Basic Information
DUALPRESS FILM-COATED TABLET 5MG/10MG
TABLET, FILM COATED
Regulatory Information
SIN16490P
May 11, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XC10BX03
Company Information
Active Ingredients
Strength: 10mg
Strength: 5mg
Detailed Information
Contraindications
**4.3. Contraindications** Amlodipine/atorvastatin is contraindicated in patients who: 1. Have known hypersensitivity to dihydropyridines\*, amlodipine, atorvastatin, or any component of this medication. 2. Have active liver disease or unexplained persistent elevations of serum transaminases >3 x the upper limit of normal \[ULN\]. 3. Are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus. 4. Are concomitantly treated with glecaprevir/pibrentasvir. \*Amlodipine is a dihydropyridine calcium channel blocker.
Indication Information
**4.1. Therapeutic indications** The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: **Amlodipine** _**Hypertension**_ The amlodipine component is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. _**Coronary Artery Disease**_ Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs. Angiographically Documented Coronary Artery Disease In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. **Atorvastatin** _**Dyslipidemia**_ The atorvastatin component is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia (FH) or combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and in patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) when response to diet and other non-pharmacological measures is inadequate. The atorvastatin component also raises high-density lipoprotein cholesterol (HDL-C) and lowers the LDL-HDL and total-C/HDL ratios. The atorvastatin component is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total-C, LDL-C and apo B in patients with homozygous FH. _**Prevention of Cardiovascular Disease**_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD, such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD. In patients with Type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD, such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI - Reduce the risk of stroke In patients with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina