Plasma levels (auc) of atomoxetine at this dose in rats are estimated to be 1 ..
The higher blood levels in pms lead to a higher rate of some adverse effects of strattera see concomitant use of potent cyp2d6 inhibitors or use in patients who are known to be cyp2d6 pms atomoxetine is primarily metabolized by the cyp2d6 pathway to 4-hydroxyatomoxetine ..
Patients should be instructed to consult a physician if they are taking or plan to take any prescription or over-thecounter medicines, dietary supplements, or herbal remedies ..
Table 4 above displays the incidence of sexual side effects reported by at least 2 of adult patients taking strattera in placebo-controlled trials ..
Strattera was administered as a single dose in the early morning and titrated on a weight-adjusted basis according to clinical response, up to a maximum dose of 1 ..
. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the and each time you get a refill ..
Patients should be instructed to consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking strattera. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. There are no adequate and well-controlled studies examining sexual dysfunction with strattera treatment.
Adhd symptoms were statistically significantly improved on strattera compared with placebo, as measured on the adhdrs scale. The first dose is usually taken when you wake up in the morning. Volume of distribution is similar across the patient weight range after normalizing for body weight.
Dosage adjustment of strattera may be necessary when coadministered with potent cyp2d6 inhibitors (e. The postmarketing seizure cases include patients with pre-existing and those with identified risk factors for seizures, as well as patients with neither a history of nor identified risk factors for seizures. In placebo-controlled registration studies involving adult patients, tachycardia was identified as an adverse event for 1.
Keep a list of all the products you use (including prescriptionnonprescription drugs and herbal products) and share it with your doctor and. Strattera is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social) for patients with this syndrome. You may report side effects to fda at 1-800-fda-1088 or at www.
The most commonly observed adverse reactions in patients treated with strattera (incidence of 5 or greater and at least twice the incidence in placebo patients) were constipation, , nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation (see table 4). Atomoxetine is excreted primarily as 4-hydroxyatomoxetine-o-glucuronide, mainly in the urine (greater than 80 of the dose) and to a lesser extent in the feces (less than 17 of the dose). In both studies, adhd symptoms statistically significantly improved more on strattera than on placebo, as measured on the adhdrs scale.
In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver dysfunction (e. Taking this medication late in the day may cause swallow the capsules whole. Coadministration of strattera (60 mg bid for 12 days) with midazolam, a model compound for cyp3a4 metabolized drugs (single dose of 5 mg), resulted in 15 increase in auc of midazolam. Strattera was administered as a divided dose in the early morning and late afternoon (after school) and titrated on a weight-adjusted basis according to clinical response.
Patients beginning treatment for adhd should be monitored for the appearance or worsening of aggressive behavior or hostility. The blood levels in pms are similar to those attained by taking strong inhibitors of cyp2d6. Keep all do not flush medications down the toilet or pour them into a drain unless instructed to do so. If the capsule is accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible with water. Strattera did not worsen anxiety in these patients as determined by the liebowitz social anxiety scale (lsas).
Poor metabolizers (pms) of cyp2d6 have a 10-fold higher auc and a 5-fold higher peak concentration to a given dose of strattera compared with extensive metabolizers (ems). Volume of distribution is similar across the patient weight range after normalizing for body weight. Selected from data included with permission and copyrighted by first databank, inc. Strattera has not been systematically evaluated in adult patients with a seizure disorder as these patients were excluded from clinical studies during the products premarket testing. Consideration should be given to not treating adults with clinically significant cardiac abnormalities.