XEMOMIЦIN

Active material: Azithromycin
When ATH: J01FA10
CCF: Macrolide antibiotics – azalid
ICD-10 codes (testimony): A31.0, A38, A46, A48.1, A56.0, A56.1, A56.4, A69.2, B96.0, H66, J01, J03, J15, J15.7, J16.0, J20, J32, J35.0, J42, K25, K26, L01, L30.3, N34, N72
When CSF: 06.07.01
Manufacturer: HEMOFARM A.D. (Serbia)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, light blue, size №0; contents of capsules – white powder.

Excipients: lactose bezvodnaya, corn starch, sodium lauryl, magnesium stearate.

The composition of the shell: titanium dioxide E171, patent blue dye VE131, gelatin.

6 PC. – blisters (1) – packs cardboard.

Pills, Film-coated grayish-blue, round, lenticular.

Excipients: microcrystalline cellulose, microcrystalline cellulose, and silicate, sodium carboxymethyl (Type A), povidone, magnesium stearate, talc, colloidal silicon dioxide.

The composition of the shell: Titanium dioxide, talc, kopovydon, ethyl cellulose, macrogol 6000, indigokarmin (indigotin) E132, dye paint green 8%: indigokarmin (indigotin) E132, hinolinovыy zheltыy E104.

3 PC. – blisters (1) – packs cardboard.

Powder for oral suspension white or nearly white, with a fruity odor; cooked slurry is nearly white with a fruity odor.

Excipients: Xanthan Gum, sodium saccharin, calcium carbonate, colloidal silicon dioxide, Sodium phosphate anhydrous, sorbitol, cherry flavor, apple and strawberry flavors.

11.43 g – vials of dark glass (1) complete with measuring spoon – packs cardboard.

Powder for oral suspension white or nearly white, with a fruity odor; A suspension almost white color with a fruity odor.

Excipients: Xanthan Gum, sodium saccharin, calcium carbonate, colloidal silicon dioxide, Sodium phosphate dodecahydrate, sorbitol, cherry flavor, apple and strawberry flavors.

10 g – vials of dark glass (1) complete with measuring spoon – packs cardboard.

Pharmacological action

Broad-spectrum antibiotic. Azithromycin is a representative subgroup of macrolide antibiotics – azalides. In high concentrations it has a bactericidal effect.

Xemomiцin active against aerobic Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. Group C, F and G, Streptococcus viridans, Staphylococcus aureus; Aerobic Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Helicobacter pylori, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; Anaerobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.

Preparation active against intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, and also against Treponema pale.

C drug resistant Gram-positive bacteria, resistant to erythromycin.

Pharmacokinetics

Absorption

Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic medium and lipophilicity. After oral dose Hemomitsin 500 mg C_max azithromycin plasma levels achieved after 2.5-2.96 h and is 0.4 mg / l. Bioavailability is 37%.

Distribution

Azithromycin well into the respiratory tract, organs and tissues of the urogenital tract, in prostate, in skin and soft tissue. High concentrations in tissues (in 10-50 times higher, than in blood plasma) and a long T_1/2 due to low binding of azithromycin from plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrated in a low pH environment, environmental lysosomes. It, in turn, It defines a large apparent V_d (31.1 l / kg) and high plasma clearance. The ability of azithromycin to accumulate mainly in lysosomes is particularly important for elimination of intracellular pathogens. Proved, that phagocytes deliver azithromycin to the localization of infection, where it is released in the process of phagocytosis. The concentration of azithromycin in the foci of infection was significantly higher, than in healthy tissues (on average 24-34%) and correlate with the degree of inflammatory edema. Despite the high concentration in phagocytes, Azithromycin has no significant effect on their function.

Azithromycin remains in bactericidal concentrations of inflammation within 5-7 days after the last dose, which allowed the development of short (3-day and 5-day) treatments.

Deduction

Derivation of azithromycin in plasma passes 2 Phase: T_1/2 is 14-20 hours, ranging from 8 to 24 hours after dosing and 41 h - in the range of 24 to 72 no, allowing you to use the drug 1 time / day.

Testimony

Infectious-inflammatory diseases, caused by susceptible to malaria infections:

- Infections of the upper respiratory tract and ENT (sore throat, sinusitis, tonsillitis, otitis media);

- Scarlet fever;

- Infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);

- Urogenitalynogo tract infections (uncomplicated urethritis and / or cervicitis);

- Infections of the skin and soft tissues (mug, impetigo, secondarily infected dermatitis);

- Lyme disease (ʙorrelioz) for the treatment of early stage (Erythema migrans);

- Diseases of the stomach and duodenum, associated with Helicobacter pylori (in a combination therapy) (Pill).

Dosage regimen

The drug is taken orally 1 time / day for 1 hours before meals or 2 hours after meals, tk. when taken with food decreases absorption of azithromycin.

In the case of missing a single dose of the drug, it should be taken as early as possible, and the subsequent dose – intervals 24 no.

Capsules

Adults at infections of the upper and lower respiratory tract Hemomitsin appoint 500 mg (2 caps.) daily for 3 days; kursovaya dose – 1.5 g.

At infections of skin and soft tissue appointed 1 g (4 caps.) 1 day, further – by 500 mg (2 caps.) daily from 2 on the 5th day; kursovaya dose – 3 g.

At Acute uncomplicated urethritis or cervicitis administered once 1 g (4 caps.).

At Lyme disease (ʙorrelioze) for the treatment of early stage (Erythema migrans) appoint 1 g (4 caps.) at day 1 and 500 mg (2 caps.) daily from 2 on the 5th day (kursovaya dose – 3 g).

At diseases of the stomach and duodenum, associated with Helicobacter pylori, appoint 1 g (4 caps.) daily for 3 days in a combination therapy of H. pylori.

Children over 12 years at infections of the upper and lower respiratory tract, skin and soft tissue the drug is prescribed on the basis of 10 mg / kg 1 times / day for 3 days (kursovaya dose – 30 mg / kg) or the first day of – 10 mg / kg, then 4 day – by 5-10 mg / kg / day.

At treatment of erythema migrans – 20 mg / kg 1 day and 10 mg / kg at a 2 on the 5th day.

Pills

Adults and children over 12 years at infections of the upper and lower respiratory tract appoint 500 mg / day for 3 days; kursovaya dose – 1.5 g.

At infections of skin and soft tissue appointed 1 g / day on the first day, hereinafter 500 mg daily with 2 on the 5th day; kursovaya dose – 3 g.

At Acute uncomplicated urethritis or cervicitis prescribe a single dose 1 g.

At Lyme disease (ʙorrelioze) for the treatment of early stage (Erythema migrans) the drug is prescribed in a dose 1 g in 1 day and 500 mg daily with 2 on the 5th day; kursovaya dose – 3 g.

At diseases of the stomach and duodenum, associated with Helicobacter pylori, appoint 1 g / day for 3 days in a combination therapy of H. pylori.

Suspension 200 mg / 5 ml 100 mg / 5ml

In older children 12 Months use suspension 200 mg / 5ml, in older children 6 Months – suspension 100 mg / 5ml.

Babies at infections of the upper and lower respiratory tract, infections of skin and soft tissue (with the exception of chronic erythema migrans) Hemomitsin administered in the form of a suspension of calculation 10 mg / kg body weight for 3 days.

The recommended dosing regimen Hemomitsin depending on the child's weight and the concentration of the suspension and in the following table.

Adults at infections of the upper and lower respiratory tract appoint 500 mg / day for 3 days; kursovaya dose – 1.5 g. At infections of skin and soft tissue, as well as Lyme disease (ʙorrelioz) to treatment of early stage (Erythema migrans) appointed 1 g / day Day 1, hereinafter 500 mg daily with 2 on the 5th day; kursovaya dose – 3 g.

At Chronic erythema migrans – administered in one day at a dose rate of 20 mg / kg body weight, then with 2 on the 5th day – by 10 mg / kg body weight.

At urogenital tract infections drug prescribed Children up to 8 years with a body weight 45 kg calculated 10 mg / kg once.

The recommended dosing regimen for the treatment of Hemomitsin Erythema migrans in children depending on the body weight and the concentration of the slurry in the following table.

1-Day

2 – 5-Day

Rules suspension

In vial, containing powder, water added (distilled or boiled and cooled) up to the mark. The contents of the vial thoroughly stirred until a homogeneous suspension. The prepared suspension is stable at room temperature for 5 days.

Before use, the suspension should be shaken.

Immediately after receiving a suspension of the child should be allowed to drink a few sips of fluid (water, tea) for, and to flush the remaining swallow oral suspension.

Side effect

From the digestive system: diarrhea (5%), nausea (3%), stomach ache (3%); 1% less – dyspepsia, vomiting, flatulence, ground, cholestatic jaundice, increase in liver enzymes, children – constipation, anorexia, gastritis, change in taste, candidiasis of the oral mucosa.

Cardio-vascular system: heartbeat, chest pain (1% less).

CNS: dizziness, headache, vertigo, drowsiness; children – headache (for the treatment of otitis media), giperkineziya, anxiety, neurosis, sleep disturbance (1% less).

On the part of the reproductive system: vaginal candidiasis.

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

Allergic reactions: rash, angioedema; children – conjunctivitis, itch, hives.

Other: fatigue, photosensitivity.

Contraindications

- Liver failure;

- Renal failure;

- Children up to age 12 years (for capsules and tablets);

- Children up to age 12 Months (for suspension 200 mg / 5ml);

- Children up to age 6 Months (for suspension 100 mg / 5ml);

- Hypersensitivity to macrolide antibiotics.

FROM caution should be prescribed during pregnancy, arrhythmia (ventricular arrhythmias and QT prolongation), children with severe hepatic or renal function.

Pregnancy and lactation

When pregnancy Hemomitsin appoint only, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should decide the issue of termination of breastfeeding at the time of the drug.

Cautions

Do not take the drug during meals.

Recommended observance interval of not less than 2 hours between taking antacids and Hemomitsin.

After discontinuation of treatment in some patients, hypersensitivity reactions may persist, which requires specific treatment and medical monitoring.

Overdose

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

Treatment: gastric lavage, symptomatic therapy.

Drug Interactions

With simultaneous use of antacids and Hemomitsin (aluminum- E magniisodyerjashikh) It slows down the absorption of azithromycin.

Ethanol and food slow down and reduce the absorption of azithromycin.

The joint appointment of warfarin and azithromycin (at conventional doses) changes in prothrombin time is not revealed, However, given the, that the interaction of macrolides and warfarin may increase the anticoagulant effect, Patients should be closely monitored prothrombin time.

Combined use of azithromycin and digoxin increases the concentration of the latter.

With simultaneous use of azithromycin with ergotamine and dihydroergotamine noted increased toxic effect last (vasospasm, dysesthesia).

Co-administration of triazolam and azithromycin reduces the clearance and enhances the pharmacological effect of triazolam.

Azithromycin slows down and increases the plasma concentration and toxicity of cycloserine, anticoagulants, methylprednisolone, Felodipine, and drugs, undergoing microsomal oxidation (Carbamazepine, terfenadine, cyclosporine, geksoʙarʙital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemics, Theophylline and other xanthine derivatives) – due to inhibition of azithromycin microsomal oxidation in hepatocytes.

Linkozaminy weaken the effectiveness of azithromycin, and tetracycline and chloramphenicol – increase.

Pharmaceutical interaction

Pharmaceutically azithromycin incompatible with heparin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, protected from light, at a temperature from 15 ° to 25 ° C. Shelf life – 2 year.