Ziromin (azithromycin) coated tablets 500 mg. №3

Description

Ziromin (azithromycin) coated tablets 500 mg. №3

Composition

active substance: azithromycin;

1 tablet contains azithromycin dihydrate equivalent to azithromycin 500 mg;

Excipients: calcium hydrogen phosphate, pregelatinized starch, crospovidone, polysorbate 80, colloidal anhydrous silica, microcrystalline cellulose, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide (E 171).

Dosage form

Coated tablets.

Basic physical and chemical properties: 500 mg tablets: White, biconvex, capsule-shaped, film-coated tablets with a fracture line on one side and smooth tablets on the other.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Macrolides, lincosamides and streptogramins. Azithromycin. ATX code J01F A10.

Pharmacological properties

Azithromycin is a macrolide antibiotic that belongs to the group of azalides. The molecule is formed by introducing a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is to inhibit bacterial protein synthesis by binding to the 50 S-subunit of ribosomes and inhibiting peptide translocation.

Indications

Ziromin coated tablets is indicated for infections caused by microorganisms sensitive to this antibiotic:

•  otorhinolaryngological (sinusitis, otitis media, sore throat, pharyngitis);
•  respiratory tract (bronchitis, pneumonia, including atypical, pleural empyema, lung abscess);
•  soft tissues, skin (pyoderma, erysipelas, acne, impetigo, abscess, boils, phlegmon, secondary infected dermatoses);
•  urogenital system (gonorrheal or non-gonorrheal urethritis, cervicitis, cystitis, endometritis, prostatitis, pyelonephritis);
•  at the initial stage of Lyme disease (tick-borne borreliosis) – erythema migrans.

Contraindications

Ziromin coated tablets is not used:

•  at intolerance of components of drug;
•  with allergies to macrolides in the past;
•  with severe hepatic / renal impairment;
•  at a body weight not exceeding 45 kg.

Use during pregnancy and breastfeeding

Azithromycin penetrates the placental barrier, so administration to pregnant women is permissible only in cases where the benefits to the mother outweigh the risks to the fetus.

If treatment is required during lactation, cessation of breastfeeding is indicated.

Method of application and dose

Ziromin coated tablets powder is administered orally.

The doctor sets the dose taking into account the severity of the disease, the nosological form, the sensitivity of the pathogen.

The standard dose for adults is 500-1000 mg once a day, for children – 5-10 mg / kg / day.

The duration of treatment is individual, depends on the demonstrated therapeutic effect, the severity of the infectious process. Usually 2-5 days.

Overdose

Symptoms: diarrhea, temporary hearing loss, vomiting.

In case of overdose, gastric lavage, administration of enterosorbents, symptomatic therapy are indicated.

Side effects:

• neurological disorders: cephalgia, vertigo, paresthesia, agitation, fatigue, drowsiness, tinnitus, hyperkinesia, hearing impairment (reversible) up to deafness, anxiety, conjunctivitis, nervousness, sleep disturbance;
• cardiovascular disorders: chest pain, palpitations;
• digestive disorders nausea, flatulence, diarrhea, abdominal pain, cholestasis, jaundice, discoloration of the tongue, constipation, pseudomembranous colitis, pancreatitis, loss of appetite, liver failure, liver necrosis, candidiasis of the mucous membranes of the mouth, active hypertension, gastritis, gastritis bilirubin;
• genitourinary disorders: candidal colpitis, nephritis;
• allergic reactions: anaphylactic shock, itching, hives, rash, Quincke’s edema (angioneurotic).