APO-HYDRALAZINE 10 MG
HYDRALAZINE HYDROCHLORIDE : 10 MG · DIN 00441619 · APOTEX INC
Health Canada status: MARKETED
What is APO-HYDRALAZINE?
APO-HYDRALAZINE 10 MG contains HYDRALAZINE HYDROCHLORIDE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 00441619, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 02-Oct-2017. 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 APO-HYDRALAZINE used for?
Treatment of essential hypertension, used in conjunction with other antihypertensives such as beta-blockers and diuretics.
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 | 00441619 |
|---|---|
| Brand name | APO-HYDRALAZINE |
| Generic / active ingredient | HYDRALAZINE HYDROCHLORIDE : 10 MG |
| Manufacturer | APOTEX INC |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C02DB02 HYDRALAZINE |
| AHFS class | 24:08.20 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 02-Oct-2017 |
| Original market date | 1990-12-31 00:00:00 |
How is it administered?
Initial: 10 mg 4x daily (2-4 days), then 25 mg 4x daily (rest of week), then 50 mg 4x daily. Maintenance: 50-200 mg daily. Do not exceed 100 mg/day without determining acetylator phenotype.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in the provided text (section 11 is listed in Table of Contents but text ends at section 9.5).
How is it supplied?
Bottles of 100 tablets.
Contraindications
Hypersensitivity to hydralazine; Idiopathic SLE; severe tachycardia; high cardiac output heart failure; myocardial insufficiency (obstruction); cor pulmonale; aortic aneurysm; coronary artery disease.
Warnings and precautions
May provoke SLE-like syndrome (especially >100mg/day or slow acetylators). Can precipitate angina or MI in CAD. Risk of peripheral neuritis (pyridoxine may help). Monitor blood counts and ANA.
What can be used instead?
Other Canadian products sharing ATC code C02DB02 HYDRALAZINE. 14 of 34 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-HYDRALAZINE | 25 MG | TABLET | APOTEX INC | MARKETED | DIN 00441627 |
| APO-HYDRALAZINE | 50 MG | TABLET | APOTEX INC | MARKETED | DIN 00441635 |
| HYDRALAZINE | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02539802 |
| HYDRALAZINE | 25 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02539810 |
| HYDRALAZINE | 50 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02539829 |
| HYDRALAZINE HYDROCHLORIDE INJECTION, USP | 20 MG | SOLUTION | AURO PHARMA INC | MARKETED | DIN 02516160 |
| HYDRALAZINE HYDROCHLORIDE INJECTION, USP | 20 MG | SOLUTION | EUGIA PHARMA INC. | MARKETED | DIN 02537699 |
| JAMP-HYDRALAZINE | 10 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02457865 |
| JAMP-HYDRALAZINE | 25 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02457873 |
| JAMP-HYDRALAZINE | 50 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02457881 |
Who else supplies HYDRALAZINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. HYDRALAZINE appears in 26 registered pack listings across 4 markets, published on 3 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.