BENTYLOL TABLET 10MG 10 MG
DICYCLOMINE HYDROCHLORIDE : 10 MG · DIN 02103087 · APTALIS PHARMA CANADA ULC
Health Canada status: CANCELLED POST MARKET
What is BENTYLOL TABLET 10MG?
BENTYLOL TABLET 10MG 10 MG contains DICYCLOMINE HYDROCHLORIDE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02103087, held by APTALIS PHARMA CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 19-Nov-2018. 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 BENTYLOL TABLET 10MG used for?
Functional gastrointestinal tract conditions involving smooth muscle spasm (irritable colon, spastic constipation) and adjunctive therapy in organic GI conditions.
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 | 02103087 |
|---|---|
| Brand name | BENTYLOL TABLET 10MG |
| Generic / active ingredient | DICYCLOMINE HYDROCHLORIDE : 10 MG |
| Manufacturer | APTALIS PHARMA CANADA ULC |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Ethical |
| ATC code | A03AA07 DICYCLOVERINE |
| AHFS class | 12:08.08 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 19-Nov-2018 |
| Original market date | 1995-12-31 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02103087 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2103087 |
| Brand name | BENTYLOL TABLET 10MG |
| Active ingredient / INN | DICYCLOMINE HYDROCHLORIDE : 10 MG |
| ATC code | A03AA07 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A03 |
| AHFS class | 12:08.08 |
| Health Canada schedule | Ethical |
| Biosimilar biologic | No |
| Market authorization holder | APTALIS PHARMA CANADA ULC |
How is it administered?
Adults: 10-20 mg 3-4 times daily (max 160 mg/day). Children (2-12 yrs): 10 mg 3-4 times daily. Infants (6 mo-2 yrs): 5-10 mg 3-4 times daily, 15 min before feeding.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature (15-30°C). Protect from excessive heat and moisture.
How is it supplied?
Tablets: Bottles of 100. Syrup: Bottles of 250 mL.
Which pack is which?
| Strength on the label | 10 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Packaging as described in the monograph | Tablets: Bottles of 100. Syrup: Bottles of 250 mL. |
| Storage | Store at room temperature (15-30°C). Protect from excessive heat and moisture. |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Contraindications
Infants <6 months; nursing mothers; obstructive uropathy/GI disease; paralytic ileus; severe ulcerative colitis; myasthenia gravis; reflux esophagitis; glaucoma; unstable cardiovascular status.
Warnings and precautions
Serious respiratory symptoms and deaths reported in infants. May cause drowsiness or blurred vision. Psychosis and delirium reported in sensitive individuals.
What can be used instead?
Other Canadian products sharing ATC code A03AA07 DICYCLOVERINE. 3 of 15 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 |
|---|---|---|---|---|---|
| JAMP-DICYCLOMINE HCL | 10 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02391619 |
| JAMP-DICYCLOMINE HCL | 20 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02366088 |
| RIVA-DICYCLOMINE | 10 MG | CAPSULE | LABORATOIRE RIVA INC. | MARKETED | DIN 00557102 |
| BENTYLOL | 10 MG / 5 ML | SYRUP | APTALIS PHARMA CANADA ULC | CANCELLED POST MARKET | DIN 02102978 |
| BENTYLOL DOSPAN 30MG | 30 MG | TABLET (EXTENDED-RELEASE) | MERRELL PHARMS INC., DIVISION OF MERRELL DOW (CAN) | CANCELLED POST MARKET | DIN 00218723 |
| BENTYLOL INJ 10MG/ML | 10 MG | LIQUID | MERRELL PHARMS INC., DIVISION OF MERRELL DOW (CAN) | CANCELLED POST MARKET | DIN 00133965 |
| BENTYLOL TABLET 20MG | 20 MG | TABLET | APTALIS PHARMA CANADA ULC | CANCELLED POST MARKET | DIN 02103095 |
| DICYCLOMINE CAP 10MG | 10 MG | CAPSULE | DUCHESNAY INC | CANCELLED POST MARKET | DIN 00431028 |
| DICYCLOMINE HYDROCHLORIDE INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | DIN 00392812 |
| DICYCLOMINE HYDROCHLORIDE USP | 10 MG | CAPSULE | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | DIN 00392820 |
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.