Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Mundipharma (Pty) Ltd, Block D, Grosvenor Square, Park Lane, Century City, 7441, Cape Town, South Africa
TarginAct 5 mg/2,5 mg.
TarginAct 10 mg/5 mg.
TarginAct 20 mg/10 mg.
TarginAct 40 mg/20 mg.
Strength:
5 mg/2,5 mg.
10 mg/5 mg.
20 mg/10 mg.
40 mg/20 mg.
Pharmaceutical form:
Prolonged Release Tablets.
| Pharmaceutical Form |
|---|
|
Prolonged Release Tablets. TarginAct 5 mg/2,5 mg is a blue capsule shaped tablet, marked “OXN” on one side and “5” on the other side. TarginAct 10 mg/5 mg is a white capsule shaped tablet, marked “OXN” on one side and “10” on the other side. TarginAct 20 mg/10 mg is a pink capsule shaped tablet, marked “OXN” on one side and “20” on the other side. TarginAct 40 mg/20 mg is a yellow capsule shaped tablet, marked “OXN” on one side and “40” on the other side. |
Oxycodone hydrochloride and naloxone hydrochloride.
Each TarginAct 5 mg/2,5 mg contains 5 mg oxycodone hydrochloride and 2,5 mg naloxone hydrochloride. Contains lactose 71,75 mg.
Each TarginAct 10 mg/5 mg contains 10 mg oxycodone hydrochloride and 5,0 mg naloxone hydrochloride. Contains lactose 64,25 mg.
Each TarginAct 20 mg/10 mg contains 20 mg oxycodone hydrochloride and 10,0 mg naloxone hydrochloride. Contains lactose 54,50 mg.
Each TarginAct 40 mg/20 mg contains 40 mg oxycodone hydrochloride and 20,0 mg naloxone hydrochloride. Contains lactose 109 mg.
For 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: ethylcellulose, lactose monohydrate, magnesium stearate, stearyl alcohol, talc. TarginAct 5 mg/2,5 mg contains hydroxypropylcellulose. TarginAct 10 mg/5 mg; 20 mg/10 mg and 40 mg/20 mg contain povidone K30. Tablet coat: polyvinylalcohol, macrogol, talc, titanium dioxide. TarginAct 5 mg/2,5 mg contains Brilliant blue FCF aluminium lake. TarginAct 10 mg/5 mg contains no additional colourant. TarginAct 20 mg/10 mg contains Iron oxide red. TarginAct 40 mg/20 mg contains Iron oxide yellow. TarginAct contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, should not take TarginAct. |
TarginAct is supplied in clear PVC and silver aluminium foil blister packs of 28, which are enclosed in a cardboard carton.
Mundipharma (Pty) Ltd, Block D, Grosvenor Square, Park Lane, Century City, 7441, Cape Town, South Africa
South Africa: S6
TarginAct 5 mg/2,5 mg: 46/2.9/0645
TarginAct 10 mg/5 mg: 46/2.9/0646
TarginAct 20 mg/10 mg: 46/2.9/0647
TarginAct 40 mg/20 mg: 46/2.9/0648
Namibia: NS4
TarginAct 5 mg/2,5 mg: 16/2.9/0137
TarginAct 10 mg/5 mg: 16/2.9/0138
TarginAct 20 mg/10 mg: 16/2.9/0139
TarginAct 40 mg/20 mg: 16/2.9/0140
06 August 2015
| Drug | Countries | |
|---|---|---|
| TARGINACT | Cyprus, Ecuador, Estonia, Croatia, Netherlands, United Kingdom, South Africa |
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