Drives

Drives – the antibiotic belonging to group of macroleads.

Form of release and structure

Dosage form – tablets, film coated: round, from two parties convex, white, with an engraving "164" on one of the parties; on cross section – white color (in blisters on 10 таб., 1 blister in a pack cardboard).

Active agent: рокситромицин – 150 mg in 1 tablet.

Auxiliary components: K30 povidone, half-oxameasures, starch corn, talc, silicon dioxide colloid, hypro rod, magnesium stearate.

Structure of a cover: dextrose, propylene glycol, titanium dioxide, gipromelloz.

Indications to use

• respiratory infections: sinusitis, tonsillitis, acute pharyngitises, bronchitis, pneumonia (including the caused atypical activators, such as Moraxella (Branhamella) catarrhalis, Chlamydia pneumonia, Legionella pneumophila, Chlamydia psittaci), bacterial infections at chronic obstructive diseases of lungs;
• infections in odontology;
• genital infections (except for gonorrhea), including tservikovaginita and uretrita;
• infections of skin and soft tissues.

Contraindications

• simultaneous use of alkaloids of an ergot (ergotamine and dihydroergotamine), tsizaprida, colchicine;
• glyukozo-galaktozny malabsorption;
• children up to 4 years and with body weight to 40 kg;
• period of pregnancy and lactation;
• hypersensitivity to Rulid's components or other macroleads.

With care:

• heavy renal failure;
• myasthenia gravis;
• inborn lengthening of an interval of QT;
• the states promoting emergence of disturbances of a cordial rhythm (clinically significant bradycardia, not corrected hypomagnesiemia or a hypopotassemia);
• simultaneous use of drugs which can lead to development of ventricular disturbances of a rhythm;
• advanced age.

Route of administration and dosage

Drives it is necessary to accept inside before meal: to swallow of tablets entirely and to wash down with enough water.

To adults and children with body weight more than 40 kg appoint on 1 tablet 2 times a day (bucketed 12 hours). Adults can take 2 pill of 1 times a day.

To patients with a liver failure appoint on 1 tablet of 1 times a day.

Duration of treatment is defined individually depending on a type of an infection, activity of the activator and weight of a course of a disease.

Side effects

• skin and allergic reactions: skin rashes, urticaria, mnogoformny erythema, purpura, reddening, urtikariya, weakness, Quincke's disease, toxic epidermal necrolysis, Stephens-Johnson's syndrome; seldom – an acute anaphylaxis;
• from digestive tract: abdominal pains, nausea, vomiting, diarrhea (in some cases with blood); in some cases – pancreatitis, pseudomembranous colitis;
• from the central nervous system: paresthesias, headache, dizziness;
• from mentality: confusion of consciousness, hallucination;
• from respiratory system: bronchospasm;
• from sense bodys: changes of sense of smell (including anosmia) and taste (including ageusia);
• from acoustic organs: sonitus, gipoakuziya (incomplete hearing loss), temporary hearing loss;
• from a liver: increase in liver enzymes, a hepatocellular or cholestatic acute hepatitis, sometimes with development of jaundice;
• from blood and lymphatic system: thrombocytopenia, neutropenia, agranulocytosis, eosinophilia;
• others: superinfection.

Special instructions

At Rulid's appointment patients with a liver failure during treatment should control function of a liver.

At suspicion on development of pseudomembranous colitis drug should be cancelled immediately. It is impossible to accept the means braking an intestines peristaltics.

During treatment it is necessary to be careful at the driving and performance of work demanding the speed of reactions and special attention. In case of development of side effects from the central nervous system (for example, dizzinesses, confusion of consciousness, etc.) should refrain from potentially dangerous occupations.

Medicinal interaction

Simultaneous use is contraindicated:

• vasoconstrictive alkaloids of an ergot (dihydroergotamine and ergotamine): the risk of development of an ergotism and necrosis of tissues of extremities increases;
• colchicine: its side effects with potentially lethal outcome amplify;
• цизаприд: can extend an interval of QT and/or cause disturbances of a cordial rhythm (usually with development of ventricular tachycardia in the pirouette type).

Simultaneous use is not recommended:

• agonists of dopamine receptors – ergot alkaloids (such, as каберголин, Bromocriptinum, перголид, лизурид): their plasma concentration increase, strengthening of their activity and emergence of signs of overdose is possible;
• терфенадин: its serumal concentration increases that can lead to development of heavy ventricular disturbances of a rhythm (usually it is ventricular tachycardia on the pirouette type);
• астемизол, Pimozidum: can extend an interval of QT and/or cause disturbances of a cordial rhythm.

The simultaneous use demanding care:

• cyclosporine: insignificant increase in its plasma concentration is noted (it is necessary to control cyclosporine level in blood and a functional condition of kidneys);
• аторвастатин, симвастатин: the risk of strengthening of their side effects, including development of a rabdomioliz increases (drugs should be used in lower doses);
• the drugs which are preferential metabolized by means of CYP3A isoenzyme (for example, рифабутин): their system exposure can increase;
• warfarin and other anticoagulants of indirect action (for example, флуиндион, аценокумарол and Fenindionum): the prothrombin time or the international normalized relation raises (it is necessary to control these indicators);
• digoxin and other cardiac glycosides: their absorption owing to what development of glikozidny intoxication is possible (dizziness, a headache, diarrhea, nausea, vomiting, delay of cordial conductivity or development of disturbances of a cordial rhythm increases) (at simultaneous use of drugs it is necessary to control the electrocardiogram and whenever possible to define serumal concentration of cardiac glycosides);
• drugs which can cause lengthening of an interval of QT and promote development of ventricular arrhythmias (including ventricular tachycardia on the pirouette type): the antiarrhytmic drugs IA and III of a class (including дронедарон, bepridit, соталол, Amiodaronum), амисульприд, aminazine, arsenic, циамемазин, to tsitalopra, difemanit methyl sulfate, erythromycin, домперидон, дофетилид, levomepromazinum, флупентиксол, Droperidolum, a haloperidol, Fluphenazin, доласетрон, levofloxacin, галофантрин, to estsitalopra, ибутилид, quinidine, Sulpiridum, мехитазин, прукалоприд, moxifloxacin, пипамперон, мизоластин, Spheromycinum, pentamidine, сультоприд, пипотиазин, вандетаниб, сертиндол, лумефантрин, зуклопентиксол, торемифен, methadone, Vincaminum, тиаприд, Disopyramidum.

Simultaneous use which has to be taken into account:

• theophylline: slightly its plasma concentration increases;
• midazolam: its effect can amplify and be prolonged.

Terms and storage conditions

To store at a temperature up to 25 °C in the place, unavailable to children.

Period of validity – 3 years.