Epizithro 500 mg

Trade Name:

Epizithro

Composition:

Each hard gelatin capsule contains:

Azithromycin 500 mg

Inactive ingredients:

Anhydrous lactose, starch, talc, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide.

Properties:

A broad-spectrum antibacterial drug from the group of azalide macrolides, acts bacteriostatically.  By binding to the 50S subunit of ribosomes, it inhibits the peptide translocase at the translation stage, inhibits protein synthesis, slows down the growth and reproduction of bacteria, and in high concentrations has a bactericidal effect.  It acts on extra- and intracellularly located pathogens.

Microorganisms may be initially resistant to the action of an antibiotic or may acquire resistance to it.

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;

– infections of the lower respiratory tract: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl.  caused by atypical pathogens;

– infections of the skin and soft tissues: acne vulgaris of moderate severity, erysipelas, impetigo, secondarily infected dermatoses;

– the initial stage of Lyme disease (borreliosis) – migrating erythema (erythema migrans);

– urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Dosage and administration:

The drug is taken orally 1 time / day, 500 mg, one hour before meals or one hour after.

Adults (including the elderly) and children over 12 years of age weighing over 45 kg

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg 1 time / day for 3 days (course dose – 1.5 g).

With erythema migrans: on the first day, 2 caps at the same time.  500 mg, then from the 2nd to the 5th day, 500 mg daily.  Heading dose 3.0 g.

For urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): 2 caps 500 mg at a time.

Contraindications:

– severe hepatic and/or renal insufficiency;

– children’s age up to 12 years with a body weight of less than 45 kg (for this dosage form);

-breast-feeding;

– simultaneous reception with ergotamine and dihydroergotamine;

– hypersensitivity to macrolide antibiotics.

Warnings and precautions:

If an antibiotic is missed, the missed dose should be taken as soon as possible and subsequent doses should be taken 24 hours apart.

After discontinuation of azithromycin therapy, hypersensitivity reactions in some patients may persist for a long time and may require specific therapy under medical supervision.

Influence on the ability to drive vehicles and mechanisms:

Given the likelihood of side effects from the central nervous system, care should be taken when driving vehicles and working with mechanisms.

Side effects:

Digestive system: nausea, vomiting, diarrhea, abdominal pain, loose stools, flatulence, indigestion, anorexia, constipation.

Allergic reactions: itching, skin rashes, angioedema, urticaria, photosensitivity, anaphylactic reaction (in rare cases fatal).

Cardiovascular system: palpitations, arrhythmia, ventricular tachycardia, an increase in the QT interval, bidirectional ventricular tachycardia.

Nervous system: dizziness / vertigo, headache, convulsions, drowsiness, paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

Senses: tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), impaired perception of taste and smell.

Circulatory and lymphatic systems: thrombocytopenia, neutropenia, eosinophilia.

Musculoskeletal system: arthralgia.

Genitourinary system: interstitial nephritis, acute renal failure.

Others: vaginitis, candidiasis.

Storage:

Store at a temperature not exceeding 25°C 

Package:

The carton box contains a blister of 3 capsules, paper leaflet.