Effexor (venlafaxine) FREQUENTLY ASKED QUESTIONS Version 3.0 / 19 August 1994 Index. 1. What is Effexor 2. How does Effexor differ from other antidepressants? 3. What kinds of depression can be treated with Effexor? 4. What are the side-effects of Effexor? 5. Which side effects force people to stop taking Effexor? 6. Are there any special hazards for people with bipolar disorder? 7. Does Effexor interact with other medications? 8. Does Effexor interact with alcohol? 9. Is Effexor safe for a woman who is pregnant, about to become pregnant, or nursing an infant? 10. Is Effexor a satisfactory antidepressant for children and adolescents? 11. Is Effexor a satisfactory antidepressant for the elderly? 12. How is treatment with Effexor initiated? 13. What is the usual final dose of Effexor? 14. How long does it take Effexor to relieve depression. 15. Are there withdrawal effects if Effexor is suddenly discontinued? 16. Is Effexor toxic if an overdose is taken? 17. What precautions are necessary when switching between Effexor and a MAO inhibitor? 18. What does Effexor cost? 19. Additions and corrections. ====================================================================== ===== 1. What is Effexor Venlafaxine (Effexor) is a new antidepressant with a novel chemical structure. Venlafaxine has a structure that does not resemble those of any currently used antidepressants. Effexor is not a tricyclic anti- depressant or an MAO inhibitor. 2. How does Effexor differ from other antidepressants? Effexor seems to have the relative freedom from side-effects associated with the SSRIs [fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine (Luvox)] and the impact on both the serotonin and norepinephrine associated with the tricyclic antidepres- sants (amitriptyline (Elavil), imipramine (Tofranil) etc.). It is hypothesized that the action of the Effexor molecule upon both serotonin and norepinephrine will cause Effexor to be a successful antidepressant for some people who have not responded to treatment with SSRIs. As Effexor and its active metabolite have relatively short half-lives9es, 4 hours and 11 hours respectively, Effexor should be administered in divided does, two or three times a day. 3. What kinds of depression can be treated with Effexor? While the pre-marketing studies were restricted to patients with a DSM-III-R diagnosis of Major Depressive Disorder (with or without melancholia), it is to be expected that Effexor will be prescribed for patients with Dysthymia, Major Depression, and Bipolar Disorder. While Effexor was only studied for periods of administration of up to 6-weeks, it is to expected that patients with long-standing depres- sions will take the drug for longer periods of time. 4. What are the side-effects of Effexor? The most common side-effects and the percentage of people reporting them during clinical trials are: Nausea 37% Headache 25% Sleepiness 23% Dry mouth 22% Dizziness 19% Insomnia 18% Constipation 15% Nervousness 13% Raised blood pressure 13% * Fatigue 12% Sweating 12% Decreased appetite 11% Male sexual dysfunction 12% Female sexual Dysfunction 2% * While the manufacturer days that hypertension only occurs in patients receiving over 300 mg/day, there been reports of moderately severe hypertension in patients taking smaller doses. 5. Which side effects force people to stop taking Effexor? In the premarketing studies 19% (537 out of the 2897) of depressed patients ?taking Effexor discontinued the medication because of side- effects. The side effects and the percentages of total patients who dropped out for each are: Nausea 6% Sleepiness 3% Insomnia 3% Dizziness 3% Male sexual dysfunction 3% * Headache 2% Nervousness 2% Anxiety 2% Dry mouth 2% Fatigue 2% Sweating 2% * % of men 6. Are there any special hazards for people with bipolar disorder? As with other antidepressants, people with bipolar disorder who are not being treated with a mood regulator such as lithium, valproate (Depakote), or carbamazepine (Tegretol), may be pushed into a manic episode when treated with Effexor. 7. Does Effexor interact with other medications? Lithium - No interaction. Diazepam (Valium) - No interaction. Cimetidine (Tagamet) - Slight increase in blood level of Effexor's active metabolite. Not of clinical significance. Fluoxetine (Prozac) - Significant increase in the concentration of Effexor and its active metabolite. Potential for increased side-effects. 8. Does Effexor interact with alcohol? Although Effexor has not been found to increase the impairment of cognitive or motor skills caused by alcohol, the manufacturer warns against drinking while taking Effexor. 9. Is Effexor safe for a woman who is pregnant, about to become pregnant, or nursing an infant? There is no data to establish the safety of Effexor for the fetus or nursing infant. 10. Is Effexor a satisfactory antidepressant for children and adolescents? Although here have been no published studies on the use of Effexor for the treatment of children and adolescents with depression, it is expected that the drug will be prescribed for depressed children and adolescents. 11. Is Effexor a satisfactory antidepressant for the elderly? No special problems were encountered when Effexor was prescribed for elderly people with depression. 12. How is treatment with Effexor initiated? b In adults, the usual starting dose of Effexor is 75 mg a day taken in two or three divided doses with food (to minimize nausea). If higher doses are needed, the dose should not be increased more rapidly than 75 mg every 4 days. When Effexor is given to elderly patients the starting doses are the same as for other adults. As older people may be more sensitive to increases in dose they should be made slowly. 13. What is the usual final dose of Effexor? While doses up to 375 mg per day are approved by the FDA, some severely depressed patients have been treated with higher doses. Most depressed people respond to doses under 300 mg per day. 14. How rapidly may a person with depression feel some relief from taking Effexor? While most people taking Effexor become aware of some lessening of depression within two to four weeks, there are some who experience relief within the first week and others who only experience relief after a couple of months of therapy. 15. Are there withdrawal effects if Effexor is suddenly discontinued? Because of the very short half-life, Effexor should be discontinued gradually over at least 2-weeks. If Effexor is suddenly discontinued, a withdrawal syndrome involving fatigue, nausea, dizziness, headache, insomnia, and nervousness, may develop. 16. Is Effexor toxic if an overdose is taken? Fourteen overdoses of Effexor have been reported. In some cases Effexor was taken along with alcohol and/or other medications. All individuals who took an overdose recovered without sequelae. 17. What precautions are necessary when switching between Effexor and a MAO inhibitor? When switching from an MAO inhibitor to Effexor, there should be a 14-day interval between the discontinuation of the MAOI and the initiation of Effexor therapy. When switching from Effexor to an MAOI a 7-day interval is adequate, because of Effexor's short half- life. 18. What does Effexor cost? Effexor is supplied in tablets ranging from 25 to 100 mg in strength. The 25 mg tablets cost pharmacies nearly as much as the 100 mg tablets ($0.71 vs. $0.83). It is expected that all strengths of Effexor will be sold for between $1.00 and $1.50 per tablet. 19. Additions and corrections to:. -- -- \\\\ (@ @) ||-----------------------------------------------------ooOo-( )-oOoo--- -|| || Ivan Goldberg, MD ~ || || ikg1@columbia.edu psydoc@netcom.com || || Voice = +1 212 876 7800 Fax = +1 212 737 0473 || || NY Psychopharmacologic Inst. 1346 Lexington Ave NYC 10128 || ||--------------------------------------------------------------------- -||