LIPANTHYL 200/MG CAP 30/CAP

Indications

Approved Uses

Adjunct to diet (and other non‑pharmacologic measures) for primary hypercholesterolaemia, mixed dyslipidaemia, and severe hypertriglyceridaemia.

Dosage & Administration

Dosing by Condition

Using this product strength: 200 mg orally once daily with food for approved dyslipidaemia indications when this strength is selected; titrate/choose alternative strengths or products if lower starting doses are required (e.g., renal impairment).

Initial Dose

200 mg once daily with food.

Maintenance Dose

200mg once daily

Maximum Dose

200 mg once daily.

Children's Dosage

Safety and effectiveness have not been established in pediatric patients.

Dose Adjustment Notes

Assess lipid response after ~4-8 weeks and adjust if needed; avoid/use lower doses in renal impairment (contraindicated in severe renal impairment), and discontinue if inadequate response after ~2-3 months at an appropriate dose.

How to Take

Swallow 1 capsule whole with water, taken with/after a meal (preferably the same time each day); do not crush or chew.

Side Effects

Common Side Effects

Gastrointestinal upset (abdominal pain, nausea, diarrhoea), headache, elevated liver enzymes, increased serum creatinine, rash, and myalgia (especially with interacting drugs).

Side Effect Frequency

Common (1-10%): abnormal liver function tests (ALT/AST), GI upset (abdominal pain, nausea, diarrhea/flatulence/constipation), headache, myalgia/back pain, rash, and increased serum creatinine. Uncommon (0.1-1%): pancreatitis, cholelithiasis, thromboembolic events, and more significant skin reactions; rare/very rare: rhabdomyolysis/serious myopathy and severe cutaneous reactions (e.g., SJS/TEN).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Baseline and periodic LFT monitoring; discontinue if ALT/AST persist >3× ULN. Monitor renal function at baseline and periodically (especially elderly/diabetes/renal impairment) and note possible reversible creatinine rise. Counsel/monitor for myopathy (higher risk with statins, renal impairment, hypothyroidism); check CK if muscle symptoms. Increased risk of gallstones-evaluate if biliary symptoms. Potentiates oral anticoagulants-monitor INR closely when starting/stopping. Stop if pancreatitis suspected.

Age Restriction

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

Drug Interactions

Drug Interactions

Statins (↑ myopathy/rhabdomyolysis risk); oral anticoagulants e.g., warfarin (↑ anticoagulant effect-monitor INR/bleeding); cyclosporine/tacrolimus (↑ renal dysfunction risk-monitor renal function); bile acid sequestrants (↓ absorption-separate dosing by 1 hour before or 4-6 hours after); colchicine (↑ myopathy risk).

Interaction Severity

MAJOR: Statins (↑ myopathy/rhabdomyolysis risk, especially with renal impairment), Cyclosporine (↑ risk of renal dysfunction). MODERATE: Warfarin/other VKAs (↑ anticoagulant effect-monitor INR closely), Colchicine (↑ myopathy risk), Bile acid sequestrants (↓ absorption-separate dosing).

Food Interaction

Take with food; food increases absorption/bioavailability of micronised fenofibrate formulations.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Safety and effectiveness have not been established in pediatric patients.

Elderly

Start at lower dose (100mg once daily) and titrate based on renal function and tolerability; monitor renal function and liver function regularly

Kidney Impairment

eGFR/CrCl 30-59 mL/min/1.73 m²: use a reduced dose (for micronised products typically not exceeding ~67 mg/day or equivalent per product labeling); eGFR/CrCl <30 mL/min/1.73 m² (or dialysis): contraindicated.

Liver Impairment

Contraindicated in active liver disease (including primary biliary cirrhosis) or unexplained persistent LFT abnormalities; otherwise use with caution and monitor LFTs, discontinuing if ALT/AST persist >3× ULN.

Storage & Patient Advice

Stopping the Medicine

No taper is required; discontinue if inadequate lipid response after ~2 months at the maximum tolerated/recommended dose or if significant adverse effects occur.

Overdose

No specific antidote; provide supportive/symptomatic care (consider decontamination if early); hemodialysis is not effective because fenofibric acid is highly protein-bound.

Patient Counseling

Take 1 capsule by mouth once daily with food (preferably the main meal) at the same time each day; swallow whole (do not crush/chew). Continue diet/exercise and limit alcohol. Seek urgent care for unexplained muscle pain/weakness (especially with fever or dark urine) or signs of liver injury (jaundice, dark urine, persistent abdominal pain). Tell your clinician if you take statins or warfarin/other anticoagulants (INR may need closer monitoring). Attend periodic blood tests (liver enzymes, renal function; consider CK if muscle symptoms). Avoid use in pregnancy and breastfeeding unless specifically advised by a specialist.

Monitoring Requirements

Baseline and periodic: fasting lipid panel (recheck ~4-8 weeks after start/dose change), liver enzymes (ALT/AST), renal function/serum creatinine (especially early and periodically), and CK if muscle symptoms; monitor INR closely if on warfarin/VKAs.

Pharmacology

Mechanism of Action

PPAR-α agonist that increases lipoprotein lipase activity and fatty-acid oxidation, reduces apoC-III, decreases hepatic VLDL production, lowering triglycerides and modestly increasing HDL.

Half-Life

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

Bioavailability

Oral bioavailability is variable and formulation/food-dependent; micronised fenofibrate has improved absorption and should be taken with food (a single fixed % such as 60% or 81% is not reliably applicable across products).

Metabolism

Rapidly hydrolysed by esterases to the active metabolite fenofibric acid, then mainly glucuronidated; not significantly metabolised by CYP450 enzymes.

Protein Binding

Over 99% (for fenofibric acid, bound to plasma albumin).

Product Information

Available Dosage Forms

Hard capsule (micronised) for this product; other fenofibrate products may exist as tablets/capsules depending on manufacturer, but 'delayed‑release capsule' is not a standard fenofibrate dosage form.

Composition per Dose

Each hard capsule: 200mg micronised fenofibrate

OTC Alternatives

No OTC alternative

Lipid Target

Triglycerides

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