LIPIZET 10MG 28 TAB

Indications

Approved Uses

Adjunct to diet for: (1) Primary hypercholesterolemia (as monotherapy or added to a statin), (2) Homozygous familial hypercholesterolemia (with a statin), and (3) Homozygous sitosterolemia (phytosterolemia).

Off-Label Uses

No well-established routine off-label use; ezetimibe has been studied in NAFLD/NASH and other conditions, but it is not guideline-endorsed as standard therapy for these indications.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia: 10mg once daily. Homozygous familial hypercholesterolemia: 10mg once daily (in combination with statin). Homozygous sitosterolemia: 10mg once daily

Initial Dose

10mg orally once daily.

Maintenance Dose

10mg orally once daily.

Maximum Dose

10mg orally once daily

Children's Dosage

Homozygous/Heterozygous Familial Hypercholesterolemia (≥10 years): 10mg orally once daily. Homozygous Sitosterolemia (≥9 years): 10mg orally once daily.

Dose Adjustment Notes

No dose adjustment is required in renal impairment or mild hepatic impairment; avoid/not recommended in moderate-to-severe hepatic impairment. No titration is needed-dose is fixed at 10 mg once daily.

How to Take

Swallow 1 tablet (ezetimibe 10 mg) once daily with water; may be taken at any time of day with or without food. If co-administered with a bile acid sequestrant (e.g., cholestyramine/colestipol/colesevelam), take ezetimibe at least 2 hours before or at least 4 hours after the sequestrant.

Side Effects

Common Side Effects

Common adverse effects include diarrhea, abdominal pain, fatigue, headache, and upper respiratory tract symptoms (e.g., URTI/nasopharyngitis/sinusitis); arthralgia and myalgia can occur, especially with concomitant statin use.

Side Effect Frequency

Common (1-10%): diarrhea, arthralgia, upper respiratory tract infection (and related URTI symptoms such as sinusitis); Uncommon (0.1-1%): increased ALT/AST, myalgia; Rare (<0.1%): hypersensitivity reactions (e.g., angioedema/rash/urticaria), myopathy/rhabdomyolysis (more often with statins).

Safety & Warnings

Contraindications

Hypersensitivity to ezetimibe or any excipient; when used in combination with a statin: active liver disease, unexplained persistent elevations in serum transaminases, pregnancy, breastfeeding

Warnings & Precautions

Not a substitute for diet/lifestyle; when used with a statin monitor LFTs and stop if clinically significant liver injury; counsel/monitor for myopathy/rhabdomyolysis (CK if symptomatic) especially with statins or interacting drugs; not recommended in moderate-severe hepatic impairment; avoid bile-acid sequestrant timing issue; fibrate coadministration increases gallstone risk-avoid gemfibrozil/most fibrates and use fenofibrate only if necessary with monitoring.

Age Restriction

Approved for primary hypercholesterolemia in children ≥10 years; for homozygous sitosterolemia in children ≥9 years. Not recommended below these ages.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: cyclosporine (↑ ezetimibe exposure and may ↑ cyclosporine-monitor levels), bile-acid sequestrants e.g., cholestyramine/colesevelam (↓ ezetimibe absorption-give ezetimibe ≥2 h before or ≥4 h after), fibrates (cholelithiasis risk; avoid gemfibrozil/other fibrates-if needed, fenofibrate is preferred with monitoring), warfarin/other coumarins (monitor INR when starting/stopping), statins (additive LDL lowering; monitor for myopathy and LFT elevations).

Interaction Severity

MAJOR: Cyclosporine (increases ezetimibe exposure; monitor levels/clinical response and consider dose adjustments per prescriber). MODERATE: Fibrates (especially gemfibrozil; increased risk of cholelithiasis and possible myopathy-use caution/monitor; fenofibrate may be used with monitoring where appropriate). MODERATE: Warfarin/other coumarins (possible INR changes-monitor INR). MINOR: Bile acid sequestrants (decrease ezetimibe absorption-separate dosing by ≥2 hours before or ≥4 hours after).

Food Interaction

No clinically meaningful food restriction-may be taken with or without food.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Homozygous/Heterozygous Familial Hypercholesterolemia (≥10 years): 10mg orally once daily. Homozygous Sitosterolemia (≥9 years): 10mg orally once daily.

Elderly

Standard adult dosing - no dose adjustment required based on age alone

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild hepatic impairment (Child-Pugh A, 5-6): no dose adjustment; moderate to severe impairment (Child-Pugh B/C, 7-15): not recommended.

Storage & Patient Advice

Storage Conditions

Store below 30°C (per SFDA verified API data).

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Safe to stop anytime; however, lipid levels will return toward baseline - consult prescriber before stopping

Overdose

Overdose is generally well tolerated; no specific toxidrome-manage with symptomatic/supportive care (consider decontamination if very recent ingestion) and seek medical attention/poison center guidance.

Patient Counseling

Take 1 tablet once daily at the same time each day, with or without food, and continue a heart-healthy diet/exercise plan. If taking a bile acid sequestrant, separate doses (ezetimibe ≥2 hours before or ≥4 hours after). Report unexplained muscle pain/weakness (especially if also on a statin) and symptoms of liver injury (e.g., jaundice, dark urine). Keep follow-up appointments for cholesterol tests and any liver tests if combined with a statin.

Monitoring Requirements

Monitor lipid panel at baseline and reassess response about 4-12 weeks after initiation or dose changes, then periodically. Check liver transaminases at baseline and as clinically indicated when used with a statin (or if symptoms of hepatotoxicity occur).

Pharmacology

Mechanism of Action

Selectively inhibits the NPC1L1 transporter at the intestinal brush border, reducing absorption of dietary and biliary cholesterol and lowering hepatic cholesterol delivery, which increases LDL receptor-mediated clearance and reduces LDL-C.

Onset of Action

Pharmacodynamic onset: measurable LDL-C reduction typically within ~1-2 weeks, with near-maximal effect by ~2-4 weeks of daily therapy.

Duration of Effect

LDL-C-lowering effect persists with continued once-daily dosing; near-maximal effect is maintained over the 24-hour dosing interval (supports once-daily dosing).

Half-Life

Approximately 22 hours (effective half-life for total ezetimibe [ezetimibe + ezetimibe‑glucuronide]).

Bioavailability

Absolute oral bioavailability is not established; ezetimibe is absorbed and extensively metabolized via first-pass glucuronidation to an active metabolite (ezetimibe-glucuronide).

Metabolism

Primarily intestinal and hepatic glucuronidation to active ezetimibe‑glucuronide; minimal/no clinically significant CYP450 metabolism.

Excretion

Excreted predominantly in feces (~78%) and to a lesser extent in urine (~11%).

Protein Binding

>90%.

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 10mg ezetimibe

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

LDL

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