ALTACE® Capsules Drug Interactions

(ramipril)

7 DRUG INTERACTIONS

7.1 Diuretics

Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ALTACE. The possibility of hypotensive effects with ALTACE can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with ALTACE. If this is not possible, reduce the starting dose [see Dosage and Administration (2)].

7.2 Agents Increasing Serum Potassium

Coadministration of ALTACE with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

7.3 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)].

7.4 Lithium

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium; therefore, frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

7.5 Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including ALTACE.

7.6 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 ramipril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving ramipril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including ramipril, may be attenuated by NSAIDs.

7.7 mTOR Inhibitors or Other Drugs Known to Cause Angioedema

Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Warnings and Precautions (5.1)].

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Drug Interactions

7 DRUG INTERACTIONS

7.1 Diuretics

Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with ALTACE. The possibility of hypotensive effects with ALTACE can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with ALTACE. If this is not possible, reduce the starting dose [see Dosage and Administration (2)].

7.2 Agents Increasing Serum Potassium

Coadministration of ALTACE with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

7.3 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)].

7.4 Lithium

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium; therefore, frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

7.5 Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including ALTACE.

7.6 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 ramipril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving ramipril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including ramipril, may be attenuated by NSAIDs.

7.7 mTOR Inhibitors or Other Drugs Known to Cause Angioedema

Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Warnings and Precautions (5.1)].

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