Chemomycin suspension powder for oral use 200mg/5ml 10g, 1pc

Composition

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of 5 ml of the finished suspension contains:

Active ingredient:  

Azithromycin 200 mg;

Auxiliary substances:  

Xanthan gum;

Sodium saccharinate;

Calcium carbonate;

Colloidal silicon dioxide;

Sodium phosphate anhydrous;

Sorbitol;

Apple flavor;

Strawberry flavor;

Cherry flavor

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 azithromycin:

infections of the upper respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);

infections of the lower respiratory tract (bacterial and atypical pneumonia, acute bronchitis, exacerbation of chronic bronchitis);

infections of skin and soft tissue (acne vulgaris moderate, erysipelas, impetigo, secondarily infected dermatoses);

Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans);

infection of the urogenital tract (urethritis and/or cervicitis) caused by Chlamydia trachomatis.

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

Hypersensitivity to azithromycin or other components of the drug;

hypersensitivity to erythromycin, other macrolides, ketolides;

concomitant use with ergotamine, dihydroergotamine;

severe liver function

disorders;severe renal function disorders (creatinine clearance less than 40 ml / min);

breast-feeding period;

children under 12 months of age.

With caution

Myasthenia gravis, mild to moderate hepatic impairment, mild to moderate renal impairment (creatinine clearance greater than 40 ml / min), in patients with proarrhythmogenic factors (especially in elderly patients):  

with congenital or acquired QT prolongation in patients receiving therapy with antiarrhythmic drugs class IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol),

cisapride, terfenadine, antipsychotic drugs (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), disorders of water and electrolyte balance, especially in the case of hypokalemia or

hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure; the simultaneous use of digoxin, warfarin, cyclosporine; pregnancy.

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.

Gradually add water (distilled or boiled and cooled) to the bottle to the mark.

The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained. If the level of the prepared suspension is below the label on the bottle label, water is re-added to the label and shaken.

The prepared suspension is stable at room temperature for 5 days.

For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic erythema migrans): children — at the rate of 10 mg / kg once a day for 3 days (the course dose is 30 mg / kg).

Suspension of 100 mg / 5 ml is recommended for use in children over 6 months,200 mg/5 ml-over 12 months. Recommended dosage regimens depending on the child’s body weight are shown in Table 1.

Table 1

Patient’s body weight, kg Daily dose of suspensions (100 or 200 mg/5 ml), mg%^%10-14100 (5 or 2.5 ml) 15-25200 (10 or 5 ml) 26-35300 (15 or 7.5 ml) 36-45400 (20 or 10 ml)more than 45 kg are prescribed doses for adults

Adults with infections of the upper and lower respiratory tract infections — 500 mg 1 time per day for 3 days (course dose — 1.5 g);

infections of skin, soft tissue, and Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) — 1 g per day in 1 day for 1 reception, then 0.5 g a day every day from the 2nd to 5th day (course dose — 3 g).

For chronic migrating erythema — once a day for 5 days: on the 1st day at a dose of 20 mg / kg, and then from the 2nd to the 5th day-10 mg/kg.

Recommendations for the use of Chemomycin 100 mg/5 ml suspension in children with erythema migrans are presented in table 2.

Table 2

Body weight, kg Daily dose (suspension 100 mg/5 ml), ml Daily dose (suspension 200 mg/5 ml), ml Day 1 from day 2 to day 5 Day 1 from day 2 to day 5 (100 mg) – 1 tablespoon 2,5 (50 mg) – 1/2 teaspoon— —8–1410 (200 mg) – 2 tablespoons 5 (100 mg) – 1 tablespoon 5 (200 mg) – 1 tablespoon 2,5 (100 mg) – 1/2 teaspoon 15-2420 (400 mg) – 4 scoops of 10 (200 mg) – 2 scoops of 10 (400 mg) – 2 spoons 5 (200) – 1 spoon 25-4425 (500 mg) – 5 tablespoons 12.5 (250 mg) – 2.5 tablespoons 12.5 (500 mg) – 2.5 spoons 6.25(250) – 1.25 spoons

The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to wash off and swallow the suspension remaining in the oral cavity.

If you miss taking 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.

Purpose

Antibiotic-azalide

Description

White or almost white powder with a fruity smell. Description of the finished suspension: the suspension is almost white in color with a fruity smell.

Functional features

Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral use of 500 mg, the maximum concentration of azithromycin in blood plasma is reached in 2.5-2.96 hours and is 0.4 mg/l. Bioavailability is 37%. Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), skin and soft tissues. The high concentration in tissues (10-50 times higher than in blood plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines the large apparent volume of distribution (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 for 5-7 days after the last dose, which allowed the development of short (3-day and 5-day) treatment courses. It is demethylated in the liver, and the resulting metabolites are not active. Azithromycin has a very long half-life of 35-50 hours. The tissue half-life is significantly longer. Azithromycin is mainly excreted unchanged-50% by the intestines,6% by the kidneys.

Complete set

Powder for the preparation of a suspension for oral use 200 mg/5 ml. 10 g of powder in a dark glass bottle with a capacity of 60 ml, capped with a screw-on plastic or metal lid with first opening control. On the upper side of the plastic lid, a diagram of opening the bottle is applied. The bottle together with a measuring spoon (with a volume of 5 ml, with a risk for a volume of 2.5 ml) and instructions for use are placed in a cardboard pack.

Special instructions

If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

Azithromycin should be taken at least one hour before or two hours after taking antacid medications.

Azithromycin should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe renal insufficiency.

In the presence of symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of the urine, tendency to bleeding, hepatic encephalopathy, therapy with the drug should be discontinued and a study of the functional state of the liver should be conducted.

In patients with mild to moderate renal impairment (creatinine clearance greater than 40 ml/min), azithromycin therapy should be carried out with caution under the control of renal function.

As with other antibacterial agents, patients with azithromycin should be regularly examined for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

The drug should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

There are no data on possible interactions between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism when macrolides are co-administered with ergotamine and dihydroergotamine derivatives, this combination is not recommended.

With prolonged use of azithromycin, pseudomembranous colitis caused by Clostridium difficile may develop, as in the form of mild diarrhea against the background of taking the drug, and clostridial pseudomembranous colitis should be excluded 2 months after the end of therapy.

Macrolide treatment, including azithromycin, has been associated with prolonged cardiac repolarization and intraval QT, which increases the risk of cardiac arrhythmias, including pirouette-type arrhythmias, which can lead to cardiac arrest.

Caution should be exercised when using the drug in patients with the presence of pruritogens factors (especially in elderly patients), including those with congenital or acquired long QT interval;

patients receiving therapy with class IA drugs (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (citalopram), fluoroquinolones

(moxifloxacin and levofloxacin), disorders of water and electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure.

The use of azithromycin can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

Influence on the ability to drive vehicles and mechanisms

Due to the possible development of adverse reactions from the central nervous system during treatment, care should be taken when driving vehicles and performing other activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Powder for the preparation of a suspension for oral use

Storage conditions

Store in a dry place, protected from light, at a temperature of 15 to 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Children older than 6 months, Children as prescribed by a doctor

Indications

Bronchitis, Sinusitis, Otitis media, Pharyngitis, Infectious diseases, Skin Infections, Sore Throat, Tonsillitis, Pneumonia, Urethritis, Respiratory tract infections