VOSTALLY (ramipril) oral solution 1 mg/mL is a clear, colorless solution. It is available in a 150 mL volume.

VOSTALLY is contraindicated in patients with:

VOSTALLY is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VOSTALLY within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor

Do not co-administer VOSTALLY with aliskiren in patients with diabetes

Single oral doses of ramipril in rats and mice of 10 g/kg–11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension.

Laboratory determinations of serum levels of ramipril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of ramipril overdose.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of ramipril and its metabolites. Similarly, it is not known which, if any, of these substances can be effectively removed from the body by hemodialysis.

Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of ramipril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat ramipril overdose by infusion of normal saline solution.

Ramipril is an angiotensin converting enzyme (ACE) inhibitor. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C–112°C.

Ramipril’s chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3- phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester.

The structural formula for ramipril is:

Its empirical formula is C

VOSTALLY is a clear, colorless solution for oral use that contains 1 mg/mL ramipril. The inactive ingredients are citric acid monohydrate, ethylparaben sodium, frozen peppermint flavor 5015241T, methylparaben sodium, purified water, and sucralose.

VOSTALLY is a clear, colorless, solution that contains 150 mL of ramipril solution 1 mg/mL. It is supplied in a glass bottle with child-resistant cap (NDC 69528-303-05).

Advise female patients of reproductive potential about the consequences of exposure to VOSTALLY during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible [see

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician [see

Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue VOSTALLY if syncope (fainting) occurs, and to follow up with their health care providers.

Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking VOSTALLY can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see

Advise women not to breastfeed during treatment with VOSTALLY [see

Advise patients not to use salt substitutes containing potassium without consulting their physician [see

Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use [see

Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

Instruct patients or caregivers to use an oral dosing syringe or oral dosing cup to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy.

NDC 69528-303-05

VOSTALLY

1 mg/mL

150mL