LIPANTHYL 145/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet (and other non‑pharmacologic measures) for: primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia.

Off-Label Uses

None endorsed as standard of care; fenofibrate has been studied off-label for hyperuricemia (urate-lowering effect) and for microvascular outcomes in diabetes, but these are not routine guideline indications.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia or mixed dyslipidemia: 145 mg orally once daily; severe hypertriglyceridemia: 145 mg orally once daily (use lower starting doses only if required by renal function or specific product labeling).

Initial Dose

145 mg once daily.

Maintenance Dose

145 mg once daily.

Maximum Dose

145 mg once daily.

Children's Dosage

Safety and efficacy not established.

Dose Adjustment Notes

Assess renal function before initiation and periodically; reduce dose in mild-moderate renal impairment and avoid use in severe renal impairment; elderly dosing should be based on renal function; recheck lipids and response after ~4-8 weeks and adjust/continue accordingly.

How to Take

Swallow 1 tablet (145 mg) whole with water once daily; may be taken with or without food; take consistently at the same time each day.

Side Effects

Common Side Effects

Common: gastrointestinal upset (abdominal pain, nausea, diarrhea/constipation), headache, back pain, rhinitis/upper respiratory symptoms; lab abnormalities may include increased ALT/AST and increased creatine kinase (especially with myalgia).

Side Effect Frequency

Common: abnormal liver function tests/transaminase increases, GI effects (abdominal pain, nausea, diarrhea/constipation), headache, back pain, rhinitis/respiratory symptoms, increased CPK, and increased serum creatinine; Uncommon/Rare: myopathy/rhabdomyolysis (risk higher with statins/renal impairment), pancreatitis, cholelithiasis, hepatitis, severe skin reactions, and venous thromboembolism.

Safety & Warnings

Contraindications

Hypersensitivity to fenofibrate (or excipients); severe renal impairment (eGFR <30 mL/min/1.73 m²); active liver disease or unexplained persistent LFT abnormalities/severe hepatic impairment; gallbladder disease; breastfeeding (nursing mothers).

Warnings & Precautions

Baseline and periodic LFT monitoring; stop if persistent significant LFT elevation (commonly >3× ULN). Monitor for muscle symptoms/CK (higher risk with statins, renal impairment, hypothyroidism, elderly); monitor renal function (especially in renal impairment/elderly and with cyclosporine). Watch for gallstones (stop if gallbladder disease develops) and pancreatitis. Be aware of possible decreases in hemoglobin/hematocrit/WBC early in therapy.

Age Restriction

Not recommended/insufficient data in patients <18 years (pediatric use not established).

Drug Interactions

Drug Interactions

Statins (↑ myopathy/rhabdomyolysis risk); oral anticoagulants such as warfarin/coumarins (↑ anticoagulant effect-monitor INR and adjust dose); cyclosporine (↑ nephrotoxicity/renal dysfunction-monitor renal function); bile acid sequestrants (↓ absorption-separate dosing); colchicine (↑ myopathy risk).

Interaction Severity

SERIOUS/MAJOR: statins (↑ myopathy/rhabdomyolysis risk), cyclosporine (↑ nephrotoxicity/renal dysfunction risk). MODERATE: warfarin/other coumarin anticoagulants (↑ anticoagulant effect-monitor INR), colchicine (↑ myopathy risk), bile acid sequestrants (↓ absorption-separate dosing).

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Contraindicated

Children

Safety and efficacy not established.

Elderly

Start at lower dose (48 mg once daily) and titrate based on renal function; monitor renal function and liver enzymes regularly

Kidney Impairment

eGFR 30-59 mL/min/1.73 m²: use a reduced dose (e.g., 48-54 mg once daily depending on formulation); eGFR <30 mL/min/1.73 m²: contraindicated/avoid.

Liver Impairment

Contraindicated in active liver disease/severe hepatic impairment; for mild-moderate hepatic impairment, use is generally not recommended or only with caution and close LFT monitoring (no established dose adjustment).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take two doses at the same time.

Stopping the Medicine

Do not stop without prescriber input; discontinue if inadequate lipid response after ~2 months at the maximal tolerated dose, or immediately if myopathy/rhabdomyolysis is suspected (marked CK elevation) or significant LFT elevation occurs.

Overdose

No specific antidote; provide supportive/symptomatic care, consider GI decontamination if early, and note fenofibric acid is not removed by hemodialysis-seek urgent medical attention.

Patient Counseling

Take 1 tablet once daily consistently (with or without food) and continue diet/exercise; report muscle pain/weakness or dark urine promptly; avoid excessive alcohol; keep scheduled labs (lipids, liver and kidney tests); if on warfarin, INR may need closer monitoring; if using bile-acid resins, separate dosing (fenofibrate ≥1 hour before or 4-6 hours after).

Monitoring Requirements

Baseline and periodic: lipid panel (reassess at ~4-8 weeks), liver enzymes (ALT/AST), renal function (SCr/eGFR); CK/CPK if muscle symptoms occur (or high-risk combination therapy); INR closely when starting/changing fenofibrate in patients on warfarin; consider periodic CBC per labeling.

Pharmacology

Mechanism of Action

PPAR-α agonist that increases lipoprotein lipase activity and fatty-acid oxidation, reduces apoC-III, enhances clearance of triglyceride-rich lipoproteins, lowers triglycerides, and can raise HDL.

Half-Life

Approximately 20 hours (for the active metabolite, fenofibric acid).

Metabolism

Fenofibrate is a prodrug rapidly hydrolyzed by esterases to fenofibric acid, then mainly undergoes glucuronidation; it is not significantly metabolized via CYP450.

Protein Binding

>99% (for fenofibric acid, primarily to albumin).

Product Information

Available Dosage Forms

For this SFDA-registered product: film-coated tablet.

Composition per Dose

Each film-coated tablet: 145 mg fenofibrate (nanoparticle formulation)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Triglycerides, LDL-C, Total-C, Apo B; increases HDL-C

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