Source: Health Products and Food Branch (CA) Revision Year: 2020
ZYTRAM XL – Tramadol Hydrochloride Controlled Release Tablets.
Table 1. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form/Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| Oral | Controlled release tablets/75 mg, 100 mg, 150 mg, 200 mg, 300 mg, 400 mg | FD&C Blue No. 2 (75 mg only), hydrogenated vegetable oil, hypromellose, iron oxide (75 mg only), lactose, magnesium stearate, polyethylene glycol, talc, titanium dioxide |
ZYTRAM XL 75 mg tablets are pale grey, film-coated, round tablets, marked with a T on one side and 75 on the other.
ZYTRAM XL 100 mg tablets are white, film-coated, round tablets, marked with a T on one side and 100 on the other.
ZYTRAM XL 150 mg tablets are white, film coated, oval shaped tablets, plain on one side and T150 on the other.
ZYTRAM XL 200 mg tablets are white, film coated, oval shaped tablets, plain on one side and T200 on the other.
ZYTRAM XL 300 mg tablets are white, film coated, oval shaped tablets, plain on one side and T300 on the other.
ZYTRAM XL 400 mg tablets are white, film coated, oval shaped tablets, plain on one side and T400 on the other.
ZYTRAM XL is supplied in opaque plastic bottles of 60 tablets.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
|
| Drug | Countries | |
|---|---|---|
| ZYTRAM | Canada, Spain |
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