Capsules, film-coated tablets
Inside,
For upper and lower respiratory tract infections prescribed 500 mg/day for 3 days ( course dose- 1.5 g).
For skin and soft tissue infections- 1 g/day on the first day for 1 dose, then 0.5 g/day daily, from the 2nd to the 5th day (course dose - 3 g).
For uncomplicated urethritis and/or cervicitis prescribed once 1 g.
For Lyme disease (borreliosis) for treatment initial stage(erythema migrans) Prescribe 1 g on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).
For stomach diseases and duodenum associated with Helicobacter pylori, prescribed 1 g per day for 3 days as part of combination therapy.
If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.
Powder for suspension for oral administration
Inside, 1 hour before or 2 hours after meals, 1 time per day.
Water (distilled or boiled and cooled) is gradually added 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 mark on the bottle label, add water again to the mark and shake.
The prepared suspension is stable at room temperature for 5 days.
For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema): children - at the rate of 10 mg/kg 1 time per day for 3 days (course dose - 30 mg/kg). A 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 presented in Table 1.
Table 1
Adults with infections of the upper and lower respiratory tract - 500 mg once a day for 3 days (course dose - 1.5 g); for infections of the skin, soft tissues, as well as Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans)- 1 g per day on the 1st day for 1 dose, then 0.5 g per day daily from the 2nd to the 5th day (course dose - 3 g).
For chronic migratory erythema- 1 time per 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.
table 2
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 drink in order to wash off and swallow the suspension remaining in the mouth.
If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.
Lyophilisate for the preparation of solution for infusion
The drug should be used only in a hospital setting.
Community-acquired pneumonia. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 500 mg/day once until the 7-10-day total course of treatment is completed.
Infectious and inflammatory diseases of the pelvic organs. 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 250 mg/day once until the 7-day total course of treatment is completed. The timing of transition to oral treatment is determined in accordance with clinical examination data.
Patients with liver and kidney failure. For patients with moderate impairment of liver and kidney function (Cl creatinine >40 ml/min), no dose adjustment is necessary.
The solution for infusion is prepared in 2 stages
Stage 1 - preparation of the reconstituted solution. Add 4.8 ml to a bottle with 500 mg of the drug sterile water for injection and shake thoroughly until the powder is completely dissolved. 1 ml of the resulting solution contains 100 mg of azithromycin. The prepared solution remains stable for 24 hours at room temperature.
Stage 2 - dilution of the reconstituted solution (100 mg/ml). It is carried out immediately before administration in accordance with the data presented below:
To obtain a concentration of azithromycin in an infusion solution of 1 mg/ml, 500 ml of solvent is required; to obtain a concentration of azithromycin in an infusion solution of 2 mg/ml - 250 ml.
The reconstituted solution is added to a vial with a solvent (0.9% sodium chloride solution; 5% dextrose solution; Ringer's solution) to obtain a final concentration of azithromycin of 1-2 mg per 1 ml of infusion solution.
Hemomycin solution cannot be administered intravenously or intramuscularly. It is recommended to administer the prepared solution dropwise for at least 1 hour.
Before administration, the solution is subjected to visual inspection. If the prepared solution contains particles of the substance, it should not be used.
The prepared solution is stable at room temperature for 24 hours.
Identification and classification
LSR-002215/07
International generic name
azithromycin
Dosage form
Powder for suspension for oral administration
Compound
5 ml of the finished suspension contains: active substance: azithromycin 100,000 mg (in the form of azithromycin dihydrate 104,809 mg); Excipients- xanthan gum, sodium saccharinate, calcium carbonate, colloidal silicon dioxide, anhydrous sodium phosphate, sorbitol, apple flavor, strawberry flavor, cherry flavor.
Description
Powder white or almost white with a fruity smell.
Description of the finished suspension: an almost white suspension with a fruity odor.
Pharmacotherapeutic group
Antibiotic azalide
Pharmacological properties. Pharmacodynamics
Azithromycin is a bacteriostatic antibiotic wide range actions from the group of macrolides-azalides. Has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.
It is active against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.
Scale of sensitivity of microorganisms to azithromycin:
| Microorganisms | MIC*, mg/l | |
|---|---|---|
| Sensitive | Sustainable | |
| Staphylococcus | ≤1 | >2 |
| Streptococcus A, B, C, G | ≤0,25 | >0,5 |
| Streptococcus pneumoniae | ≤0,25 | >0,5 |
| Haemophilus influenzae | ≤0,12 | >4 |
| Moraxella catarrhalis | ≤0,5 | >0,5 |
| Neisseria gonorrhoeae | ≤0,25 | >0,5 |
*Minimum inhibitory concentration
In most cases, the following are sensitive to azithromycin:
- Staphylococcus aureus(methicillin-sensitive), Streptococcus pneumoniae(penicillin-sensitive), Streptococcus pyogenes;
- aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
- anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.;
- other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Microorganisms with acquired resistance to azithromycin:
- aerobic gram-positive microorganisms: Streptococcus pneumoniae(penicillin-resistant).
Microorganisms that are initially resistant:
- aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus spp.(methicillin-resistant staphylococci with a very high frequency have acquired resistance to macrolides);
- gram-positive bacteria resistant to erythromycin;
- anaerobic microorganisms: Bacteroides fragilis.
Pharmacological properties. Pharmacokinetics
Azithromycin is rapidly absorbed from gastrointestinal tract(GIT), which is due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 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 prostate gland), into the skin and soft fabrics. High concentration in tissues (10-50 times higher than in blood plasma) and a long period half-life is due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the 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 predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to sites of infection, where it is released during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues(on average by 24-34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which has made it possible to develop short (3-day and 5-day) courses of treatment.
It is demethylated in the liver, the resulting metabolites are not active.
Azithromycin has a very long half-life - 35-50 hours. The half-life from tissues is much longer. Azithromycin is excreted mainly unchanged - 50% by the intestines, 6% by the kidneys.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:
- infections of the upper respiratory tract and ENT organs (pharyngitis/tonsillitis, sinusitis, otitis media);
- lower respiratory tract infections: acute bronchitis, exacerbation chronic bronchitis, pneumonia, including those caused by atypical pathogens;
- infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
- initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans).
Contraindications
- Hypersensitivity to azithromycin or other components of the drug;
- hypersensitivity to erythromycin, other macrolides, ketolides;
- simultaneous use with ergotamine, dihydroergotamine;
- severe liver dysfunction;
- fructose intolerance;
- children up to 6 months of age.
Carefully
Myasthenia gravis, mild to moderate liver dysfunction, end-stage renal failure with GFR (rate glomerular filtration) less than 10 ml/min, in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy antiarrhythmic drugs classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs(pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water and electrolyte imbalance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine.
Use during pregnancy and breastfeeding
Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to use it during lactation, the issue of stopping it should be decided. breastfeeding.
Directions for use and doses
The drug is taken orally 1 time/day. 1 hour before meals or 2 hours after meals.
Water (distilled or boiled and cooled) is gradually added 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 mark on the bottle label, add water again to the mark and shake.
The prepared suspension is stable at room temperature for 5 days.
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (except for erythema migrans)
For children: at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg). Depending on the child’s body weight, the following dosage regimen is recommended:
For pharyngitis/tonsillitis caused by Streptococcus pyogenes, Azithromycin is used at a dose of 20 mg/kg/day for 3 days (course dose 60 mg/kg). The maximum daily dose is 500 mg.
For adults: 500 mg (25 ml of suspension 100 mg/5 ml) 1 time per day for 3 days (course dose 1.5 g).
For Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans)- 1 time per day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, and then from the 2nd to the 5th day - 10 mg/kg body weight (course dose 60 mg/kg ).
1st day
From 2nd to 5th day
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 mouth.
If a dose of the drug is missed, it should be taken immediately, if possible, and then subsequent doses should be taken at intervals of 24 hours.
Patients with impaired renal function: in patients with GFR 10-80 ml/min, no dose adjustment is required.
Patients with impaired liver function: When used in patients with mild to moderate liver dysfunction, no dose adjustment is required.
Elderly patients: no dose adjustment is required. In elderly patients, special caution is recommended when using azithromycin due to possible presence proarrhythmogenic factors that may increase the risk of developing cardiac arrhythmia and torsade de pointes.
Side effect
Frequency side effects classified in accordance with the recommendations of the World Health Organization: very often - at least 10%, often - at least 1%, but less than 10%, infrequently - at least 0.1%, but less than 1%, rarely - at least 0.01 %, but less than 0.1%, very rarely - less than 0.01%; unknown frequency - cannot be estimated based on available data.
Infectious diseases: uncommon – candidiasis, including oral mucosa, vaginal infection, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis, fungal infection, bacterial infection; unknown frequency - pseudomembranous colitis.
From the side of blood and lymphatic system: uncommon - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.
Metabolism and nutrition: infrequently - anorexia.
Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.
From the outside nervous system: often - headache; uncommon - dizziness, disturbance taste sensations, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste, myasthenia gravis, delirium, hallucinations.
From the side of the organ of vision: infrequently - visual impairment.
Hearing and labyrinth disorders: infrequently - hearing loss, vertigo; unknown frequency - hearing impairment, including deafness and/or tinnitus.
From the cardiovascular system: infrequently - a feeling of palpitations, “flushes” of blood to the face; unknown frequency - decrease blood pressure, increased QT interval on the electrocardiogram, pirouette-type arrhythmia, ventricular tachycardia.
From the respiratory system: infrequently - shortness of breath, nosebleeds.
From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; uncommon - flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, ulcers of the oral mucosa, increased secretion salivary glands; very rarely - change in tongue color, pancreatitis.
From the liver and biliary tract: infrequently - hepatitis; rarely - impaired liver function, cholestatic jaundice; unknown frequency - liver failure (in rare cases with fatal mostly in the background severe violation liver function); liver necrosis, fulminant hepatitis.
For the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity reaction, acute generalized exanthematous pustulosis; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome).
From the musculoskeletal system: uncommon - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.
From the kidneys and urinary tract: infrequently - dysuria, pain in the kidney area; unknown frequency - interstitial nephritis, acute renal failure.
From the genital organs and breast: infrequently - metrorrhagia, testicular dysfunction.
Others: uncommon - asthenia, malaise, feeling of fatigue, edema, facial swelling, chest pain, fever, peripheral edema.
Laboratory and instrumental data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease in the concentration of bicarbonates in the blood plasma; infrequently - increased activity of aspartate aminotransferase, alanine aminotransferase, increased concentration of bilirubin in blood plasma, increased concentration of urea in blood plasma, increased concentration of creatinine in blood plasma, change in potassium content in blood plasma, increased activity of alkaline phosphatase in blood plasma, increased chlorine content in blood plasma , increased blood glucose concentration, increased platelet count, decreased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium content.
Overdose
Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: symptomatic.
Interaction with other drugs
Antacids
Antacids do not affect the bioavailability of azithromycin, but reduce the maximum blood concentration by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and eating.
Cetirizine
Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction or a significant change in the QT interval.
Didanosine (dideoxyinosine)
The simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic parameters of didanosine compared to the placebo group.
Digoxin and colchicine (P-glycoprotein substrates)
Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin and colchicine, leads to increased concentrations of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing digoxin in the blood serum.
Zidovudine
Concomitant use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has little effect on the pharmacokinetics, including renal excretion, of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. Clinical significance this fact is unclear.
Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.
Ergot alkaloids
Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.
Pharmacokinetic studies were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.
Atorvastatin
Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.
Carbamazepine
Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.
Cimetidine
In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected when cimetidine was used 2 hours before azithromycin.
Indirect anticoagulants (coumarin derivatives)
In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).
Cyclosporine
In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, followed by cyclosporine (10 mg/kg/day once), a significant increase in maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-5) of cyclosporine. Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.
Efavirenz
Concomitant use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.
Fluconazole
Concomitant use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.
Indinavir
Concomitant use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg three times a day for 5 days).
Methylprednisolone
Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.
Nelfinavir
The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.
Rifabutin
The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.
Sildenafil
When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.
Terfenadine
In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred.
It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.
Theophylline
No interaction has been detected between azithromycin and theophylline.
Triazolam/midazolam
No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.
Trimethoprim/sulfamethoxazole
Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not show a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.
special instructions
Hypersensitivity. As with the use of erythromycin and other macrolides, rare cases of serious allergic reactions, including angioedema and anaphylaxis (in rare cases fatal), skin reactions, including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (in in rare cases with a fatal outcome), drug rash with eosinophilia and systemic manifestations (DRESS syndrome). Some of these reactions that developed during the use of azithromycin acquired a recurrent course and required long-term treatment and observation.
During development allergic reaction the drug should be discontinued and appropriate treatment initiated. It should be borne in mind that after discontinuation of symptomatic therapy, symptoms of an allergic reaction may resume.
If you miss one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
Azithromycin should be taken at least one hour before or two hours after taking antacids.
Azithromycin should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure.
If there are symptoms of liver dysfunction, such as rapidly increasing asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy, drug therapy should be stopped and a study should be performed. functional state liver.
For impaired renal function: in patients with GFR 10-80 ml/min, no dose adjustment is required; Therapy with Chemomycin should be carried out with caution and monitoring of renal function in patients with GFR less than 10 ml/min.
As with other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of the development of superinfections, including fungal ones.
The drug should not be used in longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.
There is no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is not recommended.
With long-term use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. If antibiotic-associated diarrhea develops while taking the drug, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Cannot be used medications, inhibiting intestinal motility.
When treated with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval was observed, increasing the risk of developing cardiac arrhythmias, including torsade de pointes, which can lead to cardiac arrest.
Caution should be exercised when using the drug in patients with the presence of proarrhythmogenic factors (especially in elderly patients), including congenital or acquired prolongation of the QT interval; in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with fluid disorders electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure.
The use of azithromycin may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
Impact on the ability to drive vehicles and operate machinery
Due to possible development during treatment adverse reactions on the part of the central nervous system and organ of vision, care must be taken when managing vehicles and performing other activities that require increased concentration and speed of psychomotor reactions.
Release form
Powder for the preparation of suspension for oral administration 100 mg/5 ml.
11.43 g of powder in a dark glass bottle with a capacity of 60 ml, sealed with a screw-on, tamper-evident plastic or metal cap. On the top side of the plastic cap there is a diagram for opening the bottle.
Antibiotics are a group of drugs used in the treatment infectious diseases. Parents prefer to protect their children from them, since taking such drugs can lead to allergies and disruption of work. digestive system, immunosuppression. But sometimes antibiotic treatment is indispensable.
Hemomycin suspension for children is one of the few new generation drugs approved for use by children with early age. This article provides you with a detailed overview of it.
Hemomycin - cheap antibiotic wide spectrum of action.
Description
Manufacturer Hemomycin - Serbian pharmaceutical company Hemofarm, which has long proven itself in Russian market. This universal remedy is used to treat many infectious diseases. It includes:
- azithromycin;
- additional substances;
- flavor and smell enhancers: cherry, apple.
The drug is a powder for preparing a suspension. Medicine It tastes good and has a fruity aroma.
Review from Larisa, Katya’s mother:
“When my girl was two years old, we were put in children's department hospitals with bronchitis. Hemomycin was prescribed. My daughter ate practically nothing, but did not refuse the medicine - I suspect it was because of its sweet taste.”
Children will willingly take the sweet suspension.
The powder is available in a dark glass bottle. Sold in cardboard box. The set includes a measuring spoon and detailed instructions by application (). The labeling on the package is: 100 mg/5 ml and 200 mg/5 ml. This is an indicator of the content of the active substance (azithromycin) per 1 scoop of the finished suspension (5 ml).
How does it work
The drug is active against most types of pathogens. It penetrates easily into soft tissues and tissues respiratory organs, concentrates in areas of inflammation, where it acts for several days after administration. Thanks to this property, it became possible to establish short-term courses of treatment.
After administration, the antibiotic continues to remain in the area of inflammation for a week.
Release forms
Hemomycin Sold in the form of gelatin capsules, tablets and suspension. The first two release forms contain a high concentration active substance(250 and 500 mg) and are contraindicated in children under 12 years of age.
Review from Elena, mother of Sasha and Anton:
“I got a sore throat at the same time as my child. The doctor prescribed us the antibiotic Hemomycin. The pharmacy offered several varieties of it, and I chose the suspension: it was the only one suitable for simultaneous use by both me and my five-year-old son. In addition, I prefer to treat the child as “pleasantly” as possible. The medicine is tasty and does not irritate, like bitter pills that are not always taken down the first time.”
Indications
Hemomycin suspension is effective only against microorganisms sensitive to azithromycin. It is prescribed when the following diseases:
- , otitis media, ;
- erysipelas, repeated dermatoses;
- cervicitis, urethritis without complications;
- scarlet fever;
- bronchitis, pneumonia;
- initial stage of borreliosis.
Remember that self-diagnosis of the disease and prescribing treatment poses a danger to the child’s health.
A normal cough may be a symptom of bronchitis, in sore throat- manifestation of angina. At the first sign of infection ( heat, severe runny nose, cough, sore throat and others) contact your pediatrician. You can buy an antibiotic without a prescription, but it is taken only as prescribed by a doctor.
Only a doctor can prescribe this drug for your child.
How to give Hemomycin
The instructions for the drug say that it should be given to the child once a day after meals (2 hours later) or an hour before meals. This is explained by the fact that along with the products active substance the medicine is less absorbed.
The dosage of Hemomycin is calculated individually, taking into account the disease and the weight of the baby.
The volume of a measuring spoon is 5 ml, it contains 100 or 200 mg of active ingredient, depending on the labeling indicated on the package. Babies under 6 months are prescribed the drug at a concentration of 100 mg, children over one year old - 200 mg.
For infections, the drug is taken according to the following regimen:
Course - 3 days.
For urethritis and cervicitis, a single dose of medication is prescribed in the following dosage:
- up to 45 kg - 10 mg/kg (see calculations in the table above);
- from 45 kg - 1 g of suspension.
Detailed treatment regimen for erythema migrans:
First day:
Preparing the suspension correctly
- Boil water, cool.
- Add it to the bottle with powder up to the indicated mark (14 ml).
- Shake the product thoroughly until a homogeneous consistency is obtained (do this before each use).
The suspension is stored for no more than 5 days at room temperature. Some of the medicine may remain in the mouth, so after taking it, give the child some liquid (compote, water, tea).
It is advisable to give the child to drink the medicine with water.
Hidden dangers
Hemomycin is not prescribed for hepatic and renal failure, hypersensitivity to antibiotics. Children's body rarely reacts badly to the drug. Side effects in children the following phenomena are manifested:
- refusal to eat;
- gastritis;
- increased heart rate;
- insomnia;
- allergies (itching,).
In case of overdose, nausea and diarrhea are observed. To prevent them, carefully follow the instructions and hide the bottle with the drug out of the reach of the child.
How to protect your baby from the negative effects of antibiotics
In order for the use of Hemomycin to bring maximum benefit and not harm your little one, follow simple rules.
- Take it only as directed by your doctor.
- Follow the appointment time and instructions.
- Do not interrupt the course even if you notice that your child is feeling better.
- Do not adjust the dosage of the drug.
- Eliminate fried, fatty, spicy, and canned foods from your baby’s diet (the medicine already puts a lot of stress on the liver).
Antibiotic destroys beneficial bacteria And disrupts the intestinal microflora. To eliminate its harmful effects, do not forget to give your child probiotics (Bifiform and others) during and after the course of Hemomycin. Read more about how to restore the health and immunity of a toddler after antibiotic treatment,
0070 Macrolides and azalides
INN
Azithromycin*
6 pcs in blister; 1 blister in a cardboard pack.
in dark glass bottles of 11.43 g (complete with measuring spoon); 1 set in a cardboard pack.
in a bottle (complete with measuring spoon); 1 set in a cardboard pack.
3 pcs in blister; 1 blister in a cardboard pack.
Capsules: light blue, size No. 0. The contents of the capsules are white powder.
Powder for the preparation of suspension for oral administration: white or almost white in color with a fruity odor. The finished suspension is almost white in color with a fruity smell.
Pills: round, biconvex, covered with a filmy shell of a grayish-blue color.
Antacids (aluminum and magnesium containing), ethanol and food slow down and reduce absorption. When warfarin and azithromycin were co-administered (in usual doses), no changes in PT were detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulant effect, patients need careful monitoring of PT.
Increases the concentration of digoxin.
Ergotamine and dihydroergotamine: increased toxicity (vasospasm, dysesthesia).
Reduces clearance and enhances pharmachologic effect triazolam.
Slows down the elimination, increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs subject to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) - due to inhibition of microsomal oxidation in hepatocytes.
Lincosamines weaken the effectiveness, tetracycline and chloramphenicol enhance it. Pharmaceutically incompatible with heparin.
It is quickly absorbed from the gastrointestinal tract (due to its stability in an acidic environment and lipophilicity). After oral administration at a dose of 500 mg, Cmax is achieved after 2.5-2.96 hours and is 0.4 mg/l. Bioavailability - 37%.
Penetrates well into the respiratory tract, organs and tissues of the urogenital tract, 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 blood plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in an environment with low value pH surrounding the lysosomes. This determines the large apparent volume of distribution (31.1 l/kg) and high plasma clearance. The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. Phagocytes deliver azithromycin to sites of infection, where it is released through the process of phagocytosis. The concentration of azithromycin in foci of infection is higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function.
Azithromycin remains in bactericidal concentrations at the site of inflammation for 5-7 days after taking the last dose, which made it possible to develop short (three- and five-day) courses of treatment.
In the liver it is demethylated to form inactive metabolites.
It is released in 2 stages: T1/2 of the first phase (in the range of 8-24 hours) - 14-20 hours, the second (in the range of 24-72 hours) - 41 hours, which allows you to take the drug once a day.
Broad-spectrum macrolide antibiotic from the azalide subgroup. In high concentrations it has a bactericidal effect. Active against gram-positive cocci (Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, group CF and G streptococci, Staphylococcus aureus, Staphylococcus viridans), gram-negative bacteria (Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae, Gardnerella vaginalis), some anaerobic microorganisms (Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.), and Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Inactive against gram-positive bacteria resistant to erythromycin.
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 the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
infections 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(as part of combination therapy).
Capsules
severe dysfunction of the liver and kidneys;
children up to 12 years of age.
Carefully: pregnancy, arrhythmia (ventricular arrhythmias and prolongation of the QT interval are possible); children with severe liver or kidney dysfunction.
Powder for preparing suspension
hypersensitivity (including to other macrolides);
breastfeeding (suspended during treatment);
children up to 12 months (for 100 mg powder - up to 6 months).
Carefully: pregnancy (use is possible if the expected effect of therapy exceeds the potential risk to the fetus); arrhythmias (possible ventricular arrhythmias and prolongation of the QT interval); children with severe liver or kidney dysfunction.
Pills
hypersensitivity (including to other macrolides);
liver and/or kidney failure;
children under 12 years of age;
lactation period.
Carefully: pregnancy; arrhythmia (ventricular arrhythmias and prolongation of the QT interval are possible);
children with severe liver or kidney dysfunction.
Capsules: lactation period.
Powder for suspension, tablets: during pregnancy, use is possible if the expected effect of therapy exceeds the potential risk to the fetus.
Common to all dosage forms: Breastfeeding should be stopped during treatment.
Capsules, film-coated tablets
Inside,
For upper and lower respiratory tract infections prescribed 500 mg/day for 3 days (course dose - 1.5 g).
For skin and soft tissue infections- 1 g/day on the first day for 1 dose, then - 0.5 g/day daily, from the 2nd to the 5th day (course dose - 3 g).
For uncomplicated urethritis and/or cervicitis prescribed once 1 g.
For Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) Prescribe 1 g on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).
For diseases of the stomach and duodenum associated with Helicobacter pylori, prescribed 1 g per day for 3 days as part of combination therapy.
If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.
Powder for suspension for oral administration
Inside, 1 hour before or 2 hours after meals, 1 time per day.
Water (distilled or boiled and cooled) is gradually added 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 mark on the bottle label, add water again to the mark and shake.
The prepared suspension is stable at room temperature for 5 days.
For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema): children - at the rate of 10 mg/kg 1 time per day for 3 days (course dose - 30 mg/kg). A 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 presented in Table 1.
Table 1
Adults with upper and lower respiratory tract infections - 500 mg once a day for 3 days (course dose - 1.5 g); for infections of the skin, soft tissues, as well as Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans)- 1 g per day on the 1st day for 1 dose, then 0.5 g per day daily from the 2nd to the 5th day (course dose - 3 g).
For chronic migratory erythema- 1 time per 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.
table 2
| Body weight, kg | Daily dose(suspension 100 mg/5 ml), ml | Daily dose (suspension 200 mg/5 ml), ml | ||
| 1st day | From 2nd to 5th day | 1st day | From 2nd to 5th day | |
| <8 | 5 (100 mg) – 1 spoon | 2.5 (50 mg) - 1/2 spoon | — | — |
| 8-14 | 10 (200 mg) – 2 spoons | 5 (100 mg) – 1 spoon | 5 (200 mg) - 1 spoon | 2.5 (100 mg) - 1/2 spoon |
| 15-24 | 20 (400 mg) – 4 spoons | 10 (200 mg) – 2 spoons | 10 (400 mg) – 2 spoons | 5 (200) – 1 spoon |
| 25-44 | 25 (500 mg) – 5 spoons | 12.5 (250 mg) - 2.5 spoons | 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 drink in order to wash off and swallow the suspension remaining in the mouth.
If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.
Capsules
From the gastrointestinal tract: possible nausea, diarrhea, abdominal pain; rarely - vomiting, flatulence, transient increase in the activity of liver enzymes; melena, cholestatic jaundice.
Dermatological reactions: in some cases - rash.
Powder for suspension, tablets
From the gastrointestinal tract: diarrhea (5%), nausea (3%), abdominal pain (3%); dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of liver transaminases (1% or less); in children - constipation, anorexia, gastritis.
From the SSS side: palpitations, chest pain (1% or less).
From the nervous system: dizziness, headache, vertigo, drowsiness; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).
From the genitourinary system: vaginal candidiasis, nephritis (≤1%).
Allergic reactions: rash, photosensitivity, angioedema.
Others: increased fatigue; in children - conjunctivitis, itching, urticaria.
For powder for the preparation of suspension for oral administration(additional): in extremely rare cases - oral candidiasis.
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.
It is necessary to observe a break of 2 hours while using antacids.
Do not take the drug with food.
Hypersensitivity reactions in some patients may persist after discontinuation of treatment (specific therapy under medical supervision is required).
In a dry place, protected from light, at a temperature of 15-25 °C
Registration number P N013856/02-300707
Tradename: Hemomycin
International nonproprietary name:
AzithromycinDosage form:
powder for the preparation of suspension for oral administration.Compound:
5 ml of the finished suspension contains: azithromycin (in the form of azithromycin dihydrate 209.6 mg) - 200 mg.Excipients - xanthan gum - 20 mg, sodium saccharinate - 4 mg, calcium carbonate - 150 mg, colloidal silicon dioxide - 25 mg, sodium phosphate anhydrous - 17.26 mg, sorbitol - 2054.74 mg, apple flavoring - 4 mg, strawberry flavoring - 10 mg, cherry flavoring - 15 mg.
Description
White or almost white powder with a fruity odor.
Description of the finished suspension: an almost white suspension with a fruity odor.
Pharmacotherapeutic group:
Antibiotic, azalideCODE ATX
Broad-spectrum antibiotic. It is a representative of the subgroup of macrolide antibiotics - azalides. In high concentrations it has a bactericidal effect.
Gram-positive cocci are sensitive to azithromycin: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, streptococci of groups C, F and O, Staphylococcus aureus, Streptococcus viridans; gram negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnereila vaginalis; some anaerobic microorganisms: Bacleroides bivius, Clostridium perfringens, Peptostreptococcus spp; and Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.
Pharmacokinetics
Azithromycin is rapidly absorbed from the gastrointestinal tract due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 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 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 the 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 predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to sites of infection, where it is released during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which has made it possible to develop short (3-day and 5-day) courses of treatment.
It is demethylated in the liver, the resulting metabolites are not active. The elimination of azithromycin from blood plasma occurs in 2 stages: the half-life 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 once a day.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media);
- scarlet fever;
- infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);
- infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
- Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans).
Contraindications
Hypersensitivity (including to other macrolides); liver and/or kidney failure; lactation period; children up to 12 months.
Carefully- pregnancy, arrhythmia (ventricular arrhythmias and prolongation of the QT interval are possible), children with severe impairment of liver or kidney function.
Use during pregnancy and lactation
It can be used during pregnancy when the benefits of its use significantly outweigh the risks that always exist when using any drug during pregnancy. If it is necessary to use the drug during lactation, breastfeeding is suspended.
Directions for use and doses
The drug is taken orally 1 time per day 1 hour before meals or 2 hours after meals. 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 mark on the bottle label, add water again to the mark and shake.
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 migratory erythema), the drug is prescribed for children at a dose of 10 mg/kg body weight once a day for 3 days.
For upper and lower respiratory tract infections adults are prescribed 500 mg once a day for 3 days (course dose 1.5 g); for infections of the skin, soft tissues, as well as for Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans) - 1 g per day on the first day for 1 dose, then 0.5 g per day daily from days 2 to 5 (course dose - 3 g).
For chronic migratory erythema - once a day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, and then from the 2nd to the 5th day - 10 mg/kg body weight.
From 2nd to 5th day
Shake 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 mouth.
If a dose of the drug is missed, it should be taken immediately, if possible, and then subsequent doses should be taken at intervals of 24 hours.
Side effect
From the gastrointestinal tract: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia (flatulence, vomiting), melena, cholestatic jaundice, increased activity of “liver” transaminases; in children - constipation, anorexia, gastritis.
From the cardiovascular system: palpitations, chest pain (1% or less).
From the nervous system: dizziness, headache, drowsiness; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).
From the genitourinary system: vaginal candidiasis, nephritis (1% or less).
Allergic reactions: rash, Quincke's edema, in children - conjunctivitis, itching, urticaria.
Other: increased fatigue; photosensitivity.
Overdose
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: symptomatic; gastric lavage.
Interaction with other drugs
Antacids (aluminum and magnesium), ethanol and food slow down and reduce absorption.
When warfarin and azithromycin were co-administered (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulation effect, patients need careful monitoring of prothrombin time.
Digoxin: increased digoxin concentrations.
Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia).
Triazolam: decreased clearance and increased pharmacological action of triazolam.
Slows down the elimination and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs subjected to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocripgine, phenytoin, oral hypoglycium kemic agents, theophylline and other xanthine derivatives) - due to the inhibition of microsomal oxidation in hepatocytes by azithromycin.
Lincosamines weaken the effectiveness, tetracycline and chloramphenicol enhance it.
special instructions
It is necessary to observe a break of 2 hours while using antacids. After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under medical supervision.
Release form
Powder for the preparation of suspension for oral administration 200 mg/5 ml. 10 g of powder in a dark glass bottle, sealed with a screw-on, first-opening plastic or metal cap. On the top side of the plastic cap there is a diagram for opening the bottle. The bottle along with a measuring spoon (volume 5 ml, with a line for the volume 2.5 ml) and instructions for use in a cardboard box.
Storage conditions
List B.
Store in a dry place, protected from light, at a temperature of 15 to 25°C.
Keep out of the reach of children.
Best before date
2 years.
Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
On prescription.
Manufacturer:
Hemofarm A.D., Serbia26300 Vršac, Beogradski put bb, Serbia
Consumer complaints should be sent to:
Russia, 603950, Nizhny Novgorod
GSP-458, st. Salganskaya, 7
