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Basic Drug Info
Drug Name:TRAMADOL HYDROCHLORIDE
Manufacturer:CARACO PHARMACEUTICAL LABORATORIES, LTD.
Other Info:



Clinical Trials:


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

Tramadol hydrochloride 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 tablets within the recommended dosage range.

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

Concomitant use of tramadol hydrochloride tablets increases the seizure risk in patients taking:Selective serotonin reuptake inhibitors (SSRI antidepressants or anoretics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Other opioids.Administration of tramadol hydrochloride tablets may enhance the seizure risk in patients taking:MAO inhibitors (see also WARNINGS - Use with MAO inhibitors), Neuroleptics, or Other 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 hydrochloride tablets 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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