-------------------------------CONTRAINDICATIONS------------------------

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT.

Do not use with angiotensin receptor blockers (ARBs) or angiotensinconverting enzyme inhibitors (ACEIs) in patients with diabetes. (4) Anuria (4)

TEKTURNA® HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008

Hypersensitivity to sulfonamide-derived drugs or to any of the components. (4) -------------------------WARNINGS AND PRECAUTIONS-----------------

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning. •

When pregnancy is detected, discontinue Tekturna HCT as soon as possible. (5.1, 8.1)

•

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)

-----------------------------RECENT MAJOR CHANGES-------------------Contraindications (4) Warnings and Precautions (5.1, 5.2, 5.5, 5.8)

3/2015 3/2015

---------------------------INDICATIONS AND USAGE----------------------Tekturna HCT is a combination of aliskiren, a renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled with monotherapy. (1) • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. ---------------------------DOSAGE AND ADMINISTRATION---------------• • •

Initiate with 150/12.5mg daily. Titrate as needed up to a maximum of 300/25 mg (2.2) Order of increasing mean effect: 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg (2.1) Replacement therapy: May be substituted for titrated components (2.4)

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Avoid concomitant use with ARBs or ACEIs particularly in patients with renal impairment [creatinine clearance (CrCl)