Fromilid Uno prolonged pills 500mg №7

Dosage form

Tablets of the prolonged action, film coated

Composition

In 1 pill of the prolonged action, film coated contains: Clarithromycin 500 mg.
Excipients: sodium alginate, sodium Calcium alginate, lactose monohydrate, povidone, polysorbate 80, anhydrous colloidal silicon dioxide, Magnesium stearate, talc, hypromellose, quinoline yellow dye (E104), titanium dioxide (E171), propylene glycol.

Packaging

In the blister of 7 tablets. In a carton one blister.

Mechanism of action

Fromilid Uno is a semisynthetic macrolide antibiotic. Inhibits protein synthesis in the microbial cell, has a bacteriostatic (mainly) and bactericidal effect.

Indications and usage

- Infections of the upper respiratory tract, including: tonsillofaringitis, acute sinusitis.
- Average otitis.
- Infections of the lower respiratory tract.
- Infections of the skin and soft tissues.
- Infections caused by mycobacteria, including: Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium mannum, Mycobacterium leprae.
- Other infectious and inflammatory diseases caused by susceptible microorganisms.
- Eradication of Helicobacter pylori and reduction in the frequency of recurrence of duodenal ulcer (as part of combination therapy).

Contraindications

- Hepatic failure severe.
- Hepatitis (in history).
- Porphyria.
- I trimester of pregnancy.
- Lactation period.
- Simultaneous use with terfenadine, cisapride, pimozide or astemizole.
- Hypersensitivity to clarithromycin or other macrolide antibiotics.

Pregnancy and Breastfeeding

The use of the drug in the first trimester of pregnancy is contraindicated. The use of the drug in the II and III trimesters of pregnancy is possible only in the case when the intended benefit to the mother outweighs the potential risk to the fetus. Clarithromycin is excreted in breast milk, so if you need to use the drug during lactation, breastfeeding should be stopped.

Dosage and administration

Tablets should be taken during a meal: swallow whole, washed down with a small amount of liquid; do not crush. Adults and children over the age of 12 are prescribed 500 mg / day (1 tablet). For the treatment of severe infections, the daily dose is increased to 1000 mg / day (2 tablets). The duration of the course of treatment is usually 7-14 days.

Adverse reactions

Gastrointestinal: nausea, vomiting, diarrhea (in severe and persistent diarrhea, which may be due to pseudomembranous colitis, the drug should be canceled), abdominal pain, stomatitis, glossitis, transient change in taste; very rarely - increased activity of liver enzymes, cholestatic jaundice.
Nervous system: headache; in some cases - dizziness, confusion, fear, insomnia, nightmares.
Cardiovascular: very rarely - prolongation of the QT interval, ventricular arrhythmia (including ventricular paroxysmal tachycardia, flutter or ventricular fibrillation).
Allergic reactions: hypersensitivity reactions (including urticaria, anaphylaxis); very rarely - Stevens-Johnson syndrome.
Most patients have low intensity side effects. In the event of side effects should consult a doctor.

It should be used with caution Fromilid Uno on the background of drugs metabolized by the liver (it is recommended to measure their concentration in the blood). When used simultaneously with Warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time. Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolide antibiotics, as well as Lincomycin and Clindamycin. In severe persistent diarrhea, which may indicate pseudomembranous colitis, you should stop taking the drug and consult your doctor.

Drug interactions

Clarithromycin is metabolized in the liver, where it can inhibit the action of cytochrome P450 isoenzymes. With the simultaneous use of clarithromycin with drugs metabolized by the cytochrome P450 system, the concentrations of the latter may increase and cause side effects. Therefore, terfenadine, cisapride, pimozide and astemizole should not be used during the treatment period with clarithromycin because of the threat of life-threatening arrhythmias.Prothrombin time should be periodically monitored in patients receiving clarithromycin simultaneously with warfarin or other oral anticoagulants. The simultaneous use of clarithromycin and zidovudine reduces the absorption of zidovudine. The simultaneous use of clarithromycin and ritonavir leads to a significant increase in the level of clarithromycin in serum and a significant decrease in the content of its metabolite in serum.

Overdosage

Symptoms: nausea, vomiting, diarrhea, headache, confusion.
Treatment: wash the stomach immediately. Symptomatic treatment. Hemodialysis and peritoneal dialysis do not lead to a significant change in the level of clarithromycin in serum.

Storage conditions

Store in a cool dry place.