Fromilid® UNO

Active material: Clarithromycin
When ATH: J01FA09
CCF: Macrolide antibiotics
ICD-10 codes (testimony): A31.0, A48.1, B96.0, H66, J00, J01, J02, J03, J04, J15.7, J16.0, J20, J31, J32, J35.0, J37, J42, K25, K26, L01, L02, L03, L08.0
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Sustained-release tablets, coated (film) yellow color, Oval, lenticular, labeled “In” on one side.

Excipients: sodium alginate, sodium calcium alginate, lactose monohydrate, povidone, polysorbate 80, Colloidal anhydrous silica, magnesium stearate, talc, gipromelloza, quinoline yellow dye (E104), Titanium dioxide (E171), propylene glycol.

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

Pharmacological action

Semi-synthetic macrolide antibiotic. It inhibits protein synthesis in the microbial cell, bacteriostatic (primarily) 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.; Gram-negative microorganisms: Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi, Pasterella multocida, Campylobacter spp., Helicobacter pylori; Some anaerobes: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus; Toxoplasma gondii and All mycobacteria (except Mycobacterium tuberculosis).

Pharmacokinetics

Absorption

Clarithromycin is well absorbed from the gastrointestinal tract. Food slows the absorption, but does not significantly influence the bioavailability of clarithromycin.

The absorption of clarithromycin tablets prolonged action – moderation, but is equivalent to the absorption of the immediate release tablets in equal doses. T_max increases. After reaching C_max kinetics obeih form clarithromycin (immediate release tablets and sustained action tablets) equivalent. C_ss It is achieved by 3 Day. Bioavailability of tablets with prolonged effect below 30% in the fasting, therefore, patients should take the form of prolonged clarithromycin during meals.

Distribution

Clarithromycin can easily penetrate into tissues and body fluids, wherein the concentration reaches nearly 10 times the concentration in the serum.

Metabolism

About 20% clarithromycin immediately metabolized to 14-hydroxy-clarithromycin, has pronounced activity against Haemophilus influenzae.

Deduction

T_1/2 postdose 250 mg of 3-4 no; postdose 500 mg of 5-7 no. From 20 to 30% clarithromycin (40% when taking suspension) excreted unchanged in the urine, the remainder is excreted as metabolites.

Pharmacokinetics in special clinical situations

The drug prolonged form not recommended in patients with severe renal insufficiency with CC< 0.5 ml / sec. Such patients can be assigned to form clarithromycin immediate release tablets.

Testimony

- Infections of the upper respiratory tract (incl. tonzillofaringit, ostryi sinusitis);

- Otitis media;

- Infections of the lower respiratory tract;

- Infections of the skin and soft tissues;

- Infections, caused by mycobacteria (incl. Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium mannum, Mycobacterium leprae);

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

- Eradication of Helicobacter pylori and reduction of recurrence of duodenal ulcers (in a combination therapy).

Dosage regimen

Tablets should be taken during meals: swallowed whole, drinking a small amount of liquid; crush.

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

The duration of treatment is generally 7-14 days.

Side effect

From the digestive system: nausea, vomiting, diarrhea (with severe and persistent diarrhea, which may be the result of pseudomembranous colitis, the drug should be discontinued), abdominal pain, stomatitis, glossitis, transient change in taste; rarely – increase in liver enzymes, cholestatic jaundice.

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

Cardio-vascular system: rarely – QT prolongation, ventricular arrhythmia (incl. ventricular tachicardia, atrial or ventricular fibrillation).

Allergic reactions: hypersensitivity reactions (incl. hives, anaphylaxis); rarely – Stevens-Johnson syndrome.

In most patients the side effects of low intensity. In case of side effects should consult a doctor.

Contraindications

- Severe hepatic impairment;

- Hepatitis (history);

- Porphyria;

- I trimester of pregnancy;

- Lactation;

- Simultaneous use with terfenadine, cizapridom, pimozide or astemizole;

- Hypersensitivity to clarithromycin or other macrolide antibiotics.

Pregnancy and lactation

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

Clarithromycin is excreted in breast milk, therefore, if necessary, use during lactation should stop breastfeeding.

Cautions

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

It should be used with caution Fromilid^® Uno against the backdrop of preparations, metabolized by the liver (It recommended to measure their concentration in the blood).

In an application with warfarin or other indirect anticoagulants need to monitor the prothrombin time.

Attention is drawn to the possibility of cross resistance between clarithromycin and other macrolide antibiotics, and lincomycin and clindamycin.

In severe persistent diarrhea, which may indicate pseudomembranous colitis, you should stop taking the drug and consult your doctor.

Effects on ability to drive vehicles and management mechanisms

Fromilid^® Uno has no effect on the speed of psychomotor reactions of the patient when driving or operating machinery.

Overdose

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

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

Drug Interactions

Clarithromycin metaboliziruetsya in baked, which can inhibit the action of the cytochrome P450 isozymes.

With simultaneous use of clarithromycin with drugs, metabolized by the cytochrome P450, the concentration of the last may increase and cause side effects. Therefore, terfenadine, cisapride, pimozide and astemizole should not be used during treatment with clarithromycin because of the threat of life-threatening arrhythmias.

Periodically monitor the prothrombin time in patients, receiving clarithromycin concurrently with warfarin or other oral anticoagulants.

Concomitant use of clarithromycin and zidovudine reduces the absorption of zidovudine.

The simultaneous use of clarithromycin and ritonavir results in a significant increase in the levels of clarithromycin and a significant reduction of serum levels of a metabolite in serum.

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.