CADUET^®

Amlodipine Besylate/Atorvastatin Calcium

1. TRADE NAME(S) OF THE MEDICINAL PRODUCT

CADUET^®

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients: amlodipine besylate, atorvastatin calcium. The tablets for oral administration contain amlodipine besylate and atorvastatin calcium equivalent to 5mg/10mg, 5mg/20mg, 5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg, 10mg/40mg, and 10mg/80mg amlodipine/atorvastatin dosage strengths, respectively.

3. PHARMACEUTICAL FORM

Amlodipine/atorvastatin 5mg/10mg is a white, oval shape, him coated tablet debossed with "Pfizer" on one side and CDT 051 on the other side.

Amlodipine/atorvastatin 5mg/20mg is a white, oval shape, film-coated tablet debossed with "Pfizer" on one side and CDT 052 on the other side.

Amlodipine/atorvastatin 5mg/40mg is a white, oval shape, film-coated tablet debossed with "Pfizer" on one side and CDT 054 on the other side.

Amlodipine/atorvastatin 5mg/80mg is a white, oval shape, film-coated tablet debossed with "Pfizer" on one side and CDT 058 on the other side.

Amlodipine/atorvastatin 10mg/10mg is a blue, oval shape, film -coated tablet debossed with "Pfizer" on one side and CDT 101 on the other side.

Amlodipine/atorvastatin 10mg/20mg is a blue, oval shape, film -coated tablet debossed with "Pfizer' on one side and CDT 102 on the other side.

Amlodipine/atorvastatin 10mg/40mg is a blue, oval shape, film -coated tablet debossed with "Pfizer" on one side and CDT 104 on the other side.

Amlodipine/atorvastatin 10mg/80mg is a blue, oval shape, film-coated tablet debossed with "Pfizer" on one side and CDT 108 on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Caduet is indicated in patients for whom treatment with both amlodipine and atorvastatin is considered appropriate.

Amlodipine

Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, alpha blockers, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor. Amlodipine is indicated for the first line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Amlodipine may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine maybe used alone, as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.

Atorvastatin

Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated total cholesterol, LDL cholesterol, apolipoprotein 5, and triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa and IIb), elevated serum triglyceride levels (Fredrickson type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. Atorvastatin is also indicated for the reduction of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia when response to diet and other non pharmacological measures are inadequate.

Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary head disease, but with multiple risk factors for coronary head disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary head disease, atorvastatin is indicated to :

• Reduce the risk of myocardial infarction

• Reduce the risk of stroke

• Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary head disease, but with multiple risk factors for coronary head disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin is indicated to :

• Reduce the risk of myocardial infarction

• Reduce the risk of stroke

4.2 Posology and Method of Administration

General Considerations

Amlodipine/atorvastatin is a combination product targeting concomitant cardiovascular conditions, hypertension/angina and dyslipidemia The dosage range for amlodipine/atorvastatin is 5mg/10mg to a maximum dose of 10mg/80mg once daily. The starting dose and maintenance dose should be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension /angina and dyslipidemia. Current treatment guidelines should be consulted to establish treatment goals for patients based on their baseline characteristics. Doses maybe taken at any time of day with or without food. As a component of multiple-risk factor intervention, amlodipine/atorvastatin should be used in addition to non-pharmacological measures, including an appropriate diet, exercise and weight reduction in obese patients, smoking cassation, and to treat underlying medical problems, when the response to these measures have been inadequate. Following initiation and/or titration of amlodipine/atorvastatin, lipid levels should be analyzed and blood pressure measured within 2 to 4 weeks, and dosage of amlodipine and atorvastatin components should be adjusted accordingly. Titration for blood pressure response may proceed more rapidly if clinically warranted.

Initial Therapy

Amlodipine/atorvastatin may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. The recommended starting dose of amlodipine/atorvastatin should be based on the appropriate combination of recommendations for the amlodipine and atorvastatin components considered separately. The maximum dose of the amlodipine component of amlodipine/atorvastatin is 10 mg once daily. The maximum dose of the atorvastatin component of amlodipine/atorvastatin is 80 mg once daily.

Substitution Therapy

Amlodipine/atorvastatin may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine/atorvastatin or a dose of amlodipine/atorvastatin with increased amounts of amlodipine, atorvastatin or both for additional antianginal effects, blood pressure lowering, or lipid lowering effect. Amlodipine/atorvastatin may be used to provide additional therapy for patients already on one of its components. As initial therapy for one indication and continuation of treatment of the other, the recommended starting dose of amlodipine/atorvastatin should be selected based on continuation of the component being used previously and on the recommended starting dose for the component being added.

Concomitant Medication (See also section 4.5 Interaction with Other Medicaments and Other Forms of Interaction)

The amlodipine component of amlodipine/ atorvastatin has been safely co-administered with thiazide diuretics, alpha blockers, beta blockers, angiotensin-converting enzyme inhibitors, long acting nitrates, and with sublingual nitroglycerine. Amlodipine/atorvastatin has also been safely administered with the aforementioned medicines. The atorvastatin component of amlodipine/ atorvastatin may be used in combination with a bile acid binding resin for additive effect on lipid lowering. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided (see section 4.4 Special Warnings and Special Precautions ton Use, and section 4.5 Interaction with Other Medicaments and Other Forms of Interaction).

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