Product Overview
Structure
1 sustained-release film-coated tablet contains:
clarithromycin 500 mg.
Excipients:
sodium alginate,
sodium calcium alginate,
lactose monohydrate,
povidone
polysorbate 80,
silicon dioxide colloidal anhydrous,
magnesium stearate,
talc,
hypromellose,
quinoline yellow dye (E104),
titanium dioxide (E171),
propylene glycol.
pharmachologic effect
Fromilide 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
- Infections of the upper respiratory tract, 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 a duodenal ulcer (as part of combination therapy).
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.
Contraindications
- Liver failure of a severe degree.
- Hepatitis (history).
- Porfiry.
- I trimester of pregnancy.
- The period of lactation.
- Concomitant use with terfenadine, cisapride, pimozide or astemizole.
- Hypersensitivity to clarithromycin or other macrolide antibiotics.
Side effects
From the digestive system: nausea, vomiting, diarrhea (with severe and persistent diarrhea, which may be due to pseudomembranous colitis, the drug should be canceled), pain in the abdomen, stomatitis, glossitis, a transient change in taste; very rarely - 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, a sense of 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); very rarely - Stevens-Johnson syndrome.
Most patients have low-intensity side effects. In case of side effects, consult your doctor.
Interaction
Clarithromycin is metabolized in the liver, where it can inhibit the action of isoenzymes of the cytochrome P450 system. With the simultaneous use of clarithromycin with drugs metabolized by the cytochrome P450 system, the concentration of the latter can increase and cause side effects. Therefore, terfenadine, cisapride, pimozide and astemizole should not be used during clarithromycin treatment due to 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.
How to take, course of administration and dosage
Tablets should be taken with meals: swallow whole with a small amount of liquid; Do not break.
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.
Overdose
Symptoms: nausea, vomiting, diarrhea, headache, confusion.
Treatment: immediately flush the stomach. Symptomatic treatment Hemodialysis and peritoneal dialysis do not lead to a significant change in the level of clarithromycin in blood serum.
Special instructions
Caution is advised to use Fromilid Uno on the background of 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.
Release form
Film-coated sustained-release tablets
