2010/09/20

Amoksiklav quicktabs

Composition, structure and packing

Dispersible tablets are light yellow in color with splashes of brown, oblong, octagonal, with a fruity smell -1 pi.
amoxicillin trihydrate 574 mg, which corresponds to the contents of amoxicillin 500 mg;
clavulanate potassium 148.87 mg, which corresponds to the content of clavulanic acid 125 mg.

Excipients: tropical mix flavor, flavor sweet orange, aspartame, colloidal silicon dioxide, iron (III) oxide yellow (E172), talc, hydrogenated castor oil, microcrystalline cellulose silicon.

Dispersible tablets are light yellow in color with splashes of brown, oblong, octagonal, with a fruity smell -1 pi.
amoxicillin trihydrate 1004.5 mg, which corresponds to the contents of amoxicillin 875 mg;
clavulanate potassium 148.87 mg, which corresponds to the content of clavulanic acid 125 mg.

Excipients: tropical mix flavor, flavor sweet orange, aspartame, colloidal silicon dioxide, iron (III) oxide yellow (E172), talc, hydrogenated castor oil, microcrystalline cellulose silicon.

Clinico-pharmacological group: Antibiotic penicillin group broad-spectrum beta-lactamase inhibitor.

Pharmacological action

Broad-spectrum antibiotic, contains a semisynthetic penicillin, amoxicillin and the β-lactamase inhibitor clavulanic acid. Clavulanic acid provides a stable inactivated complex with these enzymes and provides stability to the effects of amoxicillin β-lactamase produced by microorganisms. Clavulanic acid, similar to the structure of β-lactam antibiotics, has its own weak antibacterial activity.

Amoxiclav active against amoxicillin-sensitive strains, including strains producing β-lactamases, including aerobic Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), 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-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., Gram-negative anaerobes: Bacteroides spp.

Pharmacokinetics

The 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 are well absorbed from the gastrointestinal tract, food intake does not affect the degree of suction. Bioavailability of amoxicillin and clavulanic acid - 90% and 70% respectively. Cmax plasma levels are reached 1 h after drug administration and up (depending on dose) for 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, synovial fluid, the palatine tonsils, middle ear, pleural fluid, saliva, bronchial secretion, lung, uterus, ovary, liver, prostate gland, muscle, gall bladder , peritoneal fluid). The urine drug is present in high concentrations. Amoxicillin and Clavulanic acid does not penetrate the BBB under nevospalennyh mater. The 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 subjected to intensive metabolism. Putting Amoxicillin appears kidneys virtually unchanged by tubular secretion and glomerular filtration. Clavulanic acid is obtained by glomerular filtration and partly in the form of metabolites. Smaller quantities can be displayed through the intestines and lungs. T1 / 2 of amoxicillin is 78 min. T1 / 2 clavulanic acid is 60-70 min.

Pharmacokinetics in special clinical situations

In severe renal insufficiency T1 / 2 increases to 7.5 h for amoxicillin and up to 4.5 h for clavulanic acid. Both components are removed by hemodialysis and small amounts - peritoneal dialysis.

Statement

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to the drug:
infections of the upper respiratory tract and ENT-organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
Infection of lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
urinary tract infections;
gynecological infections;
infections of skin and soft tissues, including human and animal bites;
infection of bone and connective tissue;
biliary tract infections (cholecystitis, cholangitis);
odontogenic infection.

Dosage regimen

The drug, taken orally. Tablets must be dissolved in half a glass of water (30 ml) and mix thoroughly and drink. It is possible to hold the tablet in your mouth until completely dissolved, then swallow. To reduce the risk of side effects from the gastrointestinal tract should take the drug at the beginning of the meal.

Adults and children over 12 years (c weight> 40 kg) with mild to moderate infections or appoint 1 tab. (625 mg) every 12 hours, in severe cases, infection and respiratory infections - 1 pi. (625 mg) every 8 hours or 1 tab. (1000 mg) every 12 hours

Duration of treatment - up to 14 days. In the case of treatment with parenteral administration of the drug therapy may be continued oral tablets Amoxiclav Kviktab.

In accordance with the severity of functional disorders of the kidneys should reduce the dose and / or increase the interval of application.

In renal insufficiency, moderate (CC 10-30 ml / min) appoint 1 tab. (625 mg) every 12 hours

In renal insufficiency, severe (CC <10 ml / min) - 1 tab. (625 mg) every 24 h. anuria interval between doses doses should be increased to 48 hours or more.

Side effect

On the part of the digestive system: loss of appetite, nausea, vomiting, diarrhea, rarely - increased activity of liver enzymes (ALT, AST), increased alkaline phosphatase, abnormal liver function, and in rare cases - cholestatic jaundice, hepatitis, pseudomembranous colitis.

From the side of the central nervous system: dizziness, headache, very rarely - seizures (may occur in patients with impaired renal function while taking the drug at high doses).

On the part of the hemopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia, and very rarely - hemolytic anemia, reversible increase of prothrombin time (or combined with anticoagulants).

From the urinary system: very rarely - interstitial nephritis, crystalluria. Allergic reactions: erythematous rash, itching, rash, rarely - exudative erythema multiforme, angioedema, anaphylactic shock, in rare cases - exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustullez.

Other: rarely - the development of superinfection (including candidiasis).

Side effects in most cases mild and transient.

Contraindications
indication of a history of cholestatic jaundice in or dysfunction of the liver caused by the intake of amoxicillin / clavulanic acid;
Children under 12 years (body weight <40 kg);
increased sensitivity to β-lactam antibiotics (including penicillin group, a group of cephalosporins);
hypersensitivity to amoxicillin or clavulanic acid.

Be wary prescribers for patients with pseudomembranous colitis in history, hepatic failure, severely impaired renal function, during lactation.

BeremennoAmoksiklav Kviktab can be used 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 with breast milk.

Application for violations of liver function

Precautions should use the drug in patients with hepatic insufficiency.

Application for violations of renal function

Precautions should use the drug in patients with severely impaired renal function.

Cautions

Due to the fact that a large number of patients with infectious mononucleosis and lymphocytic leukemia treated with ampicillin, observed the appearance of erythematous rash, antibiotics of ampicillin for these patients is not recommended.

During the course treatment should be monitored functions of blood, liver and kidneys.

In patients with severely impaired renal function requires adequate correction of dosing regimen or increased intervals between doses of the drug. To reduce the risk of adverse reactions from the gastrointestinal tract should take the drug during meals.

In applying Amoksiklava Kviktab possible false-positive reaction in determining the level of glucose in urine using Benedict's reagent or solution Felling (recommend the use of enzymatic reactions with glucose oxidase). Effects on ability to driving and managing data on the mechanisms of the negative impact Amoksiklava in recommended doses on the ability to drive motor vehicles and management mechanisms, no.

Overdose

Do not have reports of fatal or life-threatening side effects due to overdosing.

Symptoms: abdominal pain, diarrhea, vomiting, possibly as agitation, insomnia, dizziness, and in some cases - seizures.

Treatment: symptomatic, in the case of the recent treatment (less than 4 h) is necessary to gastric lavage and activated charcoal to appoint to reduce the absorption of the drug. The patient should be under medical supervision. Effective hemodialysis.

Drug Interactions

With simultaneous application Amoksiklava Kviktab with antacids, glucosamine, laxatives, aminoglycoside absorption is slowed down, with ascorbic acid - increases. Diuretics, allopurinol, fenilbutazon, NSAIDs and other drugs that block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived mainly by glomerular filtration).

With simultaneous application Amoksiklava Kviktab and anticoagulants there is an increase prothrombin time. Therefore, this combination is assigned with caution.

With simultaneous application Amoxiclav Kviktab enhances the toxicity of methotrexate.

With simultaneous application Amoksiklava Kviktab with allopurinol increases the risk of exanthema.

Avoid the simultaneous application of Amoksiklava Kviktab with disulfiram. The combination of amoxicillin and rifampicin antagonistic (the mutual weakening of the antibacterial action). Amoxiclav Kviktab should be applied several hours before receiving bacteriostatic antibiotics (macrolides, tetracyclines), sulphonamides. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration.

With simultaneous application Amoxiclav Kviktab reduces the effectiveness of oral contraceptives.

Terms and Conditions of storage

The drug should be stored out of reach of children, protected from moisture at temperatures below 25 ° C.

Shelf life - 2 years.