Description
Release form
Film-coated prolonged-release tablets
Packing
5 pcs.
Pharmacological action
Fromilid Uno is a semi-synthetic antibiotic from the macrolide group. It inhibits protein synthesis in a microbial cell, has a bacteriostatic (mainly) and bactericidal effect.
Indications
– Upper respiratory tract infections including: tonsillopharyngitis, acute sinusitis.
– Otitis media.
– Lower respiratory tract infections.
– 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 drug-sensitive microorganisms.
– Eradication of Helicobacter pylori and a decrease in the frequency of relapse of duodenal ulcer (as part of combination therapy).
Contraindications
– Severe hepatic failure.
– Hepatitis (history).
– Porfiry.
– I trimester of pregnancy.
– Lactation.
– Concomitant use with terfenadine, cisapride, pimozide or astemizole.
– Hypersensitivity to clarithromycin or other macrolide antibiotics.
Use during pregnancy and lactation
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 if 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 discontinued.
Special instructions
Care should be taken with Fromilid Uno against drugs metabolized by the liver (it is recommended to measure their concentration in the blood). With simultaneous use with warfarin or other indirect anticoagulants, it is necessary to control prothrombin time. Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolide antibiotics, as well as lincomycin and clindamycin. With severe persistent diarrhea, which may indicate pseudomembranous colitis, you should stop taking the drug and consult your doctor.
Composition
In 1 film-coated extended-release tablet 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.
Dosage and administration
Tablets should be taken with meals: swallow whole, do not break with a small amount of liquid. Adults and children over the age of 12 years 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 treatment is usually 7-14 days.
Side effects of the
From the digestive system: nausea, vomiting, diarrhea (with severe and persistent diarrhea that may result from pseudomembranous colitis, the drug should be canceled), abdominal pain, stomatitis, glossitis, a transient change in taste sensations is very rare – increased activity of liver enzymes, cholestatic jaundice.
From the side of the central nervous system and peripheral nervous system: headache in some cases – dizziness, confusion, fear, insomnia, nightmares.
From the cardiovascular system: very rarely – lengthening of the QT interval, ventricular arrhythmia (including ventricular paroxysmal tachycardia, flutter or ventricular fibrillation).
Allergic reactions: hypersensitivity reactions (including urticaria, anaphylaxis) are very rare – Stevens-Johnson syndrome.
Most patients have low-intensity side effects. In case of side effects, consult your doctor.
Drug Interactions
Clarithromycin is metabolized in the liver, where it can inhibit the action of isoenzymes of the P450 cytochrome system. With the simultaneous use of clarithromycin with drugs metabolized by the cytochrome P450 system, concentrations of the latter can 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. Prothrombin time should be periodically monitored in patients receiving clarithromycin concomitantly 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 level of its metabolite in serum.
Overdose
Symptoms: nausea, vomiting, diarrhea, headache, confusion.
Treatment: Wash your stomach immediately. Symptomatic treatment. Hemodialysis and peritoneal dialysis do not lead to a significant change in serum clarithromycin levels.
Storage Conditions
Store in a cool cool place.
active substance
Clarithromycin
Terms leave through pharmacies
In retseptu
Dosage form
tablet prolong.
Indications
Acne illite, Bronchitis
Possible product names
FROMILID UNO 0.5 N5 TABLE P / O PROLONG
FROMILID UNO 0.5 N5 TABLE PROLONG P / O
Fromilid Uno 500mg Tab. prolong. deyst. p / pl / rev X5 (R)
Fromilid Uno 500mg Tab. prolong. deyst. p / pl / rev X5 (R) /! Before 12.12g /
Fromilid Uno 500mg No. 5 tab
KRKA d.d. Novo mesto AO, Slovenia
