CANDESARTAN-HCTZ 16.0 MG
CANDESARTAN CILEXETIL : 16.0 MG HYDROCHLOROTHIAZIDE : 12.5 MG · DIN 02392275 · PRO DOC LIMITEE
Health Canada status: MARKETED
What is CANDESARTAN-HCTZ?
CANDESARTAN-HCTZ 16.0 MG contains CANDESARTAN CILEXETIL : 16.0 MG HYDROCHLOROTHIAZIDE : 12.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02392275, held by PRO DOC LIMITEE, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Oct-2012. 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 CANDESARTAN-HCTZ used for?
Treatment of essential hypertension in patients for whom combination therapy is appropriate. Not indicated for initial therapy.
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 | 02392275 |
|---|---|
| Brand name | CANDESARTAN-HCTZ |
| Generic / active ingredient | CANDESARTAN CILEXETIL : 16.0 MG HYDROCHLOROTHIAZIDE : 12.5 MG |
| Manufacturer | PRO DOC LIMITEE |
| Strength | 16.0 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C09DA06 CANDERSARTAN AND DIURETICS |
| AHFS class | 24:32.08 ; 40:28.20 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 17-Oct-2012 |
| Original market date | 2012-10-17 00:00:00 |
How is it administered?
Individualize dose by titration of components. Once stabilized, 16 mg/12.5 mg tablet once daily. Take with or without food at the same time each day. Not for initial therapy.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (section 11 mentioned but content not shown), typically 15-30°C for this class.
How is it supplied?
Blister packs of 30 tablets and bottles of 100 tablets.
Contraindications
Hypersensitivity to components or sulfonamides; pregnancy/nursing; anuria; severe hepatic/renal impairment; gout; combination with aliskiren in diabetes/renal impairment; children <1 year.
Warnings and precautions
Fetal toxicity risk; dual RAS blockade risks; hypotension; non-melanoma skin cancer risk; electrolyte imbalance; acute respiratory toxicity (ARDS); photosensitivity; glaucoma risk.
What can be used instead?
Other Canadian products sharing ATC code C09DA06 CANDERSARTAN AND DIURETICS. 22 of 49 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 |
|---|---|---|---|---|---|
| ATACAND PLUS | 12.5 MG | TABLET | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | DIN 02244021 |
| ATACAND PLUS | 12.5 MG | TABLET | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | DIN 02332922 |
| ATACAND PLUS | 25 MG | TABLET | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | DIN 02332957 |
| AURO-CANDESARTAN HCT | 12.5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02421038 |
| AURO-CANDESARTAN HCT | 12.5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02421046 |
| AURO-CANDESARTAN HCT | 25 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02421054 |
| CANDESARTAN HCT | 16 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02394812 |
| CANDESARTAN/HCTZ | 16 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02394804 |
| CANDESARTAN/HCTZ | 32 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02536064 |
| JAMP CANDESARTAN-HCT | 12.5 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02473259 |
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.