every 12 h for 5 days.

At renal failure moderate (CC 10-30 ml / min) appoint 1 tab. (500 mg plus 125 mg) every 12 no, at severe renal insufficiency (CC <10 ml / min) – by 1 tab. (500 mg plus 125 mg) every 24 no. At anurii the interval between doses doses should be increased to 48 h or more.

Amoksiklav – Side effect

From the digestive system: There may be loss of appetite, nausea, vomiting, diarrhea; rarely – transient increase in liver enzymes (GOLD, IS), abnormal liver function; in a few cases – cholestatic jaundice, hepatitis, psevdomembranoznыy colitis.

Allergic reactions: erythematous rash, itch, hives; rarely – erythema multiforme exudative, angioedema, anaphylactic shock; in a few cases – exfoliative dermatitis, Stevens-Johnson syndrome.

Other: rarely – development of superinfection (incl. candidiasis); reversible increase in prothrombin time (when combined with anticoagulants).

Side effects in most cases poorly expressed and fleeting.

Amoksiklav – Contraindications

- An indication of a history of cholestatic jaundice or liver dysfunction, caused by the intake of amoxicillin / clavulanic acid;

- Increased sensitivity to antibiotics of penicillin;

-increased sensitivity to amoxicillin or clavulanic acid.

FROM caution prescribe the drug to patients with known hypersensitivity to cephalosporin antibiotics, with psevdomembranoznym colitis in history, hepatic failure, severe renal impairment.

Amoksiklav – Pregnancy and lactation

Amoksiklav^® You can use during pregnancy, if the expected benefit to the mother outweighs the potential risk to the fetus. Amoxicillin and Clavulanic acid in small amounts are excreted in breast milk.

Amoksiklav – Cautions

Because, that a large number of patients with Infectious Mononucleosis and Lymphocytic Leukemia, poluchavshih ampitsillin, watched the emergence of èritematoznoj skin rashes, antibiotics ampicillin group for such patients is not recommended.

In kursovom treatment should control the functions of blood, liver and kidneys.

In patients with severely impaired renal function requires adequate correction mode or increase the interval between dosing.

To reduce the risk of adverse reactions from the blood to take medication while eating.

Because Tablet combination of amoxicillin and clavulanic acid 250 mg +125 mg and 500 mg +125 mg contain the same number of clavulanic acid – 125 mg, then 2 for tablets 250 mg +125 mg are not equivalent 1 tablet 500 mg plus 125 mg.

In primenenii Amoksiklava^® lozhnopolojitelnaya reaction is possible when determining the level of glucose in the urine when using Benedict's reagent or slurry Fellinga (recommend the use of enzymatic reactions with glucose oxidase).

Effects on ability to drive vehicles and management mechanisms

Data on negative influence of Amoxiclav^® in recommended doses, on the ability to drive vehicles and management mechanisms no.

Amoksiklav – Overdose

There is no reports of deaths or life-threatening occurrence of side effects due to drug overdose.

Symptoms: abdominal pain, diarrhea, vomiting; it is also possible agitation, insomnia, dizziness; in some cases – convulsions.

Treatment: in the case of the recent dose (less 4 no) It is necessary to carry out gastric lavage and designate activated carbon to reduce intake of the drug; the patient should be under medical supervision, if necessary, symptomatic therapy. Effective hemodialysis.

Amoksiklav – Drug Interactions

In an application Amoksiklava^® with antacids, Glucosamine, laxatives, aminoglycoside slows absorption, with Ascorbic acid – increases.

Diuretic, allopurinol, phenylbutazone, NSAIDs and other drugs, block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived mainly by glomerular filtration).

In an application Amoksiklava^® anticoagulants, and there is an increase in prothrombin time. Therefore, this combination is assigned with caution.

In an application Amoxiclav^® increases the toxicity of methotrexate.

In an application Amoksiklava^® with allopourinolom increases the risk of Exanthema.

Avoid the simultaneous application of Amoxiclav^® with disulfiram.

The combination of amoxicillin with rifampicin antagonistična (Notes mutual easing antibacterial action).

Amoksiklav^® It should not be used in conjunction with bacteriostatic antibiotics (makrolidы, tetracikliny), sulfanilamidami because of the potential effectiveness of Amoxiclav^®.

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

In an application Amoxiclav^® reduces the effectiveness of oral contraceptives.

Amoksiklav – Conditions of supply of pharmacies

The drug is released under the prescription.

Amoksiklav – Conditions and terms

List B. The drug should be stored out of reach of children, dry place at temperatures no higher than 25 ° C. Shelf life – 2 year.