RAMIPRIL

AbsorptionFollowing oral administration of ramipril, peak plasma concentrations (C max ) of ramipril are reached within 1 hour. The extent of absorption is at least 50% to 60%, and is not significantly influenced by the presence of food in the gastrointestinal tract, although the rate of absorption is reduced. In a trial in which subjects received ramipril capsules or the contents of identical capsules dissolved in water, dissolved in apple juice, or suspended in applesauce, serum ramiprilat le...

14.1 Hypertension Ramipril has been compared with other ACE inhibitors, beta-blockers, and thiazide diuretics as monotherapy for hypertension. It was approximately as effective as other ACE inhibitors and as atenolol. Administration of ramipril to patients with mild to moderate hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is infrequent, although it can occur in patients who are salt- and/or volume-depleted [see WARNINGS AND PRECAUTIONS ( 5.5 ) ]. Use of ramipril in comb...

The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of ano...

Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema.( 4 ). Ramipril is contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor).

ACE inhibitor use has been associated with the following:

• Angioedema, with increased risk in patients with a prior history ( 5.1 )
• Hypotension and hyperkalemia ( 5.5 , 5.8 )
• Renal impairment: monitor renal function during therapy ( 5.3 )
• Increased risk of renal impairment when combined with another blocker of the renin-angiotensin-aldosterone system ( 5.7 )
• Rare cholestatic jaundice and hepatic failure ( 5.2 )
• Rare neutropenia and agranulocytosis ( 5.4 ) 5.1 Anaphylactoid and Possibl...

7. DRUG INTERACTIONS

• Diuretics: Possibility of excessive hypotension ( 7.1 ).
• Lithium: Use with caution ( 7.3 ).
• Gold: Nitritoid reactions have been reported ( 7.4 ).
• NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.5 ). 7.1 Diuretics Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally e...