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Product Information A superior form of S-Adenosyl-Methionine. Boosts brain function, mood and neuroyransmitters. Detoxifies the liver. Natural anti-inflamatory effects. PROPRIETARY NAME (and dosage form): SAMe butanedisulfonate (tablets) COMPOSITION: Each tablet contains the following as active ingredients: S-adenosyl-methionine..................................400mg (butanedisulfonate salt) (tablet is enteric coated to protect against stomach acid) Inactive ingredients: Hydroxypropyl cellulose, sodium hydroxymethyl starch, silica gel, and magnesium stearate. PHARMACOLOGICAL ACTION: SAMe (s-adenosyl-methionine) is available in various salts with the butanedisulfonate form being the most stable. SAMe is a naturally occuring molecule that occurs in virtually all tissues and fluids. SAMe functions primarily as a methyl donor. A wide variety of molecules accept SAMe's methyl groups; naturally occurring recipients include proteins, phospholipids, DNA, RNA, hormones, and the energy-transporting amino acid creatine. Methyl transfer is essential to the development of the phospholipid bilayer that makes up the outer membranes of normal cells and contributes to membrane fluidity. SAMe-mediated transmethylation is also critical for the formation of neurotransmitters in the central nervous system. Hepatic transmethylation is also important: 85% of total body transmethylation occurs in the liver. After donating its methyl group, SAMe is converted to s-adenosylhomocysteine, which initiates the important trans-sulfuration pathway in the liver, resulting in the generation of glutathione, the most potent antioxidant in the liver. Both folate and vitamin B12 are essential co-nutrients in the metabolism and replenishment of SAMe. SAMe may be beneficial in osteoarthritis due to analgesic and anti-inflammatory effects. Preliminary evidence suggests SAMe might stimulate articular cartilage growth and repair, specifically chondrocyte proteoglycan synthesis and proliferation rate. SAMe might also protect against cytokine-induced cell damage by antagonizing the activity of tumor necrosis factor-alpha (TNF-alpha) on synovial cell proliferation and fibronectin mRNA expression. In AIDS-related myelopathy, endogenous SAMe can be depleted. Epidemiological data suggests that people with AIDS have a deficiency of SAMe in their cerebrospinal fluid (CSF), which may lead to myelopathy by impairing SAMe dependent myelin and oligodendrocyte repair mechanisms. In gastrointestinal stress ulcers there is some evidence that SAMe might have a cytoprotective effect. Pharmacokinetics: Oral SAMe has a low bioavailability, which is presumably the result of rapid and significant first-pass effect. Enteric-coated tablets produce peak plasma concentrations about 3 to 5 hours after ingestion, with a half-life of about 100 minutes. SAMe is excreted in the urine and faeces. SAMe crosses the blood-brain barrier. There are two forms of SAMe: the less effective and less absorbable tosylate form, and the superior butanedisulfonate form. INDICATIONS: SAMe is an amino acid that enhances brain function, improves mood and balances neurotransmitters. It has powerful liver detoxifying and natural anti-inflammatory effects. CONTRA-INDICATIONS: SAMe should not be used in manic and bi-polar patients as manic episodes could be aggravated. WARNINGS: Do not exceed recommended dosages unless on the advice of a healthcare provider. Do not use this product if you are allergic to any of the ingredients. If you are on any medication or suffering from any medical condition, it is advisable to seek medical advice before starting any new medicine, supplement or remedy. Safety in children has not been established. INTERACTIONS: Monoamine Oxidase Inhibitors (MAOI’s): because SAMe works in a similar way on serotonin and other neurotransmitters, concurrent use may have additive effects such as hypertension, hyperthermia, agitation, confusion, coma, etc. SAMe should be avoided in patients taking MAOIs and for 2 weeks after discontinuing an MAOI. Anti-depressant medicines: Concurrent use might cause additive serotonergic effects and serotonin-like side-effects. Levodopa: SAMe methylates levodopa, which might worsen Parkinsonian symptoms. The use of SAMe with the following medicines may lead to increased serotonergic effects and should thus be used with caution: Meperidine, dextromethorphan, pentazocine and tramadol. PREGNANCY AND BREAST-FEEDING: Safety in pregnancy and breast-feeding has not been established, do not use. DOSAGE AND DIRECTIONS FOR USE: Adults and children over 12 years of age: Take 1 tablet once or twice daily. Take on an empty stomach (at least 30 minutes before a meal). Children 7-12 years of age: Take 1 tablet daily. These doses can be doubled if adequate benefit is not obtained after 2 months of use. Although SAMe can be stored at room temperature, it is ideal to store SAMe in the fridge. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Side effects: Side effects are rare but, at high doses, can include insomnia, headaches, nervousness, gastro intestinal complaints, nausea, dizziness or sweating. Special precautions: Do not use SAMe with prescription antidepressants or if diagnosed with mania or bi-polar disorder, unless under the supervision of a medical practitioner. SAMe can aggravate manic episodes in manic or bi-polar patients. Surgery: Discontinue SAMe at least 2-weeks before elective surgery. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Treatment should be symptomatic and supportive. In the case of accidental overdose of the product, contact the nearest hospital or poison control centre. IDENTIFICATION: Orange coloured oval enteric coated tablet. PRESENTATION: White HDPE container with white HDPE screw cap and seal for protection. STORAGE INSTRUCTIONS: Store in a cool dry place, out of the reach of children.
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