ARLET
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: Synthesis of (Russia)
Pharmaceutical form, composition and packaging
Pills, Film-coated white or nearly white, oblong.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 250 mg |
| Clavulanic acid (in the form of potassium salt) | 125 mg |
Excipients: povidone (polyvinylpyrrolidone), talc (magnesium hydrosilicate), starch 1500, calcium stearate (calcium stearate), colloidal silicon dioxide (aэrosyl), microcrystalline cellulose.
The composition of the shell: gipromelloza (hydroxypropylmethylcellulose), propylene glycol, Titanium dioxide, macrogol 4000 (polyethylene oxide 4000).
7 PC. – packings Valium planimetric (2) – packages (1) – packs cardboard.
14 PC. – jars of dark glass (1) – packs cardboard.
Pills, Film-coated white or nearly white, oblong.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 500 mg |
| Clavulanic acid (in the form of potassium salt) | 125 mg |
Excipients: povidone (polyvinylpyrrolidone), talc (magnesium hydrosilicate), starch 1500, calcium stearate (calcium stearate), colloidal silicon dioxide (aэrosyl), microcrystalline cellulose.
The composition of the shell: gipromelloza (hydroxypropylmethylcellulose), propylene glycol, Titanium dioxide, macrogol 4000 (polyethylene oxide 4000).
7 PC. – packings Valium planimetric (2) – packages (1) – packs cardboard.
14 PC. – jars of dark glass (1) – packs cardboard.
Pills, Film-coated white or nearly white, oblong.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 875 mg |
| Clavulanic acid (in the form of potassium salt) | 125 mg |
Excipients: povidone (polyvinylpyrrolidone), talc (magnesium hydrosilicate), starch 1500, calcium stearate (calcium stearate), colloidal silicon dioxide (aэrosyl), microcrystalline cellulose.
The composition of the shell: gipromelloza (hydroxypropylmethylcellulose), propylene glycol, Titanium dioxide, macrogol 4000 (polyethylene oxide 4000).
7 PC. – packings Valium planimetric (2) – packages (1) – packs cardboard.
14 PC. – jars of dark glass (1) – packs cardboard.
Pharmacological action
Broad-spectrum antibiotic; contains a semisynthetic penicillin amoxicillin and irreversible inhibitor of β-lactamases klavulanovuju 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.
The drug has a broad spectrum of antibacterial action.
It is active against sensitive strains to amoxicillin, including strains, продуцирующие b-лактамазы: Aerobic gram-positive bacteria – Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains of), Staphylococcus epidermidis (except methicillin-resistant strains of), Staphylococcus saprophyticus, Listeria spp., Enterococcus spp.; Aerobic gram-negative bacteria – Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Helicobacter pylori, Eikenella corrodens; anaerobic Gram-positive bacteria – Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp.; anaerobic gram-negative bacteria – Bacteroides spp.
Pharmacokinetics
Main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Absorption
After taking the drug inside the two components well absorbed from the digestive tract, eating does not affect the degree of suction. Cmax plasma levels achieved after 1 hours after drug administration and is (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 (incl. 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.
T1/2 amoxicillin and clavulanic acid – 1-1.5 no.
Pharmacokinetics in special clinical situations
In severe renal insufficiency T1/2 increases to 7.5 h dlya amoksitsillina and 4.5 h for clavulanic acid. Both components are removed haemodialysis and minor amounts of – peritoneal 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;
-infections of the bone and connective tissue;
- Infection of the biliary tract (cholecystitis, kholangit);
- Odontogenic infections.
Dosage regimen
Adults and children over 12 years (or (c) weighing more than 40 kg) at light or moderate flow infection appoint 1 tab. 250/125 mg every 8 or h 1 tab. 500/125 mg every 12 no, when severe infections and respiratory infections – by 1 tab. 500/125 mg every 8 or h 1 tab. 875/125 mg every 12 no.
Children under 12 years old with a body weight of less than 40 kg dose selected individually on the basis of the recommended dosing schemes (amoxicillin) – 45 mg / kg / day 2 receiving or 40 mg / kg / day 3 admission. Optimal dosage form drug for children from 6 to 12 years are tablets 500/125 mg at the time of appointment 2 times / day.
The maximum daily dose of clavulanic acid (in the form of potassium salt) is for adults – 600 mg, for children – 10 mg / kg body weight. The maximum daily dose of amoxicillin is for adults – 6 g, for 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. 250/125 mg every 8 or h 1 tab. 500/125 mg every 12 h for 5 days.
At renal failure moderate (CC 10-30 ml / min) appoint 1 tab. 500/125 mg every 12 no adult and 15/3.75 mg / kg body weight 2 times / day Children up to 12 years.
At severe renal insufficiency (CC less than 10 ml / min) – by 1 tab. 500/125 mg every 24 no adult, Children up to 12 years – 15/3.75 mg / kg body weight 1 time / day.
At anurii the interval between meals single doses should be increased to 48 h or more.
Adults, hemodialysis, should designate product in the dose of 1 tab. 500/125 mg or 2 tab. 250/125 mg every 24 no. To compensate for the decrease in the concentration of amoxicillin and clavulanic acid in the serum during dialysis should additionally take 1 dose of the drug during dialysis and another dose at the end of the session.
Babies, hemodialysis, should designate product in the dose of 15/3.75 mg / kg body weight 1 time / day. To compensate for the decrease in the concentration of amoxicillin and clavulanic acid in the blood during dialysis should additionally take 1 the dose of the drug to start dialysis and another dose after the dialysis session.
Side effect
From the digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely – abnormal liver function, increased ALT and AST; in a few cases – cholestatic jaundice, hepatitis, psevdomembranoznыy colitis.
CNS: dizziness, headache, Reversible hyperactivity and convulsions.
From the hematopoietic system: reversible increase in prothrombin time, leukopenia, obratimыe gemoliticheskaya anemia and agranulocytosis.
From the urinary system: interstitial nephritis, kristallurija.
Allergic reactions: itch, hives, erythematous rash; rarely – erythema multiforme exudative, angioedema, anaphylactic shock; in a few cases – exfoliative dermatitis, Stevens-Johnson syndrome.
Other: development of superinfection (incl. candidiasis).
Contraindications
- Infectious mononucleosis (incl. the appearance of the rash morbilliform);
- Children up to age 3 years;
- Increased sensitivity to antibiotics of penicillin, cephalosporins;
-increased sensitivity to amoxicillin or clavulanic acid.
FROM caution prescribe the drug in patients with severe hepatic insufficiency, gastrointestinal diseases (incl. colitis, associated with antibiotic use penitsillinov, history), chronic renal failure.
Pregnancy and lactation
Be wary drug in pregnancy and lactation (breast-feeding).
Arlette® 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, Therefore, if necessary, the appointment of the drug during the lactation period, you must decide on the termination of breastfeeding.
Cautions
Preparation is used with caution in patients with human liver, during treatment, regularly control the function of the liver.
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 meals preparation.
To reduce the risk of adverse reactions from the blood to take medication while eating.
Because the pills 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 of an equivalent 1 tablet 500 mg / 125 mg.
High concentrations of amoxicillin give lozhnopolaugitionuyu reaction when determining the glucose in the urine when using reagent Benedict or mortar Fellinga (recommend the use of enzymatic reaction with glucose).
Effects on ability to drive vehicles and management mechanisms
The drug in the recommended doses does not affect the ability to drive transport and management of complex mechanisms.
Overdose
Symptoms: abdominal pain, diarrhea, vomiting; it is also possible agitation, insomnia, dizziness; in some cases – seizures.
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.
Drug Interactions
If you are Arlette® increases the toxicity of methotrexate.
If you are Arlette® with allopourinolom increases the risk of Exanthema.
If you are Arlette® with antacids, Glucosamine, laxatives, aminoglycoside slows absorption, with Ascorbic acid – increases.
If you are Arlette® with bactericidal antibiotics (incl. aminoglikozidy, cefalosproriny, cycloserine, vancomycin, rifampicin) manifesting synergies action; with antibiotic with bacteriostatic mechanism of action (incl. makrolidы, chloramphenicol, lincosamides, tetracikliny, sulfonamides) – antagonizm.
If you are Arlette® increases the efficiency of indirect anticoagulants by suppressing intestinal microflora, reduce the synthesis of vitamin k and lowering prothrombin index. When you assign this combination should be dynamic control of blood tests.
If you are Arlette® reduces the effectiveness of oral contraceptives.
While appointing Arlette® with drugs, in the process of metabolism which formed a pair-aminobensanaya acid, etinilestradiolom increases the risk of breakthrough bleeding.
Diuretic, allopurinol, phenylbutazone, NSAIDs and other drugs, block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived mainly by glomerular filtration).
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 2 year. The drug cannot be used after the expiry date.
