RHOTRAL 100 100 MG
ACEBUTOLOL HYDROCHLORIDE : 100 MG · DIN 01910140 · SANOFI-AVENTIS CANADA INC
Health Canada status: CANCELLED POST MARKET
What is RHOTRAL 100?
RHOTRAL 100 100 MG contains ACEBUTOLOL HYDROCHLORIDE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 01910140, held by SANOFI-AVENTIS CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 26-Oct-2010. 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 RHOTRAL 100 used for?
RHOTRAL is indicated for the treatment of mild to moderate hypertension. It is usually used in combination with other drugs, particularly a thiazide diuretic, but may be used alone as an initial agent in select patients. It is also indicated for the long-term management of patients with angina pectoris due to ischemic heart disease.
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 | 01910140 |
|---|---|
| Brand name | RHOTRAL 100 |
| Generic / active ingredient | ACEBUTOLOL HYDROCHLORIDE : 100 MG |
| Manufacturer | SANOFI-AVENTIS CANADA INC |
| Strength | 100 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C07AB04 ACEBUTOLOL |
| AHFS class | 24:24.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 26-Oct-2010 |
| Original market date | 1991-12-31 00:00:00 |
How is it administered?
Hypertension: Initial 400 mg daily (single or divided). Angina: Initial 400 mg daily (divided). Dosage must be individualized. Reduce dose if creatinine clearance < 50 mL/min.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
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Contraindications
Hypersensitivity to beta-blockers; sinus bradycardia; sinus syndrome; 2nd/3rd degree A-V block; right ventricular failure; congestive heart failure; cardiogenic shock; severe peripheral disorders.
Warnings and precautions
Abrupt cessation can exacerbate angina or cause MI. May mask hypoglycemia in diabetics or hyperthyroidism signs. Use caution in bronchospastic disease and Prinzmetal angina. ANA titer increases.
What can be used instead?
Other Canadian products sharing ATC code C07AB04 ACEBUTOLOL. 6 of 44 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-ACEBUTOLOL | 100 MG | TABLET | APOTEX INC | MARKETED | DIN 02147602 |
| APO-ACEBUTOLOL | 200 MG | TABLET | APOTEX INC | MARKETED | DIN 02147610 |
| APO-ACEBUTOLOL | 400 MG | TABLET | APOTEX INC | MARKETED | DIN 02147629 |
| TEVA-ACEBUTOLOL | 100 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02204517 |
| TEVA-ACEBUTOLOL | 200 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02204525 |
| TEVA-ACEBUTOLOL | 400 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02204533 |
| ACEBUTOLOL | 100 MG | TABLET | SANIS HEALTH INC | CANCELLED POST MARKET | DIN 02286246 |
| ACEBUTOLOL | 200 MG | TABLET | SANIS HEALTH INC | CANCELLED POST MARKET | DIN 02286254 |
| ACEBUTOLOL | 400 MG | TABLET | SANIS HEALTH INC | CANCELLED POST MARKET | DIN 02286262 |
| ACEBUTOLOL - 400 | 400 MG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | DIN 02164426 |
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.