Sumamed forte, powder for oral suspension 200mg/5ml 35.573g/37.5ml

Composition

Per 1 g of powder:

azithromycin dihydrate 50.094 mg, which corresponds to the content of azithromycin 47.79 mg.

Auxiliary substances:

sucrose-897.206 mg,

sodium phosphate-20 mg,

giprolose-1.6 mg,

xanthan gum-1.6 mg,

cherry flavor-4.5 mg,

banana flavor-7.5 mg,

vanilla flavor-10.5 mg,

colloidal silicon dioxide-7 mg

Pharmacological action

Bacteriostatic antibiotic of the macrolide-azalide group. 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.

Sumamed Forte is active against aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae (methicillin-susceptible 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 and strains with medium sensitivity to penicillin).

Microorganisms with natural resistance: gram-positive aerobes-Enterococcus faecalis, Staphylococcus aureus. (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains); anaerobes – Bacteroides fragilis.

Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus group A), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides, have been described.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

— infections of the upper respiratory tract and ear, including pharyngitis, tonsillitis, sinusitis, otitis media;

— infections of the lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia;

infections of skin and soft tissues, including erysipelas, impetigo, secondary infected dermatoses;

— Lyme disease (early stage of borreliosis) is a migratory erythema (erythema migrans).

Contraindications

of liver severe (no data on efficacy and safety);

— disorders of renal function (QC < 40 ml/min) (no data on efficacy and safety);

— children’s age up to 6 months;

— lactation period (breastfeeding);

— deficiency of sucrase/isomaltase, fructose intolerance, glucose-galactose malabsorption;

— hypersensitivity to the components of the drug;

— hypersensitivity to other antibiotics of the group of macrolides.

With caution, the drug should be prescribed for moderate hepatic impairment, impaired renal function (creatinine clearance > 40 ml / min), patients with prolonged QT interval, receiving therapy with antiarrhythmic agents of classes Ia and III, cisapride, with hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe heart failure; simultaneously with terfenadine, warfarin, digoxin; patients with diabetes mellitus.

Side effects

Determination of the frequency of adverse reactions (according to WHO recommendations): very common (≥10%), common (≥1% –

Infectious diseases: infrequently-candidiasis, including oral and genital mucosa; very rarely-pseudomembranous colitis.

From the side of metabolism: often – anorexia.

Allergic reactions: often-pruritus of the skin, skin rash; infrequently-hypersensitivity reaction, photosensitization reaction, urticaria, Stevens-Johnson syndrome, angioedema; very rarely – anaphylactic reaction, erythema multiforme, toxic epidermal necrolysis.

From the hematopoietic system: often – eosinophilia, lymphopenia; infrequently-leukopenia, neutropenia; very rarely-thrombocytopenia, hemolytic anemia.

From the nervous system: often-headache, dizziness, paresthesia, impaired taste sensations; infrequently-hypesthesia, drowsiness, insomnia; very rarely-anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell (or anosmia) and taste sensations, myasthenia gravis, anxiety.

From the side of the organ of vision: often-a violation of the clarity of visual perception.

From the side of the organ of hearing and labyrinth disorders: often-deafness, infrequently-tinnitus; rarely-vertigo.

From the cardiovascular system: infrequently-palpitation sensation; very rarely-decreased blood pressure, increased QT interval, pirouette-type arrhythmia, ventricular tachycardia.

From the digestive system: very often-nausea, flatulence, abdominal pain, diarrhea; often-dyspepsia, vomiting; infrequently-constipation, gastritis; very rarely – discoloration of the mucous membrane of the tongue, pancreatitis.

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

From the musculoskeletal system: often-arthralgia.

From the urinary system: infrequently-increased concentration of urea and creatinine in blood plasma;

very rarely-interstitial nephritis, acute renal failure.

Others: often-weakness; infrequently-chest pain, peripheral edema, asthenia, malaise, changes in potassium concentration.

Interaction

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

Concomitant use of azithromycin does not affect the blood concentrations of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin, methylprednisolone.

If concomitant use with cyclosporine is necessary, it is recommended to monitor the concentration of cyclosporine in the blood.

With the simultaneous use of digoxin and azithromycin, it is necessary to monitor the concentration of digoxin in the blood, since many macrolides increase the absorption of digoxin in the intestine.

If concomitant use with indirect anticoagulants (coumarin-type anticoagulants, including warfarin) is necessary, careful monitoring of prothrombin time is recommended.

Concomitant use of terfenadine and macrolide antibiotics has been found to cause arrhythmia and prolongation of the QT interval. Based on this, it is impossible to exclude the development of such complications with the simultaneous use of terfenadine and azithromycin.

When used concomitantly with nelfinavir, an increase in the concentration of azithromycin in blood plasma is possible, which is not accompanied by a significant increase in adverse reactions and does not require dose adjustment.

Consideration should be given to the possibility of inhibition of the CYP3A4 isoenzyme by azithromycin when used concomitantly with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs that are metabolized with the participation of this isoenzyme.

When used concomitantly with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in blood plasma or the renal excretion of it and its metabolite glucuronide. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in peripheral vascular mononuclear cells. The clinical significance of this fact is not clear.

Concomitant use of macrolides with derivatives of ergotamine and dihydroergotamine may cause their toxic effects.

How to take it, course of administration and dosage

The drug is prescribed orally 1 time/day,1 hour before or 2 hours after meals. After taking Sumamed ® forte, the child must be offered to drink a few sips of water so that he can swallow the remaining suspension.

Before each application of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. If the required volume of suspension has not been selected from the vial within 20 minutes after shaking, the suspension should be shaken again, the required volume should be selected and given to the child.

The required dose is measured using a dosing syringe with a division price 1 ml and a nominal suspension capacity of 5 ml (200 mg of azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg of azithromycin) or 5 ml (200 mg of azithromycin), enclosed in a cardboard package together with the bottle.

After use, the syringe (after disassembling it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next intake of Sumamed ® forte.

For infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at the rate of 10 mg/kg of body weight 1 time / day for 3 days, the course dose is 30 mg/kg.

When pharyngitis/tonsillitis caused by Streptococcus pyogenes, Sumamed ® forte is used at a dose of 20 mg / kg / day for 3 days (a course dose of 60 mg/kg). The maximum daily dose is 500 mg.

Children with a body weight of up to 10 kg should be prescribed Sumamed® in the form of a powder for the preparation of an oral suspension with a concentration of 100 mg/5 ml.

In Lyme disease (the initial stage of borreliosis) – erythema migrans (erythema migrans), the drug is prescribed on day 1 at a dose of 20 mg / kg/day, then from days 2 to 5-at a dose of 10 mg/kg/day (the course dose is 60 mg/kg).

In patients with impaired renal function (creatinine clearance >40 ml/min), no dose adjustment is required.

No dose adjustment is required in patients with moderate hepatic impairment.

Rules for suspension preparation and storage

20 ml of water is added to the contents of the bottle intended for the preparation of 37.5 ml of suspension (nominal volume) using a dosing syringe. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 42.5 ml, which exceeds the nominal volume by about 5 ml. This is intended to compensate for the unavoidable loss of suspension when dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25°C for no more than 10 days.

Overdose

Symptoms (similar to the side effects that occur when taking the drug in the recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: taking activated charcoal, performing symptomatic therapy, monitoring vital functions.

Special instructions

If you miss taking one dose of the drug, the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

Sumamed forte should be used with caution in patients with impaired liver function, due to the possibility of developing fulminant hepatitis and severe hepatic 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 Sumamed® forte should be discontinued and a study of the functional state of the liver should be conducted.

In patients with moderate renal impairment (creatinine clearance >40 ml/min), Sumamed forte therapy should be carried out with caution under the control of renal function.

In case of end-stage renal failure (CC

It should be remembered that for the prevention of pharyngitis/tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, the drug of choice is usually penicillin.

As with other antibacterial agents, patients with Sumamed forte should be regularly evaluated for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

The drug Sumamed ® forte should not be used for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin allow us to recommend a short and convenient dosage regimen.

There are no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism when macrolides are used simultaneously with ergotamine and dihydroergotamine derivatives, this combination is contraindicated.

Long-term use of Sumamed forte may cause pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be excluded.

Delayed ventricular repolarization syndrome – QT prolongation syndrome-increases the risk of arrhythmias, including pirouette-type arrhythmias when taking macrolides, as well as Sumamed forte. Caution should be exercised when using azithromycin in patients with prolonged QT interval, receiving therapy with Class Ia, III antiarrhythmic agents, cisapride, hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia, or severe heart failure.

The use of Sumamed ® forte may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

When using Sumamed ® forte in patients with diabetes mellitus, as well as when following a low-calorie diet, it should be taken into account that the suspension contains sucrose (0.32 XE/5 ml).

Influence on the ability to drive motor vehicles and manage mechanisms

When developing undesirable effects from the nervous system and the visual organ, patients should be careful when performing actions that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Purpose

Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children as prescribed by a doctor

Indications

Pneumonia, Bronchitis, Respiratory Tract Infections, Otitis Media, Sore Throat, Skin Infections, Sinusitis, Tonsillitis, Pharyngitis, Infectious diseases, Urethritis