AMOKSIKLAV KVIKTAB

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, 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, T79.3, Z29.2
When CSF: 06.01.02.04.02
Manufacturer: LEK d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Dispersible tablets light yellow in colour with brown specks, oblong, octagonal, with a fruity odor.

Excipients: flavour the tropical mix, sweet orange flavor, Aspartame, colloidal silicon dioxide, gland (III) oxide yellow (E172), talc, Hydrogenated castor oil, microcrystalline cellulose kremnijsoderzhashhaja.

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

Dispersible tablets light yellow in colour with brown specks, oblong, octagonal, with a fruity odor.

Excipients: flavour the tropical mix, sweet orange flavor, Aspartame, colloidal silicon dioxide, gland (III) oxide yellow (E172), talc, Hydrogenated castor oil, microcrystalline cellulose kremnijsoderzhashhaja.

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

Pharmacological action

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^® 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.

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. Bioavailability of amoxicillin and clavulanic acid – 90% and 70% respectively. 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 (the secret of the paranasal sinuses, joint fluid, tonsils, middle ear, pleural fluid, saliva, bronchial secretion, lungs, uterus, ovary, liver, prostate, muscle tissue, gallbladder, peritoneal fluid). Urine drug is present in high concentrations.

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 undergoes 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 is 78 m. T_1/2 clavulanic acid is 60-70 m.

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.

Testimony

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 infections;

- Gynecological infections;

- Infections of the skin and soft tissues, including human and animal bites;

-infections of the bone and connective tissue;

- Infection of the biliary tract (cholecystitis, kholangit);

- Odontogenic infections.

Dosage regimen

The drug is taken orally. The tablets dissolve half cup water (no less 30 ml) and carefully shake, drink. It is possible to take the pills in his mouth to dissolve, then swallow. To reduce the risk of side effects from the stomach medication should be taken at the beginning of the meal.

Adults and children over 12 years ((c) weighing >40 kg) at light or moderate course of infection appoint 1 tab. (625 mg) every 12 no, when heavy course of infection and respiratory infections – by 1 tab. (625 mg) every 8 or h 1 tab. (1000 mg) every 12 no.

Duration of treatment – to 14 days.

In the case of the start of treatment with Parenteral drug may continued therapy ingestion Amoxyclav tablets^® Kviktab.

In accordance with the severity of functional disorders of the kidneys reduce the dose of the drug and/or lengthen the application. At renal failure moderate (CC 10-30 ml / min) appoint 1 tab. (625 mg) every 12 no. At severe renal insufficiency (CC <10 ml / min) – by 1 tab. (625 mg) every 24 no. At anurii the interval between doses doses should be increased to 48 h or more.

Side effect

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

CNS: dizziness, headache; rarely – convulsions (may occur in patients with impaired kidney function when administered the drug in high doses).

From the hematopoietic system: rarely – reversible leukopenia (incl. neutropenia), thrombocytopenia; rarely – gemoliticheskaya anemia, reversible increase in prothrombin time (when combined with anticoagulants).

From the urinary system: rarely – interstitial nephritis, kristallurija.

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

Other: rarely – development of superinfection (incl. candidiasis).

Side effects in most cases weak and fleeting.

Contraindications

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

- Children up to age 12 years (body weight <40 kg);

-increased sensitivity to β-lactam antibiotics (incl. Group of Penicillins, cephalosporins unit);

-increased sensitivity to amoxicillin or clavulanic acid.

FROM caution shall mean patients with psevdomembranoznym colitis in history, hepatic insufficiency, severely impaired renal function, lactation.

Pregnancy and lactation

Amoksiklav^® Kviktab can be used in 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.

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 monitor the functions of the organs of Hematopoiesis, liver and kidneys.

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

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

In primenenii Amoksiklava^® Kviktab 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^® Kviktab in recommended doses on the ability to drive vehicles and management mechanisms no.

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: symptomatic, 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. Effective hemodialysis.

Drug Interactions

In an application Amoksiklava^® Kviktab 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^® Kviktab and anticoagulants increases prothrombin time. Therefore, this combination is assigned with caution.

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

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

Avoid the simultaneous application of Amoxiclav^® Kviktab with disulfiram.

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

Amoksiklav^® Kviktab should be used for a few hours before taking the bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides.

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

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

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

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