Powder for oral suspension "Azitro Sandoz ®" in this dosage is used for 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 urethritis/cervicitis caused by Chlamydia trachomatis.
Composition
The active substance is azithromycin (5 ml of suspension contains 200 mg of azithromycin in the form of azithromycin monohydrate).
Excipients: sucrose, xanthan gum, hydroxypropyl cellulose, sodium phosphate anhydrous, colloidal silicon dioxide anhydrous, aspartame (E 951), cream caramel flavor, titanium dioxide (E 171).
Contraindication
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any component of the drug; severe liver dysfunction; due to the theoretical possibility of ergotism, azithromycin should not be administered simultaneously with ergot derivatives.
Method of application
Dosage and duration of treatment are determined by the doctor. Take the suspension once a day 1 hour before or 2 hours after a meal, as simultaneous administration may impair the absorption of azithromycin.
The taste sensation after taking the suspension can be improved by drinking it with fruit juice. If one dose of the drug is missed, the next dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
Adult patients
For infections of the ENT organs and respiratory tract, skin and soft tissues (except chronic migratory erythema), the total dose of azithromycin is 1500 mg, 500 mg once a day. The duration of treatment is 3 days.
For sexually transmitted infections caused by Chlamydia trachomatis, the dose is 1000 mg orally once.
For erythema migrans, the total dose of azithromycin is 3 g: 1 g should be taken on day 1, then 500 mg once a day from day 2 to day 5. The duration of treatment is 5 days.
Children
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.
For erythema migrans, the total dose of azithromycin is 60 mg/kg: on day 1, 20 mg/kg of body weight should be taken, then 10 mg/kg of body weight once a day from day 2 to day 5. The duration of treatment is 5 days.
Azithromycin has been shown to be effective in the treatment of streptococcal pharyngitis in children given as a single dose of 10 mg/kg or 20 mg/kg for 3 days. When these two doses were compared in clinical trials, similar clinical efficacy was found, although bacterial eradication was greater with the daily dose of 20 mg/kg. However, penicillin is usually the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and secondary rheumatoid arthritis.
Body weight more than 15 kg - azithromycin 200 mg / 5 ml is used. Depending on the child's body weight, the following dosage regimen is recommended:
15-24 kg: daily dose of suspension - 5 ml (azithromycin content in the daily dose of suspension - 200 mg); 25-34 kg: daily dose of suspension - 7.5 ml (azithromycin content in the daily dose of suspension - 300 mg); 35-44 kg: daily dose of suspension - 10 ml (azithromycin content in the daily dose of suspension - 400 mg); ≥ 45 kg: daily dose of suspension - 12.5 ml (azithromycin content in the daily dose of suspension - 500 mg).
To prepare 20 ml of suspension, you need:
Shake the bottle thoroughly to separate the powder from the walls and bottom; open the bottle cap and place the adapter in the bottle neck; draw 10.5 ml of drinking water into a syringe (10 ml with 0.25 ml markings); place the tip of the syringe into the adapter; add 10.5 ml of water from the syringe to the bottle with the powder, shaking until a homogeneous suspension is obtained.
Shake well before each use.
To measure the required amount of suspension using the supplied syringe, you must:
shake the suspension; place the tip of the syringe into the adapter; turn the bottle upside down; draw the required amount of suspension into the syringe; turn the bottle in the correct position, remove the syringe and close the bottle with the cap.
Application features
Pregnant women
There are no adequate data on the use of azithromycin in pregnant women. The safety of azithromycin during pregnancy has not been established. Therefore, azithromycin should be prescribed during pregnancy only if the benefits outweigh the risks.
Azithromycin has been reported to pass into breast milk, but adequate and well-controlled clinical studies to characterize the pharmacokinetics of azithromycin excretion into breast milk have not been conducted. Therefore, it is recommended to discontinue breastfeeding during treatment and for 2 days after the end of treatment.
Fertility studies have been performed in rats; pregnancy rates were reduced following administration of azithromycin. The relevance of these findings to humans is unknown.
Drivers
There is no evidence that azithromycin can impair the ability to drive or use other mechanisms, but the possibility of developing adverse reactions such as dizziness, drowsiness, and visual disturbances should be taken into account.
Overdose
Treatment: gastric lavage, symptomatic and supportive therapy.
Side effects
Adverse reactions possibly or probably related to azithromycin, based on data obtained during clinical trials and during post-marketing surveillance, are listed below.
From the nervous system: often (≥ 1/100, <1/10) - headache.
Gastrointestinal tract: very often (≥ 1/10) - diarrhea; often (≥ 1/100, <1/10) - vomiting, abdominal pain, nausea.
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 3 years.
Store the prepared suspension at a temperature not exceeding 25 °C for 5 days.
