Sumamed powder d / prig. suspension for oral administration 100mg / 5ml, No. 1

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);

• lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, moderate acne vulgaris (for tablets));

• the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans);

• urinary tract infections (urethritis, cervicitis)

Prescribed to children aged 6 months to 3 years.

The suspension is administered orally 1 time / day, 1 hour before or 2 hours after meals.

After taking SumamedЃ, the child must be offered to drink a few sips of water so that he can swallow the rest of the suspension. Before each intake of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of the suspension has not been taken from the vial within 20 minutes after shaking, the suspension should be shaken again, the required volume should be taken and given to the child. The required dose is measured using a dosing syringe with a graduation of 1 ml and a nominal suspension capacity of 5 ml (100 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (50 mg azithromycin) or 5 ml (100 mg azithromycin), enclosed in a cardboard packaging together with a bottle. After use, the syringe (after disassembling it) and the measuring spoon are rinsed with running water,dried and stored in a dry place until the next dose of SumamedЃ.

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 1 time / day for 3 days (course dose 30 mg / kg).

For pharyngitis / tonsillitis caused by Streptococcus pyogenes, SumamedЃ is prescribed at a dose of 20 mg / kg / day for 3 days. Heading dose - 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 / day. Heading dose - 60 mg / kg.

Method of preparation and storage of suspension

To the contents of the vial intended for the preparation of 20 ml of suspension (nominal volume), using a syringe for dosing, add 12 ml of water and shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 25 ml, which exceeds the nominal volume by about 5 ml. This is intended to compensate for the inevitable loss of the suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ? C for no more than 5 days.

In case of impaired renal function: in patients with a GFR of 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: No dose adjustment required.

Powder for preparation of suspension for oral administration 100 mg / 5 ml from white to yellowish-white color, with a characteristic strawberry odor; after dissolving in water - a homogeneous suspension of yellowish-white color, with a characteristic strawberry smell.

1 g azithromycin dihydrate ** 25.047 mg,

which corresponds to the content of azithromycin 23.895 mg

Excipients: sucrose ** - 929.753 mg, sodium phosphate - 20 mg, hyprolose - 1.6 mg, xanthan gum - 1.6 mg, strawberry flavor - 10 mg, titanium dioxide - 5 mg, colloidal silicon dioxide - 7 mg.

• Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug;

• severe liver dysfunction;

• simultaneous reception with ergotamine and dihydroergotamine;

• children's age up to 6 months (for powder for preparing a suspension);

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption (for powder for suspension preparation).

• With care: myasthenia gravis; dysfunction of the liver of mild to moderate severity; end-stage renal failure with a GFR less than 10 ml / min; in patients with the presence of proarrhythmogenic factors (especially in old age) - 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 water and electrolyte balance, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or severe heart failure; with the simultaneous use of digoxin, warfarin, cyclosporin;diabetes mellitus (for powder for suspension preparation).

pharmachologic effect

Bacteriostatic antibiotic of the macrolide-azalide group. Possesses a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of the microbial cell. By binding to the 50S-subunit of the ribosome, it inhibits peptide translocase at the stage of translation and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.

Pharmacokinetics

Suction

After oral administration, azithromycin is well absorbed and rapidly distributed in the body. After a single dose of 500 mg, bioavailability is 37% due to the 'first pass' effect through the liver. Cmax in blood plasma is reached after 2-3 hours and is 0.4 mg / l.

Distribution

Protein binding is inversely proportional to plasma concentration and is 7-50%. The apparent Vd is 31.1 l / kg. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates histohematogenous barriers and enters tissues. Concentration in tissues and cells is 10-50 times higher than in plasma, and in the focus of infection - 24-34% higher than in healthy tissues. Metabolism Demethylated in the liver, losing activity. Excretion of T1 / 2 is very long - 35-50 hours. T1 / 2 from tissues is much larger. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.

Side effect

Infectious diseases: infrequently - candidiasis (including the mucous membrane of the oral cavity and genitals), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency - pseudomembranous colitis.

Blood and lymphatic system disorders: 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, impaired taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision: infrequently - visual impairment.

On the part of the organ of hearing and labyrinth disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment up to deafness and / or tinnitus.

From the side of the cardiovascular system: infrequently - a feeling of palpitations, flushing of the face; unknown frequency - decrease in blood pressure, increase in the QT interval on the ECG, arrhythmia of the 'pirouette' type, ventricular tachycardia.

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

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 the salivary glands; very rarely - discoloration of the tongue, pancreatitis.

From the liver and biliary tract: infrequently - hepatitis; rarely - liver dysfunction, 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.

Skin and subcutaneous tissue disorders: infrequently - skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely - photosensitivity 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.

On the part of the genitals and mammary gland: infrequently - metrorrhagia, dysfunction of the testicles.

Others: infrequently - asthenia, malaise, fatigue, facial edema, 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 content of potassium in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma , an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma, a change in the sodium content in the blood plasma.

Application during pregnancy and lactation

During pregnancy and during breastfeeding, the use of the drug is possible only if the expected potential benefit of therapy to the mother outweighs the potential risk to the fetus and child. If it is necessary to use the drug during lactation, breastfeeding should be suspended.

Application for violations of liver function

In severe liver dysfunction (class C on the Child-Pugh scale), the drug is contraindicated. With caution should be prescribed for mild to moderate liver dysfunction.

Application for impaired renal function

In severe renal impairment (CC <40 ml / min), the drug is contraindicated. The drug should be prescribed with caution for mild and moderate renal impairment.

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea. Treatment: symptomatic therapy.