Azitrus

Azitrus – antibacterial drug with bacteriostatic action from group of macroleads (azalead), active concerning gram-positive microorganisms, except for the bacteria steady against erythromycin.

Form of release and structure

• Capsules: size No. 0, gelatinous, yellow color; contents – granules of almost white or white color (in blister strip packagings on 6 pieces, 1 packaging in a pack cardboard);
• Powder for preparation of suspension for intake (for children): almost white or white color, with an orange smell; ready suspension – homogeneous, color, white with a yellowish shade (in one-dose packages on 4,2 g, in a pack of cardboard 3 or 6 packages, in a set there can be a glass; 100 mg / 5 ml – on 17 g, 200 mg / 5 ml – on 25 g in dark glass jars, in a pack of cardboard 1 bank complete with a dosing spoon and the doser or a 2-sided dosing spoon).

Structure of 1 capsule:

• Active agent: azithromycin (in the form of a dihydrate) – 250 mg;
• Excipients: microcrystallic cellulose, calcium stearate, polyvinylpirrolidone;
• Structure of a capsular cover: gelatin, пропилгидроксибензоат, titanium dioxide, acetic acid, methylhydroxybenzoate.

Structure of 1 package of powder:

• Active agent: azithromycin (in the form of a dihydrate) – 50, 100 or 200 mg;
• Excipients: sucrose, sodium saccharinate, sodium citrate (sodium citrate trisubstituted), коллидон CL-M (кросповидон), fragrance food orange.

Indications to use

Azitrus is applied to treatment of the infectious and inflammatory diseases of bodies and systems caused by sensitive microorganisms:

• ENT organs and upper parts of respiratory tracts: sinusitis, quinsy, pharyngitis, tonsillitis, average otitis;
• Lower parts of respiratory tracts: the bronchitis, an exacerbation of chronic pneumonia, bacterial infections including caused by atypical causative agents of pneumonia;
• Skin and soft tissues: for the second time the infected dermatosis, impetigo, an ugly face;
• Urinary tract: urethritis (including gonorrheal);
• Female generative organs: cervicitis.

Also Azitrus is applied to treatment of the following diseases:

• Scarlet fever;
• Erythema creeping (erythema migrans) – an initial stage of a disease of Lyme (tick-borne borreliosis);
• The diseases of a stomach and 12-perstny gut associated with Helicobacter pylori bacterium (as a part of complex therapy).

Contraindications

Absolute:

• Renal and liver failure;
• Children's age: up to 6 months – for the suspension prepared from powder; up to 3 years and/or with body weight it is less than 25 kg – for capsules;
• Lactation period;
• Hypersensitivity to components of drug or other macroleads.

With care:

• Disturbances of a cordial rhythm;
• Pregnancy;
• The expressed dysfunctions of livers/kidneys at children.

Route of administration and dosage

Azitrus it is necessary to accept in 1 times a day in 1 hour prior to food or in 2 hours after meal.

The recommended dosages for adults depending on indications:

• Respiratory infections: on 500 mg/days a 3-day course;
• Infections of skin and soft tissues, erythema creeping: the 1st day – 1000 mg, 2-5 days – on 500 mg;
• Uncomplicated urethritis and/or cervicitis: 1000 mg once;
• The peptic ulcer of a stomach and 12-perstny gut caused a helikobakter of a pilora (as a part of a combination therapy): on 1000 mg/days within 3 days.

The recommended doses for children:

• Respiratory infections, soft tissues and skin: in the 1st day of 10 mg/kg, during the next 4 days – on 5-10 mg/kg/days or on 10 mg/kg of 1 times a day within 3 days;
• The erythema is creeping: the 1st day – 20 mg/kg, 2-5 days – on 10 mg/kg/days.

To children Azitrus is more senior than 6 months appoint in the form of the suspension prepared from powder.

The recommended daily (one-time) doses of suspension depending on the body weight of the child at use of powder in a dose of 100 mg / 5 ml – azithromycin (suspension):

• 5 kg – 50 mg (2,5 ml);
• 6 kg – 60 mg (3 ml);
• 7 kg – 70 mg (3,5 ml);
• 8 kg – 80 mg (4 ml);
• 9 kg – 90 mg (4,5 ml);
• 10-14 kg – 100 mg (5 ml).

The recommended daily (one-time) doses of suspension depending on the body weight of the child at use of powder in a dose of 200 mg / 5 ml – azithromycin (suspension):

• 15-24 kg – 200 mg (5 ml);
• 25-34 kg – 300 mg (7,5 ml);
• 35-44 kg – 400 mg (10 ml);
• From 45 kg – doses for adults (from 500 to 1000 mg).

Rules of preparation of suspension for intake: in a pure glass to pour a small amount of boiled and chilled water, to pour out contents of 1 package and to mix before receiving homogeneous suspension. After administration of drug to wash out a glass clear water, to dry up and store in the pure dry place.

Side effects

• Allergic reactions: rash, skin itch, small tortoiseshell, Quincke's disease; children have an itch, urticaria, conjunctivitis;
• From the alimentary system:> 1% – an abdominal pain, nausea, diarrhea; ≤1% – a melena, vomiting, a meteorism, increase in activity of hepatic transaminases, cholestatic jaundice; at children (≤1%) – taste change, a loss of appetite, candidiasis of a mucous membrane of an oral cavity, locks, gastritis;
• From an urinary system: ≤1% – nephrite;
• From the central nervous system: ≤1% – a headache, dizziness, drowsiness; at children (≤1%) – sleep disorders, uneasiness, a hyperkinesia, neurosis, a headache (at treatment of average otitis);
• From cardiovascular system: ≤1% – thorax pains, heartbeat;
• From a reproductive system: vaginal candidiasis;
• Others: photosensitization, adynamy.

Special instructions

It is not necessary to accept Azitrus during food.

In case of the admission of the next reception the passed dose needs to be accepted as soon as possible, and to accept the subsequent bucketed 24 hours.

At the accompanying purpose of antacids between administrations of drugs it is necessary to observe a break at least 2 hours.

After Azitrus's cancellation at some patients hypersensitivity reactions can remain, in these cases performing specific therapy under medical control is recommended.

At purpose of high doses of drug it is possible to take a pill, film coated, Azitrus forte in a dose of 500 mg.

Medicinal interaction

• Aluminum - and magnesium the containing antacids, ethanol and food: azithromycin absorption is slowed down and decreases;
• Digoxin: its concentration in a blood plasma increases;
• Ergotamine, dihydroergotamine: their toxic action (a dizesteziya, a vasospasm) amplifies;
• To triazoles: its clearance decreases and pharmacological action amplifies;
• Linkozamina: efficiency of azithromycin decreases;
• Tetracycline, chloramphenicol: the effect of azithromycin amplifies;
• Indirect anticoagulants, фелодипин, Methylprednisolonum, Cycloserinum and drugs which are exposed to a microsomal oxidation (peroral hypoglycemic means, ergot alkaloids, cyclosporine, Bromocriptinum, терфенадин, Disopyramidum, hexobarbital, Phenytoinum, valproic acid, carbamazepine, xanthine derivatives, including theophylline): their removal is slowed down, concentration in plasma and toxicity increase.

As macroleads, interacting with warfarin, strengthen its anticoagulating action, the similar effect can be expected at co-administration of Azitrus therefore it is necessary to control a prothrombin time carefully.

Terms and storage conditions

To store in the dry, dark, protected from children place at a temperature up to 25 ºС.

Period of validity – 2 years.