Label Changes for:

Altace (ramipril) capsules

May 2014

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

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

 

May 2014

5 WARNINGS AND PRECAUTIONS

5.7 Dual Blockade of the Renin-Angiotensin Aldosterone System
  • added...Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

7 DRUG INTERACTIONS

7.2 Other Agents Affecting RAS
  • In general, avoid combined use of RAS inhibitors. [see Warnings and Precautions (5.7)]. Do not co-administer aliskiren with ALTACE in patients with diabetes [see Contraindications (4)]. 

  

October 2013

CONTRAINDICATIONS

  • Do not co-administer aliskiren with Altace in patients with diabetes.

WARNINGS AND PRECAUTIONS

Dual Blockade of the Renin-Angiotensin- Aldosterone System

  • Avoid concomitant use of aliskiren with Altace

DRUG INTERACTIONS

Aliskiren
  • Avoid concomitant use of aliskiren with Altace

 

September 2013

4 CONTRAINDICATIONS

  • Do not co-administer aliskiren with ALTACE in patients with diabetes or in patients with renal impairment (GFR < 60 mL/min/1.73 m2)

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactoid and Possibly Related Reactions
  • Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema. [see Drug Interactions (7.7)]
5.7 Dual Blockade of the Renin-Angiotensin-Aldosterone System
  • Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on ALTACE and other agents that affect the RAS.

Aliskiren

  • Do not co-administer aliskiren with ALTACE in patients with diabetes or in patients with renal impairment (GFR <60 mL/min/1.73 m2). [see Drug Interactions (7.6)]

DRUG INTERACTIONS

7.6 Aliskiren
  • Do not co-administer aliskiren with ALTACE in patients with diabetes or in patients with renal impairment (GFR <60 mL/min/1.73 m2). [see Warnings and Precautions (5.7)].
7.7 mTOR Inhibitors
  • Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at increased risk for angioedema. [see Warnings and Precautions (5.1)] 

 

April 2012

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Altace as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
 
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