Rominazit

Composition

Azithromycin – 500 mg

Indications for use

Rominazit is indicated in adults and children weighing more than 45 kg for the treatment of infections known or suspected to have been caused by one or more azithromycin- susceptible microorganisms:
• Upper res p i ratory tract i nfecti ons – pharyng itis/ton si I litis, sinusitis and otitis media
• Lower respiratory tract infections – bacterial bronchitis and community acquired pneumonia
• Skin and subcutaneous tissues – moderate acne vulgaris, erythema chronicum migrans (first stage of Lyme disease), erysipelas, impetigo and secondary pyoderma
• Sexually transmitted diseases – uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis.
The use of the product should be in line with national and local guidelines and recommendations for conducting antibacterial therapy.

Mode of application

Adults, including the elderly and children weighing more than 45 kg

• Upper and lower respiratory tract infections: Total course dose of 1500 mg, which should be taken for 3 days (500 mg once daily)
• Moderate acne vulgaris: Total course dose of 6 g, which should be taken under the following recommended dosage regime: 500 mg once daily for 3 consecutive days, 500 mg once weekly for the next 9 weeks. The dose for the second week should be taken 7 days after the administration of the first dose and the dose for the third to eighth weeks should betaken over 7-day intervals.
• Uncomplicated sexually transmitted diseases caused by Chlamidia trachomatis The therapeutic dose is 1,000 mg, taken as a single dose.
• Erythema chronicum migrans (first stage of Lyme disease): Total course dose of 3 g azithromycin, which should be taken under the following dosage regime: a single daily dose of 1 g on Day 1, single daily doses of 500 mg on Days 2-5.

Children weighing less than 45 ka: Rominazit 500 mg capsules are not recommended in children weighing less than 45 kg, due to the lack of accurate dosing.

Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance >40 ml/min).

Caution should be exercised in patients with severe renal impairment (creatinine clearance <40 ml/min) (see section 4.4).

Hepatic impairment: Since azithromycin is metabolised in the liver and excreted in the bile, the product in contraindicated in patients suffering from severe liver diseases. No studies have been conducted in relation to the use of azithromycin in this patient group.

Method of administration: Rominazit capsules should be swallowed whole, as a single daily dose. Like the other antibiotics, the product should be taken at least one hour before or two hours after meal.

Mode of Administration: Oral