Hydrochlorothiazide/Aliskiren

DEA Class; Rx

Common Brand Names; Tekturna HCT

• Renin Inhibitors/Combos

Aliskiren, a direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic, are combined in 1 tablet to treat hypertension.

Indicated for the treatment of hypertension.

Hypersensitivity to aliskiren, hydrochlorothiazide, or sulfonamides

Anuria

Concomitant use with ACEIs or ARBs in patients with diabetes

Adverse reactions reported with combination product and individual agents

Increased BUN

Dizziness (2%)

Vertigo (1%)

Hypokalemia (2%)

Increased uric acid level (2%)

Hyperkalemia (1%)

Diarrhea (2%)

Increased ALT (1%)

Flu-like syndrome (2%)

Cough (1%)

Weakness (1%)

Arthralgia (1%)

Aliskiren

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

Hydrochlorothiazide

• AnorexiaEpigastric distress
• Hypotension
• Orthostatic hypotension
• Photosensitivity
• Anaphylaxis
• Anemia
• Confusion
• Erythema multiforme
• Stevens-Johnson syndrome
• Exfoliative dermatitis including toxic epidermal necrolysis
• Dizziness
• Hypokalemia and/or hypomagnesemia
• Hyperuricemia
• Headache

Caution in volume- or salt-depleted patients

Not for initial treatment

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported with aliskiren, necessitating hospitalization and intubation; may occur at any time during treatment and has occurred with and without a history of angioedema with ACE inhibitors or angiotensin receptor antagonist; 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

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

Patients whose renal function may depend in part on activity of renin-angiotensin– aldosterone system (RAAS; e.g., patients with renal artery stenosis, severe heart failure, postmyocardial infarction or volume depletion) or patients receiving ARB, ACE inhibitors or nonsteroidal anti-inflammatory drug (NSAID), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), therapy may be at particular risk of developing acute renal failure; monitor renal function periodically; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function

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)

Limited published studies report that hydrochlorothiazide is present in human milk; however, there is insufficient information to determine the effects hydrochlorothiazide on the breastfed infant or effects of hydrochlorothiazide on milk production