XIGDUO 1000 MG
METFORMIN HYDROCHLORIDE : 1000 MG DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) : 5 MG · DIN 02449943 · ASTRAZENECA CANADA INC
Health Canada status: MARKETED
What is XIGDUO?
XIGDUO 1000 MG contains METFORMIN HYDROCHLORIDE : 1000 MG DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02449943, held by ASTRAZENECA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Feb-2016. 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 XIGDUO used for?
Adjunct to diet and exercise in adults with type 2 diabetes mellitus already treated and controlled with dapagliflozin and metformin (with or without sulfonylurea, sitagliptin, or insulin).
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 | 02449943 |
|---|---|
| Brand name | XIGDUO |
| Generic / active ingredient | METFORMIN HYDROCHLORIDE : 1000 MG DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) : 5 MG |
| Manufacturer | ASTRAZENECA CANADA INC |
| Strength | 1000 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A10BD15 METFORMIN AND DAPAGLIFLOZIN |
| AHFS class | 68:20.04 ; 68:20.18 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 08-Feb-2016 |
| Original market date | 2016-02-08 00:00:00 |
How is it administered?
Recommended dose is one tablet twice daily with meals. Tablets must be swallowed whole. Maximum daily dose: 10 mg dapagliflozin / 2000 mg metformin.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C.
How is it supplied?
10-count blisters in cartons of 60 tablets.
Contraindications
Type 1 diabetes; metabolic acidosis (DKA, lactic acidosis); severe renal impairment (eGFR <30); hepatic disease; excessive alcohol; cardiovascular collapse; severe dehydration; pregnancy/breastfeeding.
Warnings and precautions
Lactic acidosis (metformin accumulation); Diabetic Ketoacidosis (DKA) even with normal glucose; volume depletion/hypotension; risk of hypoglycemia with insulin/secretagogues.
What can be used instead?
Other Canadian products sharing ATC code A10BD15 METFORMIN AND DAPAGLIFLOZIN. 6 of 6 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 |
|---|---|---|---|---|---|
| APO-DAPAGLIFLOZIN-METFORMIN | 5 MG | TABLET | APOTEX INC | MARKETED | DIN 02536161 |
| APO-DAPAGLIFLOZIN-METFORMIN | 850 MG | TABLET | APOTEX INC | MARKETED | DIN 02536153 |
| AURO-DAPAGLIFLOZIN / METFORMIN | 1000 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02533081 |
| AURO-DAPAGLIFLOZIN / METFORMIN | 5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02533073 |
| XIGDUO | 850 MG | TABLET | ASTRAZENECA CANADA INC | MARKETED | DIN 02449935 |
Who else supplies METFORMIN AND DAPAGLIFLOZIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. METFORMIN AND DAPAGLIFLOZIN appears in 1377 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.