Product Dossier
VASCALACE
Product Dossier for VASCALACE (ramipril, Strides Pharma Science). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Strides Pharma Science
- Active ingredient: ramipril
- Therapeutic area: Cardiology
- Related brand: TRYZAN
- Related brand: RAMIPRIL (branded generics)
- Related brand: TRITACE
- Same area: ATOZET
- Same area: OPSUMIT
What it is
VASCALACE contains ramipril. Ramipril is a prodrug which, after absorption from the gastrointestinal tract, is hydrolysed in the liver to form the active moiety, ramiprilat. Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE), which is identical to KININASE II. VASCALACE is available as tablets containing 1.25 mg, 2.5 mg, 5 mg and 10 mg of ramipril. VASCALACE CAPS is available as capsules containing 1.25, 2.5, 5 and 10 mg ramipril.
Approved indications
— Mild to moderate hypertension — Myocardial infarction in patients who showed clinical signs of heart failure — Non-diabetic nephropathy
Dosing overview
In longer-term controlled studies, once-daily doses of 2.5 to 10 mg were similar in their effect for hypertension. Single doses of 5 to 20 mg of ramipril lowered blood pressure within 1 to 2 hours, with peak reductions achieved 3 to 6 hours after dosing, and the antihypertensive effect of a single dose persisted for 24 hours.
Key safety warnings
Symptomatic postural hypotension is infrequent, although it can occur in patients who are salt and/or volume depleted. Decreased aldosterone secretion may result in a small increase in serum potassium.
Regulatory history
VASCALACE tablet formulations (1.25 mg, 2.5 mg, 5 mg and 10 mg) were first listed on the ARTG on 6 October 2011. VASCALACE CAPS capsule formulations (1.25 mg, 2.5 mg, 5 mg and 10 mg) were first listed on the ARTG on 14 August 2013.