Klaritromitsin-Borimed

General characteristics. Structure:

Active ingredient: 250 mg of a klaritromitsin in 1 tablet.

Excipients: croscarmellose sodium, povidone, silicon dioxide colloid anhydrous, magnesium stearate, stearic acid, talc, cellulose microcrystallic, опадрай II (including polyvinyl alcohol, talc, a macrogoal 3350, titanium E 171 dioxide, an aluminum varnish on the basis of E 132 indigo carmine, an aluminum varnish on the basis of yellow quinolinic E 104).

Indications to use:

Treatment of the infectious and inflammatory processes caused by sensitive microorganisms including:

- infections of a lower part of respiratory tracts (bronchitis, pneumonia);

- infections of an upper part of respiratory tracts (the acute streptococcal pharyngitises, laryngitis, tonsillitis, acute and chronic sinuites caused), acute average otitis;

- infections of skin and soft tissues (a streptoderma and a staphyloderma, including a folliculitis, a furunculosis, impetigo, an erysipelatous inflammation);

- the extended or localized infections caused by Mycobacterium avium and Mycobacterium intracellulare;

- the localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii;

- in schemes of the combined eradikation of H. pylori at a peptic ulcer of a stomach and duodenum.

Route of administration and doses:

Inside on an empty stomach, to adults and children 12 years – on 250-500 mg 2 times a day are more senior. Treatment duration – 6-14 days.

At treatment of the infections caused by Mycobacterium avium, sinuites, and also the heavy infections, infections caused by Haemophilus influenzae appoint inside, 0,5-1 g 2 times a day (as much as possible – 2 g). Reception duration – 14 days, at treatment of the infections caused by Mycobacterium avium – 6 months and more.

At H.pylori eradikation as a part of a combination therapy on 250 mg 2 times a day during food within 10 days.

At patients with a chronic renal failure (clearance of creatinine – KK less than 30 ml/min. or concentration of serumal creatinine more than 3,3 mg / 100 ml) – 250 mg/days (once), at heavy infections – on 250 mg 2 times a day. The maximum duration of treatment at patients of this group – 14 days.

Features of use:

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

With care appoint against the background of the medicines which are metabolized a liver.

In case of joint appointment with warfarin or other indirect anticoagulants it is necessary to control MNO or a prothrombin ratio.

Development of cross stability between klaritromitsiny and other antibiotics from group of macroleads, and also lincomycin and clindamycin is possible.

At prolonged or repeated use of medicine development of superinfection (growth of insensitive microorganisms) is possible.

Use during pregnancy and in the period of a lactation. Use at pregnancy is possible only when the expected effect of therapy exceeds potential risk for a fruit in the absence of alternative suitable therapy. In the I trimester of pregnancy, use is possible only according to vital indications. If pregnancy occurred during treatment klaritromitsiny, it is necessary to stop immediately medicine reception, in the subsequent carefully to watch pregnancy development. For the period of treatment it is necessary to stop breastfeeding (кларитромицин and its active metabolite get into breast milk).

Side effects:

From digestive tract: taste change, nausea, vomiting, a gastralgia, diarrhea, stomatitis, a glossitis, increase in activity of hepatic transaminases, cholestatic jaundice, is rare – glossites, stomatitises, change of coloring mucous language, pancreatitis, cholestatic hepatitis, a pseudomembranous coloenteritis.

From a nervous system: headache, dizziness, uneasiness, fear, sleeplessness, "dreadful" dreams; seldom – a disorientation, hallucinations, psychosis, depersonalization, confusion of consciousness.

From sense bodys: sonitus, taste change (dysgeusia); in isolated cases – the reversible hearing loss passing after medicine cancellation (it is more often observed at elderly women).

From bodies of a hemopoiesis and system of a hemostasis: seldom – thrombocytopenia (bleedings, hemorrhages), a leukopenia, a neutropenia.

From cardiovascular system: seldom – ventricular arrhythmias at patients with the extended QT interval.

Allergic reactions: skin rash, itch, malignant exudative erythema.

Others: development of stability of microorganisms.

Interaction with other medicines:

At a concomitant use кларитромицин increases concentration in blood of the medicines which are metabolized in a liver by means of P450 cytochrome enzymes - indirect anticoagulants, carbamazepine, theophylline, an astemizol, tsizaprid, terfenadin (by 2 – 3 times), a triazolama, midazolam, cyclosporine, Disopyramidum, Phenytoinum, a rifabutin, a lovastatin, digoxin, ergot alkaloids, etc.

It is reported about exceptional cases of an acute necrosis of the skeletal muscles matching on time co-administration of a klaritromitsin and inhibitors of GMG-KOA-reduktazy – a lovastatina and a simvastatina.

There are messages on increase in a kotsentration of digoxin in plasma of the patients who received at the same time digoxin and tablets of a klaritromitsin. At such patients it is necessary to control the content of digoxin in serum to avoid digitalis intoxication.

Klaritromitsin can reduce clearance of a triazolam and strengthen its pharmacological effects with development of drowsiness and confusion of consciousness.

Simultaneous use of a klaritromitsin and ergotamine (derivative an ergot) can lead to acute ergotaminovy intoxication, with development of a heavy peripheral vasospasm and disturbance of skin sensitivity.

Co-administration to HIV-positive patients of a zidovudine orally and a klaritromitsina can lead to reduction of equilibrium concentration of the zidovudine connected with decrease in its absorption. At reception of a klaritromitsin and zidovudine at different times days (from the intrevaly not less than 4 h) this effect can be eliminated.

At co-administration of a klaritromitsin and ritonavir values of serumal concentration of a klaritromitsin increase. Dose adjustment of a klaritromitsin in these cases for patients with normal function of kidneys is not required. However at patients with KK less than 60 ml/min., a dose of a klaritromitsn should be lowered by 50%. At KK less than 30 ml/min., a dose of a klaritromitsin should be lowered by 75%. At simultaneous treatment ritonaviry it is not necessary to appoint кларитромицин in doses over 1 g/days.

Contraindications:

- hypersensitivity to antibiotics from group of macroleads;

- a heavy liver failure (an abnormal liver function of the III-IV degree on a scale of Chayld-Pyyu);

- treatment by derivatives of alkaloids of an ergot or their concomitant use;

- concomitant use of a tsizaprid, Pimozidum, astemizol and terfenadin;

- children's age up to 12 years (data on efficiency and safety are absent).

With care:

- in the I trimester of pregnancy (data on safety are absent), use is possible only according to vital indications;

- the expressed renal failures (at clearance of creatinine <30ml/mines).

Overdose:

Symptoms: dysfunction of a GIT, headache, confusion of consciousness.

Treatment: gastric lavage, symptomatic therapy.

Storage conditions:

In the place protected from light and moisture, at a temperature not over 25 ºС. A period of validity - 2 years. Medicine cannot be used after the termination of the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging; on 2 planimetric packagings in a pack from a cardboard.