FROMILID ® UNO

Active substance: Clarithromycin
ATC code: J01FA09
CCF: Antibiotic macrolides
ICD-10 codes (testimony): (A) 31.0, (A) 48.1, B 96.0, H66, J00, J01, J02, J03, J04, (J) 15.7, (J) 16.0, J20, J31, J32, (J) 35.0, J37, J42, K25, K26, L01, L02, L03, L 08.0
Manufacturer: KRKA, d. d.. (Slovenia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Tablets prolonged action, film-coated tablets (film) yellow color, oval, Lenticular, with marking «U» on one side of the.

1 tab.
clarithromycin500 mg

Auxiliary substances: sodium alginate, sodium calcium alginate, lactose monohydrate, povidone, polysorbate 80, anhydrous colloidal silica, magnesium stearate, TALC, polymer, quinoline yellow dye (E104), titanium dioxide (E171), propylene glycol.

5 PCs. — blisters (1) — packs of cardboard.
7 PCs. — blisters (1) — packs of cardboard.
7 PCs. — blisters (2) — packs of cardboard.

 

PHARMACOLOGICAL ACTION

Polusinteticeski antibiotic group macrolides. Ingibiruet fusion protein in the microbial cell, provides bacteriostatic (mainly) and bactericidal action.

Clarithromycin active against: Mycoplasma pneumoniae, Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum; Gram-positive microorganisms: Streptococcus spp., Staphylococcus spp., Listeria monocytogems, Corynebacterium spp.; gramotricationah microorganisms: Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi, Pasterella multocida, Campylobacter spp., Helicobacter pylori; some anaerobov: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus; Toxoplasma gondii and all Mycobacteria (except for Mycobacterium tuberculosis).

 

PHARMACOKINETICS

Suction

Clarithromycin is well absorbed from the digestive tract. Food slows absorption, but has no effect on the bioavailability of clarithromycin significantly.

Absorption of clarithromycin tablets prolonged action — It, but equivalent to the absorption of the tablets for immediate action in equal doses. T max increases the. After reaching C max kinetics of both forms of clarithromycin (tablets for immediate action and tablets prolonged action) is equivalent to. (C)ss is achieved by 3 the day of the. Bioavailability of tablets with prolonged action below to 30% When taken on an empty stomach, Therefore, patients should take the form of clarithromycin extended at the time of delivery.

Distribution

Clarithromycin easily penetrates the tissues and body fluids, where is the concentration of almost 10 times higher than the concentration in serum.

Metabolism

Approximately 20% == immediately metabolized into 14-hydroxy clarithromycin, with a pronounced activity against Haemophilus influenzae.

Down

T1/2 After administration of doses 250 mg is 3-4 h; After administration of doses 500 mg is 5-7 h. From 20 up to 30% == (40% When receiving a suspension) place in an unmodified form with urine, the rest of the place in the form of metabolites.

Pharmacokinetics in special clinical cases

The drug extended form is not recommended for patients with severe renal insufficiency in QC< 0.5 ml/sec. Such patients may be assigned to clarithromycin in pill form with immediate-release.

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TESTIMONY

— infection of upper respiratory tract (w. tonzillofaringit, acute sinusitis);

-otitis media;

-infections of the lower respiratory tract infection;

-infections of the skin and soft tissues;

-infection, caused by Mycobacterium (w. Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium mannum, Mycobacterium leprae);

-other infectious and inflammatory diseases, caused by susceptible to malaria infections;

Helicobacter pylori and Nelicobacter-reduction in the rate of recurrence of duodenal ulcer (in a combination therapy).

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DOSING REGIMEN

The tablets should be taken at mealtimes: swallowed whole, squeezed small amount of liquid; not a Nutcracker.

Adults and children over the age of 12 years appoint 500 mg/day (1 table.). For treatment of severe infections dose increase to 1000 mg/day (2 table.).

Duration of treatment is usually 7-14 days.

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SIDE EFFECTS

On the part of the digestive system: nausea, vomiting, diarrhea (in severe and persistent diarrhea, that may be a consequence of psevdomembranoznogo colitis, drug should be lifted), pain in the abdomen, Stomatitis, Glossitis, transient change of taste sensations; very rarely — increased activity of liver enzymes, Cholestatic jaundice.

Of the central nervous system and peripheral nervous system: headache; in some cases, — dizziness, confusion, a sense of fear, insomnia, nightmares.

From the circulatory system: very rarely — elongation QT interval, Ventricular fibrillation (w. paroxizmalnaya ventricular tachycardia, Atrial or ventricular flicker).

Allergic reactions: hypersensitivity reactions (w. urticaria, Anaphylaxis); very rarely — Stevens-Johnson Syndrome.

The majority of patients, side effects of low-intensity. In the case of side effects should consult a physician.

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CONTRAINDICATIONS

-severe liver failure;

-hepatitis (in history);

-Porphyria;

— I trimester of pregnancy;

-lactation;

-the simultaneous use of terfenadine, cizapridom, pimozidom or astemizolom;

-hypersensitivity to clarithromycin or other antibiotics from the macrolides.

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PREGNANCY AND LACTATION

Use of the drug in the first trimester of pregnancy is contraindicated. Use of the drug in II and III trimestrah pregnancy is only possible, When the intended benefits to the mother outweighs the potential risk to the fetus.

Clarithromycin is the breast milk, Therefore, if necessary, the use of the drug during lactation, breastfeeding should be discontinued.

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SPECIAL INSTRUCTIONS

If you have chronic liver disease should be regular monitoring of serum enzymes.

You should be wary of Fromilid® UNO against drugs, metaboliziruthan in the liver (It is recommended to measure their concentration in the blood).

Together with the use of warfarin or other indirect antikoagulyantami requires control of prothrombin time.

Attention should be given to the possibility of cross resistance between klaritromitinom and other antibiotics from the macrolides, and linkomitinom klindamitinom.

In severe persistent diarrhea, that may signify pseudomembranous colitis, You should stop taking the drug and consult their doctor.

Impact on the ability to drive vehicles and management mechanisms

Fromilid® UNO has no effect on the speed psychomotor reactions of the patient while driving or working with machinery.

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OVERDOSE

Symptoms: nausea, vomiting, diarrhea, headache, confusion.

Treatment: immediately wash stomach. Symptomatic treatment. Hemodialysis and peritoneal dialysis does not lead to a significant change in the level of clarithromycin in serum.

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PRESCRIBED DRUG INTERACTION

Clarithromycin is metabolized in the liver, where can inhibit the cytochrome P450 system Isoenzymes.

Together with the use of clarithromycin with drugs, those by cytochrome P450 system, recent concentrations can rise and cause side effects. Therefore, terfenadin, cisapride, pimozide, Astemizole should not be used in the treatment of clarithromycin development of life-threatening arrhythmias.

You should periodically monitor the prothrombin time in patients, receive clarithromycin simultaneously with warfarin or other oral antikoagulyantami.

The simultaneous use of clarithromycin and reduces absorption of zidovudine zidovudine.

The simultaneous use of clarithromycin and ritonavir resulted in a significant increase of clarithromycin in serum and significantly reduce the level of its metabolite in serum.

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PHARMACY PURCHASING TERMS

The drug is available by prescription.

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STORAGE CONDITIONS

The drug should be kept out of the reach of children, safe dry place at a temperature of no higher than 25° c. Shelf life — 2 of the year.

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