Clarithromycin-Protekh - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose, hydroxypropyl methylcellulose, sodium starch glycolate, corn starch, gelatin, stearic acid, silicone dioxide, magnesium stearate, purified talc, sodium lauryl sulfate, polysorbate 80, propylene glycol, titanium dioxide, purified water.

Description:

Oval, coated tablets, white.

Pharmacotherapeutic group:Antibiotic-macrolide

ATX: & nbsp

J.01.F.A.09 Clarithromycin

Pharmacodynamics:

Bacteriostatic macrolide antibiotic is a second-generation macrolide wide spectrum of action. Disrupts the synthesis of the protein of microorganisms (binds to 50S subunit of the ribosome membrane of a microbial cell). Active in relation to: Streptococcus agalactiae (Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae), Haemophilus influenzae (parainfluenzae), Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitides, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Helicobacter (Campylobacter) pylori, Campylobacter jejuni, Chlamydia pneumoniae (trachomatis), Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Propionibacterium acnes, Mycobacterium avium, Mycobacterium leprae, Staphylococcus aureus, Ureaplasma urealyticum, Toxoplasma gondii, Corynebacterium spp., Borrelia burgdorferi, Pasteurella multocida, some anaerobes (Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus) and all mycobacteria, except M.tuberculosis.

Pharmacokinetics:

Clarithromycin is rapidly and actively absorbed when ingested, its bioavailability is approximately 50%. The drug and its stable metabolite are not cumulative. The intake of food immediately before the administration of the drug slightly slows the onset of absorption of clarithromycin, but does not affect its bioavailability and the formation of the active metabolite of 14-hydroxyclarithromycin. In this way, clarithromycin can be administered without communication with food intake.

When prescribing the drug 2 times a day for 250 mg, the maximum equilibrium concentration (FROM_m_a_x) clarithromycin in plasma was achieved after 2-3 days and averaged 1 μg / ml for clarithromycin and 0.6 μg / ml for 14-hydroxycarithromycin, while the half-lives of the starting compound and its metabolite were 3-4 and 5-6 hours, respectively.

After the administration of higher doses of clarithromycin, a further increase in C_ma_x and the duration of the half-life, which indicates a nonlinear character of the pharmacokinetics of clarithromycin.

Clarithromycin and its 14-hydroxymetabolite are quickly distributed across all tissues and body fluids.After oral administration, the concentration of clarithromycin in tissues (especially in the lungs) is several times higher than in plasma.

Clarithromycin is excreted from the body mainly with urine (40% of the administered dose) and with feces (40% of the administered dose).

Indications:

Clarithromycin is indicated for the treatment of infectious diseases caused by susceptible microorganisms.

These diseases include:

- Infections of the lower respiratory tract (bronchitis, pneumonia);

- infections of the upper respiratory tract (pharyngitis, sinusitis), otitis media;

- infections of the skin and soft tissues (folliculitis, erysipelas);

- common or localized mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii;

- clarithromycin is indicated for elimination N.pylori and a decrease in the frequency of recurrences of duodenal ulcers.

Contraindications:

Clarithromycin is contraindicated in patients with hypersensitivity to antibiotics from the macrolide group.

When treating clarithromycin, do not prescribe ergot derivatives.

When treating clarithromycin, it is forbidden to take cisapride, pimozide, astemizole and terfenadine (see also section Interaction with other medicinal products).

In patients taking these drugs concomitantly with clarithromycin, there is an increase in their concentration in the blood. It is possible to extend the interval QT and the development of cardiac arrhythmias, including ventricular paroxysmal tachycardia, ventricular fibrillation, and fluttering-fibrillation of the ventricles.

Severe violations of the liver and / or kidney function.

Pregnancy and lactation:

The safety of clarithromycin during pregnancy and lactation has not been established. Therefore, during pregnancy clarithromycin appoint only if there is no alternative therapy if the intended benefit exceeds the possible risk to the fetus.

Clarithromycin penetrates into the female milk, so its use in nursing mothers should be conducted with caution.

Dosing and Administration:

For of adults the average dose for oral administration is 250 mg 2 times / day. If necessary, you can assign to 500 mg 2 times / day. The duration of the course of treatment is 6-14 days.

Children the drug is prescribed in a dose of 7.5 mg / kg body weight / day. The maximum daily dose is 500 mg. The duration of the course of treatment is 7-10 days.

For treatment infections caused by Mycobacterium avium, Clarithromycin Assign inside - 1 g 2 times / day. The duration of treatment can be 6 months or more.

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

Side effects:

The most frequent complaints are from the gastrointestinal tract (nausea, dyspepsia, abdominal pain, vomiting and diarrhea). There are reports of the development of pseudomembranous colitis from medium to life threatening. Other adverse reactions include headaches, taste disorders and transient increases in liver enzyme activity.

There are reports of rare cases of development of paresthesia.

There are reports of rare cases of hepatitis with an increase in the level of liver enzymes in the blood and the development of cholestasis and jaundice. These liver damage in some cases were severe and, as a rule, reversible. In exceptional cases, hepatic insufficiency was observed with a fatal outcome.

There are reports of rare cases of an increase in serum creatinine, the development of interstitial nephritis, the development of renal failure.

When taking clarithromycin orally, allergic reactions were observed, the intensity of which varied from hives and skin rashes, to anaphylaxis and Stevens-Johnson syndrome.

There are reports of hearing loss during the treatment with clarithromycin, which in most cases was restored after the drug was discontinued. Also reported changes in the perception of taste, usually arising with the violation of taste. There are reports of the development of glossitis, stomatitis, candidiasis of the oral mucosa and a change in the color of the tongue during the treatment with clarithromycin. It is also reported on the change in the color of teeth in those who received clarithromycin patients. Changing the color of the teeth in most cases was reversible.

In rare cases, hypoglycemia was noted; in a number of these cases, hypoglycemia developed in patients taking hypoglycemic agents for oral intake or insulin during the treatment with clarithromycin.

Individual cases of thrombocytopenia and leukopenia have been reported.

When taking clarithromycin, transient side effects on the central nervous system were observed: dizziness, anxiety, fear, fear, insomnia, nightmares, tinnitus,confusion, disorientation, hallucinations, psychosis and depersonalization.

In the treatment with clarithromycin, as with other macrolides, the lengthening of the interval QT, ventricular arrhythmia, including ventricular paroxysmal tachycardia and flutter-fibrillation of the ventricles.

Overdose:

Probably the development of symptoms from the gastrointestinal tract (nausea, vomiting, diarrhea); headache, confusion.

In case of an overdose, immediate gastric lavage and symptomatic treatment are necessary. Hemodialysis and peritoneal dialysis does not lead to a significant change in the level of clarithromycin in the blood serum.

Interaction:

With simultaneous intake increases the concentration in the blood of drugs metabolized in the liver with the help of cytochrome P450 enzymes, - ndirect anticoagulants, carbamazepine, theophylline, astemizole, cisapride, terfenadine (2-3 times), triazolam, midazolam, cyclosporine, disopyramide, phenytoin, rifabutin, lovastatin, digoxin, ergot alkaloids and etc.

It is reported that rare cases of acute necrosis of skeletal muscles,concurrent with the simultaneous administration of clarithromycin and inhibitors of hydroxymethylglutaryl-CoA reductase-lovastatin and simvastatin.

There are reports of increased concentrations digoxin in the plasma of patients receiving 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 reduce clearance triazolam and thus increase its pharmacological effects with the development of drowsiness and confusion.

Simultaneous use of clarithromycin and ergotamine (ergot derivatives) can lead to acute ergotminic intoxication, manifested by severe peripheral vasospasm and perverted sensitivity.

Simultaneous administration of HIV-infected adults zidovudine oral and tablets of clarithromycin may lead to a decrease in equilibrium concentrations of zidovudine. Given the fact that clarithromycin, probably, changes the absorption of an orally administered zidovudine,This interaction is largely avoided with the use of clarithromycin and zidovudine at various times of the day.

With the simultaneous administration of clarithromycin and ritonavir the serum concentration of clarithromycin increases. Correction of the dose of clarithromycin in these cases is not required for patients with normal renal function. However, in patients with creatinine clearance from 30 to 60 ml / min, the dose of clarithromycin should be reduced by 50%. When creatinine clearance is less than 30 ml / min, the dose of clarithromycin should be reduced by 75%. With simultaneous treatment with ritonavir should not be prescribed clarithromycin in doses over 1 g / day.

Special instructions:

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

Caution is prescribed against the background of drugs metabolized by the liver (it is recommended to measure their concentration in the blood).

In the case of co-administration with warfarin or other indirect anticoagulants, prothrombin time should be monitored.

With heart disease in the anamnesis, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

It is necessary to pay attention to the possibility of cross-resistance between clarithromycin and other antibiotics from the macrolide group, as well as lincomycin and clindamycin.

With prolonged or repeated use of the drug, it is possible to develop superinfection (growth of insensitive bacteria and fungi).

Form release / dosage:

The tablets covered with a cover, on 250 mg.

Packaging:

10 tablets in a blister pack.

1, 10 blisters in a cardboard box with instructions.

Storage conditions:

In a dry place protected from light, at a temperature not exceeding 30 FROM.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015055 / 01

Date of registration:01.07.2009

Expiration Date:Unlimited

The owner of the registration certificate:Protek Biosystems Pvt. Ltd.Protek Biosystems Pvt. Ltd. India

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Representation: & nbspProtekh Biosystems Pvt.LtdProtekh Biosystems Pvt.LtdRussia

Information update date: & nbsp24.01.2018

Illustrated instructions

Instructions

Clarithromycin-Protek (Clarithromycin-Protech)