Dosage Information in more detail What happens if I miss a dose? Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at Overdose symptoms may include rapid heartbeats, redness or warmth in your arms or legs, or fainting. What should I avoid while taking Norvasc? Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Norvasc side effects Get emergency medical help if you have signs of an allergic reaction to Norvasc: In rare cases, when you first start taking Norvasc, your angina may get worse or you could have a heart attack.

Seek emergency medical attention or call your doctor right away if you have symptoms such as: Call your doctor at once if you have: A pharmaceutical composition comprising an amount of a compound of claim 1 or a pharmaceutically acceptable salt thereof and an amount of atorvastatin or a pharmaceutically acceptable salt thereof. A composition of claim 38 comprising the hemicalcium salt of atorvastatin.

A method of treating angina pectoris in a mammal suffering from angina pectoris comprising administering to said mammal an effective amount of a pharmaceutical composition of claim A method of treating angina pectoris in a mammal suffering form angina pectoris comprising administering to said mammal an effective amount of a pharmaceutical composition of claim A method of treating atherosclerosis in a mammal comprising administering to said mammal an atherosclerosis treating effective amount of a pharmaceutical composition of claim A method of managing cardiac risk in a mammal comprising administering to said mammal a cardiac risk treating effective amount of a pharmaceutical composition of claim A method of treating a mammal suffering from hypertension and hyperlipidemia comprising administering to said mammal a hypertension and hyperlipidemia treating effective amount of a pharmaceutical composition of claim Description This application is filed claiming priority from co-pending Provisional Application No.

This invention relates to mutual prodrugs of amlodipine and atorvastatin, pharmaceutically acceptable acid addition salts thereof, pharmaceutical compositions thereof and methods of using such prodrugs and compositions to treat subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and to treat subjects presenting with symptoms of cardiac risk, including humans.

As such, statins are collectively potent lipid lowering agents. Atorvastatin calcium, disclosed in U. As such, atorvastatin calcium is a potent lipid lowering compound. The free carboxylic acid form of atorvastatin exists predominantly as the lactone of the formula and is disclosed in U.

Amlodipine and related dihydropyridine compounds are disclosed in commonly assigned U. Amlodipine and amlodipine besylate are potent and long lasting calcium channel blockers.

As such, amlodipine, amlodipine besylate and other pharmaceutically acceptable acid addition salts of amlodipine have utility as antihypertensive agents and as antiischemic agents. Amlodipine and its pharmaceutically acceptable acid addition salts are also disclosed in commonly assigned U. Amlodipine has the formula Atherosclerosis is a condition characterized by irregularly distributed lipid deposits in the intima of arteries, including coronary, carotid and peripheral arteries.

Despite attempts to modify secondary risk factors such as, inter alia, smoking, obesity and lack of exercise, and treatment of dyslipidemia with dietary modification and drug therapy, CHD remains the most common cause of death in the United States. High levels of blood cholesterol and blood lipids are conditions involved in the onset of atherosclerosis. It has now been established that lowering LDL-C levels affords protection from coronary heart disease see, e. Randomised trial of cholesterol lowering in patients with coronary heart disease: Angina pectoris is a severe constricting pain in the chest, often radiating from the precordium to the left shoulder and down the left arm.

Often angina pectoris is due to ischemia of the heart and is usually caused by coronary disease. Currently the treatment of symptomatic angina pectoris varies significantly from country to country. Patients who undergo PTCA or other surgical procedures designed to treat angina pectoris frequently experience complications such as restenosis. This restenosis may be manifested either as a short term proliferative response to angioplasty-induced trauma or as long term progression of the atherosclerotic process in both graft vessels and angioplastied segments.

The symptomatic management of angina pectoris involves the use of a number of drugs, frequently as a combination of two or more of the following classes: Most, if not all, of these patients require therapy with a lipid lowering agent as well.

Amlodipine helps to prevent myocardial ischemia in patients with exertional angina pectoris by reducing Total Peripheral Resistance, or afterload, which reduces the rate pressure product and thus myocardial oxygen demand at any particular level of exercise. In patients with vasospastic angina pectoris, amlodipine has been demonstrated to block constriction and thus restore myocardial oxygen supply.

Further, amlodipine has been shown to increase myocardial oxygen supply by dilating the coronary arteries. Hypertension frequently coexists with hyperlipidemia and both are considered to be major risk factors for developing cardiac disease ultimately resulting in adverse cardiac events. This clustering of risk factors is potentially due to a common mechanism. Further, patient compliance with the management of hypertension is generally better than patient compliance with hyperlipidemia.

It would therefore be advantageous for patients to have a single therapy which treats both of these conditions. Coronary heart disease is a multifactorial disease in which the incidence and severity are affected by the lipid profile, the presence of diabetes and the sex of the subject.

Incidence is also affected by smoking and left ventricular hypertrophy which is secondary to hypertension. To meaningfully reduce the risk of coronary heart disease, it is important to manage the entire risk spectrum. For example, hypertension intervention trials have failed to demonstrate full normalization in cardiovascular mortality due to coronary heart disease.

Treatment with cholesterol synthesis inhibitors in patients with and without coronary artery disease reduces the risk of cardiovascular morbidity and mortality. The Framingham Heart Study, an ongoing prospective study of adult men and women, has shown that certain risk factors can be used to predict the development of coronary heart disease.

These factors include age, gender, total cholesterol level, high density lipoprotein HDL level, systolic blood pressure, cigarette smoking, glucose intolerance and cardiac enlargement left ventricular hypertrophy on electrocardiogram, echocardiogram or enlarged heart on chest X-ray. Calculators and computers can easily be programmed using a multivariate logistic function that allows calculation of the conditional probability of cardiovascular events.

These determinations, based on experience with 5, men and women participating in the Framingham study, estimate coronary artery disease risk over variable periods of follow-up. That reference further suggests that atherosclerosis can be treated with a combination of amlodipine and a lipid lowering agent. Human trials have shown that calcium channel blockers have beneficial effects in the treatment of early atherosclerotic lesions. This invention is particularly directed to a mutual prodrug of amlodipine and atorvastatin having the formula I, and pharmaceutically acceptable salts thereof.

This invention is more particularly directed to a compound of formula I wherein the carbon atom at the 4-position of the dihydropyridine ring has the R -configuration and pharmaceutically acceptable salts thereof. This invention is also more particularly directed to a compound of formula I wherein the carbon atom at the 4-position of the dihydropyridine ring has the S -configuration and pharmaceutically acceptable salts thereof. This invention is also directed to a mutual prodrug of amlodipine and atorvastatin which is a compound having the formula II, wherein R1 and R2 are independently selected from H and C1-C4 alkyl.

It is particularly preferred that R1 and R2 are each H and pharmaceutically acceptable salts thereof. This invention is more particularly directed to a compound of formula II wherein the carbon atom at the 4-position of the dihydropyridine ring has the R -configuration and pharmaceutically acceptable salts thereof.

This invention is also more particularly directed to a compound of formula II wherein the carbon atom at the 4-position of the dihydropyridine ring has the S -configuration and pharmaceutically acceptable salts thereof.

This invention is also directed to pharmaceutical compositions comprising a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, vehicle or diluent. This invention is also directed to methods of treating angina pectoris in a mammal suffering from angina pectoris comprising administering to said mammal an angina pectoris treating effective amount of a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof.

This invention is also directed to methods of treating angina pectoris in a mammal suffering from angina pectoris comprising administering to said mammal an angina pectoris treating effective amount of a pharmaceutical composition comprising a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, vehicle or diluent.

This invention is also directed to methods of treating hypertension and hyperlipidemia in a mammal suffering from hypertension and hyperlipidemia comprising administering to said mammal a hypertension and hyperlipidemia treating effective amount of a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof. This invention is also directed to methods of treating hypertension and hyperlipidemia in a mammal suffering from hypertension and hyperlipidemia comprising administering to said mammal a hypertension and hyperlipidemia treating effective amount of a pharmaceutical composition comprising a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, vehicle or diluent.

This invention is also directed to methods of treating atherosclerosis in a mammal suffering from atherosclerosis comprising administering to said mammal an antiatherosclerosis effective amount of a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof.

This invention is particularly directed to those cases where said antiatherosclerotic effect is manifested by a slowing of the progression of atherosclerotic plaques, including wherein said atherosclerotic plaque formation is slowed in coronary arteries, carotid arteries or in the peripheral arterial system. This invention is also directed to methods of treating atherosclerosis in a mammal suffering from atherosclerosis comprising administering to said mammal an antiatherosclerosis effective amount of a pharmaceutical composition comprising a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, vehicle or diluent.

This invention is also directed to methods of managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, comprising administering to said mammal a cardiac risk treating effective amount of a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof. This invention is also directed to methods of managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, comprising administering to said mammal a cardiac risk treating effective amount of a pharmaceutical composition comprising a mutual prodrug of amlodipine and atorvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, vehicle or diluent.

This invention is also directed to methods of preparing atorvastatin in vivo by administering to a mammal, e. Only low prices for pills. Amlodipine Besylate Tablets, 2. See images of Norvasc Amlodipine , including the medication and its packaging October 1, Norvasc Pill Images - What does Norvasc look like?

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Similar results were obtained in patients receiving amlodipine besylate tablets and concomitant beta blockers. In clinical studies in which amlodipine besylate tablets were administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.

In clinical trials with angina patients alone, amlodipine besylate tablet therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks. Clinical Studies Effects in Hypertension Adult Patients The antihypertensive efficacy of amlodipine besylate tablets has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving patients on amlodipine besylate tablets and on placebo.

Maintenance of the blood pressure effect over the hour dosing interval was observed, with little difference in peak and trough effect.

Tolerance was not demonstrated in patients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the reduction in supine and standing blood pressures was dose-related within the recommended dosing range. Effects on diastolic pressure were similar in young and older patients. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure.

Effects were similar in black patients and in white patients. Pediatric Patients Two hundred sixty-eight hypertensive patients aged 6 to 17 years were randomized first to amlodipine besylate tablets 2. Patients receiving 5 mg at the end of 8 weeks had lower blood pressure than those secondarily randomized to placebo.

The magnitude of the treatment effect is difficult to interpret, but it is probably less than 5 mmHg systolic on the 5 mg dose. Adverse events were similar to those seen in adults. In 5 of the 8 studies significant increases in exercise time bicycle or treadmill were seen with the 10 mg dose.

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