Category: Macrolide Antibiotic • Catalog ID: AZITHRAL-500 • Reviewed by MediMatch Clinical Pharmacology Review Board

Azithral 500 Tablet — Azithromycin Dihydrate 500mg

Evidence-based clinical monograph for Azithral 500 Tablet, formulated with active pharmaceutical ingredient Azithromycin Dihydrate 500mg and manufactured by Alembic Pharmaceuticals. Includes FDA/EMA/WHO international nomenclature cross-walk, 6-point patient safety matrix, and multi-currency generic reference pricing.

1. Quick Facts & Global Nomenclature Cross-Walk (WHO INN / US FDA USAN / UK BNF)

Brand Name	Azithral 500 (Tablet)
Active Salt (WHO INN)	Azithromycin Dihydrate 500mg
U.S. FDA USAN / Orange Book	Azithromycin Dihydrate 500mg
UK BNF / EMA BAN	Azithromycin Dihydrate 500mg
Global Commercial Brand Equivalents by Region	🇺🇸 USA/Canada: Azithral 500 US Equivalent (FDA Orange Book) (Azithral 500 Health Canada DPD Equivalent) • 🇬🇧 UK/Europe: Azithral 500 UK/EU Equivalent (BNF / EMA) • 🇦🇺 Australia: Azithral 500 Australia TGA / PBS Equivalent • 🇦🇪 UAE/GCC: Azithral 500 UAE MOHAP / DHA Equivalent • 🇮🇳 India: Azithral 500 / PMBJP Jan Aushadhi
Same-Salt Commercial Brand Substitutes	Azithral 500Azee 500Zady 500Azibact 500Azithro 500
Dosage Form & Route	Tablet (Oral Systemic Administration)
Manufacturer	Alembic Pharmaceuticals
Branded MRP vs Jan Aushadhi Generic	MRP ₹132.00 vs Jan Aushadhi ₹24.00 • Save ₹108.00 (82% Off)

2. 6-Point Clinical Safety Profile (Pregnancy, Lactation, Alcohol, Driving, Renal & Hepatic)

Clinical pharmacology safety verification for Azithral 500 Tablet (Azithromycin Dihydrate 500mg) across special patient populations:

Safety Parameter	Clinical Status Badge	Pharmacological Guidance & Precaution
Pregnancy (FDA PLLR / TGA)	CAUTION — CONSULT DOCTOR	Use during pregnancy only if clearly needed and prescribed by an obstetrician after risk-benefit evaluation (FDA PLLR / TGA clinical guidance).
Breastfeeding (Lactation)	CAUTION — CONSULT DOCTOR	Excreted in trace amounts or clinical data limited; verify infant safety with your physician before breastfeeding.
Alcohol Interaction	AVOID	Avoid alcohol consumption during therapy to prevent additive hepatotoxicity, gastric irritation, or central nervous system sedation.
Driving & Alertness	SAFE	Generally does not impair psychomotor alertness at standard doses; avoid driving if dizziness or fatigue occurs.
Kidney (Renal Dosing)	CAUTION — CONSULT DOCTOR	Dose interval adjustment may be required in moderate-to-severe renal impairment (eGFR < 30 mL/min/1.73m²).
Liver (Hepatic Dosing)	CAUTION — CONSULT DOCTOR	Monitor liver enzymes and adjust dosage in patients with chronic hepatic insufficiency.

3. Clinical Indications, Mechanism of Action & Pharmacokinetics

Azithral 500 (Tablet) containing Azithromycin Dihydrate 500mg is clinically indicated for the management and treatment of:

Typhoid & Bacterial Fever: Targeted therapeutic efficacy via Macrolide Antibiotic pathway modulation.
Throat & Tonsil infections: Targeted therapeutic efficacy via Macrolide Antibiotic pathway modulation.
Community Acquired Pneumonia: Targeted therapeutic efficacy via Macrolide Antibiotic pathway modulation.
Chlamydia & STIs: Targeted therapeutic efficacy via Macrolide Antibiotic pathway modulation.

Mechanism of Action & Pharmacokinetics: Following administration as a tablet, Azithromycin Dihydrate 500mg undergoes calibrated systemic absorption and hepatic/renal clearance in accordance with WHO-GMP, USP, and Indian Pharmacopoeia (IP) dissolution and bioequivalence standards.

4. Standard Dosage Table, Administration & Storage Guidelines

Dosage & Administration Reference Table: Always follow your physician's prescription for Azithral 500 Tablet (ISMP safety normalized):

Prescription Sig Code	Administration Schedule	Meal & Timing Guidance	Clinical Patient Group
OD (Once Daily)	1 unit (Tablet) every 24 hours	1 hour before or 2 hours after meals	Adults
BD / BID (Twice Daily)	1 unit (Tablet) every 12 hours (Morning & Night)	1 hour before or 2 hours after meals	Adults
TDS / TID (Thrice Daily)	1 unit (Tablet) every 8 hours (if prescribed)	Maintain minimum 6–8 hour spacing	As directed by registered physician

Storage & Stability: Store Azithral 500 (Tablet) in a cool, dry place below 30°C (86°F) away from direct sunlight, heat, and moisture. Keep blister strips sealed until administration and out of reach of children.

5. Side Effects, Contraindications & Drug-Drug Interactions

Potential adverse reactions reported with Azithral 500 Tablet (Azithromycin Dihydrate 500mg):

Nausea
Abdominal cramps
Diarrhea
Temporary taste changes

Contraindications & Clinical Safety Precautions:

Usually taken once daily for 3 to 5 days
Take 1 hour before or 2 hours after meals
Contraindicated in patients with known hypersensitivity to Azithromycin Dihydrate 500mg or any excipient of Azithral 500 Tablet.
Verify active salt (Azithromycin Dihydrate 500mg) before co-administering other OTC or prescription medicines to avoid accidental therapeutic duplication.

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6. PMBJP Jan Aushadhi Generic Comparison Table & Multi-Currency Reference Price

Bioequivalent generic Azithromycin Dihydrate 500mg (Tablet) is available across global public formularies and at NABL-certified PMBJP Jan Aushadhi Kendras in India for ₹24.00 — saving ₹108.00 (82%) compared to Azithral 500 by Alembic Pharmaceuticals at ₹132.00.

Region & Formulary Tariff	Currency	Branded Originator Reference	Verified Bioequivalent Generic Price
🇮🇳 India Jan Aushadhi (₹ INR) — PMBJP / NPPA	`₹ INR`	₹132.00 (Azithral 500)	₹24.00 (82% Savings)
🇺🇸 US FDA Generic ($ USD) — CMS NADAC / Orange Book	`$ USD`	$46.20	$4.32 (AB-Rated Generic)
🇬🇧 UK NHS Tariff (£ GBP) — Drug Tariff / BNF	`£ GBP`	£34.32	£3.36 (NHS Category M/A)
🇪🇺 EU EMA Generic (€ EUR) — EMA Reference Tariff	`€ EUR`	€38.28	€3.84 (EMA Bioequivalent)
🇦🇺 Australia PBS (A$ AUD) — TGA Dispensed Tariff	`A$ AUD`	A$59.40	A$6.00 (PBS Listed Generic)

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Global Multilingual Patient Guide — Español • Français • العربية • हिन्दी

🌐 English (EN) — Clinical Patient Summary

Azithral 500 (Tablet) contains active ingredient Azithromycin Dihydrate 500mg. Indicated for: Typhoid & Bacterial Fever, Throat & Tonsil infections. Pregnancy status: CAUTION — CONSULT DOCTOR. Avoid alcohol and verify bioequivalent generics with your pharmacist.

🇪🇸 Español (ES): ¿Para qué sirve Azithral 500 (Azithromycin Dihydrate 500mg), dosis y efectos secundarios?

Azithral 500 (Tablet) contiene Azithromycin Dihydrate 500mg. Indicado para: Typhoid & Bacterial Fever, Throat & Tonsil infections. Embarazo: CAUTION — CONSULT DOCTOR. Evite el alcohol y consulte a su médico o farmacéutico para equivalentes genéricos bioequivalentes.

🇫🇷 Français (FR): Indications, posologie et effets secondaires de Azithral 500 (Azithromycin Dihydrate 500mg)

Azithral 500 (Tablet) contient le principe actif Azithromycin Dihydrate 500mg. Utilisé pour : Typhoid & Bacterial Fever, Throat & Tonsil infections. Grossesse : CAUTION — CONSULT DOCTOR. Demandez le générique bioéquivalent (DCI) en pharmacie.

🇦🇪 العربية (AR): دواعي استعمال Azithral 500 والجرعة والآثار الجانبية

يحتوي دواء Azithral 500 (Tablet) على المادة الفعالة Azithromycin Dihydrate 500mg. يستخدم لعلاج الحالات السريرية الموصوفة. يرجى استشارة الطبيب أو الصيدلي للتحقق من الجرعة والبدائل الجنيسة المعتمدة.

🇮🇳 हिन्दी / Hinglish (HI): Azithral 500 के उपयोग, खुराक और साइड इफेक्ट्स (Azithral 500 Uses in Hindi)

Azithral 500 (Tablet) में मुख्य साल्ट Azithromycin Dihydrate 500mg है। प्रधानमंत्री भारतीय जनऔषधि केंद्र (PMBJP) पर इसका समान असर वाला जेनेरिक विकल्प मात्र ₹24.00 (82% बचत) में उपलब्ध है।

8. Frequently Asked Questions (Azithral 500 Tablet)

Q: What is Azithral 500 Tablet (Azithromycin Dihydrate 500mg) used for?

Azithral 500 Tablet contains Azithromycin Dihydrate 500mg and is manufactured by Alembic Pharmaceuticals. It is primarily indicated for Typhoid & Bacterial Fever, Throat & Tonsil infections, Community Acquired Pneumonia, Chlamydia & STIs under the Macrolide Antibiotic therapeutic class.

Q: Is a generic equivalent or Jan Aushadhi substitute available for Azithral 500 Tablet?

Yes, bioequivalent generic Azithromycin Dihydrate 500mg (Tablet) is available globally ($4.32 USD NADAC / £3.36 UK NHS Tariff) and at PMBJP Jan Aushadhi Kendras in India for ₹24.00 per strip, saving 82% compared to branded MRP ₹132.00.

Q: What is the dosage instruction for Azithral 500 Tablet?

Common dosage frequencies for Azithral 500 (Tablet) are OD (once daily), BD/BID (twice daily), or TDS/TID (thrice daily) as prescribed by your physician. 1 hour before or 2 hours after meals

Q: Is Azithral 500 Tablet safe during pregnancy, breastfeeding, or with alcohol?

Pregnancy guidance: CAUTION — CONSULT DOCTOR (Use during pregnancy only if clearly needed and prescribed by an obstetrician after risk-benefit evaluation (FDA PLLR / TGA clinical guidance).) Alcohol guidance: AVOID (Avoid alcohol consumption during therapy to prevent additive hepatotoxicity, gastric irritation, or central nervous system sedation.)