mogul [30:<1% (Limited to important or life-threatening): Angioedema, hyperkalemia, hypotension, increased blood urea nitrogen, increased serum creatinine ALERT: U.S. Boxed Warning Fetal toxicity: When pregnancy is detected, discontinue aliskiren/amlodipine as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. 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. Monitoring Parameters Blood pressure; serum potassium, BUN, serum creatinine Pregnancy Considerations [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. Animal reproduction studies have not been conducted with this combination. See individual agents. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience cough, loss of strength and energy, diarrhea, or flu-like symptoms. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling), severe dizziness, passing out, angina, shortness of breath, excessive weight gain, swelling of arm or leg, difficulty swallowing, muscle rigidity, tremors, abnormal movements, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about aliskiren/amlodipine Side Effects During Pregnancy Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: miscellaneous antihypertensive combinations Consumer resources Aliskiren and Amlodipine Aliskiren and amlodipine (Advanced Reading) Professional resources Other brands: Tekamlo Related treatment guides High Blood Pressure> ] Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Aliskiren / amlodipine Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! 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