Azithromycin Tablets USP 500 mg
- Azithromycin Tablets USP 500 mg
Therapeutic Class: Anti-Infectives
Dosage Forms: Tablets
Brand Name: Conithro-500™
How it works?
Uses of Azithromycin Tablets USP 500 mg
Uses of Azithromycin Tablets 500 mg
Azithromycin 500 mg belongs to the macrolide antibiotic therapeutic class. It is indicated for the treatment of infections caused by microorganisms sensitive to azithromycin, including:
- Acute bacterial sinusitis – when adequately diagnosed.
- Acute bacterial otitis media – middle ear infections.
- Pharyngitis and tonsillitis – throat infections.
- Acute exacerbation of chronic bronchitis – bacterial flare‑ups in chronic lung disease.
- Community‑acquired pneumonia – mild to moderately severe cases.
- Skin and soft tissue infections – bacterial skin conditions.
- Uncomplicated genital infections – urethritis and cervicitis caused by Chlamydia trachomatis.
Precautions of Azithromycin Tablets USP 500 mg
Precautions while taking Azithromycin Tablets 500 mg
Serious allergic reactions
Rare but severe reactions such as angioedema and anaphylaxis (sometimes fatal) have been reported. Some may recur and require prolonged monitoring.
Hepatic impairment
Since the liver is the main route of elimination, caution is advised in patients with significant liver disease. Stop treatment if signs of liver dysfunction (jaundice, dark urine, bleeding tendency) appear.
Superinfection
As with other antibiotics, monitor for secondary infections with non‑susceptible organisms, including fungi.
Clostridium difficile‑associated Diarrhoea (CDAD)
Reported with nearly all antibacterial agents, including azithromycin. Severity ranges from mild diarrhoea to fatal colitis. CDAD can occur even two months after therapy, so persistent Diarrhoea should be carefully evaluated.
Renal impairment
In severe renal impairment (GFR <10 ml/min), systemic exposure increases by ~33%. Use with caution.
Dosages administration of Azithromycin Tablets USP 500 mg
Dosage & Administration of Azithromycin Tablets 500 mg
Adults
- Uncomplicated Chlamydia trachomatis urethritis/cervicitis: 1000 mg single oral dose.
- All other indications: 1500 mg total dose, given as:
- Option 1: 500 mg once daily for 3 consecutive days.
- Option 2: 500 mg on day 1, then 250 mg daily on days 2–5.
Older patients
- Same dosage as adults.
- Extra caution due to risk of cardiac arrhythmia and torsades de pointes in those with proarrhythmic conditions.
Pediatric patients
- Tablets should only be given to children weighing more than 45 kg, using the normal adult dose.
- For children under 45 kg, use oral suspension formulations.
Renal impairment
- No dose adjustment required for mild to moderate impairment (GFR 10–80 ml/min).
- Hepatic impairment
- No dose adjustment required for mild to moderate impairment.
Side effects of Azithromycin Tablets USP 500 mg
Side Effects of Azithromycin of Azithromycin Tablets 500 mg
Blood & lymphatic disorders
- Occasional mild neutropenia (transient, causal link not established)
- Rare: thrombocytopenia
- Ear & labyrinth disorders
Hearing impairment (often reversible)
- Vertigo
- Gastrointestinal disorders
- Nausea, vomiting, diarrhea, loose stools
- Abdominal pain/cramps, flatulence
- Dyspepsia, constipation, pseudomembranous colitis
- Rare: pancreatitis, tongue discoloration
Hepatobiliary disorders
- Abnormal liver function
- Hepatitis, cholestatic jaundice
- Rare: hepatic necrosis, liver failure (sometimes fatal)
- Skin & subcutaneous disorders
- Rash, pruritus, urticaria, angioedema
- Photosensitivity, edema
- Rare: erythema multiforme, Stevens‑Johnson syndrome, toxic epidermal necrolysis
General disorders
- Abdominal pain, headache, abnormal vision, hearing impairment (noted in long‑term DMAC treatment in HIV patients)
- Infections
- Moniliasis (oral thrush), vaginitis
- Immune system disorders
- Rare: anaphylaxis (sometimes fatal)
- Metabolism & nutrition disorders
- Anorexia
Psychiatric disorders
- Nervousness, agitation, anxiety, aggressive reactions
- Nervous system disorders
- Dizziness, headache, convulsions, hyperactivity
- Hypoesthesia, paresthesia, somnolence, syncope
- Rare: taste/smell disturbances
- Cardiac disorders
- Palpitations, arrhythmias (including ventricular tachycardia)
- Rare: QT prolongation, torsades de pointes
Vascular disorders
- Hypotension
- Musculoskeletal disorders
- Arthralgia
- Renal & urinary disorders
- Interstitial nephritis, acute renal failure
Storage instruction of Azithromycin Tablets USP 500 mg
Store below 30° C temperature.
Protect from light. Keep the medicine out of reach of children.
Packing details of Azithromycin Tablets USP 500 mg
Alu-Alu blister packs.
Azithromycin Tablets USP 500 mg are available in an Alu-Alu blister of 3 tablets. Such 10 blisters in a unit carton with a package insert.
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Trusted GMP Certified Azithromycin Tablets 500 mg Manufacturer
At Conical Pharmaceuticals, we are a trusted manufacturer of Azithromycin Tablets 500 mg from our GMP certified facility in Ahmedabad, India. Belonging to the macrolide antibiotic class, Azithromycin Tablets 500 mg is registered in Myanmar, Cambodia widely prescribed for bronchitis, community‑acquired pneumonia, sinusitis, pharyngitis/tonsillitis, otitis media, skin infections, and uncomplicated genital infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae.
We provide private label contract manufacturing and bulk supply solutions, serving hospitals, tenders, distributors, and innovators worldwide. Importers benefit from complete regulatory documentation including GMP Certificate, Free Sale Certificate, COPP, and tailored country‑specific dossiers to ensure smooth and compliant market entry.
We are actively planning to exports into Central America (Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama), Central Africa (Cameroon, Chad, DRC, Equatorial Guinea, Gabon, Republic of the Congo), and CIS countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan), while strengthening distribution in Ethiopia, Kenya, Uganda, Iraq, Ghana, Sri Lanka, Nigeria, UAE, Iran, Philippines, Saudi Arabia, Malaysia, United States, and Australia.
With strong R&D capabilities, we deliver consistent quality formulations. MOQ is offered as per buyer requirements, ensuring flexibility for tenders, bulk supply, and private label projects.
CUSTOM PACKAGING
Options available in size and style to meet your exact specifications and branding needs
SAMPLES AVAILABLE
Test before committing to bulk orders with complimentary samples for quality verification
LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
Shelf Life: 24 months , Storage Conditions: Below 30°C temperature and protect from direct sun light
Frequently Asked Questions
Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.
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Yes. At Conical Pharmaceuticals, we manufacture Azithromycin Tablets 500 mg at our GMP certified facility in Ahmedabad, India, supplying hospitals, tenders, and distributors worldwide.
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