Chemomycin suspension powder for oral use 100mg/5ml 11.43g, 1pc

Composition

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of 5 ml of the finished suspension contains:

Active ingredient azithromycin (in the form of azithromycin dihydrate 104.809 mg) 100 mg,

Auxiliary substances:  

Xanthan gum — 20.846 mg,

Sodium saccharinate — 4,134 mg,

Calcium carbonate-162,503 mg,

Colloidal silicon dioxide — 26,008 mg,

Sodium phosphate anhydrous-17.259 mg,

Sorbitol — 2145.682 mg,

Apple flavor — 3,303 mg,

Strawberry flavor — 8,159 mg,

Cherry flavor — 12,096 mg.

Pharmacological action

Azithromycin is a broad-spectrum bacteriostatic antibiotic from the group of macrolides-azalides.

It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of microbial cell protein synthesis.

Binding to the 50S subunit of the ribosome, it inhibits peptidtranslase 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 has activity against a number of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.

Microorganisms may initially be resistant to the action of an antibiotic or may become resistant to it.

Scale of sensitivity of microorganisms to azithromycin:

———————————————————————————————————

Microorganisms | MIK*, 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, people are sensitive to azithromycin:

— aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-susceptible), Streptococcus pneumoniae (penicillin-susceptible), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus groups C, G;

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. Peptostreprococcus spp. ;

— other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Borrelia burgdoferi.

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—

– anaerobes: Bacteroides fragilis.

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 tissues (acne vulgaris moderate, erysipelas, impetigo, secondarily infected dermatoses);

– infections of the urogenital tract (urethritis and/or cervicitis) caused by Chlamydia trachomatis;

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

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 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 (suspended for the duration of treatment); children under 6 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): patients with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure; concomitant use of digoxin, warfarin, cyclosporine; pregnancy.

Side effects

The frequency of side effects is classified according to the recommendations of the World Health Organization:  

very often — not less than 10%, often at least 1% but less than 10%, infrequently — no more than 0.1% but < 1%, rare — not less than 0.01%, but less is 0.1%, very rare — less than 0.01%; frequency unknown — cannot be determined based on available data.

Infectious diseases: infrequently-candidiasis, including oral and genital mucosa, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency-pseudomembranous colitis.

From the blood and lymphatic system: infrequently-leukopenia, neutropenia, eosinophilia; very rarely-thrombocytopenia, hemolytic anemia.

From the side of metabolism and nutrition: infrequently — anorexia.

Allergic reactions: infrequently-angoneurotic edema, hypersensitivity reaction; unknown frequency — anaphylactic reaction.

From the nervous system: often-headache; infrequently-dizziness, impaired taste sensations, paresthesia, drowsiness, insomnia, nervousness; rarely-agitation; unknown frequency-hypesthesia, anxiety,

aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste sensations, delirium hallucinations.

Hearing disorders and labyrinth disorders: infrequently-hearing disorders, vertigo; unknown frequency-hearing disorders, including deafness and / or tinnitus.

From the cardiovascular system: infrequently-palpitation sensation, “flushes” of blood to the face; unknown frequency — lowering of blood pressure, increase in the QT interval on the electrocardiogram, arrhythmia of the “pirouette” type, ventricular tachycardia.

From the respiratory system: infrequently-shortness of breath, nosebleeds.

From the gastrointestinal tract: very often-diarrhea; often-nausea, vomiting, abdominal pain; infrequently-flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, increased salivary gland secretion; very rarely — discoloration of the tongue, pancreatitis.

From the liver and biliary tract: infrequently-hepatitis; rarely-impaired liver function, cholestatic jaundice, unknown frequency-liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.

From the skin and subcutaneous tissues: infrequently-skin satiety, pruritus, urticaria, dermatitis, dry skin, sweating; rarely-photosensitization reaction; unknown frequency-Stephen-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Musculoskeletal disorders: infrequently-osteoarthritis, myalgia, back pain, neck pain; unknown frequency-arthralgia.

From the side of the kidneys and urinary tract: infrequently-dysuria, pain in the kidney area; unknown frequency-interstitial nephritis, acute renal failure.

From the genitals and breast: infrequently-metrorrhagia, testicular dysfunction.

Others: infrequently-asthenia, malaise, fatigue, facial swelling, chest pain, fever, peripheral edema.

Laboratory data: often, a decrease in the number of lymphocytes, increase in the number of eosinophils, increased number of basophils, increased number of monocytes, increasing the number of neutrophils,

a decrease in the concentration of bicarbonate in the blood plasma; rarely — increased activity of aspartate aminotransferase, alanine aminotransferase, increased concentration of bilirubin in blood plasma,

increasing the concentration of urea in blood plasma, increasing the concentration of creatinine in the blood plasma, a change in the content of potassium in the blood plasma, increased activity of alkaline phosphatase in blood plasma,

increasing the chlorine content in the blood plasma, the increase in the concentration of glucose in the blood, increasing the number of platelets, increased hematocrit, increasing the concentration of bicarbonate in the blood plasma, a change in the content of sodium in the blood plasma.

How to take, course of use and dosage

The drug is taken orally 1 time/day. 1 hour before a meal or 2 hours after a meal. 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 of body weight once a day for 3 days (a course dose of 30 mg / kg). Depending on the child’s body weight, the following regimen is recommended: dispensing:——- Patient’s body weight – Daily dose (suspension 100 mg / 5 ml)——- For acne vulgaris of moderate severity (adults):On the 1st,2nd and 3rd days of treatment,500 mg (25 ml of 100 mg/5 ml suspension) is taken 1 time a day, then a break is taken from the fourth to the seventh day of treatment, from the eighth day of treatment,500 mg (25 ml) is taken 1 time a week (with an interval of 7 days) for 9 weeks. The course dose is 6 g. For uncomplicated urethritis and / or cervicitis caused by Chlamydia trachomatis, the drug is prescribed for adults: 1 g (50 ml) once. In Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans)-1 time a day for 5 days: on the 1st day at a dose of 20 mg/kg of body weight, and then from the 2nd to the 5th day-10 mg/kg of body weight. The following dosage regimen of CHEMOMYCIN suspension is recommended in children with erythema migrans: Day 1—————————————————————————————–Patient’s body weight – Daily dose (suspension 100 mg / 5 ml)—————————————————————————————- < 8 kg-5 ml (100 mg) – 1 spoon 8-14 kg-10 ml (200 mg) – 2 spoons 15-24 kg-20 ml (400 mg) – 4 spoons 35-45 kg 25 ml (500 mg) – 5 spoons 25-34 kg-35 ml (700 mg) – 7 spoons——————————————————————————————-From day 2 to day 5—————————————————————————————–Patient’s body weight – Daily dose (suspension 100 mg / 5 ml)—————————————————————————————- 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. In the event that a dose of the drug was missed, it should, if possible, be taken immediately, and then subsequent doses should be taken at intervals of 24 hours. Patients with impaired renal function When used in patients with mild to moderate renal impairment (creatinine clearance > 40 ml/min), no dose adjustment is required. Patients with impaired hepatic function When used in patients with mild to moderate hepatic impairment, no dose adjustment is required. Elderly patients In elderly patients, no dose adjustment is required.

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 of 100 mg/5 ml. 11.43 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 one dose of the drug is missed, the missed dose should be taken as early 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 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 proarrhythmogenic factors (especially in elderly patients), including those with a congenital or acquired prolonged QT interval;in patients receiving therapy with class IA drugs (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (citalopram), fluoroquinolones(moxifloxacin and levofloxacin), with impaired water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac 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

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.

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

Respiratory Tract infections, Pneumonia, Pharyngitis, Sore Throat, Infectious Diseases, Bronchitis, Sinusitis, Sinusitis, Otitis Media, Skin Infections, Tonsillitis