Tramadol hydrochloride are an opioid agonist. It is a centrally acting analgesic which possesses opioid agonist properties. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl] -1-(3-methoxyphenyl) cyclohexanol hydrochloride.
INDICATIONS AND USAGE:
It is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve it for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
- Have not been tolerated or are not expected to be tolerated.
- Have not provided adequate analgesia or are not expected to provide adequate analgesia.
DOSAGE AND ADMINISTRATION:
Start it at 25mg/day and titrated in 25mg increments as separate doses every 3 days to reach 100mg /day (25mg four times a day). Thereafter the total daily dose may be increased by 50mg as tolerated every 3 days to reach 200mg/day (50mg four times a day). After titration, it can be administered (50 to 100mg) as needed for pain relief every 4 to 6 hours not to exceed 400mg/day.
The usual dose is 50 or 100mg 4-6 hourly by the intravenous or intramuscular route. Dosage should be adjusted
according to pain severity and response. Intravenous injections must be given slowly over 2-3 minutes. For post-operative pain administer an initial bolus of 100mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 400mg.
STORAGE AND INSTRUCTIONS:
To be sold and used on the prescription of a registered medical practitioner only. Keep out of the reach of children. Do not store
above 30°C. After opening store between 2°C to 8°C and use within 24 hours. Keep in dry place. Protect from light.
It is contraindicated for:
- All children younger than 12 years of age
- Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Hypersensitivity to tramadol, any other component of this product or opioids
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days
- In patients suffering from acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic medicinal products
- In patients with epilepsy not adequately controlled by treatment
- For use in narcotic withdrawal treatment
Patients should consult with their physician before taking any medicine.