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Basic Drug Info
Drug Name:Tramadol Hydrochloride
Manufacturer:ALPHAPHARM PTY LTD
Other Info:

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose.

Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.

In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride be increased to 12 hours, with a maximum daily dose of 200 mg.

Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.

The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.

In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

For elderly patients over 75 years old, total dose should not exceed 300 mg/day.



Clinical Trials:


Indications and Usage
Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.
Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Contraindications

Tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids.

Tramadol is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.

Tramadol may worsen central nervous system and respiratory depression in these patients.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

LUNG FUNCTION DECREASED --

Warnings

Seizures have been reported in patients receiving tramadol hydrochloride within the recommended dosage range.

Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol hydrochloride above the recommended range.

Concomitant use of tramadol increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g.,cyclobenzaprine, promethazine, etc.), orOther opioids.Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors), Neuroleptics, orOther drugs that reduce the seizure threshold.Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).

In tramadol overdose, naloxone administration may increase the risk of seizure.
Branded Drugs
The following US Branded drugs contain Tramadol Hydrochloride


TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN -- BARR LABORATORIES INC

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN -- CARACO PHARMACEUTICAL LABORATORIES LTD

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN -- KALI LABORATORIES INC

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN -- MYLAN PHARMACEUTICALS INC

ULTRACET -- ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC

RYZOLT -- PURDUE PHARMA PRODUCTS LP

ULTRAM ER -- BIOVAIL LABORATORIES INTERNATIONAL SRL

ULTRAM -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC


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