Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Seqirus (NZ) Ltd, PO Box 62 590, Greenlane, Auckland 1546, New Zealand, Telephone: 0800 502 757
Tramal (tramadol hydrochloride) immediate release capsules 50 mg.
Tramal (tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL.
Tramal SR tablets (tramadol hydrochloride) sustained release tablets) 50 mg, 100 mg, 150 mg, 200 mg.
| Pharmaceutical Form |
|---|
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Tramal capsules are oblong, yellow/yellow, shiny hard gelatin capsules size 4. Tramal solution for injection is clear, colourless solution. Tramal SR 50mg sustained release tablets are pale yellow coloured, round, biconvex, filmcoated tablets, engraved with “T0” on one side and Grunenthal logo on the other side. Tramal SR 100 mg sustained release tablets are supplied as white, round, biconvex, filmcoated tablets, engraved with"T1" on one side and the Grunenthal logo on the other side. Tramal SR 150 mg sustained release tablets are supplied as pale orange-coloured, round, bi-convex, film-coated tablets, engraved with “T2” on one side and the Grunenthal logo on the other side. Tramal SR 200 mg sustained release tablets are supplied as slightly brownish orangecoloured, round, bi-convex, film-coated tablets, engraved with “T3” on one side and the Grunenthal logo on the other side. |
Tramal 50 mg capsules are yellow-yellow capsules containing: 50 mg tramadol hydrochloride.
Tramal 50 mg and 100 mg injections contain: tramadol hydrochloride 50 mg/mL.
Tramal SR sustained release tablets contain: tramadol hydrochloride in the following dose strengths: 50, 100, 150 and 200 mg.
For full list of excipients, see section 6.1 List of excipients.
Tramal capsules, Tramal solution for injection, and Tramal SR tablets contain tramadol hydrochloride which is (+)-cis-2-(dimethylaminomethyl)1(3-methoxyphenyl)-cyclohexanol hydrochloride. Tramadol hydrochloride is an odourless, white to off-white crystalline powder that is readily soluble in both water and ethanol and has a pKa of 9.41. The water/n-octanol partition coefficient is 1.35 at pH 7.
It belongs to the synthetic analgesics class and has opioid-like activity, with the formula: C16H25NO2. HCl. MW = 299.84.
The structural formula of tramadol hydrochloride is:
The CAS Registry Number is 36282-47-0
| Active Ingredient | Description | |
|---|---|---|
| Tramadol |
Tramadol, a cyclohexanol derivative, is a centrally acting opioid analgesic. It is a non-selective pure agonist at μ, δ and κ opioid receptors with a higher affinity for the μ receptor. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. |
| List of Excipients |
|---|
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Tramal 50 mg capsules: Excipients include: cellulose-microcrystalline, magnesium stearate, sodium starch glycollate, silica-colloidal anhydrous. Excipients in the capsule shell are: iron oxide yellow (CI 77492), titanium dioxide (CI 173015), sodium lauryl sulphate and gelatine. Tramal 50 mg and 100 mg injections: Excipients are: sodium acetate, Water for Injections. Tramal SR sustained release tablets: Excipients are: hypromellose105 mPa.s, silica-colloidal anhydrous, magnesium stearate, microcrystalline cellulose. Excipients in the film coat are: hypromellose 6 mPa.s, lactose monohydrate, macrogol 6000, propylene glycol, purified talc, titanium dioxide, quinoline yellow aluminium lake CI 47005 (150 and 200 mg tablets only), iron oxide red CI 77491 (150 and 200 mg tablets only), iron oxide yellow CI 77492 (50 and 200 mg tablets only) and iron oxide black CI 77499 (200 mg tablet only). Excipients with known effect: Lactose. |
Tramal 50mg immediate release capsules-packs of 6, 10, 20, 30 and 50 capsules.
Tramal 50, solution for injection-pack containing 5 ampoules of 1 mL each.
Tramal 100, solution for injection-pack containing 5 ampoules of 2 mL each.
Tramal SR 50 mg, 100 mg, 150 mg and 200 mg sustained release tablets – packs of 20 and 60 tablets.
Not all pack sizes may be marketed.
Seqirus (NZ) Ltd, PO Box 62 590, Greenlane, Auckland 1546, New Zealand, Telephone: 0800 502 757
Tramal capsules – 25/9/1997
Tramal solution for injection – 25/9/1997
Tramal SR 50mg – 2/11/2006
Tramal SR 100 mg – 2/3/2000
Tramal SR 150mg – 2/3/2000
Tramal SR 200 mg – 2/3/2000
| Drug | Countries | |
|---|---|---|
| TRAMAL | Austria, Australia, Brazil, Germany, Ecuador, Estonia, Finland, Croatia, Israel, Japan, Netherlands, New Zealand, Poland, Romania, Tunisia, South Africa |
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