Azimed powder for oral suspension is indicated for the treatment of infections caused by microorganisms sensitive to azithromycin:
ENT organs (bacterial pharyngitis/tonsillitis, sinusitis, otitis media); respiratory tract infections (bacterial bronchitis, community-acquired pneumonia); skin and soft tissue infections: erythema migrans (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatoses; sexually transmitted infections: uncomplicated genital infections caused by Chlamydia trachomatis.
Composition
Active ingredient: azithromycin;
5 ml of suspension contains azithromycin dihydrate equivalent to azithromycin 200 mg;
Excipients: sucrose, sodium phosphate, hydroxypropyl cellulose, xanthan gum, colloidal anhydrous silicon dioxide, cherry flavor, banana flavor, vanilla flavor.
Contraindication
Hypersensitivity to the active substance, other components of the drug or to other macrolide antibiotics. Given the theoretical possibility of ergotism, azithromycin should not be used simultaneously with ergot derivatives.
Do not use in children weighing less than 5 kg.
Method of administration and doses
Administer as a single daily dose at least 1 hour before or 2 hours after a meal. Measure the dose using the oral dosing syringe or spoon provided in the package.
Immediately after using the suspension, the child should be given a few sips of liquid to wash away and swallow any remaining suspension in the oral cavity.
If you miss a dose of the drug, the missed dose should be taken as soon as possible, and the following doses should be taken at intervals of 24 hours.
For infections of the ENT organs and respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 30 mg/kg body weight (10 mg/kg body weight 1 time per day). The duration of treatment is 3 days.
Application features
Pregnant women
Azithromycin should be prescribed during pregnancy only if absolutely necessary.
Children
Use in children weighing 5 to 15 kg. Children weighing more than 15 kg are recommended to use Azimed®, powder for oral suspension, 200 mg/5 ml.
Drivers
There is no evidence that azithromycin can impair the ability to drive or operate other mechanisms, but the possibility of developing adverse reactions such as dizziness, drowsiness, and visual disturbances should be taken into account.
Overdose
Clinical experience with azithromycin suggests that the side effects that develop when taking higher than recommended doses of the drug are similar to those observed with the use of conventional therapeutic doses. They may include diarrhea, nausea, vomiting, reversible hearing loss. In case of overdose, if necessary, it is recommended to take activated charcoal and carry out general symptomatic and supportive measures.
Side effects
Blood and lymphatic system disorders: infrequently - leukopenia, neutropenia, eosinophilia; not known - thrombocytopenia, hemolytic anemia; mental disorders: infrequently - nervousness, insomnia; rarely - agitation; not known - aggressiveness, restlessness, increased psychomotor activity, delirium, hallucinations; nervous system disorders: often - headache; infrequently - dizziness, drowsiness, paresthesia, dysgeusia; not known - fainting, convulsions, anosmia, parosmia, ageusia, myasthenia gravis, hypoesthesia; visual disorders: often - visual disturbances; hearing disorders: infrequently - hearing impairment, vertigo; not known - hearing impairment, including deafness and/or tinnitus; cardiac disorders: infrequently - palpitations; not known - torsade de pointes, arrhythmia, including ventricular tachycardia (it has been found that they are also caused by other macrolide antibiotics), prolongation of the QT interval on the ECG; from the vascular system: infrequently - hot flashes; not known - arterial hypotension; from the respiratory system: infrequently - dyspnea, epistaxis, respiratory function disorders, rhinitis; from the digestive tract: very often - diarrhea; often - nausea, vomiting, abdominal discomfort (pain / cramps); infrequently - gastritis, flatulence, dyspepsia, dysphagia, dry mouth, eructation, mouth ulcers, hypersecretion of saliva, anorexia, constipation; not known - tongue discoloration, pancreatitis;
Interaction
Azithromycin should be administered with caution simultaneously with other drugs that may prolong the QT interval.
Antacids: Concomitant administration of antacids generally does not alter the bioavailability of the drug, although peak plasma concentrations of azithromycin are reduced by 30%. Azithromycin should be taken at least 1 hour before or 2 hours after taking an antacid.
Cetirizine: In healthy volunteers, concomitant administration of azithromycin for 5 days with cetirizine 20 mg at steady state did not result in any pharmacokinetic interaction or significant changes in the QT interval.
Digoxin: Concomitant use of macrolide antibiotics, including azithromycin, and P-glycoprotein substrates, such as digoxin, has been reported to increase serum levels of the P-glycoprotein substrate. Therefore, the possibility of increased serum digoxin concentrations should be considered when azithromycin and digoxin are coadministered.
Zidovudine. Single doses of 1000 mg and 1200 mg or multiple doses of 600 mg of azithromycin did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these findings is unclear but may be useful for patients.
Ergot. Given the theoretical possibility of ergotism, the simultaneous administration of azithromycin with ergot derivatives is not recommended.
Azithromycin does not have a significant interaction with the hepatic cytochrome P450 system. It is believed that the drug does not have the pharmacokinetic drug interactions observed with erythromycin and other macrolides. Azithromycin does not cause induction or inactivation of cytochrome P450 through the cytochrome-metabolite complex.
Pharmacokinetic studies have been conducted on the use of azithromycin and the following drugs, the metabolism of which occurs to a large extent with the participation of cytochrome P450.
Atorvastatin: Concomitant administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter plasma concentrations of atorvastatin (based on an HMG-CoA reductase inhibition assay).
Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the plasma levels of carbamazepine or its active metabolites.
Cimetidine: In a pharmacokinetic study of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, taken 2 hours before azithromycin, no changes in the pharmacokinetics of azithromycin were observed.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Store the prepared suspension in its original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
The shelf life of the finished suspension is 10 days.
