AMIODARONE HYDROCHLORIDE FOR INJECTION, USP 50 MG
AMIODARONE HYDROCHLORIDE : 50 MG · DIN 02245248 · FRESENIUS KABI CANADA LTD
Health Canada status: MARKETED
What is AMIODARONE HYDROCHLORIDE FOR INJECTION, USP?
AMIODARONE HYDROCHLORIDE FOR INJECTION, USP 50 MG contains AMIODARONE HYDROCHLORIDE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02245248, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 25-May-2023. 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 AMIODARONE HYDROCHLORIDE FOR INJECTION, USP used for?
Initiation of treatment for life-threatening, frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) refractory to other treatment.
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 | 02245248 |
|---|---|
| Brand name | AMIODARONE HYDROCHLORIDE FOR INJECTION, USP |
| Generic / active ingredient | AMIODARONE HYDROCHLORIDE : 50 MG |
| Manufacturer | FRESENIUS KABI CANADA LTD |
| Strength | 50 MG |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | C01BD01 AMIODARONE |
| AHFS class | 24:04.04.20 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-May-2023 |
| Original market date | 2002-04-23 00:00:00 |
How is it administered?
Must be diluted. First 24h: 150mg rapid loading (10 min), 360mg slow loading (6h), then 540mg maintenance (18h). Maintenance rate 0.5 mg/min. Administer via volumetric pump and in-line filter.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Amiodarone Hydrochloride for Injection, USP does not need to be protected from light during administration. (Specific temperature range not provided in text snippet).
How is it supplied?
5 mL Type I amber glass multiuse vials containing 3 mL of solution (50 mg/mL). Available in packages of 25 vials.
Contraindications
Known hypersensitivity to components; cardiogenic shock; severe sinus-node dysfunction causing bradycardia; second- or third-degree AV block; syncope due to bradycardia (except with pacemaker).
Warnings and precautions
Serious pulmonary toxicity (fatal in 10%); liver injury; proarrhythmia; hypotension. Must be initiated in hospital. Adsorbs to PVC; leaches DEHP. Use central venous catheter for long infusions.
Is AMIODARONE in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by JAMP PHARMA CORPORATION, last seen 20 Mar 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 AMIODARONE HYDROCHLORIDE FOR INJECTION, USP
What can be used instead?
Other Canadian products sharing ATC code C01BD01 AMIODARONE. 12 of 35 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 |
|---|---|---|---|---|---|
| AMIODARONE | 200 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02364336 |
| AMIODARONE | 200 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02385465 |
| AMIODARONE HYDROCHLORIDE FOR INJECTION | 50 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02242325 |
| APO-AMIODARONE TABLETS | 200 MG | TABLET | APOTEX INC | MARKETED | DIN 02246194 |
| JAMP AMIODARONE | 200 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02531844 |
| PMS-AMIODARONE | 100 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02292173 |
| PMS-AMIODARONE | 200 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02242472 |
| PRO-AMIODARONE - 200 | 200 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02309661 |
| RIVA-AMIODARONE | 200 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02247217 |
| SANDOZ AMIODARONE | 200 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02243836 |
Who else supplies AMIODARONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. AMIODARONE appears in 722 registered pack listings across 9 markets, published on 9 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.
Request a quote for AMIODARONE HYDROCHLORIDE FOR INJECTION, USP
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.