DYNACIRC SRO Modified release capsule Ref.[8732] Active ingredients: Isradipine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Novartis New Zealand Limited, 109 Carlton Gore Road, Newmarket, Auckland 1023, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335

Product name and form

DYNACIRC SRO 2.5mg Modified Release (SRO) Capsules.

DYNACIRC SRO 5mg Modified Release (SRO) Capsules.

Pharmaceutical Form

2.5 mg and 5 mg modified release capsules (SRO capsules) for oral administration.

Qualitative and quantitative composition

One 2.5mg Modified Release (SRO) Capsule contains 2.5 mg of isradipine.

One 5 mg Modified Release (SRO) Capsule contains 5 mg of isradipine.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Isradipine

Isradipine is a potent dihydropyridine calcium channel blocker with selective activity on voltage-gated calcium channels (L-type or “long acting”). Isradipine has a higher affinity for such calcium channels in arterial smooth muscle than for those in the myocardium. It thus dilates arterial vascular beds, in particular those of the heart, brain and skeletal muscle without depressing cardiac function.

List of Excipients

Cellulose, microcrystalline
Cetyl palmitate
Gelatine
Iron oxide, black (only for Dynacirc 2.5 mg SRO)
Iron oxide, red (only for Dynacirc 5 mg SRO)
Iron oxide, yellow
Magnesium stearate
Hypromellose
Shellac
Silica Colloidal anhydrous
Titanium dioxide

Pack sizes and marketing

Alu/PVC/PVDC blister pack containing 10 or 30 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis New Zealand Limited, 109 Carlton Gore Road, Newmarket, Auckland 1023, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335

Marketing authorization dates and numbers

30 May 1991

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.