Сумамед®

General characteristics. Structure:

One capsule contains active agent of azithromycin (in the form of a dihydrate) – 250 mg and auxiliary components: cellulose microcrystallic, sodium lauryl sulfate, magnesium stearate.

One tablet, coated contains active agent of azithromycin (in the form of a dihydrate) - 125 mg or 500 mg and auxiliary components: a kernel – calcium phosphate disubstituted anhydrous, a gipromelloza, starch corn, starch prezhelatinizirovanny, cellulose microcrystallic, sodium lauryl sulfate, magnesium stearate and a cover – a gipromelloza, dye similar Indigotin (E132), polysorbate 80, titanium dioxide (E171), talc.

Powder for preparation of suspension for intake of 100 mg / 5 ml: contains in 1 g of active agent of azithromycin (in the form of a dihydrate) – 27,17 mg and auxiliary components: sucrose, sodium carbonate anhydrous, Natrium benzoicum, tragacanth gum, titanium dioxide, glycine, silicon dioxide colloid, aroma of strawberry, aroma of apple and aroma of a peppermint.

Description:

Capsules – firm, gelatinous, opaque, No. in size 1. Color of the case – blue, a cover – blue. Capsule contents: powder from white till light yellow color.

Tablets: tablets of blue color, round (125 mg) or oblong shape (500 mg) with biconvex surfaces and the designation "PLIVA" on one and "125" or "500" - on other party. A look in a break – from white till almost white color.

Powder for preparation of suspension for intake of 100 mg / 5мл – the granulated powder of white or light yellow color with a characteristic smell of strawberry. After dissolution in water - homogeneous suspension of white or light yellow color with a characteristic smell of strawberry.

Pharmacological properties:

Bacteriostatic antibiotic of a broad spectrum of activity from group of macroleads azaleads. The mechanism of effect of azithromycin is connected with suppression of synthesis of protein of a microbic cell. Contacting ribosome 50S-subunit, oppresses to a peptidtranslokaz at a stage of broadcasting and suppresses protein synthesis, slowing down growth and reproduction of bacteria. In high concentration has bactericidal effect.

Has activity concerning a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.

 Microorganisms can be initial steady against action of an antibiotic or can gain resistance to it.

 In most cases sensitive microorganisms

 1. Gram-positive aerobes

 Staphylococcus aureus is metitsillinochuvstvitelny; Streptococcus pneumoniae is penitsillinochuvstvitelny; Streptococcus pyogenes

 2. Gram-negative aerobes

 Haemophilus influenzae; Haemophilus parainfluenzae; Legionella pneumophila; Moraxella catarrhalis; Pasteurella multocida; Neisseria gonorrhoeae

 3. Anaerobe bacterias

 Clostridium perfringens; Fusobacterium spp.; Prevotella spp.; Porphyriomonas spp.

 4. Other microorganisms

 Chlamydia trachomatis; Chlamydia pneumoniae; Chlamydia psittaci; Mycoplasma pneumoniae; Mycoplasma hominis; Borrelia burgdorferi

 The microorganisms capable to develop azithromycin resistance gram-positive aerobes, Streptococcus pneumoniae penicillin - steady

 Initially steady microorganisms gram-positive aerobes of Enterococcus faecalis; Staphylococcus (metitsillinoustoychivy staphylococcus with very high frequency have the acquired resistance to macroleads).

Pharmacokinetics. At intake azithromycin is well soaked up and quickly redistributed from plasma in fabrics and bodies. After a single dose in 500 mg of azithromycin of 37% of drug it is absorbed, and in 2–3 h in plasma Cmax of drug — 0,41 mkg/ml is noted. It is known that meal can reduce azithromycin absorption, however because of insufficiency at manufacturing firm of own data on influence of food on azithromycin pharmacokinetics at reception of Sumameda® in the form of suspension, it should be taken at least for 1 h to or in 2 h after food.

 Drug is quickly distributed on all organism, the high concentration by 50 times exceeding concentration of azithromycin in plasma are observed in fabrics.

 Depending on body/fabric, concentration of drug fluctuates within 1–9 mkg/ml. Vd averages 31 l/kg.

 Therapeutic concentration of azithromycin in fabrics is noted within 5–7 days after reception of the last dose.

 Gets in cells, in т.ч phagocytes which migrate in the inflammation center, promoting creation of the therapeutic concentration of drug exceeding MPK for contagiums. Concentration of azithromycin in the infected fabrics — higher in comparison with not infected fabrics.

 Possesses long T1/2 and it is slowly brought out of fabrics (on average — 2–4 days). Removal of azithromycin with bile — the main way of removal. On average to 50% it is removed with bile in not changed form. Other 50% are removed in the form of 10 metabolites formed in the course of N-and O-demethylation, a hydroxylation of a dezozamin and an aglikonovy ring and as a result of splitting of a kladinoza of a conjugate. Metabolites have no antibacterial activity.

 With urine 6% of the entered drug dose are removed on average.

 At elderly patients (65 years are more senior) Vd slightly higher (30%) in comparison with patients, which age less than 45 years that clinically not significantly and does not demand change of a dosage.

 The azithromycin pharmacokinetics at healthy volunteers after single in/in infusion lasting more than 2 h in a dose of 1000-4000 mg (concentration of solution — 1 mg/ml) has linear dependence and is proportional to the entered dose. T1/2 of drug makes 65–72 h. High level of observed Vd (33,3 l/kg) and clearance of plasma (10,2 ml/min.) allows to assume that long T1/2 of drug is a consequence of accumulation of an antibiotic in fabrics with the subsequent its slow release.

 At healthy volunteers at in/in infusion of azithromycin in a dose of 500 mg (concentration of solution — 1 mg/ml) during 3 h Cmax of drug in blood serum made 1,14 mkg/ml. The minimum level in blood serum (0,18 mkg/ml) was noted for 24 h and AUC made 8,03 mkg/ml · h. Similar pharmacokinetic values were received also at patients with community-acquired pneumonia which were appointed in/in infusion (3-hour) for from 2 to 5 days.

 After daily administration of azithromycin in a dose of 500 mg (infusion duration — 1 h) within 5 days on average 14% of a dose are removed with urine throughout a 24-hour interval of dosing.

Indications to use:

Сумамед® (capsules; powder for preparation of suspension for intake)

Сумамед® forte (powder for preparation of suspension for intake)

 upper respiratory tract infections, ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);

 lower respiratory tract infections (bacterial bronchitis, intersticial and alveolar pneumonia, exacerbation of chronic bronchitis);

 infections of skin and soft tissues (the chronic migrating erythema — an initial stage of a disease of Lyme, an ugly face, impetigo, secondary pyodermatoses);

 infections, sexually transmitted (urethritis, cervicitis);

 the diseases of a stomach and duodenum associated with Helicobacter pylori.

 Сумамед® (tablets, film coated)

upper respiratory tract infections, ENT organs (pharyngitis/tonsillitis, sinusitis, average otitis);

 lower respiratory tract infections (an acute bronchitis, an exacerbation of chronic bronchitis, pneumonia, including caused by atypical activators);

 infections of skin and soft tissues (an acne вулгарис moderate severity, the ugly face, impetigo for the second time infected a dermatosis);

 initial stage of a disease Laima (borreliosis) — erythema mygrans;

 the infections of urinogenital ways transmitted to Chlamidia trachomatis (an urethritis, a cervicitis).

 Сумамед® (lyophilisate for preparation of solution for infusions)

 Treatment of the heavy infections caused by sensitive strains of microorganisms:

 the community-acquired pneumonia of a heavy current caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae;

 the infectious and inflammatory diseases of bodies of a small pelvis of a heavy current caused by Chlamydia trachomatis or Neisseria gonorrhoeae and Mycoplasma hominis.

Route of administration and doses:

Сумамед® Capsules

 Inside, 1 time a day. Capsules are accepted, at least, to 1 h to or in 2 h after food.

 Children from 6 months are recommended to use drug in the form of peroral suspension or tablets on 125 mg.

 At an infection of upper and lower respiratory tracts, skin and soft tissues (except for the chronic migrating erythema)

 Adult — 500 mg once a day within 3 days (a course dose — 1,5 g); to children — at the rate of 10 mg/kg once a day within 3 days (a course dose — 30 mg/kg).

 At the chronic migrating erythema. The adult — 1 time a day within 5 days: the 1st day — 1,0 g, then (from the 2nd to the 5th day) on 500 mg (a course dose — 3,0 g); to children: in the 1st day — in a dose of 20 mg/kg and then, from the 2nd to the 5th day — daily in a dose of 10 mg/kg (a course dose — 30 mg/kg).

 At infections, sexually transmitted

 Uncomplicated urethritis / cervicitis — 1 g, once.

 Way of preparation of suspension

 Bring 12 ml of the distilled or prokipyachenny water in the bottle containing 17 g of powder. The volume of the received suspension — 23 ml. A period of validity of the prepared suspension — 5 days. Before reception bottle contents are carefully shaken up before receiving homogeneous suspension. Directly after suspension reception to the child allow to drink several drinks of tea to wash away and swallow the remained amount of suspension in an oral cavity.

 After use the dosing syringe is disassembled and washed out flowing water, dried and stored in the dry place with drug.

 Mg tablets Сумамед® 125

Inside, without chewing, at least for 1 h to or in 2 h after food, 1 times a day. For children 3 years are younger appoint Sumamed® suspension (100 mg / 5 ml).

To children dose proceeding from value of body weight: at the body weight of 18-30 kg — 2 tab. on 125 mg (250 mg); 31–44 kg — 3 tab. (375 mg); more or equally 45 kg appoint the doses recommended for adults.

 At infections of upper and lower respiratory tracts, ENT organs, skin and soft tissues. At the rate of 10 mg/kg once a day within 3 days (a course dose — 30 mg/kg). For convenience of dosing it is recommended to consider information on dosing given above proceeding from the mass of a body /

 Because at the migrating erythema the course dose makes 60 mg/kg (20 mg/kg in the 1st day once a day, then — at the rate of 10 mg/kg once a day, from the 2nd to the 5th day) that demands reception of a large number of tablets of 125 mg, in this case purpose of the drug Sumamed® suspension for intake of 100 mg / 5 is recommended to ml.

 Mg tablets Сумамед® 500

 Inside, without chewing, 1 time a day, irrespective of meal.

 The adult (including elderly people) and to children 12 years with body weight over 45 kg / are more senior

 At infections of upper and lower respiratory tracts, ENT organs, skin and soft tissues. According to 1 tab. (500 mg) once a day within 3 days (a course dose — 1,5 g).

At an acne вульгарис moderate severity. A course dose — 6,0 g. According to 1 tab. (500 mg) once a day within 3 days, then — according to 1 tab. (500 mg) once a week during 9 weeks. The first weekly pill should be taken in 7 days after reception of the first daily tablet (the 8th day for an initiation of treatment), the subsequent 8 weekly tablets — at an interval of 7 days.

At the migrating erythema. 1 time a day within 5 days: the 1st day — 1,0 g (2 tab. on 500 mg), then (from the 2nd to the 5th day) — according to 1 tab. (500 mg) (a course dose — 3,0 g).

 At infections of the urinogenital ways caused by Chlamidia trachomatis (an urethritis, a cervicitis)

 Uncomplicated urethritis / cervicitis — 1 g (2 tab. on 500 mg) once.

 Appointment to patients with renal failures. For patients with moderate renal failures (creatinine Cl> of 40 ml/min.) dose adjustment is not necessary.

 Сумамед® Lyophilisate for preparation of solution for infusions

 In/in in the form of infusion, kapelno, during 3 h — at concentration of 1 mg/ml, during 1 h — at concentration of 2 mg/ml. It is necessary to avoid introduction of higher concentration because of danger of emergence of reactions in an injection site.

 Сумамед® it is impossible to enter intravenously struyno or intramusculary!

 Community-acquired pneumonia: 500 mg once in days during at least two days. After the termination in/in introductions purpose of azithromycin inside in the form of a single daily dose of 500 mg before full completion of a 7-10-day general course of treatment is recommended.

 Infectious and inflammatory diseases of bodies of a small pelvis: 500 mg in/in once in days within 2 days. After the termination in/in introductions purpose of azithromycin inside in a dose of 250 mg before full completion of a 7-day general course of treatment is recommended.

 Transition terms from in/in administrations of drug to intake are defined by the doctor according to data of clinical inspection.

 Renal failure. For patients with moderate renal failures (creatinine Cl> of 40 ml/min.) dose adjustment is not necessary.

 Preparation of solution for infusion

 Solution for infusion prepares in 2 stages.

 The 1st stage — preparation of primary solution: from 500 mg of drug add 4,8 ml of sterile water for injections to a bottle and carefully stir up before full dissolution of powder. 1 ml of the received solution contains 100 mg of azithromycin, it should be used immediately for further cultivation. The recovered solution is checked for lack of the visible not dissolved particles, otherwise solution should not be used.

 The 2nd stage — secondary cultivation of the recovered solution (100 mg/ml) is carried out just before introduction, according to below the submitted table.

 Table 2

Concentration of azithromycin in infusion solution, mg/ml   Amount of solvent, ml
                                                                                                    1,0 500
                                                                                                    2,0 250

Primary solution bring in a bottle with solvent (0,9% of sodium chloride, 5% of Dextrosum, Ringer's solution) before obtaining final concentration of azithromycin of 1,0-2,0 mg/ml in infusion solution.

 Before introduction solution is subjected to direct vision. If divorced solution contains substance particles, then it should not be used. The prepared divorced solution should be used immediately.

 Powder for preparation of suspension for intake

 Inside, 1 time a day, at least, for 1 h to or in 2 h after food. The necessary dose is measured by means of the syringe or the measured spoon enclosed in packaging with drug: at body weight to 15 kg the syringe is used, with body weight it is higher than 15 kg — a measured spoon.

 At infections of upper and lower respiratory tracts, ENT organs, skin and soft tissues

 At the rate of 10 mg/kg of body weight once a day within 3 days (a course dose of 30 mg/kg) — the scheme of calculation of a dose is given below.

 At the migrating erythema

 In the 1st day — in a dose of 20 mg/kg of body weight and then from 2 to the 5th day — daily in a dose of 10 mg/kg of body weight (a course dose of 60 mg/kg).

 For exact calculation of necessary amount of drug at appointment in a dose of 10 mg/kg of body weight of the child it is necessary to use the table:

 Table 3

Body weight                                                the Necessary volume of suspension is 100 mg / 5 ml on 1 reception, ml
5 kg                                                                                     2,5 (50 mg)
6 kg                                                                                     3,0 (60 mg)
7 kg                                                                                     3,5 (70 mg)
8 kg                                                                                      4,0 (80 mg)
9 kg                                                                                     4,5 (90 mg)
10 kg                                                                                     5 (100 mg)

Appointment to patients with renal failures

 For patients with moderate renal failures (creatinine Cl> of 40 ml/min.) dose adjustment is not necessary.

 Way of preparation and dosing of suspension

 Add 11 ml of water to contents of a bottle and shake up before receiving homogeneous suspension. The total taken (nominal) amount of suspension — not less than 20 ml from each bottle; the total actual amount of suspension in each bottle — about 25 ml. The actual volume of suspension exceeds the taken (nominal) volume approximately on 5 ml that is necessary for compensation of inevitable losses of suspension at a drug dosing.

 Before each administration of drug bottle contents are carefully shaken up before receiving homogeneous suspension. If the necessary volume of suspension was not selected from a bottle within 20 min. after agitation, suspension should be shaken up again, to select necessary volume and to give to the child. The necessary volume of suspension is selected from a bottle by means of the syringe or a measured spoon. Directly after suspension reception to the child allow to drink several drinks of water to wash away and swallow the remained amount of suspension in an oral cavity.

 After use the syringe (previously having sorted it) and a measured spoon are washed out flowing water, dried and stored in the dry place before the following administration of drug.

 Сумамед® forte
 
Powder for preparation of suspension for intake

 Inside, 1 time a day, at least for 1 h to or in 2 h after food.

 At an infection of upper and lower respiratory tracts, skin and soft tissues (except for the chronic migrating erythema) — a total dose of 30 mg/kg, i.e. on 10 mg/kg once in days within three days.

 To children dose proceeding from weight (see tab. 4):

 Table 4

Body weight, kg                                                         Volume of drug, ml (amount of azithromycin, mg)
                                                                                          10-14 2,5 (100)
                                                                                          15-24 5,0 (200)
                                                                                          25-34 7,5 (300)
                                                                                         35-44 10,0 (400)
 ≥45                                                                                           12,5 (500)

At the chronic migrating erythema the total dose of drug makes 60 mg/kg: in the 1st day — once 20 mg/kg; in the next days (from the 2nd for the 5th) — on 10 mg/kg.

 At the diseases of a stomach and duodenum associated with Helicobacter pylori: 20 mg/kg once in day in combination with anti-secretory means and other medicines according to the recommendation of the doctor.

 If the dose of drug was passed, it needs to be accepted, whenever possible, at once, and then the subsequent doses — at an interval of 24 h.

 At infections, sexually transmitted

 Uncomplicated urethritis / cervicitis — 1 g, once.

 Way of preparation of suspension

 For preparation of 15 ml of suspension (nominal volume) it is necessary to add to the bottle containing 800 mg of azithromycin 8 ml of water (the actual volume — 20 ml of suspension).

 For preparation of 30 ml of suspension (nominal volume) it is necessary to add to the bottle containing 1400 mg of azithromycin 14,5 ml of water (the actual volume — 35 ml of suspension).

 For preparation of 37,5 ml of suspension (nominal volume) it is necessary to add to the bottle containing 1700 mg of azithromycin 16,5 ml of water (the actual volume — 42,5 ml of suspension).

 Each bottle has to contain suspensions 5 ml more course dose for fuller extraction of drug from a bottle.

 Period of validity of the prepared suspension — 5 days, at a temperature not above 25 °C.

 By means of the syringe for dosing measure a necessary amount of water, add to a bottle with powder. Before reception bottle contents are carefully shaken up before receiving homogeneous suspension.

 For dosing of ready suspension use the syringe or a measured spoon.

 Directly after suspension reception to the child allow to drink several drinks of tea or juice to wash away and swallow the remained amount of suspension in an oral cavity.

 After use the syringe is disassembled and washed out flowing water, dried and stored together with drug.

Features of use:

In case of the admission of reception of one dose of drug – it is necessary to accept the passed dose as soon as possible, and the subsequent – with breaks in 24 h.
 
The patient should be warned about need to report to the doctor about emergence of any side effect.

Use at a renal failure

At heavy renal failures drug is contraindicated. With care it is necessary to appoint drug at easy and moderate renal failures.

Use at an abnormal liver function

At heavy abnormal liver functions drug is contraindicated. With care it is necessary to appoint at easy and moderate abnormal liver functions.

Pregnancy and lactation

At pregnancy and in the period of a lactation (breastfeeding) purpose of drug is possible only if the advantage of its use for mother surpasses possible risk for a fruit or the baby.

Side effects:

Сумамед® (capsules; powder for preparation of suspension for intake)

Сумамед® forte (powder for preparation of suspension for intake)

 - hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys.

 With care:

 - newborns (due to the lack of sufficient clinical experience);

 - pregnancy and the period of a lactation i.e. when the expected advantage of its use exceeds the potential risk existing when using any drug during these periods;

 - abnormal liver function and kidneys;

 - arrhythmias or to predisposition to them and lengthening of an interval of QT; (according to literature, occurrence in 0,001% of cases).

 Сумамед® (tablets, film coated)

- hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys;

 - children's age up to 12 years with body weight less than 45 kg (for tablets on 500 mg);

 - children's age up to 3 years (for tablets on 125 mg);

 - breastfeeding;

 - a concomitant use with ergotamine and dihydroergotamine.

 With care:

 - moderate abnormal liver functions and kidneys;

 - arrhythmias or to predisposition to them and lengthening of an interval of QT;

 - joint purpose of a terfenadin, warfarin, digoxin.

 Сумамед® (lyophilisate for preparation of solution for infusions)

 - hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys;

 - breastfeeding;

 - a concomitant use with ergotamine and dihydroergotamine;

 - children's age up to 16 years.

 With care

 - moderate abnormal liver functions and kidneys;

 - arrhythmia, predisposition to arrhythmia, lengthening of an interval of QT;

 - joint purpose of a terfenadin, warfarin, digoxin.

Interaction with other medicines:

Сумамед® (capsules; tablets, coated; powder for preparation of suspension for intake)

Сумамед® forte (powder for preparation of suspension for intake)

 Antiacid means do not influence bioavailability of azithromycin, but reduce the maximum concentration in blood by 30% therefore drug should be accepted at least in one hour prior to or in two hours after reception of these drugs and food.

Azithromycin does not influence concentration of carbamazepine, a didanozin, rifabutin and Methylprednisolonum in blood when sharing.

At parenteral use azithromycin does not influence concentration of Cimetidinum, efavirenz, flukonazol, indinavir, midazolam, a triazolam, Trimethoprimum/sulfamethoxazole in blood when sharing, however it is not necessary to exclude possibilities of such interactions at purpose of azithromycin for intake.

Azithromycin does not influence theophylline pharmacokinetics, however at joint reception with other macroleads concentration of theophylline in a blood plasma can increase.

In need of combined use with cyclosporine it is recommended to control the content of cyclosporine in blood. In spite of the fact that there are no data on influence of azithromycin on change of concentration of cyclosporine in blood, other representatives of a class of macroleads are capable to change its level in a blood plasma.

At joint reception of digoxin and azithromycin it is necessary to control digoxin level in blood since many macroleads increase absorption of digoxin in intestines, increasing that its concentration in a blood plasma.

In need of joint reception with warfarin it is recommended to carry out careful control of PV.

 It was established that the concomitant use of a terfenadin and antibiotics of a class of macroleads causes arrhythmia and lengthening of an interval of QT. Proceeding from it, it is impossible to exclude development of the above-stated complications at joint reception of a terfenadin and azithromycin.

As there is a possibility of inhibition of CYP3A4 enzyme azithromycin in a parenteral form at joint appointment with cyclosporine, terfenadiny, ergot alkaloids, tsizapridy, Pimozidum, quinidine, astemizoly and other drugs which metabolism happens to participation of this enzyme it is necessary to consider a possibility of such interaction at purpose of azithromycin for intake.

At joint reception with nelfinaviry increase in frequency of by-effects from azithromycin is possible.

At joint reception of azithromycin and a zidovudine azithromycin does not influence pharmacokinetic parameters of a zidovudine in a blood plasma or on removal by kidneys of its and its metabolite of a glucuronide. Nevertheless, concentration of an active metabolite — a fosforilirovanny zidovudine in mononuclear cells of peripheral vessels increases. Clinical value of this fact is not clear.

At a concomitant use of macroleads with ergotamine and dihydroergotamine manifestation of their toxic action is possible.

Contraindications:

Сумамед® (capsules; powder for preparation of suspension for intake)

Сумамед® forte (powder for preparation of suspension for intake)

 - hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys.

 With care:

 - newborns (due to the lack of sufficient clinical experience);

 - pregnancy and the period of a lactation i.e. when the expected advantage of its use exceeds the potential risk existing when using any drug during these periods;

 - abnormal liver function and kidneys;

 - arrhythmias or to predisposition to them and lengthening of an interval of QT; (according to literature, occurrence in 0,001% of cases).

 Сумамед® (tablets, film coated)

- hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys;

 - children's age up to 12 years with body weight less than 45 kg (for tablets on 500 mg);

 - children's age up to 3 years (for tablets on 125 mg);

 - breastfeeding;

 - a concomitant use with ergotamine and dihydroergotamine.

 With care:

 - moderate abnormal liver functions and kidneys;

 - arrhythmias or to predisposition to them and lengthening of an interval of QT;

 - joint purpose of a terfenadin, warfarin, digoxin.

 Сумамед® (lyophilisate for preparation of solution for infusions)

 - hypersensitivity to antibiotics of group of macroleads;

 - heavy abnormal liver functions and kidneys;

 - breastfeeding;

 - a concomitant use with ergotamine and dihydroergotamine;

 - children's age up to 16 years.

 With care

 - moderate abnormal liver functions and kidneys;

 - arrhythmia, predisposition to arrhythmia, lengthening of an interval of QT;

 - joint purpose of a terfenadin, warfarin, digoxin.

Overdose:

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: symptomatic therapy.

Storage conditions:

List B.: To store at a temperature of 15-25 °C. To store in the place, unavailable to children. Capsules, tablets – 3 years.
Powder for preparation of suspension for intake - 2 years.
The prepared suspension – 5 days.

Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

capsules of 250 mg:
6 capsules in the blister from PVC / aluminum foil.
1 blister together with the application instruction in a cardboard pack.

tablets of 125 mg:
 6 tablets in the blister from PVC / aluminum foil.
1 blister together with the application instruction in a cardboard pack.

mg tablets 500:
3 tablets in the blister from PVC / aluminum foil.
1 blister together with the application instruction in a cardboard pack.

powder for suspension preparation (100 mg / 5 ml)
17 g of powder place in a glass bottle of 50 ml of brown color, with a polypropylene resistant cover.
1 bottle together with a measured, 2-sided spoon (big - with a capacity of 5 ml, small - 2,5 ml) and/or the syringe for dosing on 5 ml and the application instruction is put in a cardboard pack.