Fromilide® UNO

Active substance: Clarithromycin
ATX Code: J01FA09
KFH: Antibiotic group of macrolides
ICD-10 codes (indications): 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 dd (Slovenia)

DRUGS FORM, COMPOSITION AND PACKAGING

The tablets of the prolonged action covered with a cover (film) yellow color, oval, biconcave, marked "U" on one side.

1 table.
clarithromycin500 mg

Excipients: sodium alginate, sodium calcium alginate, lactose monohydrate, povidone, polysorbate 80, silicon dioxide colloidal anhydrous, magnesium stearate, talc, hypromellose, dye quinoline yellow (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.

 

PHARMACHOLOGIC EFFECT

Semisynthetic antibiotic from the group of macrolides. Inhibits the synthesis of protein in a microbial cell, has bacteriostatic (mainly) and bactericidal action.

Clarithromycin is 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 (with the exception of Mycobacterium tuberculosis).

 

PHARMACOKINETICS

Suction

Clarithromycin is well absorbed from the digestive tract. Food slows down absorption, but does not significantly affect the bioavailability of clarithromycin.

Absorption of clarithromycin from prolonged-action tablets is delayed, but is equivalent to absorption from tablets of immediate action in equal doses. TMax increases. After achieving CMax the kinetics of both forms of clarithromycin (immediate tablets and prolonged action tablets) is equivalent. Css is reached by the 3 day. Bioavailability of tablets with prolonged action is lower by 30% when taken on an empty stomach, so patients should take the prolonged form of clarithromycin while eating.

Distribution

Clarithromycin easily penetrates into tissues and body fluids, where it reaches a concentration of almost 10 times the concentration in the serum.

Метаболизм

Approximately 20% of clarithromycin is immediately metabolized to 14-hydroxy-clarithromycin, which has a pronounced activity against Haemophilus influenzae.

Excretion

T1 / 2 after taking a dose 250 mg is 3-4 h; after taking a dose 500 mg is 5-7 h. From 20 to 30% clarithromycin (40% when taking a suspension) is unchanged in the urine, the rest is excreted as metabolites.

Pharmacokinetics in special clinical cases

The drug of the prolonged form is not recommended for patients with renal insufficiency of a serious degree with KK <0.5 ml / sec. Such patients can be given clarithromycin in the form of immediate-release tablets.

 

INDICATIONS

- infections of the upper respiratory tract (including tonsillopharyngitis, acute sinusitis);

- otitis media;

- infections of the lower respiratory tract;

- skin and soft tissue infections;

- infections caused by mycobacteria (including Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium mannum, Mycobacterium leprae);

- other infectious and inflammatory diseases caused by microorganisms sensitive to the preparation;

- eradication of Helicobacter pylori and a decrease in the frequency of recurrences of duodenal ulcers (in combination therapy).

 

DOSING MODE

Tablets should be taken during meals: swallow whole, squeezed a small amount of liquid; do not break it.

Adults and children over the age of 12 years prescribe by 500 mg / day (1 tab.). To treat severe infections, the daily dose is increased to 1000 mg / day (2 tab.).

The duration of treatment is usually 7-14 days.

 

SIDE EFFECT

From the digestive system: nausea, vomiting, diarrhea (with severe and persistent diarrhea, which may be a consequence of pseudomembranous colitis, the drug should be canceled), pain in the abdomen, stomatitis, glossitis, a transient change in taste sensations; very rarely - increased activity of liver enzymes, cholestatic jaundice.

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

From the cardiovascular system: very rarely - prolongation of the QT interval, ventricular arrhythmia (including ventricular paroxysmal tachycardia, flutter or fibrillation of the ventricles).

Allergic reactions: reactions of hypersensitivity (including urticaria, anaphylaxis); very rarely - Stevens-Johnson syndrome.

In most patients, adverse events are of low intensity. In case of side effects, consult a physician.

 

CONTRAINDICATIONS

Hepatic failure of severe degree;

- Hepatitis (in the anamnesis);

- porphyria;

- I trimester of pregnancy;

- lactation period;

- simultaneous application with terfenadine, cisapride, pimozide or astemizole;

- hypersensitivity to clarithromycin or other antibiotics from the macrolide group.

 

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 perceived benefit to the mother exceeds the potential risk to the fetus.

Clarithromycin excreted in breast milk, so if you need to use the drug during lactation, breastfeeding should be discontinued.

 

SPECIAL INSTRUCTIONS

In the presence of chronic liver diseases it is necessary to carry out regular monitoring of serum enzymes.

It is necessary to use with care Lemylid® uno against 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, prothrombin time should be monitored.

Attention should be paid to the possibility of cross-resistance between clarithromycin and other antibiotics from the macrolide group, as well as lincomycin and clindamycin.

In severe persistent diarrhea, which may indicate pseudomembranous colitis, discontinue taking the drug and consult a doctor.

Impact on the ability to drive vehicles and manage mechanisms

Fromromide® uno does not affect the speed of psychomotor reactions of the patient when driving or working with machinery.

 

OVERDOSE

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

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

 

DRUG INTERACTION

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 can increase and cause side effects. Therefore, terfenadine, cisapride, pimozide and astemizole should not be used during the treatment with clarithromycin because of the threat of life-threatening arrhythmias.

Periodic prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.

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

Simultaneous use of clarithromycin and ritonavir leads to a significant increase in the level of clarithromycin in the serum and a significant decrease in the level of its metabolite content in the serum.

 

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

 

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from moisture at a temperature not higher than 25 ° C. Shelf life is 2 years.