РоксиГЕКСАЛ

РоксиГЕКСАЛ – drug with antibacterial action.

Form of release and structure

РоксиГЕКСАЛ release in the form of tablets, coated: almost white or white; on 50 mg – oblong, have on both parties of a notch; on 150 mg – convex, round, on one party a notch, on another – "R 150"; on 300 mg – convex, round, on one party a notch, on another – "R 300" (on 50/150 mg: on 10 pieces in blisters, on 1-2 blisters in a cardboard pack; on 300 mg: on 7, 10 or 14 pieces in blisters, on 1 blister in a cardboard pack).

Structure of 1 tablet:

• Active agent: рокситромицин – 50, 150 or 300 mg;
• Auxiliary components: PEG 400, microcrystallic cellulose, isopropyl alcohol, titanium dioxide, magnesium stearate, a gidroksipropilmetiltsellyuloza, half-oxameasures 188, K30 povidone, the purified water.

Indications to use

РоксиГЕКСАЛ appoint for treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to action of a roksitromitsin:

• Infections of upper/lower parts of respiratory tracts (pharyngitis, tonsillitis, average otitis, sinusitis, bronchitis, pneumonia);
• Chronic prostatitis;
• Infections of soft tissues and skin (including ordinary eels);
• Infections of an urogenital path (except gonococcal infections);
• Acute gastroenterocolitis (including the caused Campylobacter jejuni);
• The chronic gastritis and ulcer of a duodenum (caused by Helicobacter pylori);
• Dontogenous infections;
• The infections caused by Chlamydia spp., Mycoplasma spp., Legionella spp.;
• Rheumatic fever (prevention);
• Other infectious diseases caused by microorganisms, sensitive to action of a roksitromitsin, at patients with the known reaction of hypersensitivity to penicillinic antibiotics.

Contraindications

• The combined use with the drugs containing ergotamine, dihydroergotamine or other Secale cornutum alkaloids;
• The combined use with the drugs containing such substances as Pimozidum, астемизол, терфенадин, цизаприд (because of probability of lengthening of a QT interval and development of arrhythmia of torsades de pointes);
• Porphyria;
• I trimester of pregnancy;
• Hypersensitivity to drug components, and also to other antibiotics macroleads.

In the II-III trimesters of pregnancy purpose of ROKSIGEKSALA is perhaps exclusive according to vital indications.

It is possible to use drug in the period of a lactation only under observation of the specialist.

Route of administration and dosage

РоксиГЕКСАЛ accept inside, washing down with liquid in enough, approximately in 15 minutes prior to meal. It is not necessary to chew tablets.

The average daily adult dose makes 300 mg (in 2 receptions by equal parts with an interval of 12 hours or once).

The mode of dosing should be adjusted in the following cases:

• Heavy abnormal liver functions: once a day on 150 mg; therapy is carried out under control of hepatic function;
• Heavy renal failure (at clearance of creatinine it is less than 0,25 ml/min.): once a day on 150 mg.

The recommended daily dose for children weighing from 40 kg makes 5-8 mg/kg (is determined by a type of the activator and weight of infectious process) in 2 receptions or 300 mg (2 times a day by 150 mg).

To children weighing up to 40 kg of ROKSIGEKSAL, as a rule, appoint in a daily dose 5-7,5 mg/kg (in 2 receptions).

The recommended dosing mode for children (a single dose with frequency rate of reception 2 times a day):

• 7-13 kg – 25 mg;
• 14-26 kg – 50 mg;
• 27-40 kg – 100 mg.

To patients of advanced age correction of the mode of dosing is not carried out.

At a simultaneous liver and renal failure it is necessary to exercise control of level of a serumal roksitromitsin and, in case of need, to adjust a dose.

Duration of therapy is defined by weight of clinical symptoms. After disappearance of symptoms of a disease treatment needs to be continued, at least, on an extent of 2 days.

Duration of treatment of streptococcal infections, uretrit, tservikovaginit, tservitsit – up to 10 days, in other cases – up to 28 days.

Side effects

At use of ROKSIGEKSALA side reactions, as a rule, develop seldom (at 3-4% of patients). In case of their emergence it is recommended to consult with the specialist. Therapy cancellation, as a rule, is not required.

Possible side reactions:

• Alimentary system: stomach aches, vomiting, nausea, diarrhea; seldom – increase in level of transaminases (alaninaminotranspherase, aspartate aminotransferase, gamma глутамилтрансферазы); very seldom – a liver failure (reversible character);
• Allergic reactions: seldom – hypersensitivity reactions (in most cases on mucous membranes and skin in the form of hypostases, an erythema, skin rash);
• Others: in isolated cases – tinnit, a headache, fervescence, increase in number of eosinophils.

Special instructions

It is necessary to consider the available cross resistance of ROKSIGEKSALA with erythromycin.

Patients with a diabetes mellitus should consider that 1 tablet corresponds less than 0,01 GU (grain unit).

When carrying out a long course or at repeated reception of ROKSIGEKSALA microorganisms or fungal infections (mycoses), steady against action of a roksitromitsin, can develop.

At a hypopotassemia, disturbances of AV of conductivity, arrhythmias or the extended QT interval drug is appointed carefully, under regular ECG control.

At development of long diarrhea or in cases of existence of suspicion of an intestinal disease (pseudomembranous colitis) ROKSIGEKSAL cancel. It is not necessary to accept the medicines braking an intestines peristaltics.

At development of heavy hypersensitivity reactions (for example, the anaphylaxis) needs to cancel immediately treatment and to hold necessary events of ambulance (reception of sympathomimetics, corticosteroids, antihistamines, if necessary – carrying out artificial ventilation of the lungs).

Because of probability of increase in level of plasma concentration on steady-state level, to patients of advanced age of ROKSIGEKSAL appoint with care (possibly carrying out correction of the mode of dosing).

Medicinal interaction

At the combined use of ROKSIGEKSALA with some medicinal means / substances development of the following effects is possible:

• Ergot alkaloids (with vasoconstrictive properties): development of an ergotism – an arterial spasm, up to development of a necrosis of extremities (the combination is contraindicated);
• Antagonists of vitamin K (the drugs promoting braking of coagulability of blood): increase in a prothrombin time;
• Terfenadin: increase in its serumal level that can lead to developing of heavy arrhythmia (the combination is not recommended);
• Theophylline: decrease in its elimination and strengthening of manifestations of side effects (it is necessary to exercise regular control of size of serumal theophylline, in particular if before purpose of ROKSIGEKSALA it made 15 mg/l or more);
• Cyclosporine: insignificant increase in its serumal level (correction of doses, as a rule, is not required);
• Tsizaprid, астемизол, Pimozidum: increase in their serumal level that can lead to development of disturbances of a cordial rhythm (the combination is not recommended);
• Digoxin and other cardiac glycosides: increase in level of their concentration in blood and increase in side reactions;
• Disopyramidum: decrease in size of its linkng with proteins that leads to increase in level of free drug in blood;
• Midazolam: increase in time of its semi-removal and size of the area under a pharmacokinetic curve (leads to strengthening and lengthening of its action).

Terms and storage conditions

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

Period of validity – 3 years.