AzitRus, powder for suspension 200mg sachets 4,2g 3pcs

Composition

1 package contains:

azithromycin (in the form of dihydrate) 200 mg;

excipients:

sodium citrate (three-substituted sodium citric acid),

food grade orange flavor,

sodium saccharinate,

collidone CL-M (crospovidone),

sucrose.

Pharmacological action

Azitrus is a broad-spectrum antibiotic of the macrolide group, azalide. It acts bacteriostatically. Binding to the 50S subunit of the ribosome, it suppresses protein synthesis and slows down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect. It acts on extracellular and intracellular pathogens.

Active against gram-positive microorganisms: Streptococcus spp. (groups C, F and G, except for erythromycin resistant), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus epidermidis, Staphylococcus aureus; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp., as well as intracellular pathogens: Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium avium complex, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi.

Azithromycin is not active against gram-positive bacteria resistant to erythromycin.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of the upper respiratory tract and ENT organs (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media);
• scarlet fever;
• infections of the lower respiratory tract (bacterial, including caused by atypical pathogens of pneumonia, exacerbation of chronic pneumonia, bronchitis);
• infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);
• urinary tract infection (gonococcal urethritis and degeneracy);
• infections of the female genital organs (cervicitis);
• Lyme disease (borreliosis) in the initial stage (erythema migrans);
• diseases of the stomach and duodenum, associated with Helicobacter pylori (in combination therapy).

Contraindications

• renal failure;
• hepatic impairment;
• lactation (breastfeeding);
• children up to age 6 months (for suspension);
• children’s age up to 3 years of age and/or weighing less than 25 kg (for capsules);
• children’s age up to 12 years of age and/or weighing less than 50 kg (for tablets, film-coated);
• hypersensitivity to the components of Azarosa, as well as to other macrolides.

Side effects

From the digestive system:  possible – diarrhea (5%), nausea (3%), abdominal pain (3%); ≤ 1% — flatulence, vomiting, melena, cholestatic jaundice, increased activity of hepatic transaminases; in children — constipation, decreased appetite, gastritis, candidiasis of the oral mucosa, taste changes (≤ 1%).

From the cardiovascular system:  palpitations, chest pain (<1%).

From the central nervous system:  dizziness, headache, drowsiness; in children-headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disorders (≤ 1%).

From the urinary system:  jade (≤ 1%).

From the side of the reproductive system:  vaginal candidiasis.

Allergic reactions:  rash, urticaria, pruritus of the skin, angioedema; in children-conjunctivitis, pruritus, urticaria.

Other services:  asthenia, photosensitization.

Interaction

When used concomitantly, antacids (aluminum – and magnesium-containing), ethanol, and food slow down and reduce the absorption of azithromycin. When azithromycin was co-administered in therapeutic doses with warfarin, no changes in prothrombin time were observed, however, given that the interaction of macrolides with warfarin may increase the anticoagulant effect, when prescribing this combination to patients, careful monitoring of prothrombin time is necessary. With simultaneous use, the concentration of digoxin in the blood plasma increases. When used simultaneously, the toxic effect (vasospasm, dysesthesia) of ergotamine and dihydroergotamine increases.

How to take, course of use and dosage

Inside 1 hour before or 2 hours after meals 1 time a day.

Adults: for upper and lower respiratory tract infections-500 mg / day for 1 dose for 3 days (course dose-1.5 g).

For skin and soft tissue infections-1000 mg / day on the first day for 1 dose, then 500 mg / day daily from day 2 to day 5 (course dose – 3 g).

In acute infections of the genitourinary organs (uncomplicated urethritis or cervicitis) – once 1 g. For Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) – 1 g on the first day and 500 mg daily from day 2 to 5 (course dose – 3 g).

In gastric and duodenal ulcers associated with Helicobacter pylori – 1 g / day for 3 days as part of combined anti-helicobacter therapy.

Children with infections of the upper and lower respiratory tract, skin and soft tissues are prescribed at the rate of 10 mg/kg of body weight 1 time per day for 3 days (the course dose is 30 mg/kg of body weight) or for 5 days: on the first day – 10 mg/kg of body weight, then 5-10 mg/kg of body weight 1 time per day for 4 days.

Depending on the child’s body weight, the following dosage regimens are recommended:

In the treatment of erythema migrans in children, the drug is prescribed once a day for 5 days: 20 mg/kg of body weight on the first day and 10 mg/kg of body weight from day 2 to 5.

Preparation of the suspension.

Single-dose package. A small amount of boiled and cooled water is poured into a clean cup, then the contents of one bag are poured out and mixed until a homogeneous suspension is obtained.

After taking the cup, rinse it with water, dry it and store it in a dry and clean place.

Pot. In a jar containing 400 mg or 800 mg of azithromycin, using a polymer compound dispenser, add 12 ml of boiled and chilled water or distilled water; in a jar containing 1200 mg of azithromycin – 18 ml.

The suspension is shaken before use.

The suspension is dosed with a double-sided spoon: a large spoon contains 5 ml of suspension, a small one-2.5 ml; or a spoon with two marks: the lower one corresponds to 2.5 ml of suspension and the upper one-5 ml; or a polymer compound dispenser. After use, the spoon and dispenser should be rinsed with water, dried and stored in a dry and clean place.

Overdose

Symptoms:  nausea, temporary hearing loss, vomiting, diarrhea.

Treatment:  gastric lavage, symptomatic therapy.

Special instructions

The drug is not taken during meals. If a missed dose is missed, the missed dose should be taken as early as possible, and subsequent doses should be taken at 24 – hour intervals.

It is necessary to observe a break of at least 2 hours between taking AzitRus and antacids.

After discontinuation of the drug, hypersensitivity reactions may persist in some patients; in such cases, it is recommended to prescribe specific therapy under the supervision of a doctor.

Form of production

Powder for the preparation of a suspension for oral use

Storage conditions

The drug should be stored out of the reach of children, dry, protected from light at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Oral suspension