Contents
- Sumamed – general characteristics of the drug
- Sumamed – the composition of the drug
- Sumamed – the action of the drug
- Sumamed – metabolism and drug excretion
- Sumamed in the form of coated tablets – dosage of the drug
- Sumamed – dosage of the drug in the form of hard capsules
- Sumamed in powder form – dosage
- Sumamed in the form of tablets for oral suspension – dosage
- Sumamed – indications, contraindications and precautions
- Sumamed – side effects
- Sumamed- interactions with drugs and other substances
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Sumamed is a macrolide antibiotic that can only be obtained with a prescription. It is used to treat general bacterial infections. The active ingredient in this antibiotic is azithromycin. What is Sumamed characterized by? What indications and contraindications exist for its use? What drugs and substances should not be combined with? How to use Sumamed correctly and what side effects can it cause?
Sumamed – general characteristics of the drug
Sumamed is a macrolide antibiotic, i.e. it is bacteriostatic and can only be obtained with a prescription. The active substance of the drug is azithromycin, i.e. a semi-synthetic derivative of erythromycin.
Sumamed is mainly used in infections of the upper and lower respiratory tract, acute otitis media, infections of the skin and soft tissues.
Sumamed is sold in the form of capsules, powder for oral suspension, tablets for oral suspension and coated tablets.
Sumamed is available in packages where PVC / A1 blisters may contain:
- 6 coated tablets (125 mg);
- 2, 3, 6, 12 film-coated tablets (500 mg);
- 3 dispersible tablets (6,12 mg and 24 mg);
- 1, 2, 3, 6 dispersible tablets (1000 mg);
- 6 hard capsules.
Sumamed is also available as a powder for oral suspension (100 mg / 5 ml) with a capacity of 20 ml or (200 mg / 5 ml) with a capacity of 20 ml, 30 ml or 37,5 ml.
Sumamed should be stored out of the reach and sight of children at a temperature of about 25 ° C. The oral suspension made up of the 20 ml powder pack should be kept below 5 ° C for a maximum of 25 days, and kept at a temperature below 30 ° C for a maximum of 37,5 days, and 10 ml or XNUMX ml suspension packets should be kept for a period not longer than XNUMX days.
The Marketing Authorization Holder for Sumamed is Teva Pharmaceutical, which has been operating since 1901 and is a world leader in generics and biopharmaceuticals.
The price of the drug Sumamed depends on the packaging and in the case of a package containing 3 tablets (50 mg), after reimbursement from the National Health Fund, it is about PLN 20.
What is azithromycin and how to use it? Check: Azithromycin
Sumamed – the composition of the drug
The active substance of Sumamed is azithromycin. Composition of Sumamed may vary slightly depending on the form of the drug. The main component of the antibiotic is azithromycin in the form of azithromycin dihydrate and in various forms of the drug, the concentration of this active substance is different:
- 250 mg capsules in one tablet contain 250 mg of azithromycin;
- in the powder for oral suspension, after reconstitution with 5 ml of suspension, there is 100 mg of azithromycin;
- 500 mg dispersible tablets contain 500 mg of azithromycin;
- in film-coated tablets, one tablet contains 125 mg or 500 mg of azithromycin, respectively.
The other ingredients of Sumamed are:
- in coated tablets: calcium hydrogen phosphate anhydrous, hypromellose, maize starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, color – indigo carmine lake, titanium dioxide, polysorbate, talc;
- in hard capsules: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide, patent blue, brilliant black, cochineal red;
- in powder for oral suspension: sucrose, anhydrous trisodium phosphate, hydroxypropyl cellulose, xanthan gum, colloidal anhydrous silica, cherry flavor, banana flavor, vanilla flavor;
- in tablets for oral suspension: sodium saccharin, microcrystalline cellulose, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame, orange flavor (contains aromatic components, maize maltodextrin) and α-tocopherol.
What should I remember when taking medication? Read on: How to take medications effectively?
Sumamed – the action of the drug
Sumamed is a macrolide antibiotic from the azalide class that works mainly against aerobic Gram-negative bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Neisseria gonorrhoeae. It also affects other microorganisms such as: Chlamydia pneumoniae, Chlamydia trachomatis, Legionella pneumophila, Mycobacterium avium, Mycoplasma pneumoniae.
In addition, Sumamed is used to treat species where acquired resistance may be a problem, such as: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus pyogenes, Ureaplasma urealyticum.
Sumamed is also active against microorganisms with innate resistance, i.e. Staphylococcus aureus (strains resistant to methicillin and strains resistant to erythromycin), Streptococcus pneumoniae (strains resistant to penicillin), Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa group.
The action of Sumamed is based on the penetration of azithromycin into the foci of infection in the tissues, causing the inhibition of the bacterial protein synthesis process, as a result of which bacterial cells cannot multiply and the disease process is limited or stopped.
What should you know about bacteria? Check: Bacteria – role, research, pathogenic bacteria
Sumamed – metabolism and drug excretion
After oral administration of Sumamed, the bioavailability of azithromycin is approximately 37% and its maximum concentration is achieved 2-3 hours after administration.
The drug penetrates rapidly from the serum into the tissues and is excreted mainly in the bile in unchanged form and in the form of metabolites.
Is the presence of bile in the stomach dangerous? Check: What does bile in the stomach mean?
Sumamed in the form of coated tablets – dosage of the drug
Sumamed coated tablets should be used strictly with the information contained in the package leaflet or the doctor’s instructions.
The selection of the appropriate dose depends, among others, on the patient’s weight, ailments and, above all, the form in which the drug was prescribed by the doctor. This medicine comes in various forms, one of them being film-coated tablets, which are taken orally.
Sumamed as a drug in upper and lower respiratory tract infections, skin and soft tissue infections (except for erythema migrans) and in the case of otitis media should be used:
- in children and adolescents weighing less than 45 kg (for a dose of 125 mg), the total dose is 30 mg / kg body weight, i.e. 10 mg / kg body weight, once a day for 3 days;
- in children and adolescents weighing more than 45 kg and in adults (for a dose of 125 mg and 500 mg), the total dose of Sumamed is 1,5 g over 3 days (500 mg as a single daily dose).
The total dose of 1500 mg can also be administered for 5 days in doses:
- 500 mg on the first day of dosing;
- 250 mg on other days.
In turn, in the treatment of erythema migrans for a dose of 125 mg, the total dose is 60 mg / kg body weight and should be given:
- at a dose of 20 mg / kg body weight on the first day;
- then from the second to the fifth day in single daily doses at a dose of 10 mg / kg body weight.
For 500 mg tablets, the total dose is 3 g administered:
- on the first day at a dose of 1 g, i.e. 2 coated tablets of 500 mg;
- from the second to the fifth day in single daily doses of 500 mg, i.e. 1 film-coated tablet of the drug.
Sumamed in the treatment of common acne of moderate severity is used only in adults.
The total dose is (for a 500 mg dose) 6 g and should be administered:
- for the first 3 days at a dose of 500 mg, i.e. 1 film-coated tablet once a day;
- for the next 9 weeks in the amount of 1 500 mg film-coated tablet once a week.
In the second week of treatment, the dose of the drug should be taken 7 days after the first dose, and eight consecutive doses at 7-day intervals.
In uncomplicated infections caused by Chlamydia trachomatis, for a dose of 500 mg, Sumamed is used in a dose of 1 g, i.e. 2 coated tablets of 500 mg administered as a single dose.
How to recognize and treat acne vulgaris? Read: Common acne
Sumamed – dosage of the drug in the form of hard capsules
Sumamed in the form of hard capsules is administered orally. In most conditions, such as: upper and lower respiratory tract infection, skin and soft tissue infection (except erythema migrans) and in the case of otitis media, in children and adolescents weighing over 45 kg and in adults, the total dose of Sumamed is 1,5, 3 g over 500 days, administered at 1500 mg in a single daily dose. The total dose of 5 mg can also be administered for XNUMX days according to the following schedule:
- 500 mg on the first day;
- from the second to the fifth day of treatment, 250 mg of the drug.
For the treatment of erythema migrans, the total dose is 3 g according to the following dose breakdown:
- on the first day 1g (4 capsules of 250 mg);
- then, from the second to the fifth day in single daily doses of 500 mg, i.e. two capsules.
Infection caused by Chlamydie trachomatis requires the use of Sumamed in a dose of 1 g in a single dose, i.e. 4 capsules of 250 mg of the drug.
Elderly patients should use the same dose as other adults, but with caution due to the risk of heart disease. The drug should not be used in people who have severe liver failure, but in the case of kidney problems, it may be necessary to reduce the usual dose of the drug.
Swallow the hard capsules whole, at least 1 hour before or 2 hours after a meal.
Sumamed in powder form – dosage
The antibiotic Sumamed is also available as a powder for oral suspension.
For upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except erythema migrans), the total dose is 30 mg / kg body weight i.e. 10 mg / kg body weight administered once daily for 3 days. Dosage of Sumamed powder in children and adolescents depends on body weight, which is presented in the tables below:
| Sumamed (100mg/5ml) | |
|---|---|
| Body weight | Drug dose (volume of suspension) |
| 5 kg | 50 mg (2,5 ml) |
| 6kg | 60 mg (3 ml) |
| 7kg | 70 mg (3,5 ml) |
| 8kg | 80 mg (4 ml) |
| 9kg | 90 mg ( 4,5 ml) |
| 10 14-kg | 100 mg (5 ml) |
| Sumamed (200mg/5ml) | |
|---|---|
| Body weight | Drug dose (volume of suspension) |
| 10 14-kg | 100 mg (2,5 ml) |
| 15 24-kg | 200 mg (5 ml) |
| 25 34-kg | 300 mg (7,5 ml) |
| 35 44-kg | 400 mg (10 ml) |
| ≥45 kg | The adult dose should be used |
Treatment of erythema migrans requires a total dose of 60 mg / kg body weight administered on the first day at a dose of 20 mg / kg body weight followed by 2 mg / kg body weight on the 5nd to 10th day of treatment, once daily.
Sumamed is also used to treat pharyngitis and tonsillitis caused by Streptococcus pyogenes. The dose for children is a total dose of 60 mg / kg body weight. The dosage of Sumamed in children is presented in the table below:
| Dosage of 100 mg / 5ml suspension for children weighing 5-13 kg | |||
|---|---|---|---|
| Body weight in kg | 3-day dosing 20 mg / kg body weight, once daily | 5-day dosing of 12 mg / kg body weight, once daily | The contents of the bottle in ml |
| 5 kg | 100 mg (5 ml) | 60 mg (3 ml) | 20ml |
| 6 kg | 120 mg (6 ml) | 72 mg (3,6 ml) | 20ml |
| 7 kg | 140 mg (7 ml) | 84 mg (4,2 ml) | 2x20ml |
| 8 kg | 160 mg (8 ml) | 96 mg (4,8 ml) | 2x20ml |
| 9 kg | 180 mg (9 ml) | 108 mg (5,4 ml) | 2x20ml |
| 10 kg | 200 mg (10 ml) | 120 mg (6 ml) | 2x20ml |
| 11 kg | 220 mg (11 ml) | 132 mg (6,6 ml) | 2x20ml |
| 12 kg | 240 mg (12 ml) | 144 mg (7,2 ml) | 2x20ml |
| 13 kg | 260 mg (13 ml) | 156 mg (7,8 ml) | 2x20ml |
| Dosage of 200 mg / 5 ml suspension for children weighing 10-25 kg | |||
|---|---|---|---|
| Body weight in kg | 3-day dosing 20 mg / kg body weight, once daily | 5-day dosing of 12 mg / kg body weight, once daily | The contents of the bottle in ml |
| 10 kg | 200 mg (5 ml) | 120 mg (3 ml) | 20 ml |
| 11 kg | 220 mg (5,5 ml) | 132 mg (3,3 ml) | 20 ml |
| 12 kg | 240 mg (6 ml) | 144 mg (3,6 ml) | 20 ml |
| 13 kg | 260 mg (6,5 ml) | 156 mg (3,9 ml) | 20 ml |
| 14 kg | 280 mg (7 ml) | 168 mg (4,2 ml) | 30 ml |
| 15 kg | 300 mg (7,5 ml) | 180 mg (4,5 ml) | 30 ml |
| 16 kg | 320 mg (8 ml) | 192 mg (4,8 ml) | 30 ml |
| 17 kg | 340 mg (8,5 ml) | 204 mg (5,1 ml) | 30 ml |
| 18 kg | 360 mg (9 ml) | 216 mg (5,4 ml) | 30 ml |
| 19 kg | 380 mg (9,5 ml) | 228 mg (5,7 ml) | 30 ml |
| 20 kg | 400 mg (10 ml) | 240 mg (6 ml) | 30 ml |
| 21 kg | 420 mg (10,5 ml) | 252 mg (6,3 ml) | 37,5 ml |
| 22 kg | 440 mg (11 ml) | 264 mg (6,6 ml) | 37,5 ml |
| 23 kg | 460 mg (11,5 ml) | 276 mg (6,9 ml) | 37,5 ml |
| 24 kg | 480 mg (12 ml) | 288 mg (7,2 ml) | 37,5 ml |
| 25 kg | 500 mg (12,5 ml) | 300 mg (7,5 ml) | 37,5 ml |
In the case of adults and children weighing more than 25 kg, Sumamed is administered in a dose of 500 mg, once a day for 3 days or for 5 days, 500 mg on the first day and 250 mg on the second to the fifth day.
In the elderly, there is no need to modify the dosage, but people with impaired renal and hepatic function should inform their doctor about their symptoms before starting antibiotic treatment. The suspension should be prepared using the double-sided measuring spoon or syringe provided in the package. Always shake the bottle before use and take the medicine with or without food.
What should you know about antibiotics? Check: Antibiotics – types, action, use and side effects [EXPLAIN]
Sumamed in the form of tablets for oral suspension – dosage
Sumamed tablets for oral suspension should always be used in accordance with the doctor’s instructions and if in doubt, always consult your doctor or pharmacist.
Adults, children and adolescents weighing more than 45 kg and the elderly are recommended a total dose of 1500 mg taken as a single daily dose of 500 mg for 3 days. The same total dose can be administered for 5 days as follows:
- the first day of treatment, a dose of 500 mg;
- 250 mg from the second to the fifth day in single daily doses.
When using the drug in the treatment of uncomplicated infections caused by Chlamydia trachomatis, it is recommended to take 1 g in a single dose.
However, for the treatment of erythema migrans, the recommended total dose is 3 g and it is taken in the following schedule:
- the first day of treatment, the dose is 1 g;
- from the second to the fifth day in single daily doses of 500 mg.
Dosage of Sumamed tablets for oral suspension in children and adolescents under 45 kg is determined by the doctor depending on the body weight, but the maximum dose of Sumamed is 1500 mg. The recommended dose is 10 mg / kg body weight administered as a single dose once daily for 3 days.
Treatment can also be carried out over a 5-day period, with a dose of 10 mg / kg body weight on the first day and 5 mg / kg body weight on the remaining four days.
In the case of patients with renal and hepatic disorders, the dosage of the drug in this form should be consulted with a doctor, as it may be necessary to adjust the dose of the drug.
The dispersible tablet should be dissolved in at least 30 ml of liquid, e.g. water, apple juice or orange juice, and the rest of drinking should be later suspended in a little water and drunk.
Sumamed – indications, contraindications and precautions
Sumamed is an antibiotic used to treat infections caused by microorganisms that are sensitive to the active ingredient azithromycin. Sumamed, in all forms in which it is available, is used in the treatment of:
- upper respiratory tract infections, including sinusitis, tonsillitis, bacterial pharyngitis;
- lower respiratory tract infections, including: acute bronchitis or exacerbation of chronic bronchitis, pneumonia, including interstitial pneumonia;
- acute otitis media;
- skin and soft tissue infection, including: erythema migrans, impetigo, erysipelas, secondary dermatitis.
In addition to the indications mentioned above, Sumamed 500 mg coated tablets and 250 mg capsules are used in the treatment of sexually transmitted diseases, including uncomplicated Chlamydia trachomatis infections, while the 500 mg film-coated tablets are also used in adults with acne vulgaris.
Sumamed is a drug to be used that is decided by a physician, assessing the individual risk of using it during treatment. The main contraindications in use and situations requiring special care in the use of this antibiotic are:
- allergy to azithromycin, erythromycin or other macrolide or ketolide antibiotics, or other excipients included in the drug;
- conditions conducive to the development of arrhythmias such as: very slow heartbeat, severe heart failure, electrolyte disturbances, congenital or ever abnormal heart rhythm, taking other drugs that may prolong the QT interval on the ECG;
- severe renal and hepatic impairment;
- nervous or mental disorders;
- infected burn wounds;
- new infections or fungal infections;
- sexually transmitted diseases coexisting with infection with syphilis,
- the use of ergotamine derivatives (ergot preparations).
The use of Sumamed should also be consulted with a doctor by pregnant women who suspect that they may be or are planning to have children.
Breastfeeding women during treatment with Sumamed should not breastfeed, because azithromycin passes into breast milk. In the case of pregnant women, Sumamed may be used only when, in the doctor’s opinion, the benefits for the mother outweigh the risks for the child.
What are the most common myths about antibiotics? Check: Six myths about antibiotics
Sumamed – side effects
Sumamed, like any other drug, can cause side effects, although not everyone may experience them.
It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.
The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).
In the event of the following side effects, after using an antibiotic, it is necessary to consult a doctor or go to the nearest emergency department, in this case:
- severe hypersensitivity reaction (difficulty breathing and swallowing, swelling of the lips, tongue, face, itchy rash);
- severe skin reaction (blisters with white or yellow liquid), severe skin rash, severe pemphigus and bleeding in the lips, eyes, mouth or nose;
- weakness, yellowing of the skin or the whites of the eyes, and dark-colored urine;
- unusual bruising or bleeding;
- severe or chronic diarrhea with blood or mucus;
- fast or irregular heartbeat or changes in ECG rhythm.
Other side effects that may occur with Sumamed according to their frequency of occurrence are:
- very common (more than 1 in 10 people): diarrhea;
- common (less than 1 in 10 people): vomiting, nausea, headache, abdominal pain, changes in the number of certain blood cells, low blood bicarbonate levels;
- uncommon (may affect up to 1 in 100 people): palpitations, changes in the number of white blood cells, yeast and bacterial infection, angioedema, various severity of allergic reactions, anorexia, nervousness, sleepiness or trouble falling asleep, taste disturbance, dizziness , numbness in extremities, impaired hearing, hot flush, increased sweating, difficulty breathing, nosebleed, constipation, wind, indigestion, gas, bloating, skin rash, itching, muscle pain, painful and difficult urination;
- rare (may affect up to 1 in 1000 people): agitation, photosensitivity reactions, e.g. to light, abnormal liver function, skin rash with areas of reddening rapidly appearing;
- Very rare side effects (may affect less than 1 person in 10): aggressive behavior, anxiety, hallucinations, thrombocytopenia, anaphylactic reaction, loss of consciousness, hearing impairment, pancreatitis, drop in blood pressure, acute kidney failure.
In the event of any of the above undesirable effects or other disturbing reactions to the Sumamed antibiotic, contact a doctor as soon as possible, and in the event of a life-threatening emergency, call an ambulance.
Sumamed- interactions with drugs and other substances
Sumamed is an antibiotic whose active ingredient is azithromycin, which may interact with other medications. If you start treatment with Sumamed, inform your doctor or pharmacist that you are taking the following drugs:
- antacids for heartburn or indigestion, e.g. aluminum hydroxide;
- drugs that prolong the QT interval, including: antiarrhythmic drugs used in the treatment of cardiac arrhythmias (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol);
- cisapride used in stomach disorders;
- terfenadine used to treat allergies;
- pimozide, phenothiazines used to treat certain mental / mood disorders;
- citalopram used to treat depression;
- antibacterial drugs such as moxifloxacin, levofloxacin;
- digoxin for heart failure or colchicine for gout and familial Mediterranean fever;
- zidovudine and nelfinavir used to treat HIV;
- ergot alkaloids, incl. ergotamine used to treat migraine;
- astemizole, an antihistamine or alfentanil, a pain reliever;
- atorvastatin used to lower cholesterol;
- coumarin derivatives, e.g. warfarin, used to stop blood clots;
- ciclosporin, used to prevent the body rejecting transplanted organs;
- theophylline, used to treat breathing problems.
The use of Sumamed is not dependent on the meals taken. Alcohol is not recommended during treatment with this antibiotic. Alcohol is a strain on the body and can weaken your defenses, so that the medicine’s effects may be inhibited, which may mean that your recovery may be slower.
Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.
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