Apotrigon 40 mg or 160 mg Capsules
Clinical Summary
Quick overview from the medicine insert
Indication
Used for the treatment of dyslipidemia, including hypercholesterolemia and hypertriglyceridemia.
Dosage (summary)
The usual recommended dose is one capsule (40 mg Fenofibrate and 160 mg Pravastatin) taken orally once daily.
Onset of Action / Duration
Effects on lipid levels may be observed within 2 to 4 weeks of initiation.
Special Populations
- Patients with renal impairment
- Elderly patients
- Patients with liver impairment
Pregnancy & Breastfeeding
Use is not recommended during pregnancy and lactation due to potential risks to the fetus and infant.
Key Drug Interactions
- Increased risk of myopathy and rhabdomyolysis with concomitant use of other statins or fibrates.
- Caution with anticoagulants, as Pravastatin may enhance their effects.
- Potential interaction with cyclosporine, leading to increased Pravastatin levels.
Contraindications
- Active liver disease or unexplained persistent elevations of hepatic transaminases.
- Severe renal impairment.
- Hypersensitivity to any component of the formulation.
Common side effects
- Muscle pain or weakness.
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain).
- Elevated liver enzymes.
- Rash or pruritus.
Counselling Points
- Advise patients to report any unexplained muscle pain, tenderness, or weakness.
- Instruct patients to maintain a healthy diet and lifestyle to enhance treatment efficacy.
- Inform patients about the importance of regular follow-up and lipid level monitoring.
Serious warnings
- Monitor liver function tests before and during treatment.
- Use caution in patients with a history of muscle disorders.
- Discontinue use if muscle symptoms occur, especially if accompanied by fever or malaise.
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