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Ultram (Tramadol)



Ultram


Ultram is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. procedures and pain following oral surgery (extraction of impacted molars). ULTRAN received U.S. Food and Drug Administration (FDA) approval in March, 1995. In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg of Ultram ( Tramadol ) tended to provide analgesia superior to codeine sulfate 60 mg, but it was not effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. Ultram ( Ultram ( Tramadol ) ) has been prescribed in more than 55 million patients worldwide and ULTRAM has been prescribed in more than 21 million patients in the United States.

Ultram ( Tramadol ) (generic for Ultram) is a white, bitter, crystalline and odorless powder. Each Ultram ( Tramadol ) tablet tablet tablet contains 50 mg of Ultram ( Tramadol ) hydrochloride and is white in color.

HOW DOES Ultram ( Tramadol ) WORK?

Ultram ( Tramadol ) acts on the central nervous system and unlike codeine and its derivative medications is a totally synthetic analgesic compound. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: the binding of parent compound and its metabolite to opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin by nerves located within the central nervous system. Ultram ( Tramadol )-induced analgesia is only partially reversed by the opiate antagonist naloxone in several animal tests. Ultram ( Tramadol ) has been shown to inhibit reuptake of norepinephrine and serotonin in vitro. These mechanisms may contribute independently to the overall analgesic profile of Ultram ( Tramadol ). Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

HOW EFFECTIVE IS Ultram ( Tramadol )?

Ultram ( Tramadol ) has been given in single oral doses of 50, 75, 100, 150 and 200 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars). In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg of Ultram ( Tramadol ) tended to provide analgesia superior to codeine sulfate 60 mg, but it was not effective as the combination of aspirin 650 mg with codeine phosphate 60 mg. In single- dose models of pain following surgical procedures, 150 mg provided analgesia generally comparable to the combination of acetaminophen 650 mg with propoxyphene napsylate 100 mg, with a tendency toward later peak effect. Ultram ( Tramadol ) has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving Ultram ( Tramadol ). Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of Ultram ( Tramadol ) in divided doses were generally comparable with five doses of acetaminophen 300 mg with codeine phosphate 30 mg (Tylenol with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (Tylox) daily.

HOW DO I USE Ultram ( Tramadol )?

For the treatment of painful conditions Ultram ( Tramadol ) 50 mg to 100 mg can be administered as needed for relief every four to six hours, not to exceed 400 mg per day. For moderate pain Ultram ( Tramadol ) 50 mg may be adequate as the initial dose, and for more severe pain, Ultram ( Tramadol ) 100 mg is usually more effective as the initial dose.

Individualization of Dose :

Patients 65 to 75 years of age : No dose adjustment is necessary.

Patients over 75 years old : No more then 300 mg/day in divided doses

Patients with kidney impairment : The dosing interval of Ultram ( Tramadol ) should be increased to 12 hours with a maximum daily dose of 200 mg.

Dialysis patients : These patients can receive their regular dose on the day of dialysis.

Patients with cirrhosis : Recommended dosage is 50 mg every 12 hours.

Patients receiving chronic carbamazepine : Doses up to 800 mg daily may be required, this is up to twice the recommended dose of Ultram ( Tramadol ).

ADVERSE REACTIONS :

Ultram ( Tramadol ) was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. TABLE 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to Ultram ( Tramadol ) administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for Ultram ( Tramadol ) and the active control groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325 mg with codeine phosphate 30 mg. (TABLE 2)



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