Aliskiren and amlodipine

Name: Aliskiren and amlodipine

Uses of Aliskiren and Amlodipine

  • It is used to treat high blood pressure.
  • It may be given to you for other reasons. Talk with the doctor.

Pharmacologic Category

  • Antianginal Agent
  • Antihypertensive
  • Calcium Channel Blocker
  • Calcium Channel Blocker, Dihydropyridine
  • Renin Inhibitor

Pharmacology

Aliskiren: Decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin I.

Amlodipine: Inhibits calcium ion from entering the "slow channels" or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Dietary Considerations

May be taken with or without food, however, a high-fat meal reduces absorption. Consistent administration with regards to meals is recommended.

Warnings/Precautions

Concerns related to adverse effects:

• Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of dihydropyridine calcium channel blockers, including amlodipine. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.

• Hyperkalemia: May occur; risk increased in patients with renal impairment or diabetes, or concomitant use with ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts.

• Hypersensitivity: Anaphylaxis and angioedema have been reported. Since the effect of aliskiren on bradykinin levels is unknown, the risk of kinin-mediated etiologies of angioedema occurring is also unknown. Use with caution in any patient with a history of angioedema (of any etiology) as angioedema has been observed with aliskiren use. Discontinue immediately following the occurrence of anaphylaxis or angioedema; do not readminister. Prolonged frequent monitoring may be required especially if tongue, glottis, or larynx are involved as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Aggressive, early, and appropriate management is critical.

• Hypotension: During the initiation of therapy, symptomatic hypotension may occur, particularly in volume or salt-depleted patients or with concomitant use of other agents acting on the renin-angiotensin-aldosterone system. Prior to initiation, correct hypovolemia or salt depletion, or closely monitor during treatment initiation. If hypotension does occur, this is not a contraindication for further use; once blood pressure has been stabilized, aliskiren usually can be continued without difficulty.

• Renal effects: Changes in renal function, including acute renal failure, may occur with aliskiren; risk is increased in patients with renal artery stenosis, severe heart failure, post-myocardial infarction, volume depletion, or patients receiving ARB, ACEI, or NSAIDs. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

• Peripheral edema: The most common side effect of amlodipine is peripheral edema; occurs within 2 to 3 weeks of starting therapy.

Disease-related concerns:

• Aortic stenosis: Use amlodipine with extreme caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in ischemia.

• Diabetes: Use in patients with diabetes has demonstrated an increased incidence of renal impairment, hypotension, and hyperkalemia; use is contraindicated in patients with diabetes who are taking an ACE inhibitor or ARB.

• Hepatic impairment: Use with caution in patients with hepatic impairment; consider using lower doses.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition.

• Renal impairment: Use with caution in patients with renal impairment; risk of developing acute renal failure and hyperkalemia is increased. Avoid concomitant use with an ACE inhibitor or ARB in patients with CrCl <60 mL/minute.

Concurrent drug therapy:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Exposure to amlodipine is increased in the elderly; consider using lowest initial dose.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

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