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Safety Facts & Side Effects Jump to Safety | Dosage | Possible Side Effects | Drug Interactions | Precautions IS AMORYN SAFE? Yes, AMORYN is well tolerated and poses no health risks when taken as directed. Clinical research demonstrates the safety of the primary active ingredient in AMORYN, Hypericum perforatum extract. A recent meta-analysis considering 22 randomized, controlled trials found that "adverse effects occurred more frequently with standard antidepressants than with [hyperiucm extract]."1 Another meta-analysis found that "rates of side effects were low" with Hypericum extract.2 A 2001 review concluded that, "In view of its efficacy and safety records, [Hypericum extracts] should be considered for the first-line treatment of mild to moderate depression."3 The researchers conducting a double-blind study with 375 patients, published in the American Journal of Psychiatry, concluded that "Hypericum extract was found to be safe."4 The mild doses of 5-HTP and B vitamins in AMORYN provide metabolic support for the action of the Hypericum perforatum extract but pose no additional health risks. 5-HTP is the immediate precursor to serotonin. Tryptophan, an amino acid found in many common foods, is metabolized into 5-HTP by the body. The mild dose (50mg) of 5-HTP can facilitate production of serotonin in the CNS, especially in those with inadequate protein intake. 5-HTP is commonly taken as a dietary supplement in doses of 50-500mg without adverse effects. The moderate doses of B vitamins in AMORYN can help prevent deficiencies commonly associated with depression, but are not outside normal dietary ranges and are well below doses found in many common "B complex" supplements. DOSAGE INSTRUCTIONS AMORYN should be taken twice daily, one capsule in the morning and one capsule in the afternoon or evening. Small or sensitive patients should take only one capsule of AMORYN for the first week, and then increase to two capsules if no side effects occur. After taking AMORYN for four weeks without any negative side effects, the daily dose may be increased to three or four capsules daily. Patients should not exceed four capsules daily. AMORYN can be taken with food. Ideally the daily dose (2-4 capsules of AMORYN) is divided throughout the day. But the dosing schedule can be modified for each individual. For instance, the entire daily dose can be taken before sleep if AMORYN causes drowsiness or fatigue. Or, if a person experiences insomnia when taking AMORYN in the evening, the entire daily dose can be taken in the morning and early afternoon. Four to eight weeks is necessary to experience the full benefits of AMORYN, although some people notice positive changes within days. DOSE CLASSIFICATIONS One (1) capsule daily Hyperforin 22.5mg, 5-HTP 25mg Light / Introductory Two (2) capsules daily Hyperforin 45mg, 5-HTP 50mg Moderate Three (3) capsules daily Hyperforin 67.5mg, 5-HTP 75mg Strong Four (4) capsules daily Hyperforin 90mg, 5-HTP 100mg Maximum POSSIBLE SIDE EFFECTS Most people do not experience any negative side effects when taking AMORYN. Side effects, when they do occur, are typically mild. Mild side effects may include headache, abdominal pain, diarrhea, insomnia, fatigue, dizziness and dry mouth. Taking AMORYN with food may minimize some of these side effects. AMORYN may increase the skin's sensitivity to sunlight. Individuals with fair skin or extreme sensitivity to sunlight should use extra sunblock. When taken as directed above, AMORYN has no known serious and/or life-threatening side effects. Clinical research suggests that the ingredients in AMORYN are generally better tolerated than synthetic SSRIs and tricyclics. DRUG INTERACTIONS Cytochrome 3A4: AMORYN may induce cytochrome isoenzyme 3A4, affecting metabolism of certain medications and reducing serum concentrations. Drugs metabolized by 3A4 include theophylline, HIV protease inhibitors, HIV non-nucleoside reverse transcriptase inhibitors, cyclosporin/tacrolimus, diltiazem/nifedipine. Irinotecan: Due to changes in hepatic metabolism caused by AMORYN, levels of irinotecan metabolite SN-38 may be lowered by as much as 40% for up to 3 weeks following discontinuation of AMORYN. Warfarin: May increase or decrease activity of warfarin when administered concomitantly. Digoxin: Prolonged concurrent administration may result in decreased absorption of digoxin with lowered plasma concentrations. Oral contraceptives: May reduce blood levels resulting in decreased efficacy. Triptans, SSRIs, MAOIs, and Tricyclic Antidepressants: Concurrent administration results in an increased serotonergic effect and possible serotonin syndrome. PRECAUTIONS Individuals diagnosed with bipolar or manic-depressive disorder should not take AMORYN without the approval and supervision of a psychiatrist. Individuals diagnosed with schizophrenia should take AMORYN only under the close supervision of a physician. AMORYN should not be combined with an MAO inhibitor. The 5-HTP in AMORYN is contraindicated with MAOIs, and combining AMORYN with an MAOI can lead to hypertensive crisis or serotonin syndrome. AMORYN should be combined with SSRIs only under the close supervision of a physician. Patients taking AMORYN with a prescription SSRI suffer increased risk of serotonin syndrome. Children under 12 should not take AMORYN. Pregnant women should not take AMORYN. AMORYN may decrease the effectiveness of medications, such as protease inhibitors, taken for the treatment of HIV. AMORYN may increase the skin's sensitivity to sunlight. If you have any questions or concerns about this information, feel free to contact us. REFERENCES: (1) Whiskey E, Werneke U, Taylor D. A systematic review and meta-analysis of Hypericum perforatum in depression: a comprehensive clinical review. Int Clin Psychopharmacol 2001 Sep;16(5):239-52. (2) Gaster B, Holroyd J. St John's wort for depression: a systematic review. Arch Intern Med 2000 Jan 24;160(2):152-6. (3) Di Carlo G, Borrelli F, Izzo AA, Ernst E. St. John's wort: Prozac from the plant kingdom. Trends Pharmacol Sci. 2001 Nov;22(11):557-9. (4) Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John's wort extract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry 2002 Aug;159(8):1361-6.

	©2005-2008 BioNeurix Corp. | About Us | Privacy and Security | Terms and Conditions of Sale | Contact Us | Site Map AMORYN is not a drug and is not intended to diagnose, treat, cure or prevent major depressive disorder, bipolar disorder, dysthymic disorder, generalized anxiety disorder, panic disorder, or any other disease. AMORYN should not be considered equivalent to or a substitute for an FDA-approved drug. AMORYN and its logo are trademarks of BioNeurix Corp. Placing an order indicates that you understand and agree to the Terms and Conditions of Sale. The statements on the amoryn.com website have not been evaluated by the Food and Drug Administration. AMORYN is a dietary supplement, not a drug. AMORYN is not intended to diagnose, treat, cure or prevent any disease.