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Tramadol Drug Abuse and Dependence

 

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Tramadol Hydrochloride may induce psychic and physical dependence of the morphine-type (µ-opioid). (See WARNINGS .) Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence.

The risk in patients with substance abuse has been observed to be higher. Tramadol is associated with craving and tolerance development. Withdrawal symptoms may occur if Tramadol Hydrochloride is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations.

Other symptoms that have been seen less frequently with reference listed drug discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.

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ULTRAM® (tramadol hydrochloride tablets) DESCRIPTION

ULTRAM® (tramadol hydrochloride tablets) is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2- [(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. 7

 The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It isreadily soluble in water and ethanol and has a pKa of 9.41. The
 water/n-octanol partition coefficient is 1.35 at pH 7. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color.

Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and 20 wax.

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