Azitromitsin-Astrafarm kaps. 250 mg No. 6

"Azitromitsin-Astrafarm" of 250 mg, the instruction for use

"Azithromycin" — an antibiotic macrolead of systemic action, is applied to treatment of the infectious diseases caused by the causative organisms sensitive to azithromycin.

Structure

Active ingredient: azithromycin.

1 capsule contains azithromycin (in the form of dihydrate azithromycin in terms of 100% substance) 250 mg or 500 mg.

Excipients: microcrystalline cellulose, silicon dioxide colloidal waterless, magnesium stearate.

Structure of a cover of the capsule: gelatin, titan dioxide (E171), indigo carmine (E132).

Dosage form

Medicine "Azitromitsin-Astrafarm" is issued in capsules.

Main physical and chemical properties

Solid gelatin capsules, a form cylindrical with the hemispherical ends. Color of the body and cover blue. Contents of capsules — powder of white color.

Pharmacological properties

Pharmacodynamics

"Azithromycin" — the representative of group of antibiotics azaleads. Possesses a wide range of antibacterial action. The efficiency is based on ability to suppress production of bacterial protein of microorganisms.

. These indicators change depending on the area. In this regard it is recommended to have local information on resistance, including at treatment of heavy infections.

"Azithromycin" shows antibacterial activity concerning aerobic gram-positive bacteria, streptococci of the C, F and G groups, aerobic gram-negative bacteria, anaerobic bacteria (Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Pasteurella multocida, Clostridium perfringens). Drug is also active concerning Chlamydia trachomatis.

Active ingredient of medicine is quickly absorbed by

from a GIT. After intake of 500 mg of "Azithromycin" the maximum concentration of active ingredient in blood is reached in 2.5-3 hours.

a bioavailability Indicator — about 37%. Elimination half-life of components — 14–72 hours (depending on a reception interval). It is recommended to accept to or after a meal as meal considerably influences pharmacokinetics of antibacterial agent.

After oral administration on all organism. It gets into bodies and fabrics of an urinogenital system, into airways, soft tissues and skin. Concentration in fabrics is much higher, than in blood. This fact is caused by low ability of active ingredient to contact blood proteins (12–52%).

Azithromycin collects in phagocytes which transport it in the centers of an infection and inflammation where they are gradually released in the course of phagocytosis. In the inflammation center medicine keeps bactericidal efficiency within 5–7 days after reception of the last dose.

Metabolism of azithromycin happens in a liver. Out of an organism it is brought mainly with bile in an invariable look and it is insignificant — with urine. The removal period — 72 hours.

At moderate or easy degree of a renal or liver failure "Azithromycin" keeps pharmacokinetic properties. At patients with a heavy renal failure area indicators under a curve "concentration – time" and also the maximum concentration of active ingredient and plasma clearance change.

At patients with a liver failure of light and moderate severity the increase in clearance of azithromycin in urine can be observed.

For patients of advanced age.

Indication

Azitromitsin-Astrafarm Capsule at the infections caused by the microorganisms sensitive to azithromycin:

• an upper respiratory tract infection (bacterial pharyngitis, tonsillitis, sinusitis, average otitis);
• a lower respiratory tract infection (bacterial bronchitis and exacerbation of chronic bronchitis, not hospital pneumonia);
• an infection of leather and soft tissues: the chronic migrating erythema (I stage of a disease of Lyme), an ugly face, impetigo, a secondary pyoderma;
• genital infections: the uncomplicated and complicated urethritis/cervicitis caused by Chlamydia trachomatis.

Contraindication

Hypersensitivity to azithromycin or other makrolidny and ketolidny antibiotics and excipients of medicine. Through a theoretical possibility of an ergotism it is not necessary to appoint it along with ergot derivatives. To patients with the expressed bradycardia, heavy heart failure, arrhythmia of "Azitromitsin-Astrafarm" it is contraindicated.

At reception of makrolidny antibiotics, including "Azithromycin", manifestation of serious allergic reactions is possible

Feature of application though such risk insignificant. Isolated cases of development of an anaphylaxis and Quincke's disease with a lethal outcome were celebrated. Some allergic reactions demand longer observation and treatment as recurrent symptoms were noted.

Drug is generally removed by

from an organism through a liver with bile therefore to patients with heavy abnormal liver functions the antibiotic is appointed with care. At medicament intake, cases of development of fulminantny hepatitis which poses hazard to life were noted and also it was reported about cases of a liver failure. At emergence of symptoms and symptoms of an abnormal liver function the patient needs careful inspection. If the abnormal liver function against the background of use of "Azithromycin" is confirmed, then reception of this antibiotic should be stopped.

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At patients with a reduced speed of filtration (less than 10 ml a minute) notes increase in system exposure of azithromycin by 33%.

lengthening of warm repolarization and an interval of QT can cause

Antibiotiki-makrolidy. Besides, risk of developing cardiac arrhythmia, trembling and ventricular fibrillation increases. At administration of medicament it is impossible to exclude similar effect completely. Therefore to patients with such violations "Azithromycin" is appointed with care.

Care is required by

also to patients who during expected treatment by antibiotics receive antiarrhytmic medicines (Zinedine, "" Prokainamid, Dofetilid, "Amiodaronum", Sotalol), neuroleptics, ftorkhinolona, antidepressants, Tsizaprid, Terfenadin, undergo treatment of violations of electrolytic exchange.

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noted strengthening of a myasthenic syndrome at the patients accepting "Azithromycin" along with the main treatment.

"Azithromycin" should not be choice medicine at treatment of tonsillitis and pharyngitis, the caused Streptococcus pyogenes. In this case, as well as for prevention of sharp rheumatic fever, it is reasonable to use penicillin.

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did not establish safety and efficiency of intravenous administration of "Azithromycin" for treatment of infections at children.

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As well as when using other antibacterial medicines, at use of "Azithromycin" does not exclude the probability of emergence of superinfection (fungal).

Reception of any antibiotics, including "Azithromycin", is accompanied by risk of developing of the diarrhea associated with Clostridium difficile. In this case diarrhea can be easy, and sometimes leads to heavy colitis with the subsequent lethal outcome. The similar effect is caused by change of normal flora of a large intestine under the influence of antibacterial medicines and the overgrowth of the pathogenic bacteriums producing toxins. In order to avoid serious consequences at all patients with the diarrhea associated with reception of antibiotics it is necessary to exclude the diarrhea caused by Clostridium difficile. Development of diarrhea and in 2 months after completion of intake of antibacterial agents therefore and after treatment it is necessary to collect the detailed medical anamnesis is not excluded.

is not recommended to apply

Capsule to treatment of children if the weight of the child is less than 45 kg.

Interaction with other medicines

Should appoint by

carefully "Azithromycin" to patients together with other medicaments which can extend QT interval.

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registered the following significant interactions at a concomitant use of "Azithromycin" with other medicines and substances:

Antacids can change

• azithromycin pharmacokinetics therefore it is not recommended to accept them along with antibiotics. It is necessary to observe a time interval between intake of these medicaments — 1 hour to or in 2 hours after reception of antiacid means.
• Colchicine and digoxin at simultaneous application with antibiotics macroleads increase R-glycoprotein substrate level in blood serum.
• Derivative ergot. Poisoning with ergot alkaloids at simultaneous application with "Azithromycin" can be observed.
• Atorvastatin. In combination with "Azithromycin", changes of concentration of statines in blood were not observed.
• Anticoagulants of a mosquito row. At a combination to antibiotics macroleads it is necessary to monitor at the patients accepting anticoagulants a prothrombin time.
• "Cyclosporine". In combination with antibiotics appoint with care.
• Rifabutin. Development of a neutropenia is possible.

Simultaneous use of "Azithromycin" and Tsetirizin, Didanozin, "Zidovudine", "Carbamazepine", "Cimetidinum", Efavirents, Flukonazol, Indinavir, "Methylprednisolonum", "Midazolam", Sildenafil, Terfenadin, "Theophylline", Triazolam, "Trimethoprimum" did not cause clinically significant changes of pharmacological and pharmacokinetic properties of the taken medicine.

Use during pregnancy and feeding by a breast

Considering insufficiency of data on safety of use of medicine, it is not recommended to appoint "Azithromycin" during pregnancy, except for cases when the expected positive effect for mother exceeds possible risk from use of medicine for a fruit.

Ability to influence speed of response at control of transport

is not recommended to be applied in need of control of vehicles and in operating time with other mechanisms.

Route of administration and doses

Capsule 1 time a day to food (in 1 hour) or after — in 2 hours. It is impossible to chew, swallow it is necessary entirely.

Dose for children weighing not less than 45 kg and adult:

1. Infectious diseases of airways, skin and soft tissues (except the chronic migrating erythema) — 500 mg (2 capsules on 250 mg) 1 time a day. Duration — 3 days.
2. Urethritis/cervicitis — 1 g (4 capsules on 250 mg) once.

in case of the admission of reception of 1 dose of medicine should accept the passed dose as soon as possible, and the subsequent — with an interval of 24 hours.

Overdose

Experience of clinical use of "Azithromycin" demonstrates to what side effects which develop at reception of higher than is recommended, medicine doses, are similar that are observed at application of usual therapeutic doses.

Typical symptoms of overdose: a reverse hearing loss, the expressed nausea, an abdominal pain, vomiting, diarrhea, strengthening of manifestations of other side reactions.

Treatment: in case of overdose it is necessary to accept activated carbon and to carry out the symptomatic therapy directed to maintenance of vital signs of an organism.

Side reactions

during post-marketing observation and also during clinical trials of influence of "Azithromycin" on bodies and the systems of an organism revealed development of the following side reactions with various frequency of manifestation:

• an infection: seldom — pneumonia, candidiasis, a fungal infection, pharyngitis, rhinitis, breath dysfunction, vaginal infections, a gastroenteritis, oral candidiasis, pseudomembranous colitis (frequency is unknown);
• nervous system: often — a headache, infrequently — drowsiness, paresthesias, dizziness, frustration of flavoring feelings, frequency is unknown — spasms, a faint, increase in psychomotor activity, an adynamy, neurosis;
• violation of mentality: infrequently — insomnia, nervousness, sometimes — agitation, it is very rare — uneasiness, aggression, hallucinations;
• organs of sight: decrease in visual acuity;
• organs of hearing: sonitus, a ring in ears, deafness. These reactions have reversible character and are shown at prolonged use of high doses of "Azithromycin";
• blood and lymphatic system: seldom — the eosinophilia, a neutropenia, a leukopenia, frequency is unknown — hemolytic anemia, thrombocytopenia;
• immune responses: infrequently — hypersensitivity, a Quincke's disease, anaphylactic reactions (frequency is unknown);
• cardiovascular system: sometimes — inflows, heartbeat failures, frequency it is unknown — trembling of ventricles, lengthening of an interval QT, ventricular tachycardia and arrhythmia, a stethalgia;
• respiratory organs: sometimes — short wind, nasal bleeding;
• bodies of a GIT: often — an abdominal pain, diarrhea, vomiting, nausea, infrequently — dyspepsia, gastritis, a meteorism, swelling, an eructation, dryness in a mouth, ulcerations in an oral cavity, frequency is unknown — pseudomembranous colitis, pancreatitis, anorexia;
• skin and hypodermic fabrics: infrequently — an itch, urticaria, dermatitis, a hyperhidrosis, xeroderma, it is rare — sharp generalized eczematic pustulez, an epidermal necrolysis, a polymorphic erythema;
• musculoskeletal system: sometimes — back, joints, bones and muscles pain;
• bodies of urination: infrequently — kidney pain, a renal failure, interstitial nephrite, the painful and speeded-up urination;
• reproductive system: infrequently — bleeding from a uterus, a vaginitis, violation of a spermatogenesis;
• general and local reactions: infrequently — excessive fatigue, an indisposition, peripheral hypostases, puffiness of the person, erubescence, a stethalgia;
• laboratory indicators: decrease in lymphocytes, increase in quantity of eosinophils, decrease in concentration of bicarbonate of blood, increase in basophiles and level of monocytes, neutrophils, infrequently — increase in level of liver enzymes and bilirubin in blood, increase in concentration of urea and creatinine in blood, change of indicators of potassium in blood, the increased content of glucose, alkaline phosphatase, chloride, platelets, decrease in a hematocrit, violation of level of sodium.

to Store

at a temperature not above 25 °C. To store out of children's reach. An expiration date - 2 years.

Category of a holiday

According to the prescription.

List of the used literature

1. Reference book of medicines the Compendium.
2. State Register of Medicines of Ukraine;
3. JAMA