Sumamed Forte 200 Mg / 5 Ml - Instruction, Application For Children, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sumamed forte

Sumamed forte: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. In case of impaired liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sumamed forte

ATX code: J01FA10

Active ingredient: Azithromycin (Azithromycin)

Producer: PLIVA HRVATSKA (Croatia)

Description and photo update: 2018-22-10

Prices in pharmacies: from 220 rubles.

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Sumamed forte is an antibacterial drug, azalide.

Release form and composition

Dosage form Sumamed forte - powder for preparation of suspension for oral administration: from yellowish-white to white, with a characteristic aroma of banana, strawberry or raspberry; when dissolved in water, a suspension is formed with a homogeneous structure, from yellowish-white to white, with an aroma corresponding to the smell of a powder [in a polyethylene bottle with a polypropylene resistant cap: with a banana aroma - 16.74 g (15 ml) each, in a cardboard box 1 bottle of 50 ml, complete with a syringe and / or measuring spoon for dosing; with strawberry flavor - 29.295 g (30 ml) each, with raspberry flavor - 35.573 g (37.5 ml) each, in a cardboard box 1 bottle of 100 ml, complete with a syringe and (or) measuring spoon for dosing].

1 g of powder contains:

• active substance: azithromycin dihydrate - 50.094 mg (with a theoretical activity of the substance of 95.4%), which is equivalent to the content of 47.79 mg of azithromycin, respectively;
• auxiliary components: xanthan gum, sodium phosphate, sucrose, hyprolose, colloidal silicon dioxide, titanium dioxide;
• Flavors: Banana Flavor Powder - Banana Flavor and Vanilla Flavor, Strawberry Flavor Powder - Strawberry Flavor, Raspberry Flavor Powder - Raspberry Flavor.

Pharmacological properties

Pharmacodynamics

Sumamed forte is an antibiotic of the macrolide-azalide group, has the ability to suppress or slow down the growth and reproduction of a wide range of bacteria. The antimicrobial effect is due to the ability of azithromycin to suppress protein synthesis of the microbial cell. After binding to the 50S-subunit of the ribosome at the stage of translation, the antibiotic inhibits peptide translocase and, by inhibiting protein synthesis, slows down the growth and reproduction of bacteria. The bactericidal effect is manifested at high concentrations of the drug.

Azithromycin is active against a number of intracellular, anaerobes, gram-positive, gram-negative and other microorganisms.

Sensitive to Sumamed forte are:

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

Resistance to azithromycin can develop gram-positive aerobes - strains with medium sensitivity to penicillin and penicillin-resistant strains of Streptococcus pneumoniae.

The following microorganisms are naturally resistant to Sumamed Forte:

• gram-positive aerobes: methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Enterococcus faecalis;
• anaerobes: Bacteroides fragilis.

Cases of cross-resistance between beta-hemolytic Streptococcus pyogenes group A, Enterococcus faecalis, Streptococcus pneumoniae and Staphylococcus aureus, including methicillin-resistant strains, to azithromycin, erythromycin and other lincosamides and macrolides are known.

Pharmacokinetics

The bioavailability of the drug is 37%, after oral administration its maximum concentration (Cmax) in the blood plasma occurs in 2-3 hours.

The binding of azithromycin to blood plasma proteins is 12–52%. Vd (volume of distribution) of the drug - 31.1 l / kg. The effectiveness of the drug for infections caused by intracellular pathogens is due to its ability to overcome cell membranes. Transportation of azithromycin to the site of infection is carried out by phagocytes, polymorphonuclear leukocytes and macrophages; there it is released in the presence of bacteria. It enters the tissue by easy penetration through the histohematogenous barriers. In tissues and cells its concentration is 50 times higher than in blood plasma, in healthy tissues the content of azithromycin is 24–34% less than in the focus of infection.

Demethylated in the liver, losing activity.

It is excreted slowly from tissues, T1 / 2 (half-life) - 48–96 hours. After taking the last dose, the level of therapeutic concentration of azithromycin continues to persist for 168 hours. 50% of the active substance is excreted unchanged by the intestines, 12% by the kidneys.

In severe renal failure, with creatinine clearance (CC) less than 10 ml / min, the T1 / 2 of the drug increases by 33%.

Indications for use

According to the instructions, Sumamed forte is indicated for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug, including:

• pharyngitis or tonsillitis, otitis media, sinusitis, and other upper respiratory tract infections;
• exacerbation of chronic bronchitis, acute bronchitis, community-acquired pneumonia and other infections of the lower respiratory tract;
• impetigo, erysipelas, secondary infected dermatoses and other infections of the skin and soft tissues;
• erythema migrans (Erythema Migrans) - Lyme disease (the first stage of borreliosis).

Contraindications

• severe liver dysfunction;
• severe renal dysfunction;
• intolerance to fructose, sucrase or isomaltase deficiency, glucose-galactose malabsorption syndrome;
• the simultaneous use of ergotamine and dihydroergotamine;
• breast-feeding;
• individual intolerance to erythromycin, macrolides or ketolides;
• hypersensitivity to the components of the drug.

Sumamed forte is not prescribed for children under the age of 6 months.

Care must be taken when prescribing the drug to patients with myasthenia gravis, mild and moderate liver dysfunction, end-stage renal failure (CC less than 10 ml / min), diabetes mellitus, while using digoxin, warfarin or cyclosporin; in the presence (especially in elderly patients) of the following proarrhythmogenic factors: simultaneous therapy with class IA antiarrhythmics (procainamide, quinidine), III (sotalol, dofetilide, amiodarone), terfenadine, cisapride, antipsychotics (pimozide), fluoroquinolones (levofloxacin, moxifloxacin), antidepressants (citalopram), congenital or acquired prolongation of the QT interval, imbalance in water and electrolyte balance, especially with hypokalemia or hypomagnesemia, cardiac arrhythmia, clinically significant bradycardia,severe heart failure.

During pregnancy, the use of Sumamed forte is indicated only in special cases, if the benefits of treatment for the mother outweigh the potential threat to the fetus and child.

Instructions for the use of Sumamed forte: method and dosage

The finished suspension is taken 1 hour before meals or 2 hours after meals, 1 time per day. After taking the drug, children should be given a small amount of water to drink so that they can swallow the rest of the suspension.

To prepare a suspension, water should be added to the contents of the vial using a dosing syringe. When dissolving the powder, the following proportions must be strictly observed:

• bottle with 16.74 g of powder: to obtain 15 ml of suspension, 9.5 ml of water is added to the bottle. The resulting suspension volume is approximately 20 ml. Shelf life - no more than 5 days;
• vial with 29.295 g of powder: to obtain 30 ml of suspension, add 16.5 ml of water to the vial. The resulting volume of the suspension is about 35 ml. Shelf life - no more than 10 days;
• bottle with 35.573 g of powder: to obtain 37.5 ml of suspension, add 20 ml of water to the bottle. The resulting volume is approximately 42.5 ml. The shelf life is no more than 10 days.

After mixing the drug with water, the bottle is shaken to obtain a homogeneous suspension structure. The amount of suspension in each of the vials exceeds the nominal volume by about 5 ml. This is intended to compensate for the natural losses during dosing of the drug.

The suspension should be stored at temperatures up to 25 ° C.

The contents of the bottle must be shaken thoroughly before each intake of the next dose of the drug and immediately taken.

The prescribed dose of Sumamed forte is measured using the dosing syringe supplied with the package (graduation price - 1 ml, nominal capacity - 5 ml of suspension, or 200 mg of azithromycin) or a measuring spoon (nominal capacity - 2.5 or 5 ml of suspension, which corresponds to 100 mg and 200 mg azithromycin).

After use, the syringe (previously disassembled) and the measuring spoon must be rinsed with running water, dried and stored in a dry place until the next dose.

The dose of Sumamed forte is determined by the doctor based on clinical indications.

For the treatment of children weighing up to 10 kg, it is recommended to prescribe Sumamed powder for the preparation of a suspension for oral administration containing 100 mg of azithromycin in 5 ml of suspension. When using a measuring spoon for the dosage of this form of the drug, it should be borne in mind that a measuring spoon with a capacity of 2.5 ml contains 50 mg, and 5 ml contains 100 mg of azithromycin.

For children, Sumamed forte 200 mg / 5 ml is shown in the following accordance with the weight of the child:

• 10-14 kg: 2.5 ml (100 mg azithromycin);
• 15-24 kg: 5 ml (200 mg);
• 25-34 kg: 7.5 ml (300 mg);
• 35-44 kg: 10 ml (400 mg);
• 45 kg and above: 12.5 ml (500 mg, which corresponds to a single dose for adult patients).

Recommended daily dosage of Sumamed forte:

• infectious and inflammatory diseases of the upper and lower respiratory tract, soft tissues and skin: at the rate of 10 mg per 1 kg of body weight, course duration - 3 days, course dose - 30 mg per 1 kg;
• tonsillitis or pharyngitis caused by Streptococcus pyogenes: 20 mg per 1 kg, but not more than 500 mg per day. Duration of treatment - 3 days, dose for 1 course - 60 mg per 1 kg of body weight;
• Lyme disease: on the 1st day - 20 mg per 1 kg, from the 2nd to the 5th day - 10 mg per 1 kg of body weight. The maximum dose of one course is 60 mg per 1 kg.

With functional impairment of the kidneys, the recommended dose is not adjusted in patients with CC 10–80 ml / min.

In case of mild to moderate hepatic dysfunction and in the treatment of elderly patients, the recommended doses should not be reduced.

Side effects

• from the nervous system: often - headache; infrequently - paresthesia, insomnia, impaired taste, dizziness, nervousness, drowsiness; rarely - agitation; possibly (frequency unknown) - psychomotor hyperactivity, hypesthesia, anxiety, fainting, convulsions, aggression, loss of taste, loss of smell, myasthenia gravis, perverted sense of smell, hallucinations, delirium;
• infectious diseases: infrequently - rhinitis, pneumonia, candidiasis (including the mucous membrane of the mouth, genitals), pharyngitis, respiratory diseases, gastroenteritis; very rarely - pseudomembranous colitis;
• on the part of the cardiovascular system: infrequently - rush of blood to the skin of the face, palpitations; possibly - ventricular tachycardia, lowering of blood pressure (BP), prolongation of the QT interval on electrocardiography, arrhythmia such as pirouette;
• from the side of the blood and lymphatic system: infrequently - leukopenia, eosinophilia, neutropenia; very rarely - hemolytic anemia, thrombocytopenia;
• allergic reactions: infrequently - hypersensitivity reaction, angioedema; possibly anaphylactic reaction;
• labyrinth and hearing disorders: infrequently - vertigo, hearing impairment; possibly - tinnitus, deafness;
• on the part of the organ of vision: infrequently - visual impairment;
• from the respiratory system: infrequently - nosebleeds, shortness of breath;
• from the digestive tract: very often - diarrhea; often - abdominal pain, nausea, vomiting; infrequently - constipation, dryness of the oral mucosa, increased secretion of salivary glands, flatulence, dyspepsia, gastritis, dysphagia, belching, bloating, ulceration of the oral mucosa; very rarely - pancreatitis, discoloration of the tongue;
• from the hepatobiliary system: infrequently - hepatitis; rarely - cholestatic jaundice, liver dysfunction; possibly - fulminant hepatitis, liver failure (including fatal), liver necrosis;
• from the urinary system: infrequently - pain in the kidney area, dysuria; possibly - acute renal failure, interstitial nephritis;
• from the genitals and mammary gland: infrequently - dysfunction of the testicles, metrorrhagia;
• on the part of the musculoskeletal system: infrequently - back pain, osteoarthritis, neck pain, myalgia; possibly arthralgia;
• from the side of metabolism and nutrition: infrequently - anorexia;
• dermatological reactions: infrequently - dry skin, itching, skin rash, dermatitis, sweating, urticaria; rarely - photosensitivity reaction; possibly - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• laboratory indicators: often - a decrease in the blood plasma level of bicarbonates, a decrease in the number of lymphocytes, an increase in the number of basophils, eosinophils, monocytes and (or) neutrophils; infrequently - an increase in blood glucose levels, an increase in the activity of alanine aminotransferase and aspartate aminotransferase, an increase in the level of bilirubin, urea and (or) creatinine in the blood plasma, a violation of the level of potassium concentration in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the amount of chlorine and (or) bicarbonates in blood plasma, increased hematocrit, impaired sodium levels in blood plasma, increased platelet levels;
• others: infrequently - a feeling of fatigue, asthenia, peripheral edema, malaise, facial edema, fever, chest pain.

Overdose

Overdose symptoms coincide with some of the undesirable effects that occur while taking azithromycin in therapeutic doses: nausea, vomiting, diarrhea, temporary hearing loss.

Treatment: the appointment of activated carbon, symptomatic therapy with monitoring of vital functions.

special instructions

Patients with diabetes mellitus and patients following a low-calorie diet should take into account that the carbohydrate content in 5 ml of suspension (200 mg per 5 ml) corresponds to 0.32 XE.

If the next dose of the drug is accidentally missed, the patient should take it as soon as he remembered; then continue the reception at intervals of 24 hours.

With concomitant therapy with antacids, Sumamed forte should be taken 1 hour before or 2 hours after taking them.

With mild to moderate severity of liver dysfunction, there is a risk of developing fulminant hepatitis and severe liver failure. The drug must be discontinued if the following symptoms of liver dysfunction are present: darkening of urine, rapidly increasing asthenia, a tendency to bleeding, jaundice, hepatic encephalopathy - and a liver function test should be performed.

During the treatment period, patients need regular examination for the presence of refractory microorganisms and signs of the development of superinfections, including fungal infections.

The recommended duration of the course of therapy must not be exceeded.

Long-term use of Sumamed forte can contribute to the development of mild diarrhea or severe pseudomembranous colitis caused by Clostridium difficile. Patients who have undergone antibiotic-associated diarrhea while taking the drug should be examined to exclude clostridial pseudomembranous colitis, including 2 months after discontinuation of therapy. Do not use drugs that inhibit intestinal peristalsis.

Azithromycin has an effect on lengthening cardiac repolarization and the QT interval, which increase the risk of developing cardiac arrhythmias (including arrhythmias such as pirouette), up to cardiac arrest. In addition, the drug can contribute to the development of myasthenic syndrome or exacerbation of myasthenia gravis.

Influence on the ability to drive vehicles and complex mechanisms

Since Sumamed forte can cause the development of undesirable effects on the part of the organ of vision and the nervous system, it is recommended to be careful during the period of treatment when driving vehicles, mechanisms and other activities, the performance of which requires a high speed of psychomotor reactions and concentration of attention.

Application during pregnancy and lactation

The appointment of Sumamed forte during the gestation period is possible only as a last resort, when, according to the doctor, the expected effect of therapy for the mother exceeds the possible threat to the fetus and child.

It is contraindicated to take an antibiotic while breastfeeding.

Pediatric use

For the treatment of children aged 6 months and older, the drug is indicated in the form of a suspension for oral administration or tablets at a dose of 125 mg.

With impaired renal function

The appointment of Sumamed forte is contraindicated in severe renal dysfunction with CC less than 10 ml / min.

In case of mild to moderate renal dysfunction, the drug should be used with caution; dose adjustment is not required.

If liver function is impaired

It is contraindicated to prescribe the drug to patients with severe liver dysfunction.

With caution, Sumamed forte is recommended to be prescribed for mild to moderate liver dysfunction.

Use in the elderly

When using Sumamed forte in elderly patients, special care must be taken because of the possible presence of proarrhythmogenic factors in the patient that increase the risk of developing cardiac arrhythmias, arrhythmias such as pirouette.

Drug interactions

With the simultaneous use of Sumamed forte:

• antacids: reduce the maximum concentration of azithromycin in the blood by 30%;
• cetirizine: does not cause pharmacokinetic interactions and significant changes in the QT interval;
• didanosine (dideoxyinosine): does not change its pharmacokinetic indications;
• P-glycoprotein substrates, including digoxin: increase their concentration in blood serum;
• zidovudine (isoenzyme of the cytochrome P450 system): does not cause clinically significant interaction;
• ergot alkaloids: they should not be prescribed, since there is a risk of ergotism;
• atorvastatin (statins): may cause rhabdomyolysis;
• carbamazepine: does not significantly change its concentration and active metabolite in blood plasma;
• cimetidine: azithromycin does not affect the pharmacokinetics if it is taken 2 hours before the drug is used;
• warfarin and other indirect oral anticoagulants (coumarin derivatives): may increase their effect, therefore, frequent monitoring of prothrombin time is required;
• cyclosporine: increases its concentration in blood plasma;
• efavirenz, fluconazole, indinavir, methylprednisolone, sildenafil, theophylline, triazolam, midazolam, trimethoprim, sulfamethoxazole: do not produce clinically significant pharmacokinetic interactions when used in therapeutic doses;
• nelfinavir: may increase the level of equilibrium concentrations of the drug in the blood serum, which does not cause clinically significant side effects and does not require dose adjustment of azithromycin;
• rifabutin: may cause neutropenia, although a causal relationship between the use of this combination and the appearance of neutropenia has not been established;
• terfenadine: May cause prolongation of the QT interval and arrhythmias.

Analogs

Analogues of Sumamed forte are Azivon, Azimycin, Azivok, Azitrox, Azitral, Azithromycin Zentiva, Azithromycin Sandoz, Azithromycin, Azicid, AzitRus, Vero-Azithromycin, Zetamax retard, Zitnob, ZI-Factor, Sumadaz, Sumydaz, Zitrocin, Sumamox, Sumatrolide solutab, Azilid, Tremak-Sanovel, Azidrop, Hemomycin, Ecomed.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sumamed Fort

Reviews of Sumamed Fort are mostly positive, the drug has a quick effective effect, is well tolerated by children. The disadvantages include the unpleasant taste of the drug. In rare cases, it causes undesirable phenomena, including a violation of the intestinal microflora.

Price for Sumamed forte in pharmacies

The price of Sumamed forte 200 mg / 5 ml for a 50 ml bottle (16.74 g) can be 305-360 rubles, 100 ml (29.295 g) - 475-547 rubles, 100 ml (35.573 g) - 555-573 rubles …

Sumamed forte: prices in online pharmacies

Drug name Price Pharmacy

Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 16.74 g 1 pc. 220 RUB Buy

Sumamed Forte powder for prig suspension. for internal approx. 200mg / 5ml 16.74g 332 RUB Buy

Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 35.57 g 1 pc. 366 r Buy

Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 29.3 g (30 ml) 1 pc. RUB 400 Buy

Sumamed Forte powder for prig suspension. for internal approx. 200mg / 5ml 35.37g RUB 519 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!