LIPOFIRATE 145/MG TAB 30/TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia or mixed dyslipidemia: 145 mg orally once daily; severe hypertriglyceridemia: 48-145 mg once daily depending on formulation and patient factors (including renal function), with this product providing the 145 mg option.

Initial Dose

145mg once daily

Maintenance Dose

145mg once daily

Maximum Dose

145mg once daily (for Tricor brand and equivalents).

Children's Dosage

Safety and effectiveness not established in pediatric patients.

Dose Adjustment Notes

Assess response after initiation and adjust based on lipids at 4-8 week intervals; reduce dose/avoid use in renal impairment (avoid in severe renal dysfunction; use lower starting dose and monitor renal function in mild-moderate impairment).

How to Take

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

Side Effects

Common Side Effects

Abnormal liver function tests (ALT/AST elevation), abdominal pain, nausea, diarrhea or constipation, headache, back pain, myalgia, and upper respiratory/nasal symptoms (rhinitis).

Side Effect Frequency

Common (1-10%): abnormal liver function tests/transaminase increases, GI effects (abdominal pain, nausea, constipation/diarrhea), headache, back pain, rhinitis; Uncommon (0.1-1%): myalgia and skin hypersensitivity; Rare/very rare: rhabdomyolysis (especially with statins/renal impairment), pancreatitis, cholelithiasis, thromboembolism, photosensitivity.

Safety & Warnings

Contraindications

Hypersensitivity to fenofibrate/fenofibric acid or excipients; severe renal impairment (eGFR <30 mL/min/1.73 m²) including dialysis; active liver disease or unexplained persistent LFT abnormalities; gallbladder disease; breastfeeding

Warnings & Precautions

Monitor LFTs at baseline and periodically; discontinue if ALT/AST persist >3× ULN. Monitor for myopathy/rhabdomyolysis (higher risk with statins, elderly, diabetes, hypothyroidism, renal impairment). Assess/monitor renal function (can cause reversible creatinine increases; avoid if eGFR <30). Risk of gallstones-evaluate if biliary symptoms. Pancreatitis reported. Consider VTE risk (DVT/PE) and monitor clinically.

Age Restriction

Not established/Not recommended for pediatric use (<18 years) unless specialist-directed

Drug Interactions

Drug Interactions

Statins (↑ myopathy/rhabdomyolysis risk); warfarin/other VKAs (↑ anticoagulant effect-monitor INR); cyclosporine/tacrolimus (↑ nephrotoxicity/renal dysfunction-monitor renal function); bile acid sequestrants (↓ absorption-separate dosing); colchicine (↑ myopathy risk); other fibrates (avoid-↑ myopathy); ezetimibe (possible ↑ cholelithiasis/myopathy risk-use caution)

Interaction Severity

MAJOR: Statins/other myotoxic agents (increased myopathy/rhabdomyolysis risk). MODERATE: Warfarin/other vitamin K antagonists (↑ anticoagulant effect-monitor INR), cyclosporine (renal dysfunction risk-monitor renal function), colchicine (myopathy risk), bile acid sequestrants (reduced absorption-separate dosing).

Food Interaction

May be taken with or without food for many 145 mg tablet formulations; if the local product leaflet specifies otherwise, follow that labeling.

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Contraindicated

Children

Safety and effectiveness not established in pediatric patients.

Elderly

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenofibrate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose.

Liver Impairment

Contraindicated in active liver disease or unexplained persistent LFT abnormalities; no established dose adjustment for mild-moderate hepatic impairment-use with caution and monitor LFTs

Storage & Patient Advice

Stopping the Medicine

No taper is required; discontinue if inadequate lipid response after ~2 months at an adequate dose, if ALT/AST persist >3× ULN, if severe muscle toxicity occurs, or if gallbladder disease/gallstones are identified

Patient Counseling

Take once daily as prescribed; follow diet/exercise; report unexplained muscle pain/weakness (higher risk with statins/renal impairment); avoid excessive alcohol; attend periodic labs (lipids, liver enzymes, renal function); inform providers about anticoagulants (e.g., warfarin) and other lipid agents; avoid in pregnancy and breastfeeding unless specifically directed.

Monitoring Requirements

Lipid panel at baseline and again in ~4-8 weeks (then periodically); liver enzymes (ALT/AST) at baseline and periodically; renal function (SCr/eGFR) at baseline and periodically (especially in elderly/at-risk); CK if muscle symptoms occur; INR/prothrombin time if used with warfarin; consider CBC periodically during the first year.

Product Information

Available Dosage Forms

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

Composition per Dose

Each film-coated tablet: 145mg fenofibrate

OTC Alternatives

No OTC alternative

Lipid Target

Triglycerides

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