The instruction for use
of medicine for experts
Roksitromitsin of Lek / Roxitromicin Lek
A trade name
Roksitromitsin of Lek / Roxitromicin Lek
the International unlicensed
name Roksitromitsin Lekarstvennaya
the Tablet form, film coated 150 mg
One tablet contains
active agent – roksitromitsin 150 mg,
kernel: the pluronik of F-68 (polyethylene-polypropylene glycol), povidone, cellulose microcrystalline, sodium glikolit starch, prezhelatinirovanny starch, krospovidon, silicon colloidal anhydrous, magnesium stearate,
a film covering: gipromelloza, hydroxypropyl cellulose, lactose anhydrous, makrogol, titan dioxide (e 171).
White or almost white, round, biconvex tablets, film coated.
Antibiotic group, a macrolead
the Code of automatic telephone exchange J01FA06
Pharmacokinetics Roksitromitsin properties is quickly soaked up, the maximum concentration make 6 – 8 mkg/ml and are reached 2 hours later after intake of a dose of 150 mg. Roksitromitsin well gets into fabrics (lungs, tonsils, a prostate), liquids of an organism and in macrophages. It undergoes partial metabolism in a liver, the main part is removed with excrements (about 50%) in not changed look and partially in the form of metabolites, up to 12% is removed by kidneys and up to 15% – lungs. After intake of a dose of a roksitromitsin of 2.5 mg/kg its serumal concentration remain at the level above MIK within 12 and more hours.
Long elimination half-life allows to increase an interval between receptions and to reduce frequency rate of reception (1-2) within a day.
Roksitromitsin is a semi-synthetic antibiotic and belongs to group of makrolidny antibiotics.
Roksitromitsin communicates with 50s a subunit of a ribosome of bacteria, causing suppression of synthesis of cellular proteins (including a bacterial wall) and a stop of activity of bacteria.
The antibacterial range of a roksitromitsin includes many gram-positive and gram-negative microorganisms, aerobes and anaerobe bacterias. Roksitromitsin-chuvstvitelnymi pathogenic organisms are staphylococcus (including Methicillinum – resistant strains), streptococci, Corynebacterium, Bacillus cereus, Listeria monocytogenes, Neiserria gonorrhoeae, N.meningitidis, Bordatella pertussis, Helicobacter pyloridis, Gardnerella vaginalis, Branhamella (Moraxella) catarrhalis and Legionella pneumophila. The sensitivity of Haemophilus influenzae varies.
Roksitromitsin is active against the following anaerobe bacterias: Bacteroides oralis, B.melaninogenicus, B.urealyticus whereas B.fragilis is steady in relation to it. Clostridium perfringens is sensitive to a roksitromitsin whereas Clostridium difficile usually shows stability. Eubacterium, Peptococcus, Peptostreptococcus and Propionibacterium acnes are also sensitive to a roksitromitsin. Good penetration into a cell provides efficiency against Chlamidia trachomatis, Ureaplasma urealyticum, Mycoplasma pneumoniae, Rickettsio richettsii and R.conorri.
of the Infection caused by roksitromitsin-sensitive microorganisms:
– an upper respiratory tract infection (tonsillitis, pharyngitises)
– lower respiratory tract infections (an acute bronchitis, exacerbations of chronic bronchitis, pneumonia)
– infections of ENT organs (average otitis, sinusitis)
– dontogenous infections
– infections of skin and soft tissues
– Acne vulgaris (ordinary eels)
– the acute coloenteritis and system infections caused by Campilobacter jejuni
– chronic gastritis, a peptic ulcer of a stomach and 12 items k. (H. pylori)
– mycoplasmosis, legionellosis, a chlamydial infection
– infections of an urinogenital path (urogenital infections)
– other infections caused by activators, sensitive to a roksitromitsin, at patients with the known hypersensitivity to antibiotics of a penicillinic row
– whooping cough
– prevention of rheumatism
the Route of administration and doses
the Recommended dose for adults and children is more senior than 12 years (body weight over 40 kg) makes 300 mg a day: on one tablet (150 mg) each 12 hours or on 2 tablets on 150 mg – each 24 hours in 15 minutes prior to food.
For patients with a heavy liver failure the dose should be lowered: one tablet on 150 mg each 24 hours before food.
For patients with a heavy renal failure (the clearance of creatinine less than 0.25 ml / c) is recommended on 1 tablet on 150 mg each 24 hours before food).
It is not required from elderly people of dose adjustment.
The daily dose for children up to 12 years (with body weight not less than 30 kg) makes 5 – 10 mg/kg of body weight, divided into 2 receptions.
Duration of reception is defined by weight of infectious process and activity of the activator. The average duration of a course of treatment is 7-14 days.
Side effects are infrequent and only in rare instances demand therapy cancellation.
– nausea, vomiting, an abdominal distension, spasms, diarrhea or a constipation, loss of appetite
– development of superinfection, candidiasis
– is rare: skin reactions of hypersensitivity (urticaria, an itching, rash) and fervescence
– passing increase in level of liver enzymes or bilirubin, is extremely rare: a reversible abnormal liver function,
– in exclusively exceptional cases: a headache, dizziness, sonitus and tachycardia
– allergic reactions of immediate type (a Quincke’s disease, a bronchospasm, it is extremely rare – an acute anaphylaxis).
· hypersensitivity to a roksitromitsin or any other component of drug
· the first trimester of pregnancy
· a porphyria
Roksitromitsin it is not necessary to appoint Medicinal interactions along with ergotamine – the containing drugs or other alkaloids of an ergot (Secale cornutum). Ergotamine can provoke a spasm of arteries and cause heavy ischemia.
At simultaneous use with digoxin the increase in absorption of the last is possible.
Co-administration with theophylline can be followed by clinically slight increase of level of theophylline in serum. and Simultaneous use of a roksitromitsin with anticoagulants of indirect action (warfarin) can be followed by increase in a prothrombin time.
When assigning macroleads (erythromycin) with terfanidiny, tsizapridy, astemizoly increase in risk of development of disturbances from a cardiovascular system was noted, up to blinking/trembling of ventricles and other ventricular arrhythmias.
Roksitromitsin and rifampicin in a combination show synergism.
At co-administration of a roksitromitsin with Ethambutolum the efficiency against Mucobacterium avium increases.
patients Should show care when assigning a roksitromitsin with abnormal liver functions. To these patients it is appointed only according to accurate indications, it is necessary to carry out periodic control of function of a liver.
With care appoint to patients 65 years are more senior.
Pregnancy and a lactation
Roksitromitsin it is necessary to apply at pregnancy only according to accurate indications and under stringent medical control.
Roksitromitsin gets into breast milk therefore nursing mothers should appoint it only according to accurate indications.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
is not required special precautions.
Symptoms: nausea and vomiting. In rare instances injury of a liver can be observed.
Treatment: symptomatic: lavage of gastric, specific antidote does not exist.
The form of release and packing
Roksitromitsin Lek of a tablet of 150 mg, film coated, are issued in blisters on 10 tablets, together with the instruction for use in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
The PERIOD OF STORAGE
it is not necessary to use Drug after the expiry date specified on packing.
The Lek of of. Producer,
Verovshkova 57, Ljubljana, Slovenia
To develop prescription status According to the prescription