Sumamed 125 mg tablets 6 (Azithromycin)
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Bacteriostatic antibiotic of 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 protein synthesis of the microbial cell. Communicating with the 50S-subunit of the ribosome, inhibits peptide translocase at the translation stage and inhibits 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, anaerobes, intracellular and other microorganisms.
Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media);
- infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens);
- infections of the skin and soft tissues (erysipelas, impetigo, re-infected dermatoses);
- the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans);
- urinary tract infections (urethritis, cervicitis) caused by Chlamydia trachomatis.
- hypersensitivity to azithromycin, erythromycin, other macrolides or ketolids, or other components of the drug;
- severe impairment of liver function;
- simultaneous administration with ergotamine and dihydroergotamine;
- children's age up to 3 years.
With caution: myasthenia gravis; violations of liver function of mild and moderate severity; terminal renal failure with GFR 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 with antiarrhythmic drugs of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances in the water-electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or with severe heart failure; with the simultaneous use of digoxin, warfarin, cyclosporine.
Use in pregnancy and lactation
During pregnancy and during breastfeeding, the use of the drug is possible only if the expected potential benefit of therapy for the mother exceeds the potential risk to the fetus and child.
If it is necessary to use the drug during lactation, breastfeeding should be suspended.
WHO recommends azithromycin as a drug choice in the treatment of chlamydial infection in pregnant women.
Use in case of impaired liver function
Contraindication: severe liver function disorders.
With caution: violations of liver function of mild and moderate severity.
Use in renal dysfunction
In case of impaired renal function: when used in patients with GFR 10-80 ml / min, dose adjustment is not required.
With caution: terminal renal failure with GFR less than 10 ml / min.
Use in childrenContraindication: children under 3 years of age.
In case of missing one dose of the drug - the missed dose should be taken as early as possible, and subsequent - with interruptions of 24 hours.
Sumamed ® should be taken at least 1 hour before or 2 hours after taking antacid drugs.
Sumamed ® should be used with caution in patients with impaired liver function of mild and moderate severity due to the possibility of developing fulminant hepatitis and severe liver failure. In the presence of symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of urine, a tendency to bleeding, hepatic encephalopathy, therapy with Sumamed ® a study of the functional state of the liver should be discontinued and conducted.
In case of impaired renal function: in patients with GFR 10-80 ml / min, dose adjustment is not required.
As with the use of other antibacterial drugs, with therapy with Sumamed ® patients should be regularly examined for the presence of immune microorganisms and signs of the development of superinfections, including fungal ones.
Sumamed ® should not be used longer courses than indicated in the instructions, because pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosing regimen.
There is no data on the possible interaction between azithromycin and derivatives of ergotamine and dihydroergotamine, but due to the development of ergotism with the simultaneous use of macrolides with derivatives of ergotamine and dihydroergotamine, this combination is not recommended.
With prolonged use of the drug Sumamed ® pseudomembranous colitis caused by Clostridium difficile may develop, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea while taking the drug Sumamed ® , as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Drugs that thoromose intestinal motility are contraindicated.
In the treatment with macrolides, incl. azithromycin, lengthening was observed cardiac repolarization and QT interval, which increase the risk of developing cardiac arrhythmias, incl. arrhythmias of the "pirouette" type.
Caution should be exercised when using sumamed ® in patients with the presence of proarrhythmogenic factors (especially in elderly patients), incl. with congenital or acquired prolongation of the QT interval; in patients taking antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), in patients with impaired water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia; in patients with clinically significant bradycardia, cardiac arrhythmia or severe heart failure. Application of Sumamed ® can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
Influence on the ability to drive vehicles and mechanisms
With the development of undesirable effects from the nervous system and the organ of vision, caution should be exercised when performing actions that require increased concentration of attention and speed of psychomotor reactions.
Dosage and Administration
The drug is used orally 1 time / day for 1 hour before or 2 hours after a meal.
The dispersible tablet can be swallowed whole and washed down with water, and the dispersible tablet can also be dissolved in at least 50 ml of water. Before taking, you should thoroughly mix the resulting suspension.
Adults and children over 12 years of age weighing more than 45 kg
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: prescribe 500 mg 1 time / day for 3 days, the course dose is 1.5 g.
In Lyme disease (initial stage of borreliosis) - erythema migrans (erythema migrans) is prescribed 1 time / day for 5 days: on the 1st day - 1 g, then from 2 to 5 days - 500 mg each; course dose - 3 g.
Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): with uncomplicated urethritis / cervicitis - 1 g once.
Children aged 3 to 12 years weighing less than 45 kg
For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues, the drug is prescribed at the rate of 10 mg / kg body weight 1 time / day for 3 days, the course dose is 30 mg / kg.
Table 1. Calculation of the dose of the drug Sumamed ® for children weighing less than 45 kg
|Body weight||Dose of azithromycin|
|18-30 kg||250 mg|
|31-44 kg||375 mg|
|not less than 45 kg||doses recommended for adults|
In children under 3 years of age, the use of Sumamed is recommended ® in powder form for oral suspension 100 mg/5 ml or Sumamed ® forte in powder form for the preparation of a suspension for oral administration 200 mg / 5 ml.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes Sumamed ® prescribed at a dose of 20 mg / kg / day for 3 days. The course dose is 60 mg / kg. The maximum daily dose is 500 mg.
In Lyme disease (the initial stage of borreliosis) - erythema migrans (erythema migrans) is prescribed on the 1st day at a dose of 20 mg / kg 1 time / day, then from 2 to 5 days - at the rate of 10 mg / kg 1 time / day.
For the convenience of use in children, a course dose of 60 mg / kg is recommended application of Sumamed ® in powder form for oral suspension 100 mg/5 ml or Sumamed ® forte in powder form for the preparation of a suspension for oral administration 200 mg / 5 ml.
In case of impaired renal function: when used in patients with GFR 10-80 ml / min, dose adjustment is not required.
In case of impaired liver function: when used in patients with impaired liver function of mild and moderate severity, dose adjustment is not required.
Elderly patients: dose adjustment is not required. With caution should be used in elderly patients with persistent proarrhythmogenic factors due to the high risk of developing arrhythmias, incl. arrhythmias of the "pirouette" type.
Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: symptomatic therapy.
The frequency of side effects is classified according to WHO recommendations: very often (≥10%), often (≥1%, <10%), infrequently (≥0.1%, <1%), rarely (≥0.01%, <0.1%), very rare (<0.01%), unknown frequency (cannot be estimated on the basis of available data).
Infectious diseases: infrequently - candidiasis (including oral mucosa and genitals), 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: infrequently - anorexia.
Allergic reactions: infrequently - angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.
From the nervous system: often - headache; infrequently - dizziness, disturbance taste sensations, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypoesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of the sense of smell, loss of taste, myasthenia gravis, delusions, hallucinations.
From the side of the organ of vision: infrequently - visual impairment.
From the side of the organ of hearing and labyrinth disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment up to deafness and / or tinnitus.
From the cardiovascular system: infrequently - a feeling of palpitations, flushes of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the ECG, 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, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of salivary glands; very rarely - a change in the color 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 impairment of liver function), liver necrosis, fulminant hepatitis.
From the skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitization reaction; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the musculoskeletal system: infrequently - 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 genitals and mammary gland: infrequently - metrorrhagia, impaired testicular function.
Other: infrequently - asthenia, malaise, fatigue, swelling of the face, chest pain, fever, peripheral edema.
Laboratory 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 - an increase in the activity of AST, ALT, an increase in the concentration of bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the potassium content in the blood plasma, an increase in the activity of ALP in the blood plasma, an increase in the chlorine content in the blood plasma, an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in the number of platelets hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.
- Dosage form
- 125 mg
- Number of tablets
- INN Russian
- Russian title