D-Mycin 500 mg

Generic Name:
Azithromycin

Composition:
Each D-Mycin 500 mg Tablet contains Azithromycin USP 500 mg.

Pharmacology:
Azithromycin is a broad-spectrum macrolide antibiotic with a long half-life and a high degree of tissue penetration. It belongs to the azalide subclass of macrolides and binds to the 50S ribosomal subunit of bacteria, inhibiting bacterial protein synthesis by blocking the translation process.

Indications:
Azithromycin is indicated for the treatment of:

• Respiratory tract infections
• Otitis media
• Skin and soft tissue infections
• Diarrhoea
• Cholera
• Typhoid fever
• Uncomplicated genital chlamydial infections
• Non-gonococcal urethritis
• Gonorrhea

Dose & Administration:

Upper Respiratory Tract Infections:
Includes pharyngitis, tonsillitis, acute bacterial sinusitis and acute otitis media.

• Adults: 500 mg once daily
• Alternatively, 500 mg on Day 1 followed by 250 mg once daily for the next 4 days
• Children: 10 mg/kg once daily
• Duration of therapy: 3 days

Lower Respiratory Tract Infections:
Includes community-acquired pneumonia, acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) and bronchitis.

• Adults: 500 mg once daily
• Alternatively, 500 mg on Day 1 followed by 250 mg once daily for the next 4 days
• Children: 10 mg/kg once daily
• Duration of therapy: 3 days

Acne:
• 500 mg once daily for 3 days, followed by a 4-day interval
• Duration: 8–12 weeks (more effective)

Skin / Skin Structure Infection:
• Adults: 500 mg once daily
• Children: 10 mg/kg once daily
• Duration: 3 days

Genital Ulcer Disease:
• Adults: 1 g as a single dose

Non-Gonococcal Urethritis and Cervicitis:
• Adults: 1 g as a single dose

Gonococcal Urethritis and Cervicitis:
• Adults: 2 g as a single dose

Typhoid / Paratyphoid:
• Adults: 1 g once daily
• Children: 20 mg/kg once daily
• Duration: 5 days

Diarrhoea:
• Adults: 1–1.5 g once daily
• Children: 20 mg/kg once daily
• Duration: 1–3 days

Cholera:
• Adults: 1 g as a single dose
• Children: 20 mg/kg as a single dose

Shigellosis:
• Adults: 1–1.5 g once daily
• Children: 20 mg/kg once daily
• Duration: 1–5 days

Dental Infection:
• Adults: 500 mg once daily
• Children: 10 mg/kg once daily
• Duration: 3 days

Eye Infection:
• Adults: 1 g as a single dose
• Children: 20 mg/kg as a single dose

Contraindications:
• Hypersensitivity to Azithromycin or any of the macrolide antibiotics
• Co-administration with ergot derivatives should be avoided

Side Effects:
Gastrointestinal side effects may occur, including:

• Nausea
• Vomiting
• Diarrhoea
• Flatulence
• Loose stool
• Minor abdominal cramps

Warning & Precaution:
• Caution should be taken in patients with renal impairment.
• Caution should be exercised in patients with ventricular tachycardia.

Drug Interactions:
Azithromycin may interact with:

• Antacids
• Ergot derivatives
• Digoxin
• Cyclosporine
• Warfarin
• Theophylline
• Carbamazepine
• Methylprednisolone
• Cimetidine

The insert also states that absorption of Azithromycin is reduced by 50% in the presence of food in the stomach.

Use in Pregnancy & Lactation:
• Pregnancy Category B.
• The insert states that Azithromycin is recommended for use during pregnancy.
• It is not known whether Azithromycin is secreted in breast milk.
• Caution should be exercised when Azithromycin is administered to nursing or lactating mothers.

Overdose:
There are no specific data available on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics may include:

• Hearing loss
• Severe nausea
• Vomiting
• Diarrhoea

Gastric lavage and general supportive measures are indicated.

Storage:
• Store below 30°C.
• Protect from light and moisture.
• Store in a dry and cool place.
• Keep out of reach of children.

Dosage Form:
Film-coated Tablet

Commercial Packaging:
Each box contains 12 tablets in an Alu-Alu blister pack.