Instructions for Sumamed Forte (Azithromycin)
Sumamed forte is an antibacterial drug azalide.
Description:
antibacterial drug
Composition Sumamed:
azithromycin 500 mg in 1 tablet
Indications for the use of Azithromycin:
Infections of the upper respiratory tract and ENT organs caused by sensitive pathogens such as:
pharyngitis,
tonsillitis, sinusitis, otitis media; lower respiratory tract infections: pneumonia (including atypical, with chronic exacerbation), bronchitis; infections of the skin and soft tissues: acne vulgaris (moderate), erysipelas, impetigo, secondarily infected dermatoses; urinary tract infections: gonorrheal and non-gonorrheal urethritis, cervicitis; Lyme disease (initial stage - erythema migrans).
Banana or raspberry flavored prolonged release powder for oral suspension: mild to moderate acute bacterial sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae; community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae, mild to moderate. Sumamed
has antifungal property, against various infections
Pharmacokinetics Azithromycin:
It is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic environment and lipophilicity. After oral administration in a dose of 500 mg, Cmax is achieved in 2.5-2.96 hours and is 0.4 mg / l. Bioavailability is 37%. It penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular, the prostate gland), skin and soft tissues. High tissue concentration (10-50 times higher than in blood plasma) and long T1 / 2 are due to low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a low pH environment surrounding lysosomes. This, in turn, determines a large apparent volume of distribution (31.1 L / kg) and a high plasma clearance. The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that azithromycin is delivered by phagocytes to the infectious focus, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24–34%) and correlates with the degree of inflammatory edema.
Despite its high concentration in phagocytes, azithromycin does not significantly affect their function. The bactericidal concentration in the focus of inflammation persists for 5-7 days after the last dose, which made it possible to develop short (3- and 5-day) courses of treatment. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24–34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not significantly affect their function. The bactericidal concentration in the focus of inflammation persists for 5-7 days after the last dose, which made it possible to develop short (3- and 5-day) courses of treatment. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (on average by 24–34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not significantly affect their function. The bactericidal concentration in the focus of inflammation persists for 5-7 days after the last dose, which made it possible to develop short (3- and 5-day) courses of treatment.
The elimination of azithromycin from blood plasma takes place in 2 stages: T1 / 2 is 14–20 hours in the interval from 8 to 24 hours after taking the drug Sumamed and 41 hours in the interval from 24 to 72 hours, which allows the drug to be used 1 time / day.
Pharmacodynamics Sumamed:
Pharmacological action - bactericidal, antibacterial.
Active against gram-positive cocci: Streptococcus pneumoniae, St. pyogenes, St. agalactiae, group CF and G streptococci, Staphylococcus aureus, St. viridans; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, B. parapertussis, Legionella pneumophila, H. ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae, and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp .; Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Not active against erythromycin-resistant gram-positive bacteria.
Contraindications Sumamed:
Hypersensitivity (including to other macrolides), severe liver and / or kidney dysfunction, age up to 16 years (infusion), up to 12 years with a body weight of less than 45 kg (capsules, tablets), up to 6 months (suspension for ingestion).
Side effects Azithromycin:
From the nervous system and sensory organs: dizziness, vertigo, headache, paresthesia, agitation, increased fatigue, drowsiness; rarely - tinnitus, reversible hearing impairment up to deafness (when taken in high doses for a long time); in children - headache (in the treatment of otitis media), hyperkinesia, nervousness, anxiety, sleep disturbance, conjunctivitis.
From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): chest pain, palpitations.
From the digestive tract: nausea, vomiting, diarrhea, flatulence, abdominal pain, increased ALT and AST activity, bilirubin levels, cholestasis, jaundice; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, pancreatitis, liver necrosis, liver failure (possibly fatal); in children - decreased appetite, gastritis, candidiasis of the oral mucosa.
From the genitourinary system: vaginal candidiasis, nephritis.
Allergic reactions: rash, itching, urticaria; rarely - angioedema, anaphylactic shock.
Others: photosensitivity, eosinophilia, transient neutrophilia; with intravenous injection (optional) - bronchospasm, pain and inflammation at the injection site.
Method of preparation or use Sumamed:
Inside
1 hour before or 2 hours after meals, 1 time per day.
Adults with infections of the upper and lower respiratory tract are prescribed 500 mg / day for 3 days (course dose - 1.5 g).
For infections of the skin and soft tissues, it is prescribed in a dose of 1 g / day for 1 dose on the first day, then - 500 mg / day every day from 2 to 5 days. Heading dose - 3 g.
For uncomplicated urethritis and / or cervicitis, 1 g is prescribed once.
For complicated, long-term urethritis / cervicitis caused by Chlamydia trachomatis, 1 g 3 times with an interval of 7 days (taking the drug Sumamed in 1-7 14 day of treatment). Heading dose - 3 g.
In Lyme disease (borreliosis) for the treatment of stage I (erythema migrans), 1 g is prescribed on the 1st day and 500 mg daily from the 2nd to the 5th days. Heading dose - 3 g.
For gastric ulcer and duodenal ulcer associated with Helicobacter pylori, 1 g / day is prescribed for 3 days as part of a combined anti-Helicobacter pylori therapy.
For children weighing more than 45 kg with infections of the upper and lower respiratory tract, skin and soft tissues, scarlet fever, the drug Sumamed is prescribed 500 mg / day for 1 dose for 3 days.
For children over 12 years old, the drug Sumamed in a dosage of 250 mg is prescribed at the rate of 10 mg / kg 1 time / day for 3 days or on the first day - 10 mg / kg, then 4 days - 5-10 mg / kg / day for 3 days. Heading dose - 30 mg / kg.
In the treatment of erythema migrans in children, the dose of the drug Sumamed is 1 g on the 1st day and 500 mg daily from the 2nd to the 5th days. Heading dose - 3 g. The drug should be used in a dosage of 250 mg at a dose of 20 mg / kg on the 1st day and 10 mg / kg from the 2nd to the 5th day.
Vacation procedure:
According to the form of prescription form 107-1 / y
