It is expected that the usual dose of canadian rimonabant will be 20 mg once daily before breakfast. No dosage adjustment is recommended for the elderly, but this agent should be used with caution in patients older than 75 years of age.
Although rimonabant can be used in patients with mild hepatic impairment, caution is advised in patients with moderate impairment. This medication is not recommended for those with severe hepatic impairment.
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Rimonabant may be used cautiously in patients with mild-to-moderate renal impairment, but it is not recommended for patients who are severely renally impaired.
There are no data supporting the use of rimonabant in pediatric populations.
Rimonabant should not be given to patients with a known hypersensitivity to the agent or any compound found in the tablet formulation.
The drug is contraindicated in lactat-ing women and is not recommended for use in women who are pregnant.
ADVERSE DRUG EFFECTS
In four published clinical trials that evaluated the weight-loss effect of rimon-abant, nausea was the most commonly reported ADE, especially with the 20-mg dose. However, only one trial reported that very few patients discontinued treatment as a result of this effect. The most frequently reported ADE that led to early discontinuation of treatment in the studies involved psychiatric disorders, particularly depressed mood disorders. Generic Rimonabant association with psychiatric symptoms such as depression has prompted the warnings that patients with unstable psychiatric conditions should not receive rimona-bant and that use of this drug in combination with psychotropic agents has not been adequately studied. As a result, the use of rimonabant with other psy-chotropic agents is not recommended at this time.
Rimonabant offers a unique therapeutic approach for appetite control and weight reduction. It has demonstrated efficacy in sustaining weight loss but has also been associated with higher rates of psychiatric side effects, such as anxiety and depression, compared with placebo. These psychiatric side effects may significantly limit rimonabant’s use in certain patients.
Sanofi-Aventis filed for regulatory approval with the FDA in April 2005, hoping to have rimonabant ready for a 2006 launch. However, in February 2006, the FDA declined to issue a final approval and is still waiting until a number of unspecified issues are resolved. The FDA did grant rimonabant a “non-approvable” letter for its use as an aid for smoking cessation. As of this writing, the date of a final approval for rimonabant remains unclear, but it may be sometime in 2007. Therefore, practitioners wishing to use this medication as an adjunct to weight loss may have to wait for an indefinite period of time for its availability in the U.S.