MODURETIC Tablet Ref.[50873] Active ingredients: Amiloride Hydrochlorothiazide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: Pharmacy Retailing Pty Ltd, t/a Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand Telephone (09) 9185 100 Email: aspen@aspenpharma.co.nz

Product name and form

MODURETIC 50mg/5mg Tablet.

Pharmaceutical Form

MODURETIC tablets are plain, peach, diamond shaped, compressed tablets.

Qualitative and quantitative composition

Each tablet contains hydrochlorothiazide 50 mg and amiloride hydrochloride dihydrate 5 mg. For full lists of excipients, see section 6.1.

Active Ingredient Description
Amiloride

Amiloride has mild diuretic and anti-hypertensive activity. It acts primarily in the distal tubule and does not require aldosterone for its action. Amiloride is a mild natriuretic which does not initiate a concomitant decrease in potassium levels.

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted.

List of Excipients

Lactose
Dibasic calcium phosphate dihydrate (calcium hydrogen phosphate)
Starch – maize
Guar gum
Starch – pregelatinised maize
Magnesium stearate
Sunset yellow FCF lake CI15985

Pack sizes and marketing

Blister pack, PVC/PVdC/Al – 50 tablets.

Marketing authorization holder

Pharmacy Retailing Pty Ltd, t/a Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand
Telephone (09) 9185 100
Email: aspen@aspenpharma.co.nz

Marketing authorization dates and numbers

Date of first approval: 4 August 2010

Drugs

Drug Countries
MODURETIC Australia, Brazil, Estonia, Mexico, New Zealand, United Kingdom, South Africa

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