TENEX use in specific populations
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Use in Specific Populations
Pregnancy Category B
Administration of guanfacine to rats at 70 times the maximum recommended human dose and to rabbits at 20 times the maximum recommended human dose resulted in no evidence of harm to the fetus. Higher doses (100 and 200 times the maximum recommended human dose in rabbits and rats respectively) were associated with reduced fetal survival and maternal toxicity. Rat experiments have shown that guanfacine crosses the placenta.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
Tenex (guanfacine hydrochloride) is not recommended in the treatment of acute hypertension associated with toxemia of pregnancy. There is no information available on the effects of guanfacine on the course of labor and delivery.
Nursing Mothers
It is not known whether Tenex (guanfacine hydrochloride) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenex is administered to a nursing woman. Experiments with rats have shown that guanfacine is excreted in the milk.
Pediatric Use
Safety and effectiveness in children under 12 years of age have not been demonstrated. Therefore, the use of Tenex in this age group is not recommended. There have been spontaneous postmarketing reports of mania and aggressive behavioral changes in pediatric patients with attention-deficit hyperactivity disorder (ADHD) receiving Tenex. The reported cases were from a single center. All patients had medical or family risk factors for bipolar disorder. All patients recovered upon discontinuation of guanfacine HCl. Hallucinations have been reported in pediatric patients receiving Tenex for treatment of attention-deficit hyperactivity disorder.
Geriatric Use
Clinical studies of Tenex did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient 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 (see CLINICAL PHARMACOLOGY: Pharmacokinetics).[1]
References
- ↑ "TENEX (GUANFACINE HYDROCHLORIDE) TABLET [PROMIUS PHARMA, LLC]". Retrieved 25 February 2014.