Clamidum - Darnitsa

General characteristics. Structure:

international and chemical names: clarythromycin; 6-o-Metileritromitsin;
main physical and chemical properties: tablets of white color, coated;
structure: 1 tablet contains a klaritromitsin (in recalculation for 100% anhydrous substance) 250 mg or 500 mg;
excipients: microcrystallic cellulose (PH 102 type), Kollidоn® 25 povidone or Plasdone® K-25, кросповидон Polyplasdone® XL-10, sodium lauryl sulfate, stearic acid, talc, magnesium stearate, сепифилм 752 white.

Pharmacological properties:

Pharmacodynamics. Klamed - an antibiotic of group of macroleads, semi-synthetic derivative erythromycin. Unlike erythromycin, change of structure of a molecule caused big bioavailability of a klaritromitsin, stability in acid medium, increased concentration in fabrics, expanded an antimicrobic range, prolonged an elimination half-life. As well as erythromycin, Klamed oppresses in a microbic cell protein synthesis, interacting with 50S in subunit of ribosomes of a microbic cell. Drug resistant to action беталактамаз microorganisms in this connection shows high activity concerning a wide range of aerobic and anaerobic gram-positive and gram-negative microorganisms. Klamed is active against the majority of strains of the following microorganisms: 
gram-positive aerobes - Staphylococcus aureus, Streptococcus agalactiae (pyogenes, viridans, pneumoniae), Listeria monocytogenes, Corynebacterium spp.; gram-negative aerobes - Haemophilus influenzae (parainfluenzae), Neisseria gonorrhoeae, Helicobacter pylori, Campylobacter jejuni, Legionella pneumophila, Moraxella catarrhalis, Bordetella pertussis; mycobacteria - Mycobacterium leprae, M. chelonae, M. fortuitum, M. cansasii, the Mycobacterium avium complex which part are M. avium and M. intracellulare; other microorganisms - Mycoplasma pneumoniae, Chlamydia pneumonіae, Chlamydia trachomatis, Ureaplasma urealyticum, Toxoplasma gondii, Borrelia burgdorferi, Gardnerella vaginalis.

Pharmacokinetics. After oral administration drug is quickly absorbed, reaching the maximum concentration in a blood plasma in 2-3 hours. Biological availability makes about 55%. After absorption drug well gets into biological liquids and body tissues where reaches the concentration, by 10 times exceeding concentration in a blood plasma. Does not get through a blood-brain barrier. 65-75% of drug contact proteins. It is metabolized by a liver with formation of the main metabolite of a 14-gidroksiklaritromitsin which has same, or on 1-2 orders smaller antimicrobic activity. However concerning Haemophilus influenzae - - 14-gidroksiklaritromitsin the klaritromitsina is several times more active than one of the main activators of respiratory infections and ENT organs. Elimination half-life (T1/2): at reception of 250 mg - 3-4 hours, 500 mg - 5-7 hours (for not changed substance 5,3 hours, for an active metabolite 7,7 hours). Out of an organism it is brought both in not changed look, and in the form of active metabolites almost in equal parts with urine and with a stake. At patients with a functional hepatic unsufficiency or kidneys of moderate severity the elimination half-life of drug increases.

Indications to use:

The infections caused by microorganisms, sensitive to drug: upper respiratory tract infections (tonsillitis, pharyngitis, acute sinusitis); lower respiratory tract infections (pneumonia, bronchitis); dontogenous infections; otitis of a middle ear; infections of skin and soft tissues; infections of urinogenital system; diphtheria; whooping cough; eels ordinary; the acute gastroenterocolitis and system infections caused by Campylobacter jejuni; stomach ulcer and a duodenum and chronic gastritis (associated with Helicobacter pylori) in a combination with other drugs; Lyme's disease; opportunistic infections at sick HIV / AIDS, other infections caused by microorganisms, sensitive to Klamed; prevention of rheumatism. 

Route of administration and doses:

To adults and children 12 years (body weight more than 40 kg) Klamed are more senior appoint 500 mg 2 times a day irrespective of meal. 
Duration of a course of treatment - 7-14 days. At streptococcal infections treatment has to be not less than 10 days, at chlamydial infections - not less than 14 days. The maximum daily dose for adult 2 g.
For treatment of the infections caused by Mycobacterium avium appoint 1 g 2 times a day. Duration of treatment can make 6 months and more. 
Drug is recommended to children up to 12 years in an average single dose of 7,5 mg/kg of body weight at the maximum daily dose of 1 g. From 5 to 11 years (body weight of 20-37 kg) appoint 250 mg 2 times a day. Up to 5 years children's dosages of a klaritromitsin are recommended.

Features of use:

Clamidum should be taken with caution the patient with disturbances of functions of a liver and/or kidneys.
At patients with a renal failure (at clearance of creatinine less than 30 ml/min.) a dose of drug should be lowered twice. The maximum duration of a course of treatment at patients of this group has to make no more than 14 days.
In the first trimester of pregnancy drug is appointed only according to absolute indications.
Data on use of drug in the period of a lactation are absent.
On indicators of laboratory tests increase in activity of transaminases in blood serum, an urea nitrogen in blood is in rare instances possible.
Administration of drug can be combined with food, milk, to accept next the heart. 

Side effects:

Nausea, vomiting, pain in epigastric area, diarrhea, tranzitorny increase in activity of hepatic transaminases, rash on skin, a headache are possible. 

Interaction with other medicines:

At co-administration of Klamed with theophylline, carbamazepine, astemizoly, alkaloids of horns, triazolamy, midazolam, cyclosporine observe increase in contents of the last in a blood plasma.
At simultaneous use of Klamed and a rifabutin, rifampicin Klamed's concentration in blood serum decreases.
Simultaneous use of Klamed with a zidovudine reduces absorption of the last, results in its lower maximum concentration: between use of drugs it is necessary to do an interval not less than 4 hours.
Clamidum at simultaneous use strengthens effect of warfarin. Control of a prothrombin time is necessary.
Simultaneous use of Klamed and terfenadin led to increase by 2-3 times of concentration of an acid metabolite of a terfenadin in blood serum. It is necessary to avoid simultaneous use of these drugs. 
At Klamed's reception along with digoxin increase in concentration of digoxin in blood serum was noted, in such cases it is necessary to control the level of the last.

Contraindications:

Clamidum is contraindicated to patients, with hypersensitivity to macroleads.

Overdose:

Symptoms: at overdose there can be nausea, vomiting, diarrhea.
Treatment: a bystry gastric lavage and to appoint symptomatic therapy.

Storage conditions:

Store in dry, protected from light and the place, unavailable to children, at a temperature from 15 °C to 25 °C.

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging.