SivoRomycin Azithromycin Tablets

Sivo Romycin
Azithromycin Tablets 500 mg

 

Dosage Form

Film Coated Tablets

 

Composition

Each film coated tablet contains:

Azithromycin (As dehydrate) USP

Eq. to Azithromycin 500mg

Excipients q.s.

Colour: Lake Tartrazine

 

Pharmacological effects

It is an azalide antibiotic, a subclass of the macrolides. It retains the spectrum of activity of erythromycin against Gram-positive and Gram-negative pathogens and has increased activity against many Gram-negative and atypical micro-organisms. It has greater acid-stability than erythromycin and its gastrointestinal tolerance is better than that of erythromycin. It acts by interfering with microbial protein synthesis by binding to the 50 S ribosomal subunit.

 

Indications

Upper and lower respiratory tract infections, otitis media; Skin and soft tissues infections; uncomplicated genital chlamydial infections and non – gonococcal urethritis; mild or moderate typhoid due to multiple – antibacterial resistant organisms [unlicensed indication]; prophylaxis of endocarditis in children
[unlicensed indication]

 

Dosage

Upper and lower respiratory tract and skin and soft tissue infections: 500 mg once daily for 3 days; CHILD over 6 months 10 mg/kg once daily for 3 days; or body weight 15-25 kg, 200 mg once daily for 3 days; body – weight 26-35kg, 300mg once daily for 3 days; body-weight 36-45kg, 400mg once daily for 3 days.

Uncomplicated genital chlamydial infections and non gonococcal urethritis, 1 g as a single dose.

Typhoid [unlicensed indication], 500mg once daily for 7 days.

 

Contraindications

Hepatic impairment

 

Warnings and Precautions

Pregnancy: Use with caution.

Breast – feeding: Use with caution.

 

Side effects

Anorexia, dyspepsia, flatulence, constipation, pancreatitis, hepatitis, syncope, dizziness, headache drowsiness, agitation, anxiety, hyperactivity, asthenia, paraesthasia, convulsions, mild neutropenia, thrombocytopenia, interstitial nephritis, acute renal failure, arthralgia, photosensitivity, rarely taste disturbances, tongue discoloration, and hepatic failure.

 

Drug Interactions

Absorption reduced by food. Antacids reduce rate of absorption. Increases absorption of Digoxin and Cyclosporine.

 

Pack

3 or 10 tablets packed in one blister. Such 1 blisters packed in unit printed duplex board carton along with its package insert.

 

Storage

36 months from the date of manufacture. Store in a cool and dry place. Protect from light and temperature.

 

Mfg. Lic. No. G/28/1231

 

Nafdac Reg. No.: B4-0688

 

Manufactured In India by

Globela Pharma Pvt. Ltd.

357, G.I.D.C., Sachin Surat-394 230.

Gujarat (India).

www.globelapharma.com

 

Sole Agent

Adpharma Pharmaceutical Ind. Ltd.

60, Ajao Road, Surulere,

Lagos, Nigeria.

Advertisements