Plot 303A, Abisogun Leigh Street, Adeniji Estate, Ogba GRA, Ogba, Ikeja, Lagos
PT Interbat, JI. H.R.M, Mangundiprojo no. 1 Buduran, Sidoarjo-61252, East Java, Indonesia.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Capsule (NRN: 04-2390): Tramadol HCI 50 mg.
Pack Size: Box contains 1 blister of 10 capsules; Box contains 5 blisters of 10 capsules.
Injection (NRN: 04-2389): Each ampoule (2 mL) contains: Tramadol HCI 100 mg.
Pack Size: Box contains 5 ampoules of 2 mL.
Tradyl contains Tramadol HCl, a central acting analgesic which has been effective and well tolerated, and likely to be of value for treating severe pain conditions where treatment with strong opioids is not required.
Commonly, intraoperative non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol are used to control post-operative pain, but their analgesic effect is often insufficient. Opioids provide effective analgesia but fear of their side effects, especially respiratory depression, emesis and sedation, have restricted their use in day-case anaesthesia.
Tramadol has a low affinity for opioid receptors but also exerts its effect by direct modulation of central monoaminergic pathways.
In children over 1 year, Tramadol was well tolerated as an effective analgesic after operation, with adverse effects similar to those of other opioids. Because of its relative lack of sedative action and respiratory depression, it may offer an advantage over traditional opioids for relief of post-operative pain in day-case surgery.
The advantages of Tradyl:
Tradyl is an analgesic with mixed opioid and non-opioid activities which has significantly less respiratory depression effects compared to morphine at recommended doses. In contrast to morphine, Tradyl has not been shown to cause histamin release.
Tradyl offers similar analgesic potential to morphine, but is one-fifth to one-tenth as potent as morphine on a per milligram basis.
Tradyl is a pain reliever. It affects chemicals and receptors in the body that are associated with pain. It is used to relieve moderate to moderately severe pain.
Tradyl can be administered concomitantly with other analgesics.
Tradyl has been used with good results for the management of labour pain without respiratory depression of the neonate.
Tradyl is also effective for the treatment of pain from myocardial ischemia, ureteric colic and acute trauma pain.
Tradyl may impair the reactions of drivers and machine operators even when taken according to the instuctions.
Tradyl should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function, excessive bronchial secretion and in patients prone to convulsive disorders or shock.
Lung function may decrease if Tradyl is combined with another CNS depressant or if the recommended dosage is exceeded.
Tradyl is not suitable in opiate-dependent patients.
Tradyl cannot suppress morphine wiithdrawl symthoms.
1% of the dosage passes into the milk.
Tradyl is well tolerated by most pattients. Sweating, dizziness, nausea, vomiting, dry mouth, fatigue, dyspepsia, constipation, rash may occur. These side effect occur particularly when the patient is subject to physical stress.
Dosage & Administration
Tradyl can be taken with or without food.
For adults and children over 14 years, Tradyl may be administered at a dose of 50 mg. If satisfactory pain relief is not obtained within 30 - 60 minutes, another dose of 50 mg may be given. A maximum daily dose of 400 mg must not be exceeded.
In impaired renal and hepatic function, it may be neccessary to adjust the dosage intervals. Tradyl should not be given for longer than neccessary.
Store in a cool dry place. Keep out of the reach of children.