Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Mundipharma Pharmaceuticals Limited, United Drug House, Magna Drive Magna Business Park, Citywest Road, Dublin 24, D24 XKE5, Ireland
Targin 15 mg/7.5 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. Grey, oblong tablets, with a nominal length of 9.5mm and with a film coating, embossed “OXN” on one side and “15” on the other. |
Each prolonged-release tablet contains 15 mg of oxycodone hydrochloride equivalent to 13.5 mg oxycodone and 7.5 mg naloxone hydrochloride as 8.24 mg of naloxone hydrochloride dihydrate equivalent to 6.75 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains 53.0 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Naloxone |
Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists, such as pentazocine, for example, but also nalorphine. |
|
| Oxycodone |
Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative. |
|
| Oxycodone and Naloxone |
Oxycodone and naloxone have an affinity for kappa, mu and delta opiate receptors in the brain, spinal cord and peripheral organs (e.g. intestine). Oxycodone acts as opioid-receptor agonist at these receptors and binds to the endogenous opioid receptors in the CNS. By contrast, naloxone is a pure antagonist acting on all types of opioid receptors. Naloxone counteracts opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. |
| List of Excipients |
|---|
|
Tablet core: Hydroxypropylcellulose Tablet coat: Polyvinylalcohol, partially hydrolysed |
Child resistant PVC/aluminium foil blisters:
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 tablets.
Hospital pack: 100 (10 × 10) tablets.
HDPE bottles with a child-resistant PP closure:
Pack size: 100 tablets
Not all pack sizes and container types may be marketed.
Mundipharma Pharmaceuticals Limited, United Drug House, Magna Drive Magna Business Park, Citywest Road, Dublin 24, D24 XKE5, Ireland
PA1688/010/006
Date of first authorisation: 31st January 2014
Date of last renewal: 8th November 2018
| Drug | Countries | |
|---|---|---|
| TARGIN | Austria, Australia, Brazil, Canada, Germany, Spain, Hong Kong, Ireland, Israel, New Zealand, Poland, Singapore |
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