Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-3076a |
| Trade Name | Dose Form | Strength | Identifier |
| Spiractin | Tablet | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Viatris Limited P O Box 11183 Ellerslie AUCKLAND 1542 | 20/3/1980 | Consent given Approval date: 20/3/1980 | Prescription |
| Reference product: Aldactone Film coated tablet 100 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Spironolactone 100mg | Zhejiang Shenzhou Pharmaceutical Co Ltd No 9 Hongyun Road Xiandai Industrial Zone Taizhou Xianju, Zhejiang 317 300 CHINA | |
| Excipient | ||
| Erythrosine | ||
| Lactose monohydrate | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Peppermint oil | ||
| Polysorbate 80 | ||
| Povidone | ||
| Purified talc | ||
| Quinoline yellow | ||
| Sodium starch glycolate | ||
| Starch | ||
| Sunset yellow FCF |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Alphapharm Pty Ltd 100 & 102 Antimony St and 11 & 15-25 Garnet St Carole Park Brisbane QLD 4300 AUSTRALIA |
| Manufacture of Final Dose Form | Alphapharm Pty Ltd 100 & 102 Antimony St and 11 & 15-25 Garnet St Carole Park Brisbane QLD 4300 AUSTRALIA |
| Packing | Alphapharm Pty Ltd 100 & 102 Antimony St and 11 & 15-25 Garnet St Carole Park Brisbane QLD 4300 AUSTRALIA |
| NZ Site of Product Release | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE Bottle and PP Child Resistant Caps | 100 tablets | 36 months from date of manufacture stored at or below 30°C |
Indications
Essential hypertension; oedematous conditions including congestive heart failure, cirrhosis of the liver, (with or without ascites) and the nephrotic syndrome; idiopathic oedema; diagnosis and treatment of primary aldosteronism, as adjunctive therapy in malignant hypertension; in hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 13/12/2023 | Changed Medicine Notification | Excipient specifications/test methods - G2; Administrative fee (CMN) | Granted 16/1/2024 | 20/12/2023 |
