Pill Identifier App

Label Changes for:

Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets

March 2015

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

*Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS) 

Amturnide (aliskiren/amlodipine besylate/hydrochlorothiazide)
Tekamlo (aliskiren/amlodipine besylate) Tablets
Tekturna (aliskiren) Tablets
Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

March 2015

WARNINGS AND PRECAUTIONS

Renal Impairment/Hyperkalemia/Hypotension when <PRODUCT> is Given in Combination with ARBs or ACEIs
  • added...In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with creatinine clearance (CrCl) less than 60 mL/min [see Contraindications (4), Drug Interactions (7) and Clinical Studies (14)].
Impaired Renal Function section edited
  • Patients whose renal function may depend in part on the activity of the RAAS (e.g., patients with renal artery stenosis, severe heart failure, postmyocardial infarction or volume depletion) or patients receiving ARB, ACEI 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 on <PRODUCT> [see Warnings and Precautions, Drug Interactions (7), and Clinical Studies (14)]. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

ADVERSE REACTIONS

Clinical Studies Experience sections re-named

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • Fetal Toxicity [see Warnings and Precautions].
  • Anaphylactic Reactions and Head and Neck Angioedema [see Warnings and Precautions].
  • Hypotension [see Warnings and Precautions].
Postmarketing Experience
  • Aliskiren: nausea, vomiting added

DRUG INTERACTIONS

Aliskiren
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS)
  • added...Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min.
  • added...The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated [see Contraindications (4)].
Hide
(web4)