Chemomycin, capsules 250mg, 6pcs

Composition

1 capsule contains the Active ingredient:  

Azithromycin (in the form of azithromycin dihydrate-262.03 mg) — 250 mg.

Auxiliary substances:  

Lactose anhydrous — 163.60 mg* (151.57 mg),

Corn starch — 47.00 mg,

Sodium lauryl sulfate — 0.94 mg,

Magnesium stearate — 8.46 mg,

Capsule shell composition:  

Titanium dioxide E 171 — 1.44 mg,

Proprietary blue dye V E 131 — 0.0164 mg,

Gelatin – up to 96 mg.

* the amount of lactose anhydrous depends on the activity of the Active ingredient.

Pharmacological action

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

Hemomitsin active against aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. groups 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.

The drug is active against intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, as well as against Treponema pallidum.

Gram-positive bacteria resistant to erythromycin are resistant to the drug.

Pharmacokinetics

Suction

Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity.

After oral use of Chemomycin at a dose of 500 mg, the Cmax of azithromycin in blood plasma is reached in 2.5-2.96 hours and is 0.4 mg/l. Bioavailability is 37%.

Distribution

Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract, into the prostate gland, into the skin and soft tissues.

The high concentration in tissues (10-50 times higher than in blood plasma) and long T1/2 are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate into eukaryotic cells and concentrate in a low pH environment surrounding lysosomes.

This, in turn, determines the large apparent Vd (31.1 l / kg) and high plasma clearance.

The ability of azithromycin to accumulate mainly in lysosomes is particularly important for the elimination of intracellular pathogens.

Phagocytes have been shown to deliver azithromycin to the sites of infection, where it is released during phagocytosis.

The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema.

Despite the high concentration in phagocytes, azithromycin does not significantly affect their function.

Azithromycin remains in bactericidal concentrations in the focus of inflammation for 5-7 days after the last dose, which made it possible to develop short (3-day and 5-day) treatment courses.

Metabolism

In the liver, azithromycin is demethylated, the resulting metabolites are not active.

Deduction

Removal of azithromycin from blood plasma takes place in 2 stages: T1 / 2 is 14-20 hours in the range from 8 to 24 hours after taking the drug and 41 hours – in the range from 24 to 72 hours, which allows the drug to be used 1 time / day.

Indications

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

• infections of the upper respiratory tract and ENT organs (tonsillitis, sinusitis, tonsillitis, otitis media);
• scarlet fever;
• infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);
• infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);
• infection of the urogenital tract (uncomplicated urethritis and/or cervicitis);
• Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans);
• diseases of the stomach and duodenum, associated with Helicobacter pylori (in combination therapy).

Use during pregnancy and lactation

During pregnancy, Chemomycin is prescribed only when the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

If it is necessary to use the drug during lactation, the question of stopping breastfeeding for the duration of the drug should be decided.

Contraindications

• hypersensitivity (including to other macrolides);
• severe liver and kidney function disorders;
• pregnancy;
• breast-feeding (suspended for the duration of treatment);
• children under 12 years of age.

Side effects

From the digestive system: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less – dyspepsia, vomiting, flatulence, melena, cholestatic jaundice, increased activity of liver enzymes, constipation, anorexia, gastritis in children.

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

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

From the genital system: vaginal candidiasis.

From the urinary system: nephritis (1% or less).

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

Other: increased fatigue, photosensitivity.

Interaction

Simultaneous use of Chemomycin and antacids(aluminum – and magnesium-containing) slows down the absorption of azithromycin.

Ethanol and food slow and reduce the absorption of azithromycin.

When warfarin and azithromycin were co-administered (in normal doses), no changes in prothrombin time were detected, but given that the interaction of macrolides and warfarin may increase the anticoagulant effect, patients should carefully monitor prothrombin time.

The combined use of azithromycin and digoxin increases the concentration of the latter.

With the simultaneous use of azithromycin with ergotamine and dihydroergotamine, an increase in the toxic effect of the latter (vasospasm, dysesthesia) is noted.

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

Azithromycin slows excretion and increasing the plasma concentration and toxicity of cycloserine, anticoagulants, methylprednisolone, felodipine and drugs that undergo

microsomal oxidation (carbamazepine, terfenadine, cyclosporine, gexobarbitala, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic drugs,

theophylline and other xanthine derivatives) due to the inhibition by azithromycin microsomal oxidation in hepatocytes.

Lincosamines weaken the effectiveness of azithromycin, while tetracycline and chloramphenicol enhance it.

Pharmaceutical interaction

Pharmacologically, azithromycin is incompatible with heparin.

How to take, course of use and dosage

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

For upper and lower respiratory tract infections,500 mg/day is prescribed for 3 days (the course dose is 1.5 g).

For infections of the skin and soft tissues — 1 g/day on the first day for 1 reception, then-0.5 g / day daily, from the 2nd to the 5th day (the course dose is 3 g).

With uncomplicated urethritis and / or cervicitis,1 g is prescribed once.

In Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans),1 g is prescribed on day 1 and 500 mg daily from day 2 to day 5 (the course dose is 3 g).

For diseases of the stomach and duodenum associated with Helicobacter pylori,1 g per day is prescribed for 3 days as part of a combination therapy.

If you miss 1 dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones-with a break of 24 hours.

Overdose

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

Treatment: gastric lavage, symptomatic therapy.

Special instructions

Do not take the drug during meals.

It is recommended to observe an interval of at least 2 hours between taking Chemomycin and antacids.

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

Form of production

Solid gelatin capsule of light blue color size No. 0. Capsule content: white powder

Storage conditions

In a place protected from light and moisture, at a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Pregnant women as prescribed by a doctor, Children as prescribed by a doctor, Children over 12 years of age, Adults as prescribed by a doctor

Indications

Bronchitis, Otitis media, Pharyngitis, Skin Infections, Respiratory Tract Infections, Sore Throat, Urethritis, Pneumonia, Infectious Diseases, Urinary Tract Infections, Sinusitis, Sinusitis, Tonsillitis