In 1980, the Croatian company Pliva developed an effective antibacterial drug - azithromycin. Its feature was an extremely short course of treatment - only three days. Despite the emergence of new antibiotics with a similar effect, the drug is still popular. In the CIS market, it is known as Sumamed 500.
Material Content:
- 1 Composition and forms of antibiotic release
- 2 Pharmacological action and pharmacokinetics
- 3 Why is the drug prescribed?
- 4 Instructions for use Sumamed tablets 500 mg for children and adults
- 5 During pregnancy and lactation
- 6 Drug interaction
- 7 Contraindications, side effects and overdose
- 8 Analogs of Sumamed in tablets of 500 mg
Composition and forms of antibiotic release
These are small oblong tablets of a bluish tint. The number “500” is indicated on one side, and the word “PLIVA” on the other side corresponds to the name of the company that first launched the antibiotic. 500 mg of azithromycin dihydrate in one tablet, other components: sodium lauryl sulfate, food additives E132, E171, calcium phosphate, polysorbate 80, corn starch, hydroxypropyl methylcellulose, magnesium stearate, cellulose, talc.
It is also available in the form of capsules, powder and granules for the preparation of syrup (suspension), lyophilisate to create an injection solution.
Pharmacological action and pharmacokinetics
Azithromycin is an antibacterial substance belonging to the group of azalides. It is close to erythromycin (another representative of the macrolide class), but due to differences in the structure of the molecule, it is more resistant to acids. The principle of antibiotic action is to stop the process of protein formation in the bacterial cell.
It is active against groups C, F, G of gram-positive microbes, except those that are resistant to erythromycin, gram-negative and some anaerobic.
The bioavailability rate is 37%. The level of azithromycin in the blood rises to maximum levels 2-3 hours after consumption.
Plasma protein binding is from 12% to 52%. It has been clinically proven that the concentration of a substance in the blood is 50 times lower than in tissues. Due to this, the product is evenly distributed throughout the body.
The elimination half-life is up to 4 days for both plasma and muscle. 10 inactive metabolites were detected, a significant concentration of which was found in bile and urine.
Why is the drug prescribed?
Sumamed adults are prescribed for short-term therapy:
- bacterial diseases of the respiratory system (bronchitis, whooping cough, pneumonia) and ENT organs (scarlet fever, sinusitis, tonsillitis, otitis media);
- skin infections (streptoderma, erysipelas, acne, Lyme disease, erythema migrans);
- diseases of the genitourinary tract caused by microbes (urethritis, chlamydia, bacterial gastrointestinal ulcer).
Instructions for use Sumamed tablets 500 mg for children and adults
Sumamed is characterized by the concept of “total dose” - the maximum amount of the drug that is prescribed for the entire course. In the treatment of most infections, its amount is 1,500 mg. The course is divided into 3 doses - 500 mg of the antibiotic once every 24 hours.
Therapy for infections of the genital and urinary system includes 1 g of the drug - 2 doses of 500 mg at a time.
Migrating erythema requires a total dose of 3 g of the drug, while 2 tablets (1 g total) are taken on the first day of treatment, then 1 tablet once a day for 5 days.
The total dose for acne therapy is 6 g. The first three days, the drug is taken according to the standard scheme - 1 tablet in 24 hours, then they switch to 500 mg of antibiotic per week. The duration of the course is 9 weeks.
Dragees need to be washed down with some convenient volume of liquid. Do not take as dispersible tablets (do not dissolve or chew). Reception does not depend on the time of eating food.
For the treatment of children under 16 years old, it is necessary to focus on body weight, but not on age. A child weighing more than 45 kg can use the standard Sumamed 500 tablet as a single use. For patients with greater body weight, a single dose is 125 mg.
With caution, Sumamed should be taken to patients who have kidney and liver diseases, are among the group with a high risk of heart conduction disorders.
During pregnancy and lactation
There is no data on how azithromycin affects the body of the mother and fetus during pregnancy. It is known that a substance crosses the placenta, but the specific harm is not confirmed. In clinical practice, during this period, Sumamed is not prescribed or attributed in the case when the expected benefit exceeds the possible harm.
Azithromycin is able to penetrate into breast milk, but experiments on the degree of influence on the health of the newborn have not been conducted. The drug is prescribed when absolutely necessary, when the probability of a positive effect is higher than a negative one.
Drug interaction
In a series of studies, the activity of azithromycin was revealed with the combined use of an antibiotic with some other drugs.
Signs of interaction are presented in the table below.
A drug | Combination reaction with Sumamed 500 |
---|---|
Digoxin | Increased Digoxin Levels |
Antacids | A decrease in peak concentrations of azithromycin in the blood by about 25% |
Zidovudine | An increase in the number of active zidovudine metabolites in a blood test (the significance of this effect has not been determined, but it is believed that it can positively affect the patient) |
Atorvastatin | It is unlikely - myoglobinuria (muscle damage that leads to their destruction, the development of chronic pathologies of other organs, for example, acute renal failure) |
Anticoagulants (warfarin, coumarin) | Significant increase in exposure to both drugs |
Ergot derivatives | Ergotism may occur (alkaloids poisoning horns) |
Cyclosporin | Increased concentration of cyclosporin in the blood |
Nelfinavir | Increased plasma azithromycin |
Rifabutin | Neutropenia is detected, but there is no association between this symptom and the use of an antibiotic and this drug |
Terfenadine | There are no specific data on the interaction of funds, but the probability of detecting negative consequences cannot be ruled out |
Contraindications, side effects and overdose
There are no specific contraindications for taking Sumamed, only individual sensitivity to an antibiotic or one of the components in the composition is of importance. The treatment with this macrolide is not recommended in case of renal and liver failure, but if there is an urgent need, the doctor can prescribe treatment with the medication provided.
Caution should be taken when taking the drug for people at high risk: children under 16 years old, pregnant women, women who are breastfeeding.
Possible discontinuation of therapy if:
- hepatic encephalopathy, jaundice, asthenia, the manifestation of other signs of liver dysfunction;
- proarrhythmic diseases;
- kidney dysfunction.
A short course of treatment with Sumamed is due to a negative effect on the intestinal microflora, in which diarrhea of various degrees of severity can manifest itself - from mild dehydration against the background of diarrhea, to acute colitis with a possible fatal outcome.
It is recommended not to exceed the prescribed course of treatment to enhance the effectiveness of therapy.
Among other adverse reactions observed:
- flatulence, pain in the upper abdomen, melena, anorexia, decreased appetite, in children - gastritis, constipation, stomatitis, hepatitis, metallic taste in the mouth;
- short-term hearing loss, anxiety, headaches, visual impairment, tinnitus, neurosis, general weakness and drowsiness, paresthesia (phantom burning, tingling, numbness);
- increased heart rate, dull pain in the chest area;
- allergy (especially when taken earlier than other macrolides) in the form of rashes on the skin, itching, less often - angioedema;
- rarely - jade;
- chronic fatigue syndrome (asthenia), hypersensitivity to ultraviolet radiation, photophobia, conjunctivitis is detected in children, changes in taste perception, arthralgia (unsystematic joint pain), inflammation and pain at the injection site.
An overdose does not differ from possible side effects, most often manifests itself as dyspeptic disorders and general signs of intoxication. To eliminate the negative consequences of taking high doses of the drug, symptomatic treatment is recommended, and to remove toxins, use activated charcoal and rinse the stomach.
Analogs of Sumamed in tablets of 500 mg
Almost any antibacterial drug can become an analogue of Sumamed, but it is clinically proven that some microbes are more resistant to many antibiotics, and vulnerable to others, therefore when choosing an analogue, one should proceed from the disease and its pathogen.
The drug of the same name, Azithromycin, is presented on the market. It is cheaper than Sumamed, but less popular. The active substance Azithromycin and Sumamed are identical, there are differences only in the auxiliary components. Side effects and contraindications coincide, but the components of the second drug are less likely to show toxicity.
Another antibiotic based on azithromycin is chemomycin. At a price comparable to Sumamed, sometimes 50-70 rubles cheaper. But there are no special differences, only in additional components.
Suprax, a non-structural analogue of Sumamed, based on cefixime, is popular in pediatrics. Its toxic effect is much lower than that of azithromycin, but there are less indications. For example, it is not suitable for the treatment of complex diseases of the skin and genitals, but is effective in the defeat of microbes of the ENT organs and respiratory system.
Flemoxin Solutab also belongs to the group of antibacterial drugs, but it is significantly inferior to Sumamed in terms of impact. A small number of side effects allows it to be used to treat children from 1 year old, but the number of doses is greater and the course of therapy is longer.
Macrolides include another drug - Vilprafen. It has an increased number of indications due to the undeveloped resistance of most bacteria to active josamycin. It is taken longer than Sumamed - up to 21 days, but the likelihood of negative reactions of the body to this medication is more likely.
Among other analogues distinguish:
- Azitrox;
- Augmentin;
- Amoxiclav;
- Zi factor;
- Klacid.
Sumamed 500 antibiotic is an effective dose-based drug. To help such a medicine should be treated with caution - it has a wide list of side effects, but is appreciated for the short course of treatment. Therefore, to quickly destroy the pathogen bacteria, it is necessary to precisely follow the indicated dosages and follow all the recommendations of the attending physician.