In this article, you can read the instructions for the use of the medicinal product. Sumamed... The reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Sumamed in their practice are presented. A big request is to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, which may not have been declared by the manufacturer in the annotation. Sumamed's analogs in the presence of available structural analogs. Use for the treatment of angina, bronchitis, pneumonia and other infectious diseases in adults, children, as well as during pregnancy and lactation. Suspension preparation methods. The effect of alcohol on the simultaneous administration of the drug.
Sumamed- a bacteriostatic antibiotic of a broad spectrum of action from the group of macrolides-azalides. The mechanism of action of azithromycin (the active substance of the drug Sumamed) is associated with the suppression of protein synthesis of the microbial cell. By binding to the 50S-subunit of the ribosome, it inhibits peptide translocase at the stage of translation and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.
Microorganisms may initially be resistant to antibiotic action or may acquire resistance to it.
In most cases, Sumamed is active against aerobic gram-positive and gram-negative bacteria, anaerobic bacteria, and other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Pharmacokinetics
After oral administration, azithromycin is well absorbed and rapidly distributed in the body. It is transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates histohematogenous barriers and enters tissues. Concentration in tissues and cells is 10-50 times higher than in plasma, and in the focus of infection - 24-34% higher than in healthy tissues. In the liver, it is demethylated, losing activity. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media);
- lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);
- diseases of the stomach and duodenum associated with Helicobacter pylori (for powder);
- infections of the skin and soft tissues (moderate acne, erysipelas, impetigo, secondarily infected dermatoses);
- the initial stage of Lyme disease (borreliosis) - erythema migrans (erythema migrans);
- urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).
Forms of issue
Film-coated tablets 125 mg and 500 mg.
Capsules 250 mg.
Lyophilisate for the preparation of a solution for infusion (injections) 500 mg.
Powder for preparation of oral suspension 100 mg / 5 ml.
Instructions for use and dosage
The drug is administered orally 1 time per day, at least 1 hour before or 2 hours after meals. The tablets are taken without chewing.
For adults (including the elderly) and children over 12 years of age weighing more than 45 kg, the drug is prescribed in the form of tablets and capsules.
For children aged 6 months and older, the drug should be administered in the form of a suspension for oral administration, for children aged 3 years and older, the drug can also be prescribed in the form of tablets of 125 mg. The drug in the form of tablets 125 mg is dosed taking into account the child's body weight.
For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema), adults and children over 12 years old with a body weight of more than 45 kg, the drug is prescribed in a dose of 500 mg 1 time per day for 3 days, course the dose is 1.5 g. Children aged 6 months and older are prescribed at the rate of 10 mg / kg of body weight 1 time per day for 3 days, the course dose is 30 mg / kg.
For diseases of the stomach and duodenum associated with Helicobacter pylori, the drug is prescribed in the form of a powder at a dose of 1 g per day for 3 days in combination with antisecretory agents and other drugs.
With erythema migrans, the drug is prescribed 1 time per day for 5 days. Adults and children over 12 years old with a body weight of more than 45 kg are prescribed on the 1st day - 1 g, then from 2 to 5 days - 500 mg each; course dose - 3 g. Children aged 6 months and older are prescribed on the 1st day at a dose of 20 mg / kg of body weight and then from 2 to 5 days - daily at a dose of 10 mg / kg of body weight, course dose - 60 mg / kg.
For acne of moderate severity, the course dose is 6.0 g. Adults and children over 12 years old weighing more than 45 kg are prescribed in a dose of 500 mg once a day for 3 days, then 500 mg once a week for 9 weeks. The first weekly dose should be taken 7 days after the first daily dose (8th day from the start of treatment), the next 8 weekly doses should be taken 7 days apart.
For sexually transmitted infections, for the treatment of uncomplicated urethritis / cervicitis caused by Chlamydia trachomatis, the drug is prescribed in a dose of 1 once; for the treatment of complicated long-term urethritis / cervicitis caused by Chlamydia trachomatis, 1 g 3 times are prescribed with an interval of 7 days (1, 7, 14 days), the course dose is 3 g.
For patients with moderate renal impairment (CC> 40 ml / min), dose adjustment is not required.
How to dilute and take a suspension
In a bottle containing 17 g of powder, add 12 ml of distilled or boiled water. The volume of the resulting suspension is 23 ml. The shelf life of the prepared suspension is 5 days. Before taking, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained. Immediately after taking the suspension, the child is given a few sips of tea in order to wash off and swallow the remaining amount of the suspension in the oral cavity.
After use, the syringe is disassembled and washed with running water, dried and stored in a dry place along with the drug.
Sumamed forte (in the form of a suspension)
Inside, 1 time per day, at least 1 hour before or 2 hours after meals.
In case of infection of the upper and lower respiratory tract, skin and soft tissues (with the exception of chronic migratory erythema) - a total dose of 30 mg / kg, i.e. 10 mg / kg once a day for three days.
In chronic erythema migrans, the total dose of the drug is 60 mg / kg: on the 1st day - once 20 mg / kg; on the following days (from the 2nd to the 5th) - 10 mg / kg.
For diseases of the stomach and duodenum associated with Helicobacter pylori: 20 mg / kg once a day in combination with an antisecretory agent and other drugs as recommended by a doctor.
In the event that a dose of the drug has been missed, it must, if possible, be taken immediately, and then subsequent doses - with an interval of 24 hours.
With sexually transmitted infections
Uncomplicated urethritis / cervicitis -1 g, single dose.
Suspension preparation method
To prepare 15 ml of suspension (nominal volume), it is necessary to add 8 ml of water to a vial containing 800 mg of azithromycin (actual volume is 20 ml of suspension).
To prepare 30 ml of suspension (nominal volume), it is necessary to add 14.5 ml of water to a vial containing 1400 mg of azithromycin (actual volume - 35 ml of suspension).
To prepare 37.5 ml of a suspension (nominal volume), it is necessary to add 16.5 ml of water to a vial containing 1700 mg of azithromycin (the actual volume is 42.5 ml of the suspension).
Each vial should contain a suspension of 5 ml more than the course dose for a more complete extraction of the drug from the vial.
The shelf life of the prepared suspension is 5 days, at a temperature not higher than 25 ° C.
Using a syringe for dosing, measure the required amount of water, add it to the bottle with powder. Before taking, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained.
A syringe or measuring spoon is used to dispense the finished suspension.
Immediately after taking the suspension, the child is given a few sips of tea or juice in order to wash off and swallow the remaining amount of the suspension in the mouth.
After use, the syringe is disassembled and washed with running water, dried and stored together with the preparation.
Side effect
- thrombocytopenia, neutropenia, eosinophilia;
- dizziness;
- headache;
- drowsiness;
- convulsions;
- insomnia;
- hyperactivity, aggressiveness, anxiety, nervousness;
- noise in ears;
- reversible hearing impairment up to deafness (when taken in high doses for a long time);
- violation of the perception of taste and smell;
- palpitations;
- arrhythmia, including ventricular tachycardia;
- nausea, vomiting;
- diarrhea, constipation;
- abdominal pain and cramps;
- flatulence;
- anorexia;
- hepatitis;
- itching, skin rashes;
- angioedema;
- hives;
- anaphylactic reaction (rarely fatal);
- joint pain;
- vaginitis;
- candidiasis.
Contraindications
- severe impairment of liver and kidney function;
- lactation period (breastfeeding);
- simultaneous reception with ergotamine and dihydroergotamine;
- hypersensitivity to antibiotics of the macrolide group;
- children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);
- children under 3 years of age (for tablets 125 mg).
Application during pregnancy and lactation
During pregnancy, the use of the drug is possible only if the potential benefit of therapy to the mother outweighs the possible risk to the fetus.
If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
special instructions
In case of missing 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.
As with any antibiotic therapy, during treatment with azithromycin, it is possible to add superinfection (including fungal).
Penicillin is usually the drug of choice for the treatment of streptococcus pyogenes pharyngitis / tonsillitis and for the prevention of acute rheumatic fever. Azithromycin is also active against streptococcal infection in these cases, but is ineffective in preventing the development of acute rheumatic fever.
The patient should be warned about the need to inform the doctor about the occurrence of any side effect.
There was a negative effect of the combined intake of Sumamed and alcohol (hepatotoxic effect).
Influence on the ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.
Drug interactions
Antacids do not affect the bioavailability of azithromycin, but reduce the Cmax in the blood by 30%, so Sumamed should be taken at least 1 hour before or 2 hours after taking these drugs and food.
With the simultaneous use of azithromycin does not affect the concentration of carbamazepine, didanosine, rifabutin and methylprednisolone in the blood.
With parenteral administration, Sumamed does not affect plasma concentrations of cimetidine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole in the case of combination therapy, however, the possibility of such interaction should not be ruled out when Sumamed is administered orally.
Azithromycin does not affect the theophylline pharmacokinetics, however, when taken together with other macrolides, the concentration of theophylline in the blood plasma may increase.
If it is necessary to use it together with cyclosporine, it is recommended to control the content of cyclosporine in the blood. Despite the fact that there is no data on the effect of azithromycin on changes in the concentration of cyclosporine in the blood, other representatives of the macrolide class are able to change its concentration in blood plasma.
When taking digoxin and Sumamed together, it is necessary to control the concentration of digoxin in the blood, because many macrolides increase the absorption of digoxin from the intestine, thereby increasing its concentration in the blood plasma.
If it is necessary to take it together with warfarin, it is recommended to carefully monitor the prothrombin time.
It was found that the simultaneous administration of terfenadine and antibiotics of the macrolide class causes arrhythmia and prolongation of the QT interval. Based on this, it is impossible to exclude the development of these complications when taking terfenadine and azithromycin together.
When azithromycin and zidovudine are taken together, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or its excretion by the kidneys and its metabolite glucuronide. Nevertheless, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this finding is not clear.
With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effect is possible.
Analogues of the drug Sumamed
Structural analogues for the active substance:
- Azivok;
- Azimycin;
- Azitral;
- Azitrox;
- Azithromycin;
- Azithromycin Forte;
- Azithromycin dihydrate;
- AzitRus;
- AzitRus Forte;
- Azicide;
- Vero-Azithromycin;
- Zetamax retard;
- ZI-Factor;
- Zitnob;
- Zitrolide;
- Zitrolide forte;
- Zitrocin;
- Sumazid;
- Sumaclid;
- Sumamed forte;
- Sumamecin;
- Sumamecin forte;
- Sumamox;
- Sumatrolide solute;
- Tremak-Sanovel;
- Hemomycin;
- Ecomed.
In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and see the available analogues for the therapeutic effect.
Latin name: Sumamed forte
ATX code: J01FA10
Active substance: Azithromycin
Manufacturer: Pliva, Croatia
Pharmacy release condition: On prescription
"Sumamed Forte" is an antibacterial drug, belongs to the group of macrolides, has a bacteriostatic effect.
Indications for use
"Sumamed Forte" is indicated for use in infectious diseases that are accompanied by an inflammatory process:
- Infections localized in the upper respiratory system and in the middle ear (sinusitis, rhinopharyngitis, tonsillitis, and otitis media)
- Infection of soft tissues and skin, which is manifested by erysipelas, impetigo, as well as secondary dermatosis
- Infections localized in the lower respiratory system (community-acquired pneumonia, acute bronchitis)
- Manifestation of erythema migrans.
Composition
1 gram of Sumamed Forte powder contains 47.79 mg of the main active ingredient - azithromycin dihydrate. In addition, there are a number of excipients along with flavorings.
Healing properties
"Sumamed Forte" is characterized by bacteriostatic properties, and in high concentrations it has a bactericidal effect. The mechanism of action of the drug is based on inhibition of the process of protein synthesis in pathogenic cells due to the connection with their ribosomes, which disrupts metabolism, stops growth and completely blocks the reproduction of pathogenic flora, resulting in the death of microorganisms.
The drug is highly active against a number of bacteria, both gram-positive and gram-negative. In addition to this, the antibiotic has a negative effect on the vital activity of anaerobes (represented by clostridia, peptostreptococci, and also peptococci).
Compared to other types of antibacterial drugs, Sumamed Forte has the ability to penetrate cell membranes and have an effective effect on intracellular microorganisms, which are called atypical bacteria. In addition, the antibiotic has an anti-inflammatory effect, which is manifested by a decrease in the production of mucus inside the bronchi due to the suppression of necrosis of the neoplasm. It is this property of the drug that explains the high effectiveness of the treatment of such a disease as cystic fibrosis. Thanks to the complex treatment of the disease, it is possible to improve the circulation of oxygen in the respiratory tract.
Release form
Price: from 301 to 668 rubles.
A white powder with a banana aroma, intended for the preparation of a medicinal solution (suspension) by dissolving in a liquid.
A 50 ml bottle contains 16.7 g or 15 ml of powder, a dosing spoon and a syringe are placed in a cardboard box.
A bottle with a capacity of 100 ml can contain 30 ml or 37.5 ml of powder, which in terms of weight is 29.3 g and 35.6 g, respectively. Syringe and measuring spoon included.
Instructions for the use of the drug "Sumamed Forte"
Sumamed Forte is usually recommended to be taken orally once a day for 60 minutes. before the intended meal or after 2 hours. For children, it is prescribed to drink the suspension together with a small volume of liquid in order to ensure the full flow of the drug into the gastrointestinal tract.
Before taking the drug, the bottle with the contents must be shaken thoroughly until a homogeneous solution is obtained. Using a syringe or a special spoon, measure the required volume of the medicinal solution.
In diseases of the respiratory system of an infectious and inflammatory nature, with lesions of soft tissues, the daily dose of the drug is calculated from the ratio of 10 mg - 1 kg, this dosage is taken for 3 consecutive days. The total dose of the antibiotic for the course of treatment is calculated from the ratio of 30 mg - 1 kg of body weight.
- From 10 to 14 kg of weight - dose per application - 2.5 ml (content of active ingredient - 100 mg)
- From 15 to 24 kg of weight - dose per dose - 5 ml (content of active ingredient - 200 mg)
- From 25 to 34 kg - dosage per application - 7.5 ml (active ingredient content - 300 mg)
- From 35 to 44 kg - single dose - 10 ml (active ingredient content - 400 mg)
- More than 45 kg - dosage per application - 12.5 ml (mass fraction of azithromycin - 500 mg).
For children weighing less than 10 kg, a suspension is usually prescribed at a dosage of 100 mg / 5 ml.
In the case of treatment of rhinopharyngitis and tonsillitis, the daily dose is calculated taking into account the ratio of 20 mg - 1 kg of weight, the antibiotic is used for 3 days. The total dosage of the drug for the entire course of treatment is calculated in accordance with the norm of 60 mg - 1 kg of weight. The maximum dose of an antibiotic per day should not exceed 500 mg.
In the case of erythema migrans, the primary daily dose of the drug is calculated from the ratio of 20 mg - 1 kg of body weight, then the dosage is halved and taken over the next 2-5 days.
In the presence of impaired renal and liver function, additional adjustment of the daily dose is not required.
Instructions for the manufacture of a medicinal solution for oral administration
To properly prepare a suspension of various dosages, the following rules should be followed:
- Using a syringe, powder at a dosage of 200 mg / 5 ml is diluted with 9.5 ml of pure water (making a suspension with a volume of 15 ml). After shaking, a composition that is homogeneous in consistency is obtained. The total volume of the drug mixture is 20 ml, which exceeds the calculated volume of the solution by 5 ml, thanks to this it will be possible to compensate for the loss of the drug when the suspension is taken for further administration.
- Using a syringe, 16.5 ml of pure boiled water is poured into the inside of the bottle (for the preparation of a 30 ml drug). The mixture is shaken and a homogeneous consistency is obtained, ready for further use. The volume of the finished mixture is 30 + 5 ml.
- Using a special syringe, the powder should be diluted in a bottle with 20 ml of pure water. The contents of the vial are shaken to obtain a homogeneous suspension. The volume of the finished drug mixture is 42.5 ml, which is 5 ml more than the previously calculated volume.
During pregnancy and breastfeeding
The use of an antibiotic during pregnancy is possible in individual cases, when the possible risks to the fetus are significantly lower than the expected therapeutic effect for the mother. "Sumamed Forte" can be taken only on the prescription of a doctor if there are indications for his admission.
The use of an antibacterial agent for nursing mothers is contraindicated.
Contraindications
"Sumamed Forte" is not indicated for use in the presence of such pathologies:
- Serious abnormalities in liver and kidney function
- Excessive susceptibility to macrolide antibiotics.
Precautionary measures
If you miss a single dose of an antibiotic, it is recommended to take the drug as soon as possible. Further medication is taken after a day.
If any adverse reaction develops, you should consult a doctor.
Cross-drug interactions
Antacid drugs, alcohol and simultaneous food intake reduce the rate of absorption of the active substance, therefore it is recommended to take the medicine for 60 minutes. before meals or after 2 hours.
Azithromycin does not bind with isoenzymes of the cytochrome system.
Macrolides in combination with cycloserine, anticoagulant drugs, as well as metiprednazalone and felopine significantly slow down the process of elimination of azithromycin from the body, while increasing the concentration and toxicity of the components they contain. The use of azalides does not cause such an effect.
With the joint use of vafarin, there is a need for regular monitoring of blood clotting.
The combined use of macrolides with ergotamine and its derivatives can cause an increase in the toxicity of the latter, which is manifested by the development of vasospasm, as well as dysesthesia.
Lincosamines can reduce the therapeutic efficacy of azithromycin, while chloramphenicol, on the contrary, increases its effect.
According to pharmaceutical indicators, heparin cannot be combined with Sumamed Forte.
Side effects
When treated with the antibiotic "Sumamed Forte", a number of reactions can be observed:
- Gastrointestinal tract: melena, dysfunction of the stomach and intestines (nausea, gastritis, loss of appetite, pain in the abdominal region, flatulence, diarrhea or constipation, high or moderate activity of liver enzymes)
- CCC: arrhythmia, chest pain
- CNS: headaches, general weakness, vertigo, nervous tension, insomnia
- Genitourinary system: fungal infections of the genitals, nephritis
- Allergic manifestations: rash on the skin, manifestation of urticaria, Quincke's syndrome, development of conjunctivitis, photosensitization.
Chest pain can be caused by other reasons, for more details see the article:.
Overdose
Symptoms of an antibiotic overdose are nausea, vomiting, and intestinal dysfunction.
Conditions and shelf life
The ready-to-use suspension (volume 15 mg) is stored under temperature conditions (up to 20-25 C) for 5 days.
The suspension is stored for 10 days at a temperature not exceeding 20-25 C.
Analogs
Sandoz, Germany
Price from 452 to 601 rub.
"Azitro Sandoz" is an antibacterial drug, the active ingredient of which is azithromycin. The medicine is produced in the following dosage forms: tablets and powder for preparing a suspension. Azitro Sandoz is used to treat infectious diseases accompanied by an active inflammatory process.
Pros:
- Easy to carry by both adults and children
- Can be taken with probiotics at the same time
- Rarely causes adverse reactions.
Minuses:
- Available by prescription only
- Allergic reactions are not excluded
- The antibiotic is contraindicated in nursing mothers.
Kievmedpreparat, Ukraine
Price from 189 to 200 rubles.
"Azimed" is a drug with a pronounced antimicrobial effect, the drug contains azithromycin dihydrate. "Azimed" is a complete analogue of "Sumamed Forte", which indicates the same characteristics and therapeutic efficacy of these funds. The medicine is available in 2 dosage forms: tablets, powder for suspension.
Pros:
- Effectively treats infectious diseases of the ENT organs
- Acceptable price
- Can be used to treat children from 1 year old.
Minuses:
- Quite difficult to find in the pharmacy chain
- Superinfection may develop during admission.
- It is not recommended to combine the antibiotic with alcohol.
Composition and form of release
Sumamed® Capsules - 1 caps .:
- active substances: azithromycin (in the form of a dihydrate) - 250 mg;
- excipients: MCC; sodium lauryl sulfate; magnesium stearate.
In a blister 6 pcs.; 1 blister in the box.
Film-coated tablets - 1 tab .:
- active substances: azithromycin (in the form of dihydrate) - 125 mg - 500 mg;
- core: calcium phosphate disubstituted anhydrous, hypromellose, corn starch, pregelatinized starch, MCC, sodium lauryl sulfate, magnesium stearate;
- shell: hypromellose, dye similar to Indigotin (E132), polysorbate 80, titanium dioxide (E171), talc.
In a blister there are 3 (500 mg) or 6 (125 mg) pieces; 1 blister in the box.
Powder for preparation of oral suspension (prepared suspension) - 5 ml:
- active substances: azithromycin (in the form of a dihydrate) - 100 mg;
- excipients: sucrose, sodium carbonate anhydrous, sodium benzoate, tragacanth, titanium dioxide, glycine, colloidal silicon dioxide, strawberry, apple and mint flavors.
In dark glass bottles with a volume of 50 ml - 17 g of powder (complete with a dosing spoon, dosing syringe); in the box 1 bottle.
Lyophilisate for preparation of solution for infusion - 1 vial:
- active substances: azithromycin (in the form of dihydrate) - 500 mg;
- excipients: citric acid, sodium hydroxide.
In vials; in a pack of cardboard 5 bottles.
Sumamed® forte Powder for preparation of oral suspension (prepared suspension) - 5 ml:
- active substances: azithromycin (in the form of dihydrate) - 200 mg;
- excipients: sucrose, trisodium phosphate anhydrous, hydroxypropyl cellulose; xanthan gum, cherry flavor J7549, banana flavor 78701-31, vanilla flavor D-125Q38, colloidal silicon dioxide.
In vials of 20, 35 or 42.5 ml (complete with a dosing spoon or dosing syringe); in the box 1 bottle.
Description of the dosage form
Sumamed® Capsules: hard, gelatinous, opaque, size No. 1. Body color - blue, lid - blue. Capsule content: white to light yellow powder.
Film-coated tablets: blue, round (125 mg) or oblong (500 mg) with biconvex surfaces and the designation "PLIVA" on one side and "125" or "500" on the other. Broken view - from white to almost white.
Powder for preparation of suspension for oral administration 100 mg / 5 ml: granular powder of white or light yellow color.
Lyophilisate for preparation of solution for infusion: lyophilized powder or compact white mass.
Sumamed® forte Powder for preparation of suspension for oral administration: granular, white or light yellow in color with a characteristic smell of banana and cherry. After dissolving in water - a homogeneous suspension of white or light yellow color with a characteristic smell of banana and cherry.
Pharmacokinetics
When taken orally, azithromycin is well absorbed and rapidly redistributed from plasma to tissues and organs. After a single oral intake of 500 mg of azithromycin, 37% of the drug is absorbed and after 2-3 hours in the plasma, Cmax of the drug is noted - 0.41 μg / ml. It is known that food intake can reduce the absorption of azithromycin, however, due to the lack of the manufacturer's own data on the effect of food on the pharmacokinetics of azithromycin when taking Sumamed® in the form of a suspension, it should be taken at least 1 hour before or after 2 h after eating.
The drug is rapidly distributed throughout the body, high concentrations, 50 times higher than the concentration of azithromycin in plasma, are observed in tissues. Depending on the organ / tissue, the concentration of the drug ranges from 1-9 μg / ml. The volume of distribution averages 31 l / kg.
The therapeutic concentration of azithromycin in the tissues is observed within 5-7 days after taking the last dose. Penetrates into cells, including phagocytes, which migrate to the inflammatory focus, contributing to the creation of therapeutic concentrations of the drug that exceed the MIC for infectious agents. The concentration of azithromycin in infected tissues is higher than in uninfected tissues. It has a long T1 / 2 and is slowly excreted from tissues (on average - 2-4 days).
Excretion of azithromycin with bile is the main route of excretion. On average, up to 50% is excreted in the bile in an unchanged form. The remaining 50% are excreted in the form of 10 metabolites formed in the process of N- and O-demethylation, hydroxylation of desosamine and the aglycone ring, and as a result of cleavage of the conjugate cladinose. Metabolites have no antibacterial activity. On average, 6% of the administered dose of the drug is excreted in the urine.
In elderly patients (over 65 years old), the volume of distribution is slightly higher (30%) compared with patients who are less than 45 years old, which is not clinically significant and does not require a dosage change.
The pharmacokinetics of azithromycin in healthy volunteers after a single intravenous infusion lasting more than 2 hours at a dose of 1000-4000 mg (solution concentration - 1 mg / ml) has a linear relationship and is proportional to the administered dose. T1 / 2 of the drug is 65-72 hours. The high level of the observed volume of distribution (33.3 l / kg) and plasma clearance (10.2 ml / min / kg) suggests that the prolonged T1 / 2 of the drug is a consequence of the accumulation of the antibiotic in tissues with its subsequent slow release.
In healthy volunteers with intravenous infusion of azithromycin at a dose of 500 mg (solution concentration - 1 mg / ml) for 3 hours, Cmax of the drug in serum was 1.14 μg / ml. The minimum serum level (0.18 μg / ml) was observed over 24 hours and the area under the concentration-time curve was 8.03 μg / ml / h.
Similar pharmacokinetic values were obtained in patients with community-acquired pneumonia who were administered intravenous infusions (3-hour) for 2 to 5 days. After daily administration of azithromycin at a dose of 500 mg (infusion duration - 1 hour) for 5 days, an average of 14% of the dose is excreted in the urine during the 24-hour dosing interval.
Pharmacodynamics
Possesses a wide spectrum of antimicrobial action. By binding to the 50S-subunit of the ribosome, it inhibits the biosynthesis of microorganism proteins. In high concentrations, it has a bactericidal effect. Has activity against gram-positive, gram-negative anaerobes, intracellular and other microorganisms.
Has no effect on gram-positive bacteria resistant to erythromycin.
Indications for use
- infections of the upper respiratory tract and ENT organs;
- lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens ;;
- infections of the skin and soft tissues;
- urinary tract infections (urethritis, cervicitis).
Contraindications for use
- severe impairment of liver and kidney function;
- lactation period;
- simultaneous reception with ergotamine and dihydroergotamine;
- hypersensitivity to azithromycin and other components of the drug;
- hypersensitivity to antibiotics of the macrolide group;
- children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);
- children under 3 years of age (for tablets 125 mg).
Sumamed should be prescribed with caution in case of moderate impairment of liver and kidney function, in patients with impairments or predisposition to arrhythmias and prolongation of the QT interval.
Use during pregnancy and children
During pregnancy, the use of sumamed is possible only if the potential benefit of therapy to the mother outweighs the possible risk to the fetus.
If necessary, the use of sumamed during lactation, breastfeeding should be discontinued
Side effects
From the hematopoietic system: rarely - thrombocytopenia, neutropenia, eosinophilia.
From the side of the central nervous system and peripheral nervous system: sometimes - dizziness / vertigo, headache, drowsiness, convulsions; rarely - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.
From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain and cramps; sometimes - diarrhea, flatulence, indigestion, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in the values of laboratory parameters of liver function; very rarely - liver dysfunction and liver necrosis (possibly fatal).
Allergic reactions: sometimes - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug interactions
Sumamed® (capsules, coated tablets, powder for oral suspension)
Antacids (containing aluminum, magnesium, ethanol) and food intake significantly reduce the absorption of azithromycin (capsules and suspension), so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food. It does not bind to the enzymes of the cytochrome P-450 complex and, unlike macrolide antibiotics, to date, no interaction with theophylline, terfenadine, carbamazepine, methylprednisolone, cimetidine, triazolam, digoxin has been observed. Macrolides, when taken simultaneously with cycloserine, indirect anticoagulants, methylprednisolone, felodipine and drugs that undergo microsomal oxidation (cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptinic drugs, phenytoin, slow down the peroxidation and concentration of these drugs) while with the use of azalides, such an interaction has not been observed to date.
If it is necessary to take it together with warfarin, careful monitoring of PT is recommended (an increase in PT and the incidence of hemorrhages is possible). With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effect (vasospasm, dysesthesia) is possible. Lincosamides weaken, and tetracycline and chloramphenicol increase the effectiveness of azithromycin. Pharmaceutically incompatible with heparin.
Sumamed® (lyophilisate for preparation of solution for infusion)
Although there are no data on the interaction of azithromycin and ergot alkaloids, care must be taken because simultaneous administration can lead to an increase in the concentration of alkaloids in the blood and to the development of symptoms of overdose (ergotism), which is noted when alkaloids are taken together with macrolides; Macrolide antibiotics increase the blood concentration of theophylline, terfenadine, warfarin, carbamazepine, phenytoin, digoxin, cyclosporin, ergotamine, triazolam and midazolam, thereby enhancing their effect. Unlike macrolides, azithromycin does not inhibit cytochrome P450, therefore, when it is prescribed with the above drugs, no similar interactions are observed.
Dosage
Sumamed is prescribed orally 1 time, at least 1 hour before or 2 hours after meals. Sumamed is taken without chewing.
Adults and children over 12 years old with a body weight of more than 45 kg are prescribed Sumamed in the form of tablets and capsules.
Children aged 6 months and older should be prescribed Sumamed in the form of a suspension for oral administration, children aged 3 years and older Sumamed can also be prescribed in the form of 125 mg tablets.
Sumamed in the form of tablets 125 mg is dosed taking into account the child's body weight, as shown in the table.
For infections of the ENT organs, upper and lower respiratory tract, skin and soft tissues, adults and children over 12 years old with a body weight of more than 45 kg are prescribed Sumamed in a dose of 500 mg 1 time / for 3 days, the course dose is 1.5 g.
For children aged 6 months and older, sumamed is prescribed at the rate of 10 mg / kg of body weight 1 time / for 3 days, the course dose of sumamed is 30 mg / kg.
Overdose
Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: gastric lavage, symptomatic therapy.
The most effective antibiotic of the new generation is Sumamed for children, the instructions for use of which include information that the agent can be used to treat infectious diseases. The medicine is effective in the fight against respiratory infections. Children's Sumamed can affect a huge number of pathogenic microbes: staphylococcus, pneumococcus, streptococcus.
What is Sumamed
The antibacterial drug Sumamed with a high concentration of azithromycin is widely used in various fields of medicine. The active substance of a powerful drug quickly penetrates to the focus of the disease thanks to blood cells and suppresses the synthesis of microbes, slowing down their growth and preventing further reproduction. In addition, the drug has a bactericidal effect on certain microorganisms, i.e. leads to the death of the main pathogens. The antibiotic half-life is 72 hours.
Composition
The active compound of the antibiotic Sumamed includes the active ingredient - azithromycin and some auxiliary components that ensure the rapid absorption of the drug into the tissues of the body. The substance acts at a deep cellular level, while destroying the structure of microbes. The concentration of the active ingredient can be between 125 and 500 mg. Excipients of the drug:
- corn starch;
- anhydrous calcium hydrogen phosphate;
- talc;
- hypromellose;
- sodium lauryl sulfate;
- microcrystalline cellulose;
- polysorbate 80;
- magnesium stearate;
- dye indigo carmine.
Is it an antibiotic or not
Sumamed is a strong antibacterial agent belonging to the macrolide category. This non-toxic, safe group rarely causes side effects and effectively kills pathogens. This antibiotic is prescribed by a doctor for children and adults to treat bacterial infections. You can buy it without a prescription at any pharmacy. The active ingredient azithromycin is active against many bacteria, but some of them are resistant to macrolides, so a sensitivity test must be done before use.
Form of release of Sumamed for children
The drug is available in several forms that are convenient for use:
- 250 mg gelatin capsules. On sale can be found with a dosage of 500 mg.
- Powder with active ingredient 100 mg. Can be used to prepare a suspension. The syrup has a sweet pleasant taste of cherry, strawberry and banana. A syringe-dispenser (measuring spoon) is included with the bottle. Suspension Sumamed is recommended for the treatment of young children.
- Hard-film tablets. They must be swallowed whole. Available in dosages of 500 and 125 mg.
- Lyophilisate for injection and solution. It is used only for patients over 16 years old, in the treatment of severe forms of respiratory diseases and infectious and inflammatory ailments of the pelvic organs.
pharmachologic effect
The broadest spectrum antibiotic has a bacteriostatic effect and is resistant to acidic environments, which helps it to be distributed and quickly absorbed from the digestive tract. The substance is excreted from the body with bile, urine. Maintains active concentration in the affected area for one week after use. The use of macrolides is effective against gram-positive, anaerobic pathogens. The limiting content of Sumamed in the blood is reached after about 3 hours. A doctor can prescribe an antibacterial drug. The withdrawal period is on average 4 days.
Indications for use
The antibacterial drug Sumamed is indicated for ailments caused by streptococci, gram-positive cocci and anaerobic organisms. The medication can be used for admission in children from 6 months, but only on condition that the baby's weight is 10 kg or more. You cannot give Sumamed to a child on your own, because the drug is a strong antibiotic. It is necessary to contact a specialist who, after conducting an examination and passing tests, will choose a suitable treatment regimen. Children's diseases for which Sumamed can be prescribed:
- a duodenal and stomach ulcer caused by bacteria;
- Lyme disease (at an early stage);
- severe infections of ENT organs: tonsillitis, scarlet fever, otitis media, tonsillitis, sinusitis, bronchitis (Sumamed is prescribed for pneumonia in children);
- diseases of the skin: erysipelas, streptoderma, impetigo, secondary dermatitis.
How to breed Sumamed
Especially for small patients, a suspension powder was developed, which is easy to prepare yourself at home. It is necessary to add the amount of water indicated in the instructions to the bottle with the medicine (the dose of the powder is different, therefore, a certain amount of liquid will be needed for dilution) and shake well until a homogeneous consistency. After preparation, the finished suspension in the vial will be more than 5 ml. The solution is usable for no more than five days. It is recommended to use this form of medication once a day.
Instructions for use
Taking capsules, suspensions and tablets depends on the weight, age of the patient and on what stage of the disease and whether there are complications. The dosage of Sumamed for children should be calculated by the pediatrician for the course of treatment. Capsules are prescribed for children aged 12 years, tablets - for babies from 4 years old, injections - after 16, and suspension - from 6 months. The drug in any form is recommended to be drunk one hour before meals. In the case of a single missed dose of the drug, the drug should be taken as soon as possible.
For diseases of the respiratory tract, ailments of the ENT organs, skin diseases (excluding migratory chronic erythema), children weighing 45 kg and over 12 years old are prescribed a medicine at a dosage of 500 mg once a day. The course of admission is 3 days, the dose of the drug should not exceed 1.5 g. Half-year-old children and older are prescribed medication at the rate of 10 mg per kg of body weight, but not more than 30 mg. The course of admission is 5 days.
Pills
Sumamed tablets for children are dosed based on the value of body weight: at 18-30 kg, 2 tablets of 125 mg are prescribed; from 31 to 45 kg - 3 to 375 mg; more than 45 kg - adult doses are prescribed. The tablets should be taken orally without chewing, preferably one hour before meals, once a day. Children who are less than three years old need to use the medicine in powder form 100 mg / 5 ml or 200 mg / 5 ml.
Suspension
The most ideal form of treatment for children of school and preschool age is considered to be a suspension, which is convenient to take. Typically, the course of treatment is 3 or 5 days. Taking the medicine is possible only 2 hours after eating. After dissolving the powder with water, a homogeneous suspension of light yellow or white color with a pleasant strawberry smell should be obtained.
The dose of the medicine for children from 6 months to 4 years old should be calculated based on the weight of the baby, on average it should be 10 mg per kilogram - in the first two days from the onset of the disease, then it should be taken according to the 5 mg / kg scheme. Before each use of the drug, the bottle with the prepared suspension must be shaken. The medicine must be stored in the refrigerator. The required dose is measured using the supplied measuring spoon or using a syringe.
How often can you drink
Many parents are often interested in the question of how to take Sumamed to children. Proceeding from the fact that the drug is a strong antibiotic, only a doctor should be engaged in its appointment, he also prescribes a detailed dosage for taking the drug. There are certain rules that parents should follow if Sumamed is prescribed to their child:
- antibiotic therapy for a newborn can be carried out after his body weight is 10 kg (this is at least six months);
- if for 6 months the sick child has already received the medicine, then it cannot be given again;
- the drug is taken for 5 days, if after this time there is no improvement, you need to seek help from the hospital;
- infusion of the drug for children under 16 years old should not be done;
- like any modern antibacterial drug Sumamed can cause an allergic reaction, so you need to carefully monitor the baby's condition.
Drug interactions
For respiratory tract infections, the antibiotic should not be combined with alcohol. azithromycin enhances its effect and increases the concentration in the blood. Antacids containing magnesium, aluminum reduce the absorption of azithromycin, so the medicine must be drunk two hours after using these drugs. When it is necessary to use it together with warfarin, the patient's condition should be monitored. Subject to a certain time interval, Sumamed for children can be taken simultaneously with other drugs:
- lincosamines;
- Dihydroergotamine: enhances its effect;
- tetracyclines or Chloramphenicol: enhancing the effectiveness of Sumamed;
- food or antacids (while only decreasing);
- Cycloserine or indirect anticoagulants;
- valproic acid, carbamazepine, phenytoin, bromocriptine.
Side effects and overdose
Pediatricians prescribe Sumamed, as a rule, after passing tests for sensitivity, but sometimes the specialist conducts only an external examination of a small patient and, on the basis of this, makes a decision on taking Sumamed. Ideally, the doctor should find out in advance if the baby has allergies and what antibiotics they have been given over the past six months. Among the adverse reactions in the case of using a high dosage of the drug in children, it is often noted:
- skin rash;
- diarrhea;
- drowsiness;
- heart rhythm disturbance;
- nausea;
- high activity of liver enzymes;
- neurological disorders;
- vomit.
A modern antibiotic from the macrolide group, according to reviews of many parents, in general, has the most gentle effect on the child's body. Rarely, a side effect of Sumamed is a violation of the intestinal microflora. As a rule, against the background of the use of an antibiotic, dysbiosis appears, therefore, bifidobacteria and lactobacilli, probiotics Acipol or Linex are often prescribed along with the medicine. After the main treatment, parents of babies need to undergo a recovery course.
Sumamed for children is one of the most effective means of combating community-acquired respiratory infections. A modern antibiotic capable of acting on most pathogenic microbes: pneumococcus, streptococcus and other intracellular pathogens. Created on the basis of the erythromycin A molecule, Sumamed antibiotic is resistant to the acidic gastric environment. Easily penetrating into all tissues, it has a targeted effect on the site of infection, destroying bacteria and accelerating the healing process.
The only substance that can block and destroy the development of all microorganisms is an antibiotic. Thanks to the developments of scientists of the last century, we have ceased to be afraid of deadly diseases: pneumonia, gangrene, tuberculosis. On the basis of antibiotics, the pharmaceutical industry produces more than two hundred forms of drugs with a wide range of prices.
For the convenience of patients, the antibiotic is available in various forms: powders, suspensions, tablets, syrups or solutions.
Only a specialist can determine the need for taking antibiotic drugs. The physician is responsible for the correct prescription of antibacterial treatment. After examining the child, the pediatrician will explain the need for the appointment of Sumamed or its analogues. An antibiotic should be used only in cases where an infectious disease cannot be cured without antibacterial drugs.
Due to the productive effect on a large number of pathogens, Sumamed for children has an advantage over generics.
Accumulating in the body, the drug is localized at the site of the development of infectious inflammation. The mechanism of action is aimed at suppressing the production of protein by the infected cell. Convenient use of Sumamed is facilitated by the optimal dosage for children, which allows using the medicine once every 24 hours. The instructions for use recommend that you observe the period of taking the antibiotic drug for at least 5 days. The analogue usually shows its effectiveness only after two weeks.
In what forms is it produced
The active substance of Sumamed is dihydrate. The antibiotic contained in the preparation in terms of dry matter in various types of medicine determines its form:
- Oral tablets 125 mg;
- Capsules 250 mg;
- Suspension syrup 100 and 200 mg / 5 ml;
- Parenteral powder.
Biconvex round tablets with a dosage of 125 mg are produced in a blue shell. Tablets of the same shade, but elongated, contain 500 mg of the antibiotic. The block contains the number of tablets required for the course of treatment: 3 tablets. 500 mg each, 6 tab. 250 mg each and 125 mg each. Sumamed 250 capsules are contained in a hard gelatin shell, tinted blue. Inside them, dry matter from white to yellow. The minimum dosage of a blister is 6 pieces. The price of the drug also depends on the proportion of the active substance.
The liquid form of Sumamed 100 mg and 200 mg differs in the final volume of the drug. The dry substance for the syrup has shades of white and light yellow. To improve the palatability, the suspension is made with the addition of cherry, strawberry or banana flavors. The powder comes with a measuring spoon or a special dispenser. The instruction attached to the medicine recommends diluting Sumamed 100 or 200 powder with freshly prepared boiled water, cooled to room temperature.
In hospitals, azithromycin is used in the form of a lyophilisate for the preparation of drip invasions. It is used in the treatment of severe forms of the disease.
What diseases are prescribed?
A modern antibiotic based on erythromycin A is prescribed for infectious diseases of various etiologies:
- Acute and chronic respiratory tract infections: bronchitis, pneumonia.
- ENT and respiratory tract infections: otitis media, rhinosinusitis, streptococcal tonsillitis and pharyngitis.
- Infections and inflammations of the urinary tract: cystitis, urethritis.
- Diseases of soft tissues and skin: - pustular diseases of the dermis, folliculitis - purulent inflammation of the hair follicle, erysipelas of the skin, dermatoses.
- Stomach and duodenal ulcer.
- Infectious borreliosis caused by the bite of an infected ixodid tick.
Using an antibiotic to treat children with diseases from the above list, you can achieve relief of symptoms after one (maximum two) doses of Sumamed 125 mg tablet.
With tonsillitis, an antibiotic is prescribed, even if the patient does not have a high fever, but there is a sore throat and weakness. The number of applications and dosage are determined by a specialist depending on the diagnosis, age and state of health of the child.
Nuances of treatment with sumamed
The attached instructions specify that 250 mg capsules and a suspension with a dosage of 100 and 200 mg should be taken 1 time every 24 hours one hour before meals or 2 hours after. Taking pills, you can not be guided by the time of the meal. Azithromycin should be taken with plenty of fluids.
To prepare a liquid form of a medicine, the instruction recommends adding cool boiled water to a container with a dry substance and stirring vigorously. The prepared suspension is increased by 5 ml. This compensates for the possibility of dosing losses. The syrup is stored in the room for no more than 5 days. After each dose of the medicine, you must thoroughly wash the measuring spoon or dispenser.
In the treatment of children from six months to 3 years, 100/200 mg syrup or tablets are used. The dosage of the drug is 10 mg / kg of body weight. The duration of the treatment is three days. With erythema, there are the following recommendations for use: 20 mg / kg on the first day of therapy; then 10 mg / kg. The course of treatment should not exceed 5 days.
If you miss a dose of the medication, you need to immediately take the daily serving, and the next one a day later.
Side effects
Before prescribing Sumamed, the pediatrician must find out if there is an allergy to the antibiotic and its analogue. In general, azithromycin-based drugs are well tolerated. But in medicine there is not a single antibiotic drug that does not cause side reactions. Be attentive to the use of Sumamed, since activation of liver enzymes, violation of the heart rate, the appearance of pain in the abdominal cavity, nausea, diarrhea, drowsiness is possible. Rarely there is vomiting, decreased appetite. Accumulation of gases is sometimes observed. In exceptional cases, joint pain, rash and Quincke's edema may occur.
Such an antibiotic has a depressing effect not only on pathogenic bacteria, but also kills the living intestinal microflora. In order to avoid the development of dysbiosis or candidiasis during treatment, attention should be paid to the correct use of probiotics. In the event of atypical manifestations in a child, immediately contact your doctor.
Contraindications
- Children with chronic kidney disease;
- Children with exacerbation of liver disease;
- Children allergic to azithromycin and its components.
The correct dosage of the medicine will allow the child to cope with the disease faster. The prepared suspension is assigned to infants from six months. Children from 3 years old - pills. Patients under 12 years of age and weighing less than 45 kg are prohibited from taking Sumamed 500 tablets. Until the age of 16, Sumamed injections are not prescribed.
Do not use antibiotics without consulting a specialist. Do not exceed your doctor's recommended dose. Use an antibiotic only when absolutely necessary!
Analogs
Sometimes doctors recommend a more affordable analogue of Sumamed for use. For example, the price of Serbian does not affect the quality of the drug. It is actively used in the treatment of infectious ailments of various etiologies. The analogue of sumamed, Zetamax retard, is deservedly distinguished. Thanks to specially created microspheres, the active substance gradually penetrates the body, maintaining the therapeutic effect throughout the day. The pharmacy price for Zetamax does not differ from the cost of similar generics and depends on the form of release and dosage of the drug.
Of the imported drugs based on azithromycin, the following positively proven analog can be distinguished: Azicid, Azitral, Sumamox, Zimax, etc.
Russian generics of this action include: Azitrox, Zitrolit, AzitRus, Ecomed. These medicines have a more affordable price, but they do not always meet the needs of modern medicine, since they have a wider range of contraindications.
Loading ...