Basic Information
Torvalipin Tablet 20 mg
TABLET, FILM COATED
Regulatory Information
SIN14175P
June 22, 2012
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XC10AA05
Company Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Active Ingredients
Strength: 20 mg
Detailed Information
Contraindications
**4.3 Contraindications** Torvalipin is contraindicated in: - Patients with a history of hypersensitivity to the active substance or to any of the excipients. - Patients with an active liver disease or unexplained persistent elevation of serum transaminase levels where the elevation is exceeding three times the mean upper limits. - Patients with myopathy. - Pregnant and breast feeding women and women of child bearing potential not using contraceptives (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients who are concomitantly treated with glecaprevir/pibrentasvir.
Indication Information
**4.1 Therapeutic indications** _Hypercholesterolaemia_ Torvalipin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, or triglycerides in patients with primary hypercholesterolaemia including heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia (such as Frederickson’s types IIa and IIb), when satisfactory results have not been obtained by a special diet or measures other than medication. Torvalipin is also indicated to reduce total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease_ Torvalipin is indicated to reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminia or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease. In patients with type 2 diabetes and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking or hypertension, Torvalipin is indicated to: - Reduce the risk of myocardial infarction - Reduce the risk of stroke In patients with clinically evident coronary heart disease, atorvastatin is indicated to: - Reduce the risk of non-fatal myocardial infarction - Reduce the risk of fatal and non-fatal stroke - Reduce the risk of revascularization procedures - Reduce the risk of hospitalization for CHF - Reduce the risk of angina