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Re: EMSAM doses too low to effect depression ?

Posted by notfred on June 12, 2006, at 11:02:12

In reply to Re: EMSAM doses too low to effect depression ?, posted by cecilia on June 11, 2006, at 21:40:49

> In Dr. Bob's "tips' (written long before Emsam) some of the doctors say they get good results for depression on 40-60 mg day of oral selegiline. The largest "patch" 12mg/24 h is supposedly equivalent to 40 mg oral,

The mon0graph indicates something different:

EMSAM systems are transdermal patches that contain 1 mg of selegiline per cm2 and deliver approximately 0.3 mg of selegiline per cm2 over 24 hours. EMSAM systems are available in three sizes: 20 mg/20 cm2,30 mg/30 cm2, and 40 mg/40 cm2 that deliver,

on average, doses of 6 mg, 9 mg or 12 mg, respectively, of selegiline over 24 hours.

Pharmacokinetics
Absorption
Following dermal application of EMSAM to humans, 25%-30% of the selegiline content on average is delivered systemically over 24 hours (range ~ 10%-40%).Consequently, the degree of drug absorption may be 1/3 higher than the average amounts of 6 to 12 mg per 24 hours.

So not more than 12 mg a day on the largest patch,
& that requires ditary restrictions:

To further define the likelihood of hypertensive crises with use of EMSAM, several Phase I tyramine challenge studies were conducted both with and without food (see PRECAUTIONS, Drug Interactions, Tyramine). In its entirety, the data for EMSAM 6 mg/24 hours support the recommendation that a modified diet is not required at this dose. Due to the more limited data available for EMSAM 9 mg/24 hours, and the results from the Phase I tyramine challenge study in fed volunteers administered EMSAM 12 mg/24 hours (see PRECAUTIONS, Drug Interactions, Tyramine), patients receiving these doses should follow Dietary Modifications Required for Patients Taking EMSAM 9 mg/24 hours and 12 mg/24 hours.


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poster:notfred thread:655515
URL: http://www.dr-bob.org/babble/20060610/msgs/655914.html