Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Head and Neck Angioedema
- Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) may be at increased risk for angioedema.
Mammalian Target of Rapamycin (mTOR) Inhibitors
- Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see Warnings – Head and Neck Angioedema).
- 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
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
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
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
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.
PRECAUTIONS- DRUG INTERACTIONS
- 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
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