Sumamed
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Prices in online pharmacies:
from 124 rub.
Buy
Sumamed is a broad-spectrum antibacterial drug. It is an antibiotic of the macrolide group (azalide).
Release form and composition
Sumamed is available in the following dosage forms:
- film-coated tablets, 125 mg: biconvex, round, blue, engraved PLIVA on one side, engraved “125” on the other; on the break, a white or almost white core is visible (6 pcs. in blisters, 1 blister in a cardboard box);
- film-coated tablets, 500 mg: biconvex, oval, blue, engraved PLIVA on one side, engraved “500” on the other; on the break, a white or almost white core is visible (3 pcs. in blisters, 1 blister in a cardboard box);
- dispersible tablets 125 mg: flat, round, white or almost white, engraved "TEVA 125" on one side, with beveled edges (6 pcs. in blisters, 1 blister in a cardboard box);
- dispersible tablets 250 mg: flat, round, white or almost white, engraved "TEVA 250" on one side and a line on the other, with beveled edges (6 pcs. in blisters, in a cardboard box 1 blister);
- dispersible tablets 500 mg: flat, round, white or almost white, engraved "TEVA 500" on one side and a line on the other, with beveled edges (3 pcs. in blisters, in a cardboard box 1 or 2 blisters);
- dispersible tablets 1000 mg: flat, round, white or almost white, engraved "TEVA 1000" on one side and two perpendicular lines on the other, with beveled edges (1 pc. in blisters, in a cardboard box 1 or 3 blisters);
- hard gelatin capsules 250 mg: size No. 1, with a blue cap and a blue body; content - a compacted mass that disintegrates when pressed, or powder from white to light yellow (6 pcs. in blisters, 1 blister in a cardboard box);
- powder for preparation of suspension for oral administration 100 mg / 5 ml: white or yellowish-white, with a characteristic strawberry smell; ready-made suspension - homogeneous, yellowish-white, with a strawberry smell (20.925 g each in 50 ml polyethylene bottles, 1 bottle in a cardboard box complete with a syringe for dosing and / or a measuring spoon);
- lyophilisate for preparation of solution for infusion: white or almost white powder (in colorless glass vials, in a cardboard box of 5 vials).
Composition of 1 film-coated tablet:
- active substance: azithromycin (in the form of azithromycin dihydrate) - 125 mg or 500 mg;
- auxiliary components: hypromellose, microcrystalline cellulose, magnesium stearate, corn starch, calcium hydrogen phosphate anhydrous, sodium lauryl sulfate, pregelatinized starch;
- film shell: titanium dioxide, talc, hypromellose, polysorbate 80, indigo carmine dye.
Composition of 1 dispersible tablet:
- active substance: azithromycin (in the form of azithromycin dihydrate) - 125, 250, 500 or 1000 mg;
- auxiliary components: sodium lauryl sulfate, microcrystalline cellulose, povidone K30, sodium saccharinate dihydrate, colloidal silicon dioxide, crospovidone type A, magnesium stearate, aspartame, banana flavor (150 mg tablets) or orange (250 mg, 500 mg and 1000 mg tablets).
Composition of 1 capsule:
- active substance: azithromycin (in the form of azithromycin dihydrate) - 250 mg;
- auxiliary components: sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate;
- capsule shell composition: titanium dioxide, gelatin, indigo carmine.
Composition of 1 g of powder for suspension preparation:
- active substance: azithromycin (in the form of azithromycin dihydrate) - 23.895 mg;
- auxiliary components: hyprolose, sucrose, titanium dioxide, sodium phosphate, xanthan gum, colloidal silicon dioxide, strawberry flavor.
Composition for 1 bottle with lyophilisate:
- active substance: azithromycin (in the form of azithromycin dihydrate) - 500 mg;
- auxiliary components: sodium hydroxide, citric acid monohydrate.
Indications for use
Sumamed is used to treat infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:
- infections of the ENT organs and upper respiratory tract (otitis media, sinusitis, tonsillitis, pharyngitis);
- lower respiratory tract infections (pneumonia, exacerbation of chronic bronchitis, acute bronchitis, including infections caused by atypical microorganisms);
- tick-borne borreliosis in the initial stage (Lyme disease);
- infections of soft tissues and skin, for example, impetigo, erysipelas, moderate acne vulgaris, secondarily infected dermatoses (for Sumamed in the form of tablets);
- infections of the urinary tract (cervicitis, urethritis), the causative agent of which is Chlamydia trachomatis (for Sumamed in the form of tablets and capsules).
Sumamed in the form of a lyophilisate for the preparation of a solution for infusion is used for community-acquired pneumonia and infectious and inflammatory diseases of the pelvic organs (salpingitis, endometritis) caused by Neisseria gonorrhoeae or Chlamydia trachomatis and Mycoplasma hominis.
Contraindications
Absolute:
- severe renal dysfunction (creatinine clearance less than 40 ml / min);
- severe liver dysfunction;
- fructose intolerance, isomaltase / sucrase deficiency (for Sumamed in powder form for suspension preparation);
- children's age up to 6 months (for Sumamed in powder form for preparing a suspension);
- children under 3 years of age (for Sumamed in the form of tablets with a dosage of 125 mg);
- children under 12 years of age and body weight less than 45 kg (for Sumamed in the form of tablets with a dosage of 500 mg and capsules);
- children and adolescents up to 18 years old (for Sumamed in the form of a lyophilisate);
- joint reception with dihydroergotamine and ergotamine;
- hypersensitivity to azithromycin or auxiliary components of the drug, as well as erythromycin, ketolides or other macrolides.
Relative (Sumamed is used with caution):
- mild and moderate renal dysfunction (creatinine clearance more than 40 ml / min);
- mild to moderate liver dysfunction;
- the presence of proarrhythmogenic factors, especially in elderly patients (arrhythmia, clinically significant bradycardia, severe heart failure, hypomagnesemia or hypokalemia, acquired or congenital prolongation of the QT interval, concomitant use of class IA and III antiarrhythmics, antidepressants, fluoroquinolones, antipsychotic drugs and cytazapride);
- diabetes mellitus (for Sumamed in powder form for preparing a suspension);
- concomitant use of warfarin, digoxin or cyclosporin.
Method of administration and dosage
Film-coated tablets, dispersible tablets and capsules
Sumamed is taken orally 1 hour before meals or 2 hours after meals.
Recommended doses and duration of treatment for adults and children over 12 years old with a body weight of 45 kg or more:
- infections of the ENT organs, respiratory tract, soft tissues and skin: 500 mg once a day, the course of treatment is 3 days; with moderate acne vulgaris after a standard 3-day course, treatment is continued for another 9 weeks (500 mg once a week);
- the initial stage of borreliosis: 1000 mg on the first day, 500 mg on the following days, the course of treatment is 5 days;
- uncomplicated cervicitis / urethritis: 1000 mg once.
Recommended doses and duration of treatment for children aged 3–12 years with a body weight of less than 45 kg:
- infections of ENT organs, respiratory tract, soft tissues and skin: 10 mg / kg of body weight once a day, the course of treatment is 3 days;
- tonsillitis / pharyngitis caused by Streptococcus pyogenes: 20 mg / kg once a day, the course of treatment is 3 days (the maximum dose is 500 mg per day);
- the initial stage of borreliosis: on the first day - 20 mg / kg once a day, on the following days - 10 mg / kg once a day, the course of treatment is 5 days.
Oral suspension
Sumamed in the form of a suspension for oral administration is prescribed to children aged 6 months to 3 years. The drug is taken once a day 1 hour before meals or 2 hours after meals. The suspension should be taken with a little water.
To prepare the suspension, add 12 ml of water to the contents of the bottle with the powder and shake thoroughly until a homogeneous consistency is obtained. The resulting volume will be about 25 ml, which is 5 ml more than the nominal volume. Such a discrepancy is provided in order to compensate for the inevitable loss of suspension when dosing Sumamed. The finished suspension can be stored for no more than 5 days at a temperature not exceeding 25 ° C.
The prepared suspension must be shaken thoroughly before each use. The prescribed dose is metered out using the supplied dosing syringe or measuring spoon, which should be rinsed and dried after each use.
The dosage of the suspension is similar to the recommended doses for the use of tablets in children 3–12 years old (1 ml of the suspension contains 20 mg of azithromycin).
Lyophilisate for preparation of solution for infusion
Sumamed is injected intravenously over 1 hour (at a solution concentration of 2 mg / ml) or 3 hours (at a solution concentration of 1 mg / ml). Intramuscular or intravenous jet injection is prohibited.
The solution for infusion is prepared in 2 stages:
- Preparation of the reconstituted solution. Add 4.8 ml of water for injection to the vial with the lyophilisate and shake thoroughly until the powder is completely dissolved. 1 ml of the resulting solution contains 100 mg of azithromycin. The reconstituted solution is inspected for undissolved particles. If they are found, the solution cannot be used.
- Dilution of the reconstituted solution. Ringer's solution, 0.9% sodium chloride solution, or 5% dextrose solution can be used as a solvent. The volume of the solvent depends on the desired final concentration of azithromycin. To obtain a solution of 1 mg / ml, 500 ml of solvent is required, 2 mg / ml - 250 ml. The prepared solution is used immediately (provided that there are no visible undissolved particles, if any are found, the solution cannot be used).
Recommended doses and duration of treatment for adult patients:
- community-acquired pneumonia: 500 mg once a day for 2 days (by the doctor's decision, the course can be extended up to 5 days), then the patient is transferred to the oral form of Sumamed at a dose of 500 mg once a day; the general course of treatment is 7-10 days;
- infectious and inflammatory diseases of the pelvic organs: 500 mg once a day for 2 days (maximum - up to 5 days), then once a day, 250 mg Sumamed in dosage form for oral administration; the general course of treatment is 7 days.
Patients with impaired renal and / or liver function of mild and moderate severity, as well as the elderly, do not require dose adjustment.
Side effects
- gastrointestinal tract, liver and biliary tract: very often - diarrhea; often - abdominal pain, vomiting, nausea; infrequently - belching, dry mouth, dyspepsia, dysphagia, hepatitis, increased salivation, oral mucosa ulcers, constipation, flatulence, gastritis, bloating; rarely - cholestatic jaundice, liver dysfunction; very rarely - pancreatitis, discoloration of the tongue; frequency unknown - liver necrosis, liver failure, fulminant hepatitis;
- respiratory system: infrequently - nosebleeds, shortness of breath;
- cardiovascular system: infrequently - flushing of the face, palpitations; frequency unknown - ventricular tachycardia, decrease in blood pressure, pirouette-type arrhythmia, prolongation of the QT interval;
- nervous system and sensory organs: often - headaches; infrequently - taste disturbance, nervousness, insomnia or drowsiness, dizziness, paresthesia, visual impairment, vertigo, hearing impairment; rarely - pronounced emotional arousal; frequency unknown - loss or perversion of smell, psychomotor hyperactivity, delirium, loss of taste, anxiety, hallucinations, hypesthesia, fainting, myasthenia gravis, aggression, convulsions, tinnitus and / or hearing impairment;
- musculoskeletal system: infrequently - muscle pain, pain in the neck and back, osteoarthritis; frequency unknown - arthralgia;
- skin and subcutaneous tissues: infrequently - dry skin, skin rash, sweating, dermatitis; rarely - increased photosensitivity; frequency unknown - erythema multiforme, Stevens-Johnson syndrome;
- genitourinary system: infrequently - metrorrhagia, pain in the kidney area, dysuria, dysfunction of the testicles; frequency unknown - acute renal failure, interstitial nephritis;
- metabolism: infrequently - anorexia;
- lymphatic system and blood: infrequently - neutropenia, eosinophilia, leukopenia; very rarely - hemolytic anemia, thrombocytopenia;
- allergic reactions: infrequently - hypersensitivity reactions, angioedema; frequency unknown - anaphylactic reactions;
- infectious diseases: infrequently - pharyngitis, rhinitis, pneumonia, respiratory diseases, gastroenteritis, candidiasis; frequency unknown - pseudomembranous colitis;
- laboratory parameters: an increase in the activity of liver enzymes, an increase in plasma concentrations of bilirubin, urea, creatinine, glucose and chlorine, a decrease or increase in the concentration of bicarbonates, an increase in hematocrit, an increase in the activity of alkaline phosphatase, a change in the content of sodium and potassium in plasma, an increase in the number of eosinophils, monocytes, platelets, basophils and neutrophils, decreased lymphocyte count;
- other reactions: infrequently - facial edema, malaise, peripheral edema, asthenia, chest pain, fatigue, fever.
special instructions
If you miss the next dose of Sumamed, you should take the missed dose as soon as possible, subsequent doses are taken at intervals of 24 hours.
During treatment with the drug, regular examination of the patient is required for the presence of refractory pathogens and signs of superinfections, including fungal infections.
With the development of antibiotic-associated diarrhea during Sumamed therapy and 2 months after the end of treatment, it is necessary to exclude pseudomembranous colitis.
Information for patients with diabetes mellitus and patients on a diet: powder for suspension contains sucrose (0.32 bread units / 5 ml).
Information for patients on a diet with limited sodium intake: One bottle of Sumamed in the form of a lyophilisate contains 198.3 mg of sodium.
With the simultaneous appointment of antacids, oral forms of Sumamed should be taken 1 hour before or 2 hours after the use of these drugs.
In the event of side effects from the central nervous system or the organ of vision, care must be taken when driving vehicles and other potentially dangerous mechanisms.
Drug interactions
Due to the high pharmacological activity of azithromycin and the significant likelihood of the interaction of Sumamed with other drugs / substances, recommendations on their compatibility can only be given by the attending physician.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life: film-coated tablets, dispersible tablets and capsules - 3 years; powder for preparation of suspension for oral administration and lyophilisate for preparation of solution for infusion - 2 years.
Sumamed: prices in online pharmacies
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Drug name Price Pharmacy |
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Sumamed 100 mg / 5 ml powder for suspension for oral administration 20 ml 1 pc. 124 RUB Buy |
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Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 16.74 g 1 pc. 220 RUB Buy |
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Sumamed powder for prig sus. for internal approx. 100mg / 5ml / 23ml 17g 226 r Buy |
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Sumamed 125 mg film-coated tablets 6 pcs. 263 r Buy |
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Sumamed tablets p.p. 125mg 6 pcs. 317 r Buy |
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Sumamed Forte powder for prig suspension. for internal approx. 200mg / 5ml 16.74g 332 RUB Buy |
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Sumamed 250 mg capsules 6 pcs. 359 r Buy |
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Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 35.57 g 1 pc. 366 r Buy |
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Sumamed 500 mg film-coated tablets 3 pcs. 369 r Buy |
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Sumamed forte 200 mg / 5 ml powder for suspension for oral administration 29.3 g (30 ml) 1 pc. RUB 400 Buy |
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Sumamed tablets p.p. 500mg 3 pcs. 420 RUB Buy |
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Sumamed 500 mg dispersible tablets 3 pcs. 439 r Buy |
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Sumamed Forte powder for prig suspension. for internal approx. 200mg / 5ml 35.37g RUB 519 Buy |
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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
