TEVA-IRBESARTAN/HCTZ 12.5 MG
HYDROCHLOROTHIAZIDE : 12.5 MG IRBESARTAN : 300 MG · DIN 02316021 · TEVA CANADA LIMITED
Health Canada status: CANCELLED POST MARKET
What is TEVA-IRBESARTAN/HCTZ?
TEVA-IRBESARTAN/HCTZ 12.5 MG contains HYDROCHLOROTHIAZIDE : 12.5 MG IRBESARTAN : 300 MG. It is listed in the Health Canada Drug Product Database under DIN 02316021, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 10-Apr-2018. 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 TEVA-IRBESARTAN/HCTZ used for?
Treatment of essential hypertension in patients for whom combination therapy is appropriate; initial therapy in patients with severe essential hypertension (Sitting DBP ≥ 110 mmHg).
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 | 02316021 |
|---|---|
| Brand name | TEVA-IRBESARTAN/HCTZ |
| Generic / active ingredient | HYDROCHLOROTHIAZIDE : 12.5 MG IRBESARTAN : 300 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 12.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C09DA04 IRBESARTAN AND DIURETICS |
| AHFS class | 40:28.20 ; 24:32.08 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 10-Apr-2018 |
| Original market date | 2011-03-21 00:00:00 |
How is it administered?
Treatment of hypertension: 1 tablet daily. Not for initial therapy in mild-to-moderate hypertension. May be used as initial therapy in severe hypertension (DBP ≥ 110 mmHg).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to Storage and Stability section).
How is it supplied?
Not explicitly detailed in provided text (refers to Dosage Forms, Composition and Packaging section).
Contraindications
Hypersensitivity to components or sulfonamide-derived drugs; anuria; pregnancy; nursing; combination with aliskiren in patients with diabetes or renal impairment; combination with ACEIs in diabetic nephropathy.
Warnings and precautions
Fetal toxicity risk. Hypotension risk in volume/salt depleted patients. Dual blockade of RAS increases risk of hypotension and renal failure. Risk of acute myopia and angle-closure glaucoma.
Is IRBESARTAN AND DIURETICS in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by SANIS HEALTH INC, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code C09DA04 IRBESARTAN AND DIURETICS. 17 of 67 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 |
|---|---|---|---|---|---|
| AVALIDE | 12.5 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02241819 |
| AVALIDE | 150 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02241818 |
| IRBESARTAN HCT | 12.5 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02385325 |
| IRBESARTAN HCT | 150 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02385317 |
| IRBESARTAN HCT | 300 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02385333 |
| IRBESARTAN-HCTZ | 150 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02365162 |
| IRBESARTAN-HCTZ | 25 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02365189 |
| IRBESARTAN-HCTZ | 300 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02365170 |
| PMS-IRBESARTAN-HCTZ | 12.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02328526 |
| PMS-IRBESARTAN-HCTZ | 150 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02328518 |
Who else supplies IRBESARTAN AND DIURETICS worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. IRBESARTAN AND DIURETICS appears in 1256 registered pack listings across 14 markets, published on 11 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.