Product Description

Indications: Azin is indicated for the treatment of infections caused by susceptible organisms, including lower respiratory tract infections such as bronchitis and pneumonia, upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, otitis media, and skin and soft tissue infections. It is also indicated for sexually transmitted infections such as non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis in both men and women.Pharmacology: Azithromycin is an acid-stable macrolide antibiotic that can be administered orally without protection from gastric acid. It is rapidly absorbed, especially on an empty stomach, with peak plasma concentrations occurring within 2.1 to 3.2 hours after oral administration. Azithromycin concentrates extensively within tissues and phagocytic cells, allowing targeted delivery to infection sites. Tissue concentrations may exceed plasma levels by more than 50 times due to high lipid solubility and ion trapping. It has a prolonged elimination half-life of approximately 68 hours, enabling short-course therapy with sustained antibacterial activity. Azithromycin acts by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting microbial protein synthesis. It is active against a wide range of gram-positive, gram-negative, anaerobic, and atypical organisms including Streptococcus pneumoniae, Haemophilus influenzae, Chlamydia trachomatis, Mycoplasma pneumoniae, and Neisseria gonorrhoeae.Dosage & Administration:Oral Administration:Adults: 500 mg once daily for 3 days, or 500 mg on Day 1 followed by 250 mg once daily on Days 2-5.Sexually transmitted infections caused by Chlamydia trachomatis: 1 g as a single dose, or 500 mg on Day 1 followed by 250 mg daily for the next 2 days.Children over 6 months: 10 mg/kg once daily for 3 days.15-25 kg body weight: 200 mg once daily for 3 days.26-35 kg body weight: 300 mg once daily for 3 days.36-45 kg body weight: 400 mg once daily for 3 days.Typhoid fever: 500 mg once daily for 7-10 days.Intravenous Infusion:Community-acquired pneumonia: 500 mg IV once daily for at least 2 days, followed by oral Azithromycin 500 mg daily to complete a 7-10 day course.Pelvic inflammatory disease: 500 mg IV once daily for 1-2 days, followed by 250 mg orally once daily to complete a 7-day course.Administration: Shake suspension bottle well before adding boiled and cooled water up to the marked line, then shake thoroughly. Azithromycin should be taken at least 1 hour before or 2 hours after meals.Interaction: Antacids may reduce absorption; Azithromycin should be taken at least 1 hour before or 2 hours after antacids. Caution is advised when used with cyclosporine, digoxin, warfarin, theophylline, carbamazepine, and terfenadine. Concurrent use with ergot derivatives is contraindicated due to risk of ergotism.Contraindications: Contraindicated in patients hypersensitive to Azithromycin, other macrolide antibiotics, ergot derivatives, or those with significant hepatic disease.Side Effects: Common side effects include nausea, abdominal discomfort, vomiting, flatulence, diarrhea, and loose stools. Allergic reactions such as rash and photosensitivity may occur. Rare adverse effects include cholestatic jaundice, serious hypersensitivity reactions, transient neutropenia, and reversible hearing impairment with prolonged high-dose therapy.Pregnancy & Lactation: Azithromycin is classified as Pregnancy Category B. Animal studies have shown no evidence of fetal harm, but adequate human studies are lacking. It should be used during pregnancy only if clearly needed. It is unknown whether Azithromycin passes into breast milk; therefore, caution is advised during breastfeeding.Precautions & Warnings: Serious allergic reactions including angioedema and anaphylaxis have been reported. Use cautiously in patients with severe renal impairment. Since Azithromycin is primarily excreted through the liver, it should not be used in patients with hepatic disease.Use in Special Populations: No dosage adjustment is required in mild renal impairment. Use cautiously in severe renal impairment. Avoid use in hepatic disease. No evidence suggests impairment of driving or machine operation ability.Overdose Effects: Symptoms of overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss. Treatment includes gastric lavage and supportive care.Therapeutic Class: Macrolide antibiotics.Storage Conditions: Store in a cool, dry place away from light and heat. Keep out of reach of children.