Label Changes for:

Mavik (trandolapril) 1 mg, 2 mg, and 4 mg Tablets

January 2012

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

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

 

January 2012

CONTRAINDICATIONS

  • MAVIK is contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema and in patients with a history of angioedema related to previous treatment with an ACE inhibitor

WARNINGS

Head and Neck Angioedema
  • In controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients

PRECAUTIONS

Drug Interactions
Antidiabetic Agents [new section added]
  • Concomitant use of ACE inhibitors and antidiabetic medicines (insulin or oral hypoglycemic agents) may cause an increased blood glucose lowering effect with greater risk of hypoglycemia

ADVERSE REACTIONS

Postmarketing [new section added]
  • The following adverse reactions were identified during post approval use of MAVIK. Because these reactions are reported voluntarily......

note: deletions made in several Adverse Reactions sections

 

 

September 2011

PRECAUTIONS

Drug Interactions

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors)

  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including trandolapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving trandolapril and NSAID therapy.
  • The antihypertensive effect of ACE inhibitors, including trandolapril, may be attenuated by NSAIDs.

 

April 2010

 

PRECAUTIONS- DRUG INTERACTIONS 

Other
  • As with all other inhibitors of RAS, NSAIDs may reduce the antihypertensive effects of trandolapril. Blood pressure monitoring should be increased when any NSAID is added or discontinued in a patient treated with trandolapril.
  • The hypotensive effect of certain inhalation anesthetics may be enhanced by ACE inhibitors including trandolapril

ADVERSE REACTIONS

The safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received Mavik.

  • General Body Function: malaise, fever
  • Dermatologic: alopecia, sweating
  • Gastrointestinal: nausea, dry mouth
  • Hemopoietic: agranulocytosis
  • Metabolism and Endocrine: increased SGOT (AST)
  • Pulmonary: bronchitis

 

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