ORICLAR [Clarithromycin] 500 mg Film-coated tablets

ORICLAR

instructions for the medical use of the medicinal product

Tradename

Oriclar, Ориклар

International non-proprietary name or generic name

Clarithromycin, Кларитромицин

Composition

Each film-coated tablet contains:

Active substance: clarithromycin 500 mg.

Excipients: avicel 102, avicel 200, primogel, talc, magnesium stearate, PVP K-30.

Each 5 ml of suspension contains:

Active substance: clarithromycin 125 mg.

Excipients: sugar, aerosil 200, sodium benzoate, sodium citrate, anhydrous citric acid, sodium carboxymethyl cellulose, methyl paraben, propyl paraben sodium, neotame, banana flavor.

Dosage form

Tablets.

Powder for preparation of oral suspension.

Pharmacotherapeutic group

Antibiotic, macrolide.

Pharmacological properties

Pharmacodynamics

Semi-synthetic antibiotic of the macrolide group. Suppresses the synthesis of proteins in the microbial cell, interacting with the 50S ribosomal subunit of bacteria. Acts mainly bacteriostatic and bactericidal.

Active against gram-positive aerobic microorganisms - Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumonia, Listeria monocytogenes; aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Helicobacter pylori; predominantly intracellular microorganisms - Mycoplasma pneumonia, Chlamydia pneumonia (TWAR), Mycobacterium leprae, Mycobacterium kansaii, Mycobacterium chelonae, Mycobacterium fortitum, Mycobacterium avium complex (MAC) - a complex comprising Mycobacterium avium, Mycobacterium intracellulare. In vitro clarithromycin is active against most strains of the following microorganisms: aerobic gram-positive microorganisms - Streptococcus agalactiae, Streptococci (group C, F, G), Streptococcus viridans; aerobic gram-negative microorganisms - Bordetella pertussis, Pasteurella multocida, Campylobacter jejuni; anaerobic gram-positive microorganisms - Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms - Bacteroides melaninogenicus; spirochete - Borrelia burgdorferi, Treponema pallidum.

Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.

Pharmacokinetics

When taken orally, clarithromycin is well absorbed from the gastrointestinal tract. Food intake slows down absorption, but does not affect the bioavailability of the active substance.

Clarithromycin penetrates well into biological fluids and body tissues, where it reaches a concentration 10 times higher than in plasma.

Approximately 20% of clarithromycin is immediately metabolized to form the main metabolite, 14-hydroclarithromycin.

With a dose of 250 mg, T1 / 2 is 3-4 hours, with a dose of 500 mg - 5-7 hours.

It is excreted in the urine unchanged and in the form of metabolites.

Indications for use

Infectious and inflammatory diseases caused by pathogens sensitive to the drug.

• lower respiratory tract infections (including acute and chronic bronchitis, pneumonia);

• upper respiratory tract infections (including sinusitis and pharyngitis);

• infections of the skin and soft tissues;

• duodenal ulcer for H. pylori eradication (as part of complex therapy with proton pump inhibitors).

Contraindications

• hypersensitivity to antibiotics of the macrolide group;

• simultaneous appointment with ergot derivatives;

• concomitant administration of the following drugs: cisapride, pimozide, terfenadine;

• children's age up to 12 years;

• pregnancy and lactation period;

• in severe liver and kidney failure.

Method of administration and dosage

The dosage regimen and the duration of the course of treatment are determined individually, taking into account the indications, the severity of the course of the infection, the sensitivity of the pathogen.

Tablets

Inside, regardless of food intake, drinking plenty of water.

For adults and children over 12 years old, the average dose is 250 mg 2 times a day. If necessary, you can prescribe 500 mg 2 times a day. The duration of the course of treatment is 6-14 days.

For children under 12 years of age, the drug is prescribed in the form of a suspension.

In patients with renal insufficiency, with creatinine clearance less than 30 ml / min, the dose of the drug should be reduced by 2 times. The maximum duration of the course in patients of this group should be no more than 14 days.

Suspension

Inside, regardless of food intake (with milk).

The recommended daily dose of the suspension in children is 7.5 mg / kg 2 times / day.

Dosing of the drug based on the child's body weight

Body weight, kg                Dose, ml

Children weighing less than 8 kg should be treated according to their body weight.

The duration of treatment is 5-10 days, depending on the pathogen and the severity of the patient's condition.

In children with creatinine clearance less than 30 ml / min, the dose of clarithromycin should be halved.

Suspension preparation. Chilled boiled water is gradually added to the bottle with the drug to the mark, closed with a lid, shaken thoroughly until a homogeneous suspension is formed. Allow to settle for 5 minutes. Shake the finished suspension well before each use. The finished suspension is stored at room temperature and used within 14 days.

Special instructions and precautions

Cross-resistance is observed between antibiotics from the macrolide group.

Antibiotic treatment alters the normal intestinal flora, so superinfection due to resistant microorganisms may develop.

It should be borne in mind that severe persistent diarrhea may be due to the development of pseudomembranous colitis.

With simultaneous use with clarithromycin, it is recommended to control the plasma concentrations of theophylline, carbamazepine, digoxin, lovastatin, simvastatin, triazolam, midazolam, phenytoin, cyclosporine and ergot alkaloids.

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

Clarithromycin should be used with caution in patients with moderate to severe renal impairment; hepatic failure of moderate and severe degree, with ischemic heart disease, severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats / min).

There is currently insufficient data on the efficacy and safety of clarithromycin in children under 6 months of age.

Influence on the ability to drive vehicles and mechanisms

Consideration should be given to the potential development of dizziness, confusion and disorientation during the initial use of the drug, which may affect the ability to drive or operate machinery.

Application during pregnancy and during breastfeeding

Use in the first trimester of pregnancy is contraindicated.

Application in the II and III trimesters of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Interaction with other medicinal products

When taken simultaneously, it increases the concentration in the blood of drugs metabolized in the liver with the help of cytochrome P450 enzymes, indirect anticoagulants, carbamazepine, theophylline, astemizole, cisapride, terfenadine (2-3 times), triazolam, midazolam, cyclosporine, disopyramide, phenytoin, lovastatin, digoxin, ergot alkaloids.

There are reports of an increase in the concentration of digoxin in the plasma of patients who received simultaneously digoxin and clarithromycin tablets. In such patients, it is necessary to constantly monitor the serum digoxin content in order to avoid digitalis intoxication.

Clarithromycin may decrease the clearance of triazolam and thus increase its pharmacological effects with the development of drowsiness and confusion.

The simultaneous use of clarithromycin and ergotamine (ergot derivatives) can lead to acute ergotomine intoxication, manifested by severe peripheral vasospasm and perverse sensitivity.

Concomitant administration of oral zidovudine and clarithromycin tablets to HIV-infected adults may lead to a decrease in equilibrium concentrations of zidovudine. Given that clarithromycin is likely to alter the absorption of co-administered orally administered zidovudine, this interaction is largely avoided when clarithromycin and zidovudine are taken at different times of the day (at least 4 hours apart).

With the simultaneous administration of clarithromycin and ritonavir, the serum concentration of clarithromycin increases. No dose adjustment of clarithromycin is required in these cases for patients with normal renal function. However, in patients with creatinine clearance of 30 to 60 ml / min, the dose of clarithromycin should be reduced by 50%. If creatinine clearance is less than 30 ml / min, the clarithromycin dose should be reduced by 75%. With simultaneous treatment with ritonavir, clarithromycin should not be prescribed in doses exceeding 1 g / day.

Side effect

From the digestive system: nausea, vomiting, dyspepsia, diarrhea, abdominal pain, stomatitis, glossitis, oral candidiasis, pancreatitis, cholestatic jaundice, increased activity of hepatic transaminases, in rare cases, pseudomembranous enterocolitis is manifested.

From the nervous system: dizziness, fear, headache, bad dreams, insomnia, anxiety, convulsions; in rare cases - hallucinations, impaired consciousness, psychosis.

From the side of the cardiovascular system: as with other macrolides, prolongation of the QT interval, ventricular tachycardia, polymorphic ventricular tachyarrhythmia.

From the musculoskeletal system: arthralgia, myalgia.

From the senses: a feeling of tinnitus, taste disturbance, reversible hearing loss.

From the side of the blood system: in rare cases, thrombocytopenia.

Allergic reactions: itching, urticaria, angioedema, anaphylactic shock, Stevens-Johnson syndrome.

Others: the manifestation of the resistance of microorganisms.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not listed in the instructions, inform your doctor.

Overdose

Symptoms: nausea, vomiting, diarrhea, abdominal pain.

Treatment: gastric lavage, symptomatic and supportive therapy.

Hemodialysis or peritoneal dialysis is ineffective.

Storage conditions

Tablets

Store in a dry place at a temperature not exceeding 25°C.

Suspension powder

Store in a dry and dark place at a temperature not exceeding 25°C.

Store the finished suspension at a temperature not exceeding 25° C for no more than 14 days.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiration date printed on the package.

Vacation conditions

Dispensed by prescription.

Release form

Tablets

10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.

Suspension powder

1 bottle of powder for suspension preparation, measuring spoon, instructions for use in a cardboard box.