Buy Sumamed

Bacteriostatic antibiotic of macrolide-azalide group.

• It has a wide spectrum of antimicrobial action.
• The mechanism of action of azithromycin is associated with the suppression of protein synthesis of a microbial cell. By binding to the 50S subunit of the ribosome, it inhibits the peptidranslokase at the translation stage and suppresses protein synthesis, slowing the growth and multiplication of bacteria. In high concentrations 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.

The sensitivity scale of microorganisms to azithromycin (MIC, mg / L)

	MIC, mg / L	MIC, mg / L
Microorganisms	sensitive	resistant
Staphylococcus	≤1	>2
Streptococcus A, B, C, G	≤0,25	>0,5
Streptococcus pneumonia	≤0,25	>0,5
Haemophilus influenzae	≤0,12	>4
Moraxella catarrhalis	≤0,5	>0,5
Neisseria gonorrhoeae	≤0,25	>0,5

 

In most cases, the drug Sumamed is active against aerobic Gram-positive bacteria:

• Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes;
• aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
• anaerobic bacteria: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp .;
• other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms that can develop resistance to azithromycin:

• gram-positive aerobes - Streptococcus pneumoniae (penicillin-resistant strains).
• Initially, stable microorganisms: gram-positive aerobes - Enterococcus faecalis, Staphylococci (methicillin-resistant strains of staphylococcus exhibit a very high degree of resistance to macrolides);
• Gram-positive bacteria resistant to erythromycin; anaerobes - Bacteroides fragilis.

Suction

 

After oral administration, azithromycin is well absorbed and quickly 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 achieved after 2-3 hours and is 0.4 mg / l.

 

Distribution

 

Binding to proteins is inversely proportional to the concentration in the blood plasma 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 through the histohematological barriers and enters the tissues. Concentration in tissues and cells is 10-50 times higher than in plasma, and in the focus of infection - 24-34% more than in healthy tissues.

 

Metabolism

 

In the liver, demethylated, losing activity.

 

Excretion

 

T1 / 2 is very long - 35-50 h. T1 / 2 of the tissues is much larger. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted, basically, in unchanged form - 50% through the intestine, 6% by the kidneys.

• Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
•  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, including those caused by atypical pathogens);
•  infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, acne vulgaris of moderate severity (for tablets));
•  the initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);
•  urinary tract infections (urethritis, cervicitis) caused by Chlamydia trachomatis (for tablets and capsules).

• Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug;
• violations of liver function of a serious degree;
• simultaneous administration with ergotamine and dihydroergotamine;
• children under 12 years old with a body weight of <45 kg (for capsules and tablets 500 mg);
• children's age under 3 years (for tablets 125 mg);
• children's age to 6 months (for powder for the preparation of suspension);
• deficiency of sugar / isomaltase, fructose intolerance, glucose-galactose malabsorption (for powder for suspension preparation).

 

With caution:

 

• myasthenia gravis;
• violations of liver function of mild and moderate severity;
• terminal renal failure with GFR <10 ml / min;
• in patients with pro-arrhythmic factors (especially in the elderly) with congenital or acquired QT interval prolongation, in patients receiving antiarrhythmic drugs of class IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water-electrolyte balance disorders, especially with hypokalemia or hypomagnesemia, with clinically significant bradycardia, and rhythm or with severe heart failure;
• with the simultaneous use of digoxin, warfarin, cyclosporine;
• diabetes mellitus (for powder for the preparation of a suspension).

Capsules

 

• The drug is administered orally 1 time / day, at least 1 hour before or 2 hours after eating, without chewing.
• Adults and children over 12 years of age with a body weight> 45 kg
• With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues, the drug is prescribed at a dose of 500 mg 1 time / day for 3 days, the course dose is 1.5 g.
• In Lyme disease (the initial stage of borreliosis), migrating erythema (erythema migrans), the drug is prescribed 1 time / day for 5 days: on the 1st day - 1 g, then from 2 to 5 days - 500 mg; course dose - 3 g.
• Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): with uncomplicated urethritis / cervicitis, the drug is prescribed at a dose of 1 g (4 capsules) once.

 

Pills

 

• The drug is administered orally 1 time / day, at least 1 hour before or 2 hours after eating, without chewing.
• Adults and children over 12 years of age with a body weight> 45 kg
• With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues, the drug is prescribed at a dose of 500 mg 1 time / day for 3 days, the course dose is 1.5 g.
• With acne vulgaris of moderate severity, the drug is given at a dose of 500 mg 1 time / day for 3 days, then 500 mg once a week for 9 weeks. The course dose is 6 g. The first weekly dose should be taken 7 days after the first daily dose (the 8th day from the start of treatment), the subsequent 8 weekly doses should be taken at intervals of 7 days.
• With Lyme disease (the initial stage of borreliosis) - migrating erythema (erythema migrans), the drug is prescribed 1 time / day for 5 days: on the 1st day - 1 g, then from 2 to 5 days - 500 mg; course dose - 3 g.
• Urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): with uncomplicated urethritis / cervicitis, the drug is prescribed at a dose of 1 g (2 tablets of 500 mg) once.
• Children aged 3 to 12 years with a body weight of <45 kg
• With 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.
• The drug in the form of tablets 125 mg is dosed taking into account the weight of the child, as shown in Table 1.

 

Table 1.

 

Body weight The dose of azithromycin (in tablets 125 mg):

 

• 18-30 kg 2 tablets (250 mg)
• 31-44 kg 3 tablets (375 mg)
• ≥45kg doses recommended for adults
• With pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed is 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.
• With Lyme disease (the initial stage of borreliosis) - migrating erythema (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 a rate of 10 mg / kg 1 time / day. The course dose is 60 mg / kg.
• For the convenience of use in children of a dose of 60 mg / kg, it is recommended to use Sumamed in the form of a powder for the preparation of a suspension for ingestion of 100 mg / 5 ml and Sumamed forte in powder form for the preparation of a suspension for oral administration of 200 mg / 5 ml.

 

Suspension for oral administration

 

• Assign children aged 6 months to 3 years.
• Suspension is given orally 1 time / day, 1 hour before or 2 hours after eating. After taking the drug Sumamed, a child must necessarily offer to drink a few sips of water so that he can swallow the remains of the suspension.
• Before each intake of the drug, the contents of the vial are shaken carefully until a homogeneous suspension is obtained. If the required volume of the suspension has not been removed from the vial within 20 minutes after shaking, the suspension should be shaken again, take the necessary volume and give the baby.
• The required dose is measured using a syringe for dosing with a 1 ml dividing rate and a nominal slurry capacity of 5 ml (100 mg azithromycin) or a measuring spoon with a nominal capacity of 2.5 ml (50 mg azithromycin) or 5 ml (100 mg azithromycin) embedded in cardboard packing together with the bottle.
• After use, the syringe (after having disassembled it) and the measuring spoon is washed with running water, dried and stored in a dry place until the next dose of Sumamed.
• With 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). To accurately dose the drug Sumamed in accordance with the body weight of the child should use the table below.

Mass of body Volume of suspension (ml) for 1 reception:

 

• 5 kg 2.5 ml (50 mg azithromycin)
• 6 kg 3 ml (60 mg of azithromycin)
• 7 kg 3.5 ml (70 mg azithromycin)
• 8 kg 4 ml (80 mg of azithromycin)
• 9 kg 4.5 ml (90 mg of azithromycin)
• 10 kg 5 ml (100 mg of azithromycin)
• With pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed is 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.
• With Lyme disease (the initial stage of borreliosis), migrating erythema (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 a rate of 10 mg / kg / day. The course dose is 60 mg / kg. The maximum daily dose is 500 mg.With Lyme disease (the initial stage of borreliosis), migrating erythema (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 a rate of 10 mg / kg / day. The course dose is 60 mg / kg.Method of preparation and storage of the suspensionTo the contents of the vial intended for the preparation of 20 ml of the suspension (nominal volume), 12 ml of water is added with a syringe for dosing and shaken until a homogeneous suspension is obtained. The volume of the resulting suspension is about 25 ml, which exceeds the nominal volume by approximately 5 ml.
• This is provided to compensate for the inevitable loss of the suspension when the drug is dosed.
• The prepared suspension can be stored at a temperature of no higher than 25 ° C for not more than 5 days.In case of impaired renal function: in patients with GFR 10-80 ml / min dose adjustment is not required.

 

If liver function is impaired: when used in patients with mild or moderate liver function disorder, dose adjustment is not required.

Elderly patients: dose adjustment is not required.

Since older people can already have current pro-rhythmogenic conditions, caution should be exercised when using Sumamed medication because of the high risk of developing cardiac arrhythmias, incl. arrhythmias of the "pirouette" type.

• The incidence of adverse events is classified according to WHO recommendations: very often (≥10%), often (≥1% - <10%), infrequently (≥0.1% - <1%), rarely (≥0.01% - <0.1%) , very rarely (<0.01%), unknown frequency (can not be estimated based on available data).
• Infectious diseases: infrequently - candidiasis (including mucous membrane of the oral cavity and genitals), pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; an unknown frequency is pseudomembranous colitis.
• From the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.
• From the metabolism: infrequently - anorexia.
• Allergic reactions: infrequently - angioedema, hypersensitivity reaction; an unknown frequency is an anaphylactic reaction.
• From the nervous system: often - headache; infrequently - dizziness, dyspnoea, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste sensations, myasthenia gravis, delirium, hallucinations.
• From the side of the organ of vision: infrequently - impaired vision.
• From the side of the hearing organ and labyrinthine disturbances: 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, flushes of blood to the face; unknown frequency - a decrease in blood pressure, an increase in the QT interval on the ECG, arrhythmia such as "pirouette", ventricular tachycardia.
• From the respiratory system: infrequently - shortness of breath, nosebleed.
• From the digestive tract: very often - diarrhea; often - nausea, vomiting, abdominal pain; infrequent - meteorism, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - a discoloration of the tongue, pancreatitis.
• From the liver and biliary tract: infrequently - hepatitis; rarely - a violation of the liver, cholestatic jaundice; unknown frequency - hepatic insufficiency (in rare cases with a fatal outcome mainly on the background of severe impairment of liver function), liver necrosis, fulminant hepatitis.
• From the skin and subcutaneous tissues: infrequently - skin rash, itching, hives, dermatitis, dry skin, sweating; rarely - the reaction of photosensitization; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
• On the part of the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.
• From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidneys; unknown frequency - interstitial nephritis, acute renal failure.
• From the genitals and the breast: infrequently - metrorrhagia, dysfunction of the testicles.
• Other: infrequent - asthenia, malaise, fatigue, face swelling, 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; infrequent increase of AST, ALT activity, increase of bilirubin concentration in blood plasma, increase of urea concentration in blood plasma, increase of creatinine concentration in blood plasma, change of potassium content in blood plasma, increase of alkaline phosphatase activity in blood plasma, increase of chlorine content in blood plasma , increasing blood glucose, increasing the number of platelets, increasing hematocrit, increasing the concentration of bicarbonates in the blood plasma, changing the sodium content in the blood plasma.

Symptoms:

 

• nausea,
• temporary loss of hearing,
• vomiting,
• diarrhea.

 

Treatment:

 

• symptomatic therapy.

• Antacid preparations

Antacids do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed should be taken at least 1 hour before or 2 hours after taking these drugs and food.

• Cetirizine

Simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction and 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 showed no change in the pharmacokinetic indices of didanosine compared with the placebo group.

• Digoxin (substrates of P-glycoprotein)

Simultaneous use of macrolide antibiotics, incl. azithromycin, with substrates of the P-glycoprotein, such as digoxin, leads to an increase in the concentration of the P-glycoprotein substrate in the serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

• Zidovudine

Simultaneous use of azithromycin (a single dose of 1000 mg and repeated administration of 1200 mg or 600 mg) has a negligible effect on the pharmacokinetics, incl. kidney removal 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. The clinical significance of this fact is unclear.

Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It was not revealed that azithromycin is involved in the pharmacokinetic interaction with the analogous erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.

• Alkaloids of ergot

Given the theoretical possibility of the emergence of ergotism, the simultaneous use of azithromycin with derivatives of ergot alkaloids is not recommended.

Pharmacokinetic studies of the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of cytochrome P450 isoenzymes have been carried out.

• Atorvastatin

The simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause a change in the concentrations of atorvastatin in the blood plasma (based on the inhibition of GMA-CoA reductase). However, in the post-marketing period, separate reports were received on cases of rhabdomyolysis in patients receiving both azithromycin and statins.

• Carbamazepine

In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in blood plasma in patients treated with azithromycin simultaneously.

• Cimetidine

In pharmacokinetic studies of the effect of cimetidine on single-dose administration of azithromycin pharmacokinetics, there was no change in the pharmacokinetics of azithromycin, provided cimetidine was administered 2 hours before azithromycin.

• Anticoagulants of indirect action (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when administered in a single dose of 15 mg by healthy volunteers. Potential anticoagulant effect was reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, consideration should be given to the need for frequent monitoring of prothrombin time when azithromycin is used in patients who receive oral anticoagulants of indirect action (coumarin derivatives).

• Cyclosporin

In a pharmacokinetic study involving healthy volunteers who within 3 days were ingested azithromycin (500 mg / day once) and then cyclosporine (10 mg / kg / day once), there was a significant increase in Cmax in the blood plasma and AUC0-5 cyclosporine . Care should be taken when using these drugs at the same time. In case of simultaneous use of these drugs, the concentration of cyclosporin in the blood plasma should be monitored and, accordingly, the dose should be adjusted.

• Efavirenz

Simultaneous 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

Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1 / 2 azithromycin did not change with the simultaneous use of fluconazole, but a decrease in Cmax of azithromycin (by 18%) was observed, which was not clinically significant.

• Indinavir

Simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times / day for 5 days).

• Methylprednisolone

Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone.

• Nelfinavir

Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in Css azithromycin in blood plasma. Clinically significant side effects were not observed and correction of the dose of azithromycin with its simultaneous application with nelfinavir is not required.

• Rifabutin

Simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood plasma. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

• Sildenafil

When used in healthy volunteers, evidence of the effect of azithromycin (500 mg / day daily for 3 days) on AUC and Cmax sildenafil or its main circulating metabolite was not obtained.

• Terfenadine

In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. Individual cases were reported where the possibility of such interaction could not be ruled out completely, but there was not one concrete proof that such an interaction took place. It was found that simultaneous use of terfenadine and macrolides can cause arrhythmia and lengthening of the QT interval.

• Theophylline

There was no interaction between azithromycin and theophylline.

• Triazolam / midazolam

Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses have not been revealed.

• Trimethoprim / sulfamethoxazole

With the simultaneous use of trimethoprim / sulfamethoxazole with azithromycin, there is no significant effect on Cmax, total exposure or excretion of trimethoprim or sulfamethoxazole by the kidneys. The concentrations of azithromycin in the serum corresponded to those detected in other studies.

• If you miss one dose of the drug - the missed dose should be taken as soon as possible, and the next - with interruptions of 24 hours.
• Sumamed should be taken at least 1 hour before or 2 hours after taking antacid preparations.
• Sumamed should be used with caution in patients with mild to moderate liver function disorders due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency. If there are signs of liver dysfunction, such as rapidly growing asthenia, jaundice, darkening of the urine, a tendency to bleeding, hepatic encephalopathy with Sumamed should be stopped and a study of the functional state of the liver.
• If the renal function is impaired in patients with GFR 10-80 ml / min dose adjustment is not required, therapy with Sumamed should be performed with caution under the control of the state of kidney function.
• As with the use of other antibacterial drugs, when treating with Sumamed, patients should be regularly monitored for the presence of non-susceptible microorganisms and signs of development of superinfections, incl. fungal.
• Sumamed should not be used for longer courses than indicated in the instructions. 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 because of the development of ergotism with the simultaneous use of macrolides with derivatives of ergotamine and dihydroergotamine, this combination is not recommended.
• With long-term administration of Sumamed drug, it is possible to develop pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. With the development of antibiotic-associated diarrhea against the background of taking the drug Sumamed, and also 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit the intestinal peristalsis.
• When treating macrolides, incl. azithromycin, there was an increase in cardiac repolarization and QT interval, which increased the risk of cardiac arrhythmias, incl. arrhythmias of the "pirouette" type.
• Caution should be used when using Sumamed in patients with proarrhythmogenic factors (especially in elderly patients), incl. with congenital or acquired lengthening of the QT interval; in patients,
• (dopetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), in patients with disturbances of the water-electrolyte balance , especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.
• The use of the Sumamed drug can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
• When used in patients with diabetes mellitus, as well as in patients who observe a low-calorie diet, it must be taken into account that sucrose (0.32 XE / 5 ml) is included as an auxiliary substance in the powder for the suspension of Sumamed.
• Impact on the ability to drive vehicles and manage mechanisms
• With the development of undesirable effects from the nervous system and the organ of vision, care should be taken when performing actions requiring increased concentration of attention and speed of psychomotor reactions.

During pregnancy and during breastfeeding, the drug can be used only if the expected potential benefit of therapy for the mother exceeds the potential risk to the fetus and the baby.

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

• Contraindicated:

children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg); children's age to 3 years (for tablets 125 mg, children's age to 6 months (for powder for the preparation of suspension).

In severe renal impairment (CC <40 ml / min), the drug is contraindicated. Caution should be given to the drug for mild to moderate renal dysfunction.

In severe violations of the liver (class C on the scale Child-Pugh) drug is contraindicated. Caution should be given for mild to moderate liver function abnormalities.

In elderly patients, dose adjustment of Sumamed is not required. Since this category of patients may have pro-arrhythmic conditions, Sumamed should be used with caution in connection with the high risk of arrhythmias, incl. ventricular arrhythmia of the "pirouette" type.

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C. Shelf life of the drug in the form of capsules and tablets, coated with a coating - 3 years, powder for the preparation of a suspension for oral administration - 2 years, the prepared suspension - 5 days.