Aliskiren/Amlodipine/Hydrochlorothiazide

DEA Class; Rx

Common Brand Names; Amturnide

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

Combination direct renin inhibitor (aliskiren), dihydropyridine calcium-channel blocker (amlodipine), and thiazide diuretic (hydrochlorothiazide)
Used for hypertension
Black box warning for use during pregnancy

Indicated for the treatment of hypertension.

Hypersensitivity to aliskiren, amlodipine, hydrochlorothiazide, sulfonamide-derived drugs, or components of the formulation

Anuria

Pregnancy (2nd and 3rd trimesters): significant risk of fetal and neonatal morbidity/mortality

Concomitant use with ACEIs or ARBs in patients with diabetes

Adverse reactions reported with combination product and individual agents

Peripheral edema (7.1%)

Dizziness (3.6%)

Headache (3.6%)

Nasopharyngitis (2.6%)

Amlodipine

• Palpitation (1-5%)
• Dizziness (1-3%)
• Flushing (1-5%)
• Somnolence (1-2%)
• Rash (1-2%)
• Fatigue (5%)
• Pruritus (1-2%)
• Male sexual dysfunction (1-2%)
• Nausea (3%)
• Dyspepsia (1-2%)
• Dyspnea (1-2%)
• Weakness (1-2%)

Aliskiren

• Diarrhea (2.3%)
• Cough (1.1%)
• Increased creatinine kinase (1%)
• Increased BUN (≤ 7%)
• Hyperkalemia (≤1%)
• Rash (1%)

Avoid use of aliskiren with ARBs or ACEIs in moderate to severe renal impairment (ie, GFR <60 mL/min); contraindicated in patients with diabetes

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); volume or salt depletion should be corrected prior to administration of therapy, or treatment should start under close medical supervision; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once blood pressure has stabilized

Increased angina or myocardial infarction may occur on dosage initiation or increase on amlodipine

Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been reported in patients treated with aliskiren and has necessitated hospitalization and intubation; this may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACEIs or angiotensin receptor antagonists; patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures; treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement; prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and measures to ensure a patent airway may be necessary; discontinue therapy immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister

Hydrochlorothiazide may exacerbate or activate systemic lupus erythematosus

Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

Pregnancy: Can cause fetal harm when administered to a pregnant woman; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; when pregnancy is detected discontinue therapy as soon as possible

Lactation: There is no information regarding therapy in human milk, effects on the breastfed infant, or the effects on milk production; amlodipine and hydrochlorothiazide reported by some studies to be present in human milk