ALDACTONE 100 MG 100 MG
SPIRONOLACTONE : 100 MG · DIN 00285455 · PFIZER CANADA ULC
Health Canada status: CANCELLED POST MARKET
What is ALDACTONE 100 MG?
ALDACTONE 100 MG 100 MG contains SPIRONOLACTONE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 00285455, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 17-Jul-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is ALDACTONE 100 MG used for?
Primary hyperaldosteronism, edematous conditions (congestive heart failure, cirrhosis with ascites, nephrotic syndrome), essential hypertension, and treatment/prophylaxis of hypokalemia.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 00285455 |
|---|---|
| Brand name | ALDACTONE 100 MG |
| Generic / active ingredient | SPIRONOLACTONE : 100 MG |
| Manufacturer | PFIZER CANADA ULC |
| Strength | 100 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C03DA01 SPIRONOLACTONE |
| AHFS class | 24:32.20 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 17-Jul-2026 |
| Original market date | 1975-12-31 00:00:00 |
How is it administered?
Adults: 25-400 mg daily depending on indication. Primary hyperaldosteronism: 100-400 mg. Edema: 100 mg (range 25-200 mg). Hypertension: 50-100 mg. Administer in single or divided doses.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text snippet (refer to full monograph section 11).
How is it supplied?
Bottles of 100 tablets.
Contraindications
Hypersensitivity, anuria, Addison’s disease, acute renal insufficiency, severe renal impairment (GFR < 30 mL/Min/1.73 m2), hyperkalemia, pregnancy, nursing, and use with eplerenone or heparin.
Warnings and precautions
Tumorigenicity (rats); risk of hyperkalemia; gynecomastia (dose-related); somnolence/dizziness (caution driving); potential for hyperchloremic metabolic acidosis in cirrhosis.
What can be used instead?
Other Canadian products sharing ATC code C03DA01 SPIRONOLACTONE. 6 of 10 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP SPIRONOLACTONE | 100 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02518848 |
| JAMP SPIRONOLACTONE | 25 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02518821 |
| MINT-SPIRONOLACTONE | 100 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02488159 |
| MINT-SPIRONOLACTONE | 25 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02488140 |
| TEVA-SPIRONOLACTONE | 100 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 00613223 |
| TEVA-SPIRONOLACTONE | 25 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 00613215 |
| ALDACTONE 25 MG | 25 MG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00028606 |
| NTP-SPIRONOLACTONE | 100 MG | TABLET | NT PHARMA CANADA LTD | CANCELLED PRE MARKET | DIN 02347628 |
| NTP-SPIRONOLACTONE | 25 MG | TABLET | NT PHARMA CANADA LTD | CANCELLED PRE MARKET | DIN 02347601 |
Who else supplies SPIRONOLACTONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. SPIRONOLACTONE appears in 137 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.