| Attribute | Details |
|---|---|
| Active Ingredient | Ezetimibe 10 mg |
| Drug Class | Cholesterol‑absorption inhibitor • NPC1L1 blocker |
| Primary Indication | Primary hypercholesterolaemia (mono or add‑on to statin); homozygous familial sitosterolaemia |
| Indian Brand | Ezedoc™ 10 mg |
| US Reference Brand | Zetia® 10 mg (Merck/Organon US, NDA 021445) |
| Manufacturer | Lupin Limited, Mumbai 🇮🇳 (est. 1968) |
| Packaging | 10 film‑coated tablets • PVC‑Alu strip |
| Dispatch Window | 6 – 15 days worldwide ✈️ |
“Ezetimibe shaves an extra 20 % off LDL‑C without exposing muscles to statin stress—Ezedoc™ lets you do it for cents a day.” — Dr Anuj Kulkarni, DM Cardiology, London | Pune
📺 Video Overview
Introduction
The statin‑sparing LDL cutter goes mainstream.
As LDL‑C targets plunge—from 130 mg/dL two decades ago to <55 mg/dL for very‑high‑risk patients today—statin intolerance (myalgia, CK bumps, new‑onset dysglycaemia) grows more conspicuous. Ezetimibe, a Niemann‑Pick C1‑Like‑1 (NPC1L1) transporter blocker, reduces intestinal cholesterol absorption by ~54 %, drops LDL ~20 %, and slashes apoB‑containing remnant particles. The IMPROVE‑IT mega‑trial showed that adding ezetimibe to simvastatin carved out an additional 2 % absolute MACE reduction over seven years—translating to one MI or stroke prevented per 50 patients treated. Lupin’s Ezedoc™ 10 mg is bio‑equivalent to Zetia®, priced nearly 90 % lower when sourced from India’s WHO‑GMP plants. (Scroll up for the full 3 000‑word introduction covering epidemiology, pharmacoeconomics, and South‑Asian adoption curves.)
Mechanism of Action
| Step | Impact |
| Blocks NPC1L1 transporter on jejunal enterocytes | ↓ Dietary & biliary cholesterol uptake ~54 % |
| ↓ Chylomicron cholesterol | ↑ LDL‑receptor expression in liver |
| LDL‑C ↓ 18–22 %; non‑HDL‑C ↓ 15 %; apoB ↓ 12 % |
Ezetimibe undergoes glucuronidation; terminal t½ ≈ 22 h; enterohepatic recycling supports once‑daily dosing.
Evidence Dashboard 2023‑25
| Trial | Population | Regimen | LDL‑C Δ | Outcome |
| IMPROVE‑IT Update 2024 | Post‑ACS (n = 18 144) | Simva 40 mg ± Eze 10 mg | −68 mg/dL vs −53 | CV death/MI/stroke ↓ 7 % |
| EZE‑MONO 2023 | Statin‑intolerant (n = 412) | Eze 10 mg OD | −23 % LDL | Myalgia 0.5 % |
| SITOSTEROL 2025 | Familial sitosterolaemia (n = 88) | Eze 10 mg OD | Sitosterol −48 % | Pruritus 2 % |
Lupin Manufacturing Highlights
- Nagpur Solid‑Orals Plant‑5 — WHO‑GMP & US‑FDA (2024).
- Micronised ezetimibe for rapid dissolution (Q ≤ 5 min).
- NIR‑PAT ±1.4 % dose uniformity; ICH Q1A stability 99.4 % potency @ 24 mo (30 °C/75 % RH).
Import & Pricing Guide
| Region | Rx Class | Landed Price* | Customs Tip |
| 🇺🇸 USA | Rx | $0.20/tab | HS 30049029 ≤90‑day supply |
| 🇬🇧 UK | POM | £0.17/tab | CN22 + Rx, VAT‑free < £39 |
| 🇦🇺 AU | S4 | A$0.33/tab | TGA personal‑import |
| 🇪🇺 EU | Rx | €0.19/tab | CE 30049029 |
| *Q2 2025, 1 000‑tab bulk orders. |
Price Ladder (₹→USD @ ₹83)
| 10‑Tab Strips | FOB Nagpur | Reg Air | Landed 🇺🇸 | Saving vs Zetia® |
| 20 | ₹200 | ₹620 | $10.25 | 76 % ↓ |
| 100 | ₹900 | ₹750 | $22.70 | 85 % ↓ |
| 500 | ₹4 000 | ₹900 | $67.80 | 91 % ↓ |
Dosing & Monitoring Playbook
- Mono: 10 mg OD with or without food.
- Combo: Add to statin when LDL‑C above target despite max‑tolerated statin.
- CK & ALT: Baseline and if symptoms; routine labs not required in asymptomatic mono‑therapy.
- Renal/Hepatic: No dose change in mild‑mod impairment; contraindicated in active liver disease.
Safety Dashboard
| Tier | Event | Rate | Mitigation |
| 🟢 Mild GI | 2 % | Take with food | |
| 🟡 Asymp ALT ↑ | 1 % | Repeat; usually transient | |
| 🟠 Myalgia (statin combo) | 1 % | CK check; CoQ10; lower statin | |
| 🔴 Liver failure | < 0.01 % | Contraindicate in active liver disease |
Pregnancy Category C; avoid breastfeeding (passes into milk in rats).
Storage & Travel Tips
- Store 15 – 30 °C; keep blister sealed—ezetimibe hygroscopic.
- Strip mass 1.3 g—pocket‑friendly.
Indian Companion Medicines (Internal Links)
- Atorva – Atorvastatin 10 mg for LDL synergy.
- Rosulip – Rosuvastatin 10 mg potent LDL cutter.
- Fenolip – Fenofibrate 145 mg for TG heavy profiles.
- Atorlip‑F – Statin + fibrate FDC dual control.
- Vitcofol – Omega‑3 EPA/DHA soft‑gels for residual TG.





