Aliskiren/Amlodipine

DEA Class; Rx

Common Brand Names; Tekamlo

• Renin Inhibitors/Combos; 
• Antianginal Agents; 
• Calcium Channel Blockers, Dihydropyridine; 
• CCB/Renin Inhibitor Combos

Indicated for the treatment of hypertension, either alone or in combination with other antihypertensive agents.

May switch to aliskiren/amlodipine if patient inadequately controlled with aliskiren alone or amlodipine alone (or another dihydropyridine calcium channel blocker); may use as replacement therapy for patients currently maintained on aliskiren and amlodipine

Hypersensitivity

Pregnancy (2nd and 3rd trimesters; significant risk of fetal and neonatal morbidity/mortality; see Black Box Warnings)

Concomitant use with ACEIs or ARBs in patients with diabetes mellitus

Adverse reactions reported with combination product and individual agents

Amlodipine

• Peripheral edema (2-15%)
• Peripheral edema (6.2-8.9%)
• Flushing (1-5%)
• Palpitation (1-5%)
• Dizziness (1-3%)
• Fatigue (5%)
• Somnolence (1-2%)
• Rash (1-2%)
• Pruritus (1-2%)
• Male sexual dysfunction (1-2%)
• Nausea (3%)
• Dyspepsia (1-2%)
• Abdominal pain (1-2%)
• Muscle cramps (1-2%)
• Dyspnea (1-2%)
• Weakness (1-2%)
• Angioedema
• Increased BUN
• Increased creatinine
• Hyperkalemia
• Hypotension

Aliskiren

• Diarrhea (2.3%)
• Cough (1.1%)
• Increased creatinine kinase (1%)
• Increased BUN (≤ 7%)
• Hyperkalemia (≤1%)
• Rash (1%)
• Gastroesophageal reflux
• Periorbital edema
• Toxic epiderma necrolysis
• Increased uric acid
• Severe hypotension
• Stevens Johnson syndrome

Symptomatic hypotension may occur after initiation of treatment in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin– aldosterone system (RAAS)

Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

There is no information regarding the presence in human milk, the effects on the breastfed infant, or the effects on milk production