AzitRus, 100 mg, powder for the preparation of suspension for oral administration, 4.2 g, 3 pcs.
When prescribing the drug AzitRus® to patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the drug contains sucrose (about 0.3 XE in one package).
If you miss one dose of AzitRus®, the missed dose should be taken as early as possible, and subsequent doses should be taken at intervals of 24 hours.
The drug AzitRus® should be used with caution in patients with mild liver dysfunction due to the possibility of developing fulminant hepatitis and severe liver failure.
If there are symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy, therapy with AzitRus® should be stopped and a study of the functional state of the liver should be performed.
In case of mild renal dysfunction (creatinine clearance more than 40 ml/min), therapy with AzitRus® should be carried out with caution under monitoring the state of renal function.
It must be remembered that for the prevention of pharyngitis/tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, penicillin is usually the drug of choice.
As with the use of other antibacterial drugs, during therapy with AzitRus®, patients should be regularly examined for the presence of non-responsive microorganisms and signs of the development of superinfections, including fungal ones.
The drug AzitRus® should not be used in longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and convenient dosage regimen.
There is no data on a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives, but due to the development of ergotism with the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is contraindicated. With long-term use of the drug AzitRus®, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis, is possible. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Drugs that inhibit intestinal motility are contraindicated.
Slow ventricular repolarization syndrome—long QT interval syndrome—increases the risk of developing arrhythmias, including arrhythmias, while taking macrolides, as well as the drug AzitRus®. Caution should be exercised when using the drug AzitRus® in patients with the presence of proarrhythmogenic factors (especially in elderly patients): with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), in patients with fluid and electrolyte imbalance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or cardiac arrest. severe insufficiency.
The use of AzitRus® may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia.
Impact on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
If undesirable effects on the nervous system and organ of vision develop, caution should be exercised when performing actions that require increased concentration and speed of psychomotor reactions.
Instructions for use AZITHRUS
When treated with other macrolides, prolongation of cardiac repolarization and prolongation of the QT interval were observed, increasing the risk of developing cardiac arrhythmia and torsade de pointes. The same effect with azithromycin cannot be completely excluded in patients at increased risk of prolonged cardiac repolarization; Therefore, when treating patients, caution is required:
- with congenital or confirmed QT prolongation;
- currently receiving treatment with another active substance known to prolong the QT interval, such as class Ia and III antiarrhythmics, cisapride monohydrate and terfenadine;
- with electrolytic disorder, especially in the case of hypokalemia and hypomagnesemia.
- with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
It is recommended, as with all antibiotics, to monitor for signs of superinfection caused by nonsusceptible organisms, including fungal infections. There have been reports of Clostridium difficile diarrhea (CDAD) with the use of almost all antibacterial agents, including azithromycin, and the severity of cases can range from mild diarrhea to fatal colitis. Strains of Clostridium difficile that produce hypertoxin A and B contribute to the development of CDAD. The hypertoxin produced by Clostridium difficile strains is responsible for increased morbidity and mortality, as these infections may be refractory to antimicrobial therapy and may lead to the need for colonectomy. Therefore, patients with diarrhea should be evaluated for CDAD during or immediately after taking any antibiotics. A careful medical history should be maintained as CDAD has been reported to occur after two months of taking antibacterial agents. Discontinuation of azithromycin treatment and initiation of specific treatment for Clostridium difficile should be considered.
Streptococcal infections:
- Penicillin is usually the first choice for the treatment of pharyngitis/tonsillitis due to streptococcal suppuration, as well as the prevention of acute rheumatic fever. Azithromycin is generally effective against streptococcus in the oropharynx, but no data are available to indicate the effectiveness of azithromycin in preventing acute rheumatic fever.
Exacerbation of symptoms of malignant myasthenia and newly diagnosed myasthenia syndrome have been reported in patients treated with azithromycin.
Carefully
Because the liver is the primary route of elimination of azithromycin, the use of azithromycin should be used with caution in patients with significant hepatic impairment. When using azithromycin, cases of fulminant hepatitis have been described, which can lead to life-threatening liver failure. Some patients may have a pre-existing history of liver disease or may have been exposed to other hepatotoxic drugs. If signs and symptoms of liver dysfunction occur (rapidly developing asthenia, jaundice, dark urine, bleeding or hepatic encephalopathy), liver tests and related studies should be performed immediately. Azithromycin should be stopped if liver dysfunction occurs.
Azithromycin increases cardiac repolarization and the QT interval, while increasing the risk of developing cardiac arrhythmias and torsade de pointes, especially in the case of electrolyte abnormalities - hypokalemia and hypomagnesemia.
If a dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.
It is necessary to observe a break of 2 hours while using antacids.
After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under medical supervision.
When prescribing azithromycin to treat bacterial infections, patients should be aware that if they feel better early in therapy, the drug should be taken exactly as prescribed. Skipping doses or not completing the full course of therapy may (1) reduce the effectiveness of treatment and (2) increase the likelihood that the bacteria will develop resistance and become untreatable with azithromycin or other antibacterial drugs in the future.
The ability of a drug to influence the behavior or functional parameters of the body, interaction with tobacco, alcohol, food
Do not use with food. Ethanol and food slow down and reduce the absorption of azithromycin.
Impact on the ability to drive vehicles and machinery
There is no data on the effect of azithromycin on the ability to drive vehicles, operate machinery, or perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Azithrus®
The drug is taken orally 1 time/day 1 hour before or 2 hours after meals.
Adults
For infections of the upper and lower respiratory tract
prescribed 500 mg/day for 3 days (course dose - 1.5 g).
For skin and soft tissue infections
prescribed 1 g/day on the 1st day, then 500 mg daily from the 2nd to the 5th day (course dose - 3 g).
For uncomplicated urethritis and/or cervicitis
prescribed once 1 g.
For Lyme disease (borreliosis) for the treatment of the initial stage (erythema migrans)
Prescribe 1 g on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g).
For gastric and duodenal ulcers associated with Helicobacter pylori
, prescribed 1 g/day for 3 days as part of combined anti-Helicobacter therapy.
Children
The drug in capsule form is prescribed to children over 3 years of age and/or with a body weight of more than 25 kg
for
infections of the upper and lower respiratory tract, skin and soft tissues
at the rate of 10 mg/kg body weight 1 time/day for 3 days (course dose - 30 mg/kg), or on the 1st day - 10 mg/kg , then for 4 days - 5-10 mg/kg/day.
When treating the initial stage (erythema migrans)
of Lyme disease (borreliosis),
the drug is prescribed at a dose of 20 mg/kg on the 1st day, then 10 mg/kg from the 2nd to the 5th day.
The drug in the form of an oral suspension is prescribed to children over 6 months of age.
for
infections of the upper and lower respiratory tract, skin and soft tissues
at the rate of 10 mg/kg body weight 1 time/day for 3 days (course dose - 30 mg/kg), or for 5 days: on the 1st day - 10 mg/kg, then for 4 days - 5-10 mg/kg/day.
Recommended doses of the drug depending on the child’s body weight are presented in the table.
| Body mass | Average daily (single) dose |
| Powder for suspension 100 mg/5 ml | |
| 5 kg | 2.5 ml (50 mg) |
| 6 kg | 3 ml (60 mg) |
| 7 kg | 3.5 ml (70 mg) |
| 8 kg | 4 ml (80 mg) |
| 9 kg | 4.5 ml (90 mg) |
| 10-14 kg | 5 ml (100 mg) |
| Powder for suspension 200 mg/5 ml | |
| 15-24 kg | 5 ml (200 mg) |
| 25-34 kg | 7.5 ml (300 mg) |
| 35-44 kg | 10 ml (400 mg) |
| > 45 kg | prescribed doses for adults (500-1000 mg) |
When treating the initial stage (erythema migrans)
of Lyme disease (borreliosis),
the drug is prescribed at a dose of 20 mg/kg on the 1st day, then 10 mg/kg from the 2nd to the 5th day.
The drug AzitRus® forte (film-coated tablets) is prescribed to children over 12 years of age
and/or with a body weight of more than 50 kg
for
infections of the upper and lower respiratory tract, skin and soft tissues,
500 mg 1 time / day for 3 days (course dose - 1.5 g).
In the treatment of erythema migrans
in
children (over 12 years of age and/or with a body weight of more than 50 kg),
AzitRus® forte is prescribed 1 g / day on the 1st day and 500 mg daily from the 2nd to the 5th day (course dose - 3 g ).
Rules for preparing a suspension for oral administration
Single dose package
A small amount of boiled and cooled water is poured into a clean glass, then the contents of one packet are poured out and mixed until a homogeneous suspension is obtained. After use, the glass should be rinsed with water, dried and stored in a dry and clean place.
AzitRus pore d/prig suspension pack 100 mg N3 (Synthesis)
Orally 1 hour before or 2 hours after meals 1 time per day. Adults: for infections of the upper and lower respiratory tract – 500 mg/day in one dose for 3 days (course dose – 1.5 g). For infections of the skin and soft tissues - 1000 mg/day on the first day in 1 dose, then 500 mg/day daily from days 2 to 5 (course dose - 3 g). For acute infections of the genitourinary organs (uncomplicated urethritis or cervicitis) - 1 g once. For Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) - 1 g on the first day and 500 mg daily from days 2 to 5 (course dose - 3 G). For gastric and duodenal ulcers associated with Helicobacter pylori – 1 g/day for 3 days as part of combination anti-Helicobacter pylori therapy. Children with infections of the upper and lower respiratory tract, skin and soft tissues are prescribed at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose - 30 mg/kg body weight) or for 5 days: on the first day – 10 mg/kg body weight, then 5-10 mg/kg body weight 1 time per day for 4 days. Depending on the child’s body weight, the following dosage regimens are recommended: Release form Average daily (single) dose 5 kg 6 kg 7 kg 8 kg 9 kg 10-14 kg powder for preparing a suspension 100 mg/5 ml 2.5 ml (50 mg) 3 ml (60 mg) 3.5 ml (70 mg) 4 ml (80 mg) 4.5 ml (90 mg) 5 ml (100 mg) 15-24 kg 25-34 kg 35-44 kg >45 kg powder for suspension 200 mg /5 ml 5 ml (200 mg) 7.5 ml (300 mg) 10 ml (400 mg) doses are prescribed for adults (500-1000 mg) When treating erythema migrans in children, the drug is prescribed 1 time per day for 5 days: 20 mg/kg body weight on the first day and 10 mg/kg body weight from days 2 to 5. Preparation of the suspension. Single dose package. A small amount of boiled and cooled water is poured into a clean glass, then the contents of one packet are poured out and mixed until a homogeneous suspension is obtained. After use, rinse the glass with water, dry and store in a dry and clean place. Jar. Using a polymer compound dispenser, add 12 ml of boiled and cooled water or distilled water to a jar containing 400 mg or 800 mg of azithromycin; in a jar containing 1200 mg of azithromycin - 18 ml. The suspension is shaken before use. Dispense the suspension with a double-sided spoon: a large spoon contains 5 ml of suspension, a small one - 2.5 ml; or a spoon with two marks: the lower one corresponds to 2.5 ml of suspension and the upper one - 5 ml; or a polymer compound dispenser. After use, rinse the spoon and dispenser with water, dry and store in a dry and clean place.
