Ezedoc™ 10 mg

Ezetimibe

Price range: $15.00 through $35.00

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Ezedoc™ 10 mg
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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.

Authoritative External Links

Additional Information

Active

Ezetimibe

Tablets

30, 60, 90

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