VOSTALLY

Plasma concentrations of ramipril and ramiprilat (active metabolite) increase with increase in dose but are not strictly dose-proportional. The 24-hour AUC for ramiprilat, however, is dose-proportional over the 2.5 mg - 20 mg dose range. After once-daily dosing, steady-state plasma concentrations of ramiprilat are reached by the fourth dose. Steady-state concentrations of ramiprilat are somewhat higher than those seen after the first dose of ramipril, especially at low doses (2.5 mg), but the di...

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 VOSTALLY 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 VOSTALLY in combin...

The most common adverse reactions included cough and hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Rosemont Pharmaceuticals, LLC at 1-844-638-2235 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 another drug and may not reflect the rates obser...

VOSTALLY is contraindicated in patients with: a history of angioedema or hypersensitivity to this product or any other ACE inhibitor [see Warnings and Precautions (5.2) ] hereditary or idiopathic angioedema [see Warnings and Precautions (5.2)] VOSTALLY is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VOSTALLY within 36 hours of switching to or fro...

Angioedema, increased risk in patients with a prior history ( 5.2 ) Hypotension ( 5.3 ) Rare cholestatic jaundice and hepatic failure ( 5.4 ) Renal impairment: monitor renal function during therapy ( 5.5 ) Hyperkalemia ( 5.6 ) 5.1 Fetal Toxicity VOSTALLY can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and dea...

7 DRUG INTERACTIONS Diuretics: Excessive drop in blood pressure ( 7.1 ). Potassium-sparing diuretics/potassium supplements: Hyperkalemia ( 7.2 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ) Lithium: Increase serum lithium levels, symptoms of lithium toxicity ( 7.4 ). Gold: Nitritoid reactions have been reported ( 7.5 ). ...