ATOZET 10/20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for treatment of primary (heterozygous familial and non‑familial) hypercholesterolemia and mixed dyslipidemia to reduce elevated total‑C, LDL‑C, ApoB, non‑HDL‑C and TG and to increase HDL‑C; adjunct to other lipid‑lowering treatments (e.g., LDL apheresis) for homozygous familial hypercholesterolemia (HoFH).

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: 1 tablet once daily (this product provides ezetimibe 10 mg/atorvastatin 20 mg) with titration by switching to a different strength if additional LDL‑C lowering is needed; HoFH: use as adjunct to other lipid‑lowering therapies, selecting an atorvastatin intensity sufficient for LDL‑C goals (often higher atorvastatin doses than 20 mg, requiring a different strength/product).

Initial Dose

Atorvastatin 10mg/Ezetimibe 10mg or Atorvastatin 20mg/Ezetimibe 10mg once daily

Maintenance Dose

Atorvastatin 10-80mg/Ezetimibe 10mg once daily, adjusted to lipid targets

Dose Adjustment Notes

Renal impairment: no adjustment generally required; hepatic impairment/active liver disease: contraindicated in active liver disease and avoid in severe hepatic impairment; drug interactions: limit atorvastatin exposure with strong CYP3A4 inhibitors (use lowest effective dose/consider alternative statin or temporary interruption) and avoid/limit with cyclosporine per labeling; titrate based on LDL‑C response at ≥4‑week intervals.

Side Effects

Common Side Effects

Common: nasopharyngitis/upper respiratory tract infection, headache, diarrhea, myalgia, arthralgia, fatigue; may also see increases in hepatic transaminases.

Side Effect Frequency

Very common (≥10%): None established for the fixed-dose combination. Common (1-10%): Nasopharyngitis, upper respiratory tract infection, diarrhea, myalgia, arthralgia, pain in extremity, increased ALT/AST. Uncommon (0.1-1%): Influenza, dizziness, headache, constipation, flatulence, nausea, muscle spasms, back pain, fatigue. Rare/very rare (<0.1%): Myopathy/rhabdomyolysis, hepatitis, pancreatitis, peripheral neuropathy, alopecia; frequency not known: new-onset diabetes mellitus (class effect).

Safety & Warnings

Contraindications

Hypersensitivity to atorvastatin, ezetimibe, or any excipients; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy; breastfeeding.

Warnings & Precautions

Myopathy/rhabdomyolysis: counsel to report unexplained muscle pain/weakness and check CK when indicated, especially with interacting drugs or risk factors (e.g., renal impairment, hypothyroidism); hepatic effects: obtain baseline LFTs and repeat if symptoms/signs of liver injury occur; glycemic effects: small increases in glucose/HbA1c may occur-monitor in patients at risk for diabetes; review for significant drug interactions (CYP3A4 inhibitors, cyclosporine, fibrates/niacin, grapefruit).

Age Restriction

Not approved for patients under 18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major interactions include: strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole/azole antifungals, HIV protease inhibitors/cobicistat) and cyclosporine (↑ atorvastatin exposure → ↑ myopathy/rhabdomyolysis risk); fibrates (especially gemfibrozil) and niacin (↑ myopathy risk); colchicine (↑ myopathy risk); large quantities of grapefruit juice (↑ atorvastatin levels); warfarin (monitor INR when starting/stopping); digoxin (may ↑ digoxin levels).

Food Interaction

May be taken with or without food; avoid large quantities of grapefruit juice (clinically prudent to limit to ≤1 quart/≈1 liter daily).

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Elderly

Standard adult dosing; use with caution due to increased risk of myopathy in elderly patients, particularly those with renal impairment or low body weight

Storage & Patient Advice

Storage Conditions

Store below 30°C in the original package.

Stopping the Medicine

Can be stopped without tapering, but only after clinician review because LDL-C will rise toward baseline and cardiovascular risk reduction benefit is lost; stop immediately and seek medical advice if severe muscle symptoms or hepatotoxicity symptoms occur.

Pharmacology

Mechanism of Action

Atorvastatin inhibits HMG‑CoA reductase to reduce hepatic cholesterol synthesis and upregulate LDL receptors; ezetimibe inhibits NPC1L1 at the intestinal brush border to reduce absorption of dietary and biliary cholesterol.

Onset of Action

LDL‑C lowering begins within ~2 weeks; near‑maximal effect by ~4 weeks.

Duration of Effect

Lipid-lowering effect is maintained with once-daily dosing during continuous therapy; LDL-C returns toward baseline over several weeks after discontinuation.

Half-Life

Atorvastatin: ~14 hours (inhibitory activity 20-30 hours due to active metabolites). Ezetimibe: ~22 hours.

Bioavailability

Atorvastatin absolute bioavailability ~12-14%; ezetimibe systemic availability is reflected by total ezetimibe (parent + glucuronide) with substantial absorption (commonly cited ~35-65% for total ezetimibe exposure).

Metabolism

Atorvastatin: hepatic metabolism mainly via CYP3A4 to active metabolites; ezetimibe: intestinal/hepatic glucuronidation to active ezetimibe‑glucuronide with enterohepatic recirculation.

Excretion

Atorvastatin: primarily biliary/fecal elimination with minimal renal excretion (<2%); ezetimibe: predominantly fecal (~78%) with some renal excretion (~11%).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet contains: 20mg atorvastatin (as atorvastatin calcium trihydrate) and 10mg ezetimibe.

OTC Alternatives

No OTC alternative.

Lipid Target

Both

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