Composition, form of production and packaging
Capsules hard gelatinous, light blue color, size в„–0; the contents of the capsules are white powder.
1 caps.
azithromycin dihydrate 262.03 mg,
which corresponds to the content of azithromycin 250 mg
Excipients: lactose anhydrous - 163.6 mg * (151.57 mg), corn starch - 47 mg, sodium lauryl sulfate - 0.94 mg, magnesium stearate - 8.46 mg.
* The amount of lactose anhydrous depends on the activity of the active substance.
Composition of the coating: titanium dioxide (E171) - 1.44 mg, dye patented blue V (E131) - 0.0164 mg, gelatin - up to 96 mg.
6 pcs. - blisters (1) - packs of cardboard.
The tablets covered with a film membrane of grayish-blue color, round, biconcave.
1 tab.
azithromycin (in the form of dihydrate) 500 mg
Excipients: microcrystalline silicate cellulose - 69 mg, microcrystalline cellulose - 57 mg, sodium carboxymethyl starch (type A) - 46 mg, povidone - 24 mg, magnesium stearate - 10 mg, talc - 10 mg, silicon colloidal dioxide - 1 mg.
The composition of the coating : titanium dioxide - 10.58 mg, talc - 9.57 mg, kapovidone - 4.95 mg, ethyl cellulose - 4.95 mg, macrogol 6000 - 1.32 mg, indigocarmine (indigotine) E132 - 1.22 mg, dye lacquer green 8% (indigokarmin (indigotin) E132 , quinoline yellow E104) 0.41 mg.
3 pcs. - blisters (1) - packs of cardboard.
Powder for the preparation of a suspension for ingestion of white or almost white color, with a fruity smell; The prepared suspension is almost white, with a fruity odor.
5 ml of finished couscous.
azithromycin dihydrate 104.809 mg,
which corresponds to the content of azithromycin 100 mg
Auxiliary substances: xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162.503 mg, silicon dioxide colloid - 26.008 mg, sodium phosphate anhydrous - 17.259 mg, sorbitol - 2145.682 mg, apple flavor - 3.303 mg, strawberry flavor - 8.159 mg, cherry flavoring - 12.096 mg.
11.43 g - bottles of dark glass (1) complete with a measuring spoon (volume 5 ml, with a risk for volume 2.5 ml) - packs cardboard.
Powder for the preparation of a suspension for ingestion of white or almost white color, with a fruity smell; The prepared suspension is almost white, with a fruity odor.
5 ml of finished couscous.
azithromycin dihydrate 209.6 mg,
which corresponds to the content of azithromycin 200 mg
Auxiliary substances: gum xanthan, sodium saccharinate, calcium carbonate, silicon dioxide colloid, sodium phosphate anhydrous, sorbitol, apple flavor, strawberry flavor, cherry flavor.
10 g - bottles of dark glass (1) complete with a measuring spoon (volume 5 ml, with a risk for volume 2.5 ml) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antibiotic of a wide spectrum of action. Azithromycin is a representative of a subgroup of macrolide antibiotics - azalides. In high concentrations has a bactericidal effect.
Hemomycin is 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, and also with respect to Treponema pallidum.
Gram-positive bacteria resistant to erythromycin are resistant to the drug.
PHARMACOKINETICS
Suction
Azithromycin is rapidly absorbed from the digestive tract, which is due to its stability in acidic environment and lipophilicity. After administration of Hemomycin in a dose of 500 mg C max azithromycin in blood plasma is achieved through 2.5-2.96 h and is 0.4 mg / l. Bioavailability is 37%.
Distribution
Azithromycin well penetrates the respiratory tract, organs and tissues of the urogenital tract, into the prostate gland, the skin and soft tissues. High concentrations in tissues (10-50 times higher than in plasma) and long T 1/2 are due to low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a medium with a low pH surrounding the lysosome . This, in turn, determines a large apparent V d (31.1 l / kg) and high plasma clearance. The ability of azithromycin to accumulate mainly in lysosomes is especially important for the elimination of intracellular pathogens. It is proved that phagocytes deliver azithromycin to the site of infection, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (an average of 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not significantly affect their function.
Azithromycin is retained in bactericidal concentrations in the inflammatory focus within 5-7 days after administration of the last dose, which allowed the development of short (3-day and 5-day) treatment courses.
Metabolism
In the liver, azithromycin is demethylated, the metabolites formed are not active.
Excretion
Excretion of azithromycin from the blood plasma takes place in 2 stages: T 1/2 is 14-20 hours in the interval from 8 to 24 hours after taking the drug and 41 hours in the interval from 24 to 72 hours, which allows using the drug once a day.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
- infections of the upper respiratory tract and ENT organs (sore throat, sinusitis, tonsillitis, otitis media);
scarlet fever;
- Infections of the lower respiratory tract (bacterial, including those caused by atypical pathogens, pneumonia, bronchitis);
- infection of the urogenital tract (uncomplicated urethritis and / or cervicitis);
- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);
- Lyme disease (borreliosis) for treatment of the initial stage (erythema migrans);
- Diseases of the stomach and duodenum, associated with Helicobacter pylori (as part of combination therapy) (for tablets and capsules).
DOSING MODE
The drug is taken orally 1 time / day for 1 hour before a meal or 2 hours after a meal, tk. with simultaneous intake with food decreases the absorption of azithromycin.
If you miss one dose of the drug, it should be taken as soon as possible, and subsequent doses - with an interval of 24 hours.
Capsules
Adults with infections of the upper and lower respiratory tract Hemomycin appoint 500 mg (2 caps.) Per day for 3 days; course dose - 1.5 g.
For infections of the skin and soft tissues, 1 g (4 caps.) Is prescribed on the first day, then 500 mg (2 caps.) Every day from 2 to 5 days; course dose - 3 g.
In acute uncomplicated urethritis or cervicitis, administer 1 g (4 capsules) once.
In Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans), 1 g (4 caps.) On the first day and 500 mg (2 caps.) Are administered daily from day 2 to day 5 (the course dose is 3 g).
In diseases of the stomach and duodenum associated with Helicobacter pylori , 1 g (4 caps.) Is prescribed per day for 3 days as a combination of anti-Helicobacter therapy.
Children older than 12 years with infections of the upper and lower divisions of the respiratory tract, skin and soft tissues drug prescribed at the rate of 10 mg / kg 1 time / day for 3 days (course dose - 30 mg / kg) or on the first day - 10 mg / kg, then 4 days - 5-10 mg / kg / day.
In the treatment of erythema migrans - 20 mg / kg on the first day and 10 mg / kg from 2 to 5-day.
Pills
Adults and children over 12 years with infections of the upper and lower respiratory tract appoint 500 mg / day for 3 days; course dose - 1.5 g.
When skin and soft tissue infections are prescribed, 1 g / day on the first day, then 500 mg daily from 2 to 5 days; course dose - 3 g.
In acute uncomplicated urethritis or cervicitis is prescribed once in a dose of 1 g.
With Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans), the drug is prescribed at a dose of 1 g in the first day and 500 mg daily from 2 to 5 days; course dose - 3 g.
With diseases of the stomach and duodenum associated with Helicobacter pylori , appoint 1 g / day for 3 days as a combination of anti-Helicobacter therapy.
A suspension of 200 mg / 5 ml and 100 mg / 5 ml
In children older than 12 months, a suspension of 200 mg / 5 ml is used, in children older than 6 months - a suspension of 100 mg / 5 ml.
Children with infections of the upper and lower respiratory tract, skin and soft tissue infections (with the exception of chronic migratory erythema) Hemomycin in the form of suspension is prescribed at the rate of 10 mg / kg body weight 1 time / day for 3 days (course dose - 30 mg / kg).
Recommended dosage schemes for Chemomycin, depending on the weight of the child and the concentration of the suspension, are presented in the following table.
Body weight Daily dose (suspension 200 mg / 5ml) Daily dose (suspension 100 mg / 5ml)
10-14 kg 2.5 ml (100 mg) - 1/2 met. spoons 5 ml (100 mg) - 1 measured. a spoon
15-25 kg 5 ml (200 mg) - 1 met. spoon 10 ml (200 mg) - 2 met. spoons
26-35 kg 7.5 ml (300 mg) - 1.5 dimentions. tablespoons 15 ml (300 mg) - 3 measured. spoons
36-45 kg 10 ml (400 mg) - 2 met. tablespoons 20 ml (400 mg) - 4 measured. spoons
more than 45 kg prescribe doses for adults prescribe doses for adults
Adults with infections of the upper and lower respiratory tract appoint 500 mg 1 time / day for 3 days; course dose - 1.5 g.
In infections of the urogenital tract, the drug is prescribed to adults at a dose of 1 g once; children under 8 years with a body weight of more than 45 kg - 10 mg / kg once.
When chronic migratory erythema is prescribed 1 time / day for 5 days: adults - 1 g / day on the 1 st day for 1 reception, then 500 mg / day daily from 2 to 5 days, course dose - 3 g; Children - on the 1st day in a dose of 20 mg / kg of body weight, then from 2 to 5-day - 10 mg / kg body weight.
The recommended dosage regimens for hemomycin in the treatment of erythema migrans in children , depending on body weight and suspension concentration, are presented in the following table.
1st day
Body weight Daily dose (suspension 200 mg / 5ml) Daily dose (suspension 100 mg / 5ml)
<8 kg - 5 ml (100 mg) - 1 met. a spoon
8-14 kg 5 ml (200 mg) - 1 met. tablespoons 10 ml (200 mg) - 2 met. spoons
15-24 kg 10 ml (400 mg) - 2 met. tablespoons 20 ml (400 mg) - 4 measured. spoons
25-44 kg 12.5 ml (500 mg) - 2.5 dl. tablespoons 25 ml (500 mg) - 5 dl. spoons
2-5th day
Body weight Daily dose (suspension 200 mg / 5ml) Daily dose (suspension 100 mg / 5ml)
<8 kg - 2.5 ml (50 mg) - 1/2 metric. spoons
8-14 kg 2.5 ml (100 mg) - 1/2 met. spoons 5 ml (100 mg) - 1 measured. spoons
15-24 kg 5 ml (200 mg) - 1 met. spoon 10 ml (200 mg) - 2 met. spoons
25-44 kg 6.5 ml (250 mg) - 1 and 1/4 of the met. spoon 12.5 ml (250 mg) - 2.5 dl. spoons
Rules for the preparation of suspension
In the vial containing the powder, gradually add water (distilled or boiled and chilled) to the mark. The contents of the vial are shaken carefully until a uniform suspension is obtained.
If the level of the prepared suspension is below the label on the vial label, re-add water to the label and shake.
The prepared suspension is stable at room temperature for 5 days.
Before use, the suspension should be shaken.
Immediately after taking the suspension, the child should be allowed to drink several sips of liquid (water, tea) in order to wash off and swallow the remaining suspension in the oral cavity.
SIDE EFFECT
On the part of the digestive system: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia, vomiting, flatulence, melena, cholestatic jaundice, increased activity of liver enzymes, in children - constipation, anorexia, gastritis.
From the cardiovascular system: palpitation, chest pain (1% or less).
From the side of the central nervous system: dizziness, headache, vertigo, drowsiness; children - headache (with medication otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).
On the part of the reproductive system: vaginal candidiasis.
From the urinary system: nephritis (1% or less).
Allergic reactions: rash, angioedema; children - conjunctivitis, itching, hives.
Other: increased fatigue, photosensitivity.
CONTRAINDICATIONS
- liver failure;
- kidney failure;
- Children under 12 years (for capsules and tablets);
- Children's age up to 12 months (for a suspension of 200 mg / 5 ml);
- Children's age to 6 months (for a suspension of 100 mg / 5 ml);
- hypersensitivity to antibiotics of macrolides.
Caution should be given to the drug during pregnancy, with arrhythmia (possible ventricular arrhythmias and prolongation of the QT interval), children with severe impaired liver or kidney function.
PREGNANCY AND LACTATION
In pregnancy, Hemomycin is prescribed only if the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
If you need to use the drug during lactation, you should decide whether to stop breastfeeding for the duration of the drug.
APPLICATION FOR FUNCTIONS OF THE LIVER
Care should be taken when prescribing the drug to patients with severe renal dysfunction (especially children). Contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution is necessary when prescribing the drug to patients with severe liver function impairment (especially children). Contraindicated in liver failure.
APPLICATION FOR CHILDREN
Contraindication: children under 12 years (for capsules and tablets); children's age up to 12 months (for a suspension of 200 mg / 5 ml); children's age up to 6 months (for a suspension of 100 mg / 5 ml).
With caution should prescribe the drug to children with severe impaired liver or kidney function.
SPECIAL INSTRUCTIONS
Do not take the drug while eating.
It is recommended that the interval is observed for at least 2 h between taking Chemomycin and antacid preparations.
After the abolition of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy and medical control.
OVERDOSE
Symptoms: nausea, temporary loss of hearing, vomiting, diarrhea.
Treatment: gastric lavage, symptomatic therapy.
DRUG INTERACTION
With the simultaneous use of chemomycin and antacids (aluminum and magnesium-containing), the absorption of azithromycin is slowed.
Ethanol and food slow down and reduce the absorption of azithromycin.
With the co-administration of warfarin and azithromycin (in usual doses), no changes in prothrombin time have been detected, but considering that macrolides and warfarin interact may enhance the anticoagulant effect, patients need careful monitoring of 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, there is an increase in the toxic effect of the latter (vasospasm, dysesthesia).
Co-administration of triazolam and azithromycin decreases clearance and enhances the pharmacological action of triazolam.
Azithromycin slows down the excretion and increases plasma concentrations and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, and drugs that undergo microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) due to the azithromycin inhibition of microsomal oxidation in hepatocytes.
Lincosamines weaken the effectiveness of azithromycin, and tetracycline and chloramphenicol - strengthen.
Pharmaceutical interaction
Pharmaceutically, azithromycin is incompatible with heparin.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, protected from light, at a temperature of 15 В° to 25 В° C. Shelf life for tablets and powder is 2 years; for capsules - 3 years.
