Ормакс powder for suspension preparation

General characteristics. Structure:

time. baby сусп. 100 mg / 5 ml container of 11,34 g, baby 20 ml сусп., No. 1

Azithromycin

100 mg / 5 ml

Other ingredients: sucrose, sodium phosphate, Natrium benzoicum, hydroxypropyl cellulose, gum xanthane, silicon dioxide colloid anhydrous, fragrance apricot.

 No. UA/11108/02/01 from 29.10.2010 to 29.10.2015

time. baby сусп. 200 mg / 5 ml container of 11,74 g, baby 20 ml сусп.

time. baby сусп. 200 mg / 5 ml container of 17,6 g, baby 30 ml сусп.

Azithromycin

200 mg / 5 ml

Other ingredients: sucrose, sodium phosphate, Natrium benzoicum, hydroxypropyl cellulose, gum xanthane, silicon dioxide colloid anhydrous, fragrance apricot.

Pharmacological properties:

Pharmacodynamics. Azithromycin — the representative of new generation of makrolidny antibiotics, belongs to subgroup of azaleads. Antibacterial effect of drug is caused by blocking of biosynthesis of proteins of microorganisms, sensitive to it, by linkng with 50S-subunits of ribosomes. Are sensitive to azithromycin: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalacticae, Streptococcus viridans, Staphylococcus spp., H.influenzae, H.parainfluenzae, H.ducreyi, M.catarrhalis, Bordetella pertussis, Bordetella parapertussis, Brucella melitensis, H.pylori, Campylobacter jejuni, Gardnerella vaginalis, Clostridium spp., Peptococcus spp. and Peptosteptococcus spp, Legionella spp., Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Listeria monocytogenes, Treponema pallidum, Borrelia spp., Mycobacterium avium complex, some parasites, in particular Babesia microti.

Pharmacokinetics. After oral administration azithromycin is well soaked up and quickly distributed in an organism. _Cmax in a blood plasma is noted in 2–3 h, absolute bioavailability makes about 35-40%. The concomitant use of food and antacids slows down drug absorption. Linkng with proteins of a blood plasma has variable character and depends on the accepted dose, averages 7–51%. Getting in macrophages, drug is transported to the inflammation centers, the long time is in fabrics, creating high concentration which exceed those in plasma: for skin — by 35 times, for tissue of lungs — more than by 100 times, phlegms — by 30 times, for an adenoid tissue — more than by 100 times, a cervical secret — by 70 times. Azithromycin is removed from an organism in not changed view preferential with bile, about 6% of the accepted dose are removed in not changed view with urine for 1 week. Age indicators almost do not influence azithromycin pharmacokinetics.

Indications to use:

• the infections caused by the microorganisms sensitive to azithromycin:
• infections of ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
• respiratory infections (bacterial bronchitis, not hospital pneumonia);
• infections of skin and soft tissues: the migrating erythema (an initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses.

Route of administration and doses:

for suspension preparation the container with powder should be turned that powder separated from a bottom, then with powder by means of the dosing syringe add boiled water of room temperature from calculation to a bottle:

Release form	200 mg / 5 ml, 20 ml	200 mg / 5 ml, 30 ml	100 mg / 5 ml, 20 ml
Amount of water, ml	14	20	15

After water addition the bottle is closed and carefully stirred up before formation of homogeneous suspension. After that in the special column of the label it is recommended to date suspension preparation. Ready suspension is stored in the refrigerator. Before each use the bottle needs to be shaken up well. Suspension is taken inside once a day for 1 h to or in 2 h after meal. Directly after suspension reception the child needs to allow to drink several drinks of liquid to wash away and swallow the suspension remains in an oral cavity. In case of the admission of administration of drug it needs to be accepted as soon as possible, and the following dose of drug is accepted in 24 h. Infections of ENT organs and respiratory tracts, skin and soft tissues (except the chronic migrating erythema): 10 mg/kg of body weight of 1 times a day within 3 days. Depending on the body weight of the child the following scheme of dosing is recommended:

Body weight, kg	Release form	Daily dose, ml (mg)
5	Ормакс 100 mg / 5 ml	2,5 (50)
6	― // ―	3 (60)
7	― // ―	3,5 (70)
8	― // ―	4 (80)
9	― // ―	4,5 (90)
10–14	― // ―	5 (100)
15–24	Ормакс 200 mg / 5 ml (20 ml)	5 (200)
25–34	Ормакс 200 mg / 5 ml (30 ml)	7,5 (300)
35–44	― // ―	10 (400)
≥45		Appoint doses for adults

The migrating erythema (Lyme's disease): 1 time a day within 5 days in a dose of 20 mg/kg of body weight in the 1st day, then on 10 mg/kg of body weight from the 2nd to the 5th day.
Renal failure. Patients with insignificant dysfunction of kidneys (clearance of creatinine> of 40 ml/min.) have no need to change a dosage. Any research at patients with clearance of creatinine was not conducted <40 ml/min. Respectively, it is necessary to apply with care azithromycin at such patients.
Liver failure. As azithromycin is metabolized in a liver and removed with bile, drug should not be used at patients with a serious illness of a liver.

Features of use:

 It is not necessary to exceed the recommended doses of drug and to use drug longer time, than it is recommended.
Allergic reactions: it was seldom reported that azithromycin can cause heavy allergic (seldom — lethal) to reaction, such as a Quincke's disease and an acute anaphylaxis. Some of these reactions had recurrent character and demanded longer observation and treatment.
The extended cordial repolarization and interval of Q-T which increased risk of development of cardiac arrhythmia, including trembling fibrillation of ventricles, are noted at treatment by other makrolidny antibiotics. The similar effect of azithromycin cannot be excluded completely at patients with the increased risk of the extended cordial repolarization (a syndrome of the inborn and acquired extended Q-t interval).
Streptococcal infections: penicillin is drug of the first choice in treatment of the pharyngitis/tonsillitis caused by Streptococcus pyogenes and also in prevention of acute rheumatic polyarthritis. Generally azithromycin is effective in treatment of streptococcal infections of a stomatopharynx, but there are no data which show efficiency of azithromycin in prevention of acute rheumatic polyarthritis.
Superinfections: as well as in a case with other antibacterial drugs, there is a possibility of superinfection (for example mycoses).
  Because drug contains sucrose, patients should not appoint it with infrequent hereditary syndromes of an intolerantnost to fructose, glyukozo-galaktozny malabsorption or insufficiency of sucrose-isomaltase. At patients with a heavy renal failure note increase in indicators of system exposure. Patients with heavy pathology of a liver should use drug with care.
Ормакс in the form of suspension it is recommended for use in pediatric practice and  it is not applied at pregnant women.
Drug is intended for use in pediatric practice. To children with body weight over 5 kg apply dosing of 100 mg / 5 ml, and to children with body weight over 15 kg — 200 mg / 5 ml.

Side effects:

Assessment of by-effects is based on classification taking into account the frequency of reactions: very often — ≥10%; often — ≥1% — <10%; infrequently — ≥0,1% — <1%; seldom — ≥0,01% — <0,1%; very seldom — <0,01%, including separate cases.
 From circulatory and lymphatic system: seldom — thrombocytopenia. In clinical trials there were separate messages on the periods of the tranzitorny poorly expressed neutropenia. However the causal relationship with treatment by azithromycin was not confirmed.
 From mentality: seldom — aggression, concern, alarm and nervousness.
 From a nervous system: infrequently — dizziness, drowsiness, a syncope, a headache, spasms (it was revealed that they are provoked also by other makrolidny antibiotics), a food faddism and feelings of smells; seldom — paresthesias, an adynamy, sleeplessness.
 From an acoustic organ: it was seldom reported that makrolidny antibiotics cause a hearing disorder. At some patients accepting azithromycin noted a hearing disorder, developing of deafness and a ring in ears.
 From cordial activity: it was seldom reported about strong heartbeat, ventricular disturbances of a rhythm ( including tachycardia), it was revealed that they are also caused by other makrolidny antibiotics. There were rare messages on lengthening of an interval of Q-t and trembling fibrillation of ventricles, arterial hypotension.
 From a GIT: often — nausea, vomiting, diarrhea, unpleasant feelings in a stomach (pains/spasms); infrequently — a liquid chair, a meteorism, digestion disturbance, anorexia, dyspepsia; seldom — a lock, language discoloration, pancreatitis. It was reported about pseudomembranous colitis.
 From a liver and gall bladder: it was seldom reported about hepatitis and cholestatic jaundice, including pathological indicators of functional trials of a liver, and also it is rare about cases of necrotic hepatitis and dysfunction of a liver which sometimes led to a lethal outcome.
 From skin: infrequently — allergic reactions, including an itch and rashes; seldom — allergic reactions, including a Quincke's disease, a small tortoiseshell and a photosensitivity, serious skin reactions (a polymorphic erythema, Stephens's syndrome — Johnson and a toxic epidermal necrolysis).
 From skeletal and muscular system: infrequently — an arthralgia.
 From an urinary system: seldom — intersticial nephrite and an acute renal failure.
 From a reproductive system: infrequently — a vaginitis.
System disturbances: seldom — an anaphylaxis, including a Quincke's disease ( in rare instances lead to a lethal outcome), candidiasis.

Interaction with other medicines:

It is necessary to appoint carefully azithromycin to patients together with other medicines which can extend the Q-t interval (quinidine, cyclophosphamide, кетоконазол, терфенадин, a haloperidol, lithium).
Antacids: when studying influence of simultaneous use of antacids on azithromycin pharmacokinetics generally did not note changes in bioavailability though azithromycin _Cmax in a blood plasma decreased by 30%. Azithromycin needs to be accepted at least for an hour to or in 2 h after reception of antacids. Changes of pharmacokinetics of azithromycin at use of Cimetidinum for 2 h before use of azithromycin were absent.
Carbamazepine: azithromycin had no significant effect on plasma levels of carbamazepine or its active metabolites.
Cyclosporine: some of related makrolidny antibiotics influence cyclosporine metabolism. It is necessary to weigh carefully a therapeutic situation before purpose of a concomitant use of these medicines. If the combined treatment is considered justified, it is necessary to carry out careful monitoring of level of cyclosporine and to respectively regulate a dosage.
Coumarinic anticoagulants: it was reported about the raised tendency to bleedings in connection with simultaneous use of azithromycin and warfarin or kumarinopodobny peroral anticoagulants. It is necessary to pay attention to the frequency of monitoring of a prothrombin time and MNO.
Digoxin: it was reported that at some patients certain makrolidny antibiotics influence metabolism of digoxin in intestines. Respectively, in case of simultaneous use of azithromycin and digoxin it is necessary to remember a possibility of increase in concentration of digoxin and to carry out monitoring of level of digoxin.
Methylprednisolonum: azithromycin had no significant effect on Methylprednisolonum pharmacokinetics.
Terfenadin: it was not reported about interaction between azithromycin and terfenadiny. As well as in a case with other makrolidny antibiotics, it is necessary to appoint azithromycin with care in a combination with terfenadiny.
Theophylline: azithromycin did not influence theophylline pharmacokinetics at simultaneous use of azithromycin and theophylline. The combined use of theophylline and other makrolidny antibiotics sometimes led to increase in level of theophylline in blood serum.
Zidovudine: single doses of 1000 and 1200 mg or repeated doses on 600 mg of azithromycin did not influence plasma pharmacokinetics or allocation with urine of a zidovudine or its glyukuronidny metabolites. However reception of azithromycin increased concentration of a fosforilirovanny zidovudine, clinically active metabolite, in mononukleara of peripheral blood.
Didanozin: at simultaneous use of daily doses of azithromycin of 1200 mg with didanoziny to six subjects influence on pharmacokinetics of a didanozin in comparison with placebo was not revealed.
Rifabutin: simultaneous use of azithromycin and a rifabutin did not influence plasma concentration of these drugs. The neutropenia was noted at subjects which accepted at the same time azithromycin and рифабутин. Though the neutropenia was connected using a rifabutin, the causal relationship  was not established with simultaneous use of azithromycin.

Contraindications:

Hypersensitivity to active ingredient, any other component of drug or to other makrolidny antibiotics. Because of a theoretical possibility of an ergotism it is not necessary to appoint azithromycin along with ergot derivatives. Do not apply at children with body weight <5 kg a dose of 100 mg / 5 ml, at children with body weight to 15 kg do not apply a dose of 200 mg / 5 ml.

Overdose:

At overdose of azithromycin note the expressed nausea, vomiting, diarrhea, pain in a stomach, it is rare — a temporary hearing loss. There is no specific antidote, carry out symptomatic therapy.

Storage conditions:

To store at   a temperature not above 25 °C. Ready suspension is stored by no more than 5 days at  a temperature of 2-8 °C.

Issue conditions:

According to the recipe

Packaging:

Time. baby сусп. 100 mg / 5 ml container of 11,34 g, baby 20 ml сусп., No. 1