LABETALOL HYDROCHLORIDE INJECTION USP 5 MG
LABETALOL HYDROCHLORIDE : 5 MG · DIN 02385120 · STERIMAX INC
Health Canada status: MARKETED
What is LABETALOL HYDROCHLORIDE INJECTION USP?
LABETALOL HYDROCHLORIDE INJECTION USP 5 MG contains LABETALOL HYDROCHLORIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02385120, held by STERIMAX INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 26-May-2021. 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 LABETALOL HYDROCHLORIDE INJECTION USP used for?
Emergency treatment of severe hypertension when prompt and urgent reduction of blood pressure is essential.
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 | 02385120 |
|---|---|
| Brand name | LABETALOL HYDROCHLORIDE INJECTION USP |
| Generic / active ingredient | LABETALOL HYDROCHLORIDE : 5 MG |
| Manufacturer | STERIMAX INC |
| Strength | 5 MG |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | C07AG01 LABETALOL |
| AHFS class | 24:24.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-May-2021 |
| Original market date | 2021-05-26 00:00:00 |
How is it administered?
Individualize dose. Initial: 0.25 mg/kg (max 20 mg) slow IV over 2 min. Repeat 40-80 mg at 10-min intervals. Max 300 mg. Can also be given via slow continuous infusion (2 mg/min). Keep patient supine.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Stable for 24 hours refrigerated or at room temperature when diluted in compatible fluids. (Specific product storage not explicitly listed in provided text snippet).
How is it supplied?
20 mL vials (implied by dilution instructions).
Contraindications
Hypersensitivity; sinus bradycardia or sick sinus syndrome; uncontrolled congestive heart failure; cardiogenic shock; asthma or history of obstructive lung disease; >1st degree AV block.
Warnings and precautions
Postural hypotension (keep supine for 3 hours); cardiac failure; sinus bradycardia; hepatic injury (rarely fatal); mask hypoglycemia/thyrotoxicosis; risk of anaphylactic reactions.
Is LABETALOL in shortage in Canada?
A Canadian shortage report is on file for this molecule: Active — reported by OMEGA LABORATORIES LIMITED, 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.
Check availability for LABETALOL HYDROCHLORIDE INJECTION USP
What can be used instead?
Other Canadian products sharing ATC code C07AG01 LABETALOL. 10 of 22 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-LABETALOL | 100 MG | TABLET | APOTEX INC | MARKETED | DIN 02243538 |
| APO-LABETALOL | 200 MG | TABLET | APOTEX INC | MARKETED | DIN 02243539 |
| LABETALOL HYDROCHLORIDE INJECTION | 5 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | DIN 02457040 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02231689 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02541505 |
| RIVA-LABETALOL | 100 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02489406 |
| RIVA-LABETALOL | 200 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02489414 |
| TRANDATE | 100 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02106272 |
| TRANDATE | 200 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02106280 |
| LABETALOL HYDROCHLORIDE INJECTION | 5 MG | SOLUTION | JUNO PHARMACEUTICALS CORP. | CANCELLED PRE MARKET | DIN 02539101 |
Who else supplies LABETALOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. LABETALOL appears in 39 registered pack listings across 9 markets, published on 7 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.