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S-ADENOSYLMETHIONINE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) SAM (S-adenosylmethionine) is a naturally occurring substance present in virtually all body tissues and fluids. It is derived from adenosine triphosphate and the amino acid l-methionine. SAMe, an exogenous stable salt, is commonly used as a dietary supplement.

Specific Substances

    1) Ademethionine
    2) Adomet
    3) S-adenosyl-L-methionine
    4) Active methionine
    5) Adenosylmethionine
    6) L-methionine, S-adenoxyl-
    7) L-S-adenosylmethionine
    8) Methioninyladenylate
    9) S-adenosylmethionine
    10) S-adenoxyl-L-methionine
    11) S)-5'-[(3-Amino-3-carboxypropyl) methylsulphonio]-5'-deoxyadenosine hydroxide, inner salt
    12) SAM-E
    1.2.1) MOLECULAR FORMULA
    1) C15-H22-N6-O5-S

Available Forms Sources

    A) FORMS
    1) SAMe is available as a dietary supplement in the United States under the Dietary Supplement Health and Education Act of 1994 (DSHEA). It is available as enteric-coated tablets for oral use and solution for parenteral (intravenous or intramuscular) administration.
    2) Injectable forms of SAMe have been available on the pharmaceutical market since the late 1970s (Di Padova, 1987). In one study, tablets of sulfo-adenosyl-l-methionine sulfate-p-toluenesulfonate (768 mg) equal to 400 mg of SAMe were used(Jacobsen et al, 1991).
    B) SOURCES
    1) SAM (S-adenosylmethionine) is a naturally occurring substance present in virtually all body tissues and fluids. It is derived from adenosine triphosphate and the amino acid l-methionine. SAMe, an exogenous stable salt, is commonly used as a dietary supplement (Osman et al, 1993; Jacobsen et al, 1991).
    C) USES
    1) SAMe has been used to treat depression, fibromyalgia, liver disease, osteoarthritis, migraine headaches, and sleep disturbances(Pies, 2000; Osman et al, 1993; Jacobsen et al, 1991; Bottiglieri et al, 1990).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) SAMe is generally well tolerated by most patients. Anxiety, headache, dizziness, urinary frequency, pruritus, nausea, abdominal pain, heartburn, diarrhea, increased salivation, and injection site abscess have been reported following the use of SAMe. One patient with major depression developed symptoms of mania after receiving SAMe.
    0.2.20) REPRODUCTIVE
    A) SAMe has been administered to pregnant women without any apparent adverse effect.

Laboratory Monitoring

    A) Monitor fluid and electrolyte status in patients with significant diarrhea.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) SAMe overdose information is limited. Treatment is symptomatic and supportive. Limited toxicity has been reported to date. Gastrointestinal decontamination is generally not necessary. Activated charcoal should be considered after very large ingestions or if a coingestant with potential toxicity is involved.
    B) ACTIVATED CHARCOAL: Administer charcoal as a slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.
    C) GASTRIC LAVAGE: Consider after ingestion of a potentially life-threatening amount of poison if it can be performed soon after ingestion (generally within 1 hour). Protect airway by placement in the head down left lateral decubitus position or by endotracheal intubation. Control any seizures first.
    1) CONTRAINDICATIONS: Loss of airway protective reflexes or decreased level of consciousness in unintubated patients; following ingestion of corrosives; hydrocarbons (high aspiration potential); patients at risk of hemorrhage or gastrointestinal perforation; and trivial or non-toxic ingestion.
    0.4.6) PARENTERAL EXPOSURE
    A) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Range Of Toxicity

    A) A minimum toxic dose has not been established.

Clinical Effects

Summary Of Exposure

    A) SAMe is generally well tolerated by most patients. Anxiety, headache, dizziness, urinary frequency, pruritus, nausea, abdominal pain, heartburn, diarrhea, increased salivation, and injection site abscess have been reported following the use of SAMe. One patient with major depression developed symptoms of mania after receiving SAMe.

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) HEADACHE
    1) WITH THERAPEUTIC USE
    a) Headache has been reported in patients given oral doses of up to 1600 mg of SAMe daily (Rosenbaum et al, 1990; Kagan et al, 1990).
    B) ANXIETY
    1) WITH THERAPEUTIC USE
    a) One patient had transient anxiety which lessened when the dose was reduced and did not recur when a higher dose later was resumed (Rosenbaum et al, 1990).
    C) MANIA
    1) WITH THERAPEUTIC USE
    a) One of 18 patients with major depression who received 800 mg of SAMe twice daily developed symptoms of mania (i.e., energetic, talkative, irritable, grandiose, and hyperkinetic), which responded to lithium but later recurred. There have been previous instances of SAMe triggering a switch from depression to mania (Kagan et al, 1990).
    D) DIZZINESS
    1) WITH THERAPEUTIC USE
    a) In one study, one patient developed dizziness following the use of SAMe leading to withdrawal from the study(Jacobsen et al, 1991).
    b) In one study, one patient developed vertigo following the long-term use of oral SAMe(Konig, 1987).
    E) FATIGUE
    1) WITH THERAPEUTIC USE
    a) In one study, one patient developed fatigue following the long-term use of oral SAMe (Konig, 1987).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) GASTROINTESTINAL COMPLICATION
    1) WITH THERAPEUTIC USE
    a) Mild, transient nausea has occurred in the first few days of treatment when high oral doses of SAMe were given (Osman et al, 1993).
    b) In one study, nausea, abdominal pain, diarrhea, and heartburn were reported in patients following the long-term use of oral SAMe for the treatment of osteoarthritis. One patient experienced dryness of the mouth(Konig, 1987).
    c) In studies, several patients, given up to 1600 mg of SAMe daily, experienced nausea, diarrhea, or increased salivation (Jacobsen et al, 1991; Rosenbaum et al, 1990).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) INCREASED FREQUENCY OF URINATION
    1) WITH THERAPEUTIC USE
    a) Urinary frequency occurred in 3 of 20 depressed patients treated with SAMe(Rosenbaum et al, 1990).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) INJECTION SITE ABSCESS
    1) WITH THERAPEUTIC USE
    a) Two of 25 patients with fibromyalgia who received daily intramuscular injections of 200 mg of SAMe developed an abscess at the site of injection and were withdrawn from the trial (Tavoni et al, 1987).
    B) ITCHING OF SKIN
    1) WITH THERAPEUTIC USE
    a) One of 15 depressed patients given SAMe orally in a dose of 800 mg twice daily developed both pruritus of one ear and a crawling sensation on the skin(Kagan et al, 1990).
    C) ERUPTION
    1) WITH THERAPEUTIC USE
    a) In one study, one patient developed rash following the long-term use of oral SAMe (Konig, 1987).
    D) EXCESSIVE SWEATING
    1) WITH THERAPEUTIC USE
    a) In one study, one patient developed diaphoresis following the long-term use of oral SAMe (Konig, 1987).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) WITH THERAPEUTIC USE
    a) In one study, one patient developed an allergic reaction on the arm and leg following the ingestion of SAMe(Konig, 1987).

Reproductive

    3.20.1) SUMMARY
    A) SAMe has been administered to pregnant women without any apparent adverse effect.
    3.20.3) EFFECTS IN PREGNANCY
    A) HUMANS
    1) SAMe has been administered to pregnant women without any apparent adverse effect(Di Padova, 1987).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS2613-02-7 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    B) IARC Carcinogenicity Ratings for CAS23095-97-8 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    C) IARC Carcinogenicity Ratings for CAS28378-99-6 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    D) IARC Carcinogenicity Ratings for CAS86522-35-2 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    E) IARC Carcinogenicity Ratings for CAS86866-89-9 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor fluid and electrolyte status in patients with significant diarrhea.

Methods

    A) CHROMATOGRAPHY
    1) Simultaneous determination of SAMe in biological samples using solid-phase extraction and high-performance liquid chromatography (HPLC) has been reported. Limits of quantification for renal tissue and urine were 0.25-1.0 nmol/g wet weight and 0.25-0.5 microM, respectively (Delabar et al, 1999).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Monitor fluid and electrolyte status in patients with significant diarrhea.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) Limited toxicity has been reported to date. Gastrointestinal decontamination is generally not necessary. Decontamination should be considered after very large ingestions or if a coingestant with potential toxicity is involved.
    B) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Gastrointestinal decontamination is generally not necessary. Activated charcoal should be considered after very large ingestions or if a coingestant with potential toxicity is involved.
    B) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment should be symptomatic and supportive.
    B) MONITORING OF PATIENT
    1) Monitor fluid and electrolyte status in patients with significant diarrhea.
    C) SEROTONIN SYNDROME
    1) SUMMARY
    a) Benzodiazepines are the mainstay of therapy. Cyproheptadine, a 5-HT antagonist, is also commonly used. Severe cases have been managed with benzodiazepine sedation and neuromuscular paralysis with non-depolarizing agents(Claassen & Gelissen, 2005).
    2) HYPERTHERMIA
    a) Control agitation and muscle activity. Undress patient and enhance evaporative heat loss by keeping skin damp and using cooling fans.
    b) MUSCLE ACTIVITY: Benzodiazepines are the drug of choice to control agitation and muscle activity. DIAZEPAM: ADULT: 5 to 10 mg IV every 5 to 10 minutes as needed, monitor for respiratory depression and need for intubation. CHILD: 0.25 mg/kg IV every 5 to 10 minutes; monitor for respiratory depression and need for intubation.
    c) Non-depolarizing paralytics may be used in severe cases.
    3) CYPROHEPTADINE
    a) Cyproheptadine is a non-specific 5-HT antagonist that has been shown to block development of serotonin syndrome in animals (Sternbach, 1991). Cyproheptadine has been used in the treatment of serotonin syndrome (Mills, 1997; Goldberg & Huk, 1992). There are no controlled human trials substantiating its efficacy.
    b) ADULT: 12 mg initially followed by 2 mg every 2 hours if symptoms persist, up to a maximum of 32 mg in 24 hours. Maintenance dose 8 mg orally repeated every 6 hours (Boyer & Shannon, 2005).
    c) CHILD: 0.25 mg/kg/day divided every 6 hours, maximum dose 12 mg/day (Mills, 1997).
    4) HYPERTENSION
    a) Monitor vital signs regularly. For mild/moderate asymptomatic hypertension, pharmacologic intervention is usually not necessary.
    5) HYPOTENSION
    a) Administer 10 to 20 mL/kg 0.9% saline bolus and place patient supine. Further fluid therapy should be guided by central venous pressure or right heart catheterization to avoid volume overload.
    b) Pressor agents with dopaminergic effects may theoretically worsen serotonin syndrome and should be used with caution. Direct acting agents (norepinephrine, epinephrine, phentolamine) are theoretically preferred.
    c) NOREPINEPHRINE
    1) PREPARATION: Add 4 mL of 0.1% solution to 1000 mL of dextrose 5% in water to produce 4 mcg/mL.
    2) INITIAL DOSE
    a) ADULT: 2 to 3 mL (8 to 12 mcg)/minute.
    b) ADULT or CHILD: 0.1 to 0.2 mcg/kg/min. Titrate to maintain adequate blood pressure.
    3) MAINTENANCE DOSE
    a) 0.5 to 1 mL (2 to 4 mcg)/minute.
    6) SEIZURES
    a) DIAZEPAM
    1) MAXIMUM RATE: Administer diazepam IV over 2 to 3 minutes (maximum rate: 5 mg/min).
    2) ADULT DIAZEPAM DOSE: 5 to 10 mg initially, repeat every 5 to 10 minutes as needed. Monitor for hypotension, respiratory depression and the need for endotracheal intubation. Consider a second agent if seizures persist or recur after diazepam 30 milligrams.
    3) PEDIATRIC DIAZEPAM DOSE: 0.2 to 0.5 mg/kg, repeat every 5 minutes as needed. Monitor for hypotension, respiratory depression and the need for endotracheal intubation. Consider a second agent if seizures persist or recur after diazepam 10 milligrams in children over 5 years or 5 milligrams in children under 5 years of age.
    4) RECTAL USE: If an intravenous line cannot be established, diazepam may be given per rectum (not FDA approved), or lorazepam may be given intramuscularly.
    b) LORAZEPAM
    1) MAXIMUM RATE: The rate of IV administration of lorazepam should not exceed 2 mg/min (Prod Info Ativan(R), 1991).
    2) ADULT LORAZEPAM DOSE: 2 to 4 mg IV. Initial doses may be repeated in 10 to 15 minutes, if seizures persist (Prod Info ATIVAN(R) injection, 2003).
    3) PEDIATRIC LORAZEPAM DOSE: 0.1 mg/kg IV push (range: 0.05 to 0.1 mg/kg; maximum dose 4 mg); may repeat dose in 5 to 10 minutes if seizures continue. It has also been given rectally at the same dose in children with no IV access (Sreenath et al, 2009; Chin et al, 2008; Wheless, 2004; Qureshi et al, 2002; De Negri & Baglietto, 2001; Mitchell, 1996; Appleton, 1995; Giang & McBride, 1988).
    c) RECURRING SEIZURES
    1) If seizures cannot be controlled with diazepam or recur, give phenobarbital or propofol.
    d) PHENOBARBITAL
    1) SERUM LEVEL MONITORING: Monitor serum levels over next 12 to 24 hours for maintenance of therapeutic levels (15 to 25 mcg/mL).
    2) ADULT PHENOBARBITAL LOADING DOSE: 600 to 1200 mg of phenobarbital IV initially (10 to 20 mg/kg) diluted in 60 mL of 0.9% saline given at 25 to 50 mg/minute.
    3) ADULT PHENOBARBITAL MAINTENANCE DOSE: Additional doses of 120 to 240 mg may be given every 20 minutes.
    4) MAXIMUM SAFE ADULT PHENOBARBITAL DOSE: No maximum safe dose has been established. Patients in status epilepticus have received as much as 100 mg/min until seizure control was achieved or a total dose of 10 mg/kg.
    5) PEDIATRIC PHENOBARBITAL LOADING DOSE: 15 to 20 mg/kg of phenobarbital intravenously at a rate of 25 to 50 mg/min.
    6) PEDIATRIC PHENOBARBITAL MAINTENANCE DOSE: Repeat doses of 5 to 10 mg/kg may be given every 20 minutes.
    7) MAXIMUM SAFE PEDIATRIC PHENOBARBITAL DOSE: No maximum safe dose has been established. Children in status epilepticus have received doses of 30 to 120 mg/kg within 24 hours. Vasopressors and mechanical ventilation were needed in some patients receiving these doses.
    8) NEONATAL PHENOBARBITAL LOADING DOSE: 20 to 30 mg/kg IV at a rate of no more than 1 mg/kg/min in patients with no preexisting phenobarbital serum levels.
    9) NEONATAL PHENOBARBITAL MAINTENANCE DOSE: Repeat doses of 2.5 mg/kg every 12 hours may be given; adjust dosage to maintain serum levels of 20 to 40 mcg/mL.
    10) MAXIMUM SAFE NEONATAL PHENOBARBITAL DOSE: Doses of up to 20 mg/kg/min up to a total of 30 mg/kg have been tolerated in neonates.
    11) CAUTION: Adequacy of ventilation must be continuously monitored in children and adults. Intubation may be necessary with increased doses.
    7) CHLORPROMAZINE
    a) Chlorpromazine is a 5-HT2 receptor antagonist that has been used to treat cases of serotonin syndrome (Graham, 1997; Gillman, 1996). Controlled human trial documenting its efficacy are lacking.
    b) ADULT: 25 to 100 mg intramuscularly repeated in 1 hour if necessary.
    c) CHILD: 0.5 to 1 mg/kg repeated as needed every 6 to 12 hours not to exceed 2 mg/kg/day.
    8) NOT RECOMMENDED
    a) BROMOCRIPTINE: It has been used in the treatment of neuroleptic malignant syndrome but is NOT RECOMMENDED in the treatment of serotonin syndrome as it has serotonergic effects (Gillman, 1997). In one case the use of bromocriptine was associated with a fatal outcome (Kline et al, 1989).

Enhanced Elimination

    A) LACK OF INFORMATION
    1) There is no information regarding the effectiveness of hemodialysis or hemoperfusion for the removal of SAMe from plasma.

Range Of Toxicity

Summary

    A) A minimum toxic dose has not been established.

Therapeutic Dose

    7.2.1) ADULT
    A) GENERAL
    1) The dosing of dietary supplements is highly dependent on a variety of factors such as quality of raw materials, manufacturing process, and packaging. Since no official standards have been established to date to regulate the production of dietary supplements in the United States, dosage ranges must be employed as guidelines only.
    B) ORAL
    1) ARTHRITIS: 600 to 800 milligrams (mg) daily, sometimes reduced to 400 mg daily when patients began responding (Jacobsen et al, 1991; Konig, 1987).
    2) DEPRESSION: 200 to 1600 milligrams (mg) daily in the form of enteric-coated tablets; dosage often is graduated in increments of 200 mg. A majority of clinical trials have employed daily doses of 400 to 600 mg (Bell et al, 1994; Bressa, 1994; Bottiglieri et al, 1990).
    3) FIBROMYALGIA: 600 or 800 milligrams (mg) daily, sometimes reduced to 400 mg daily when patients began responding (Jacobsen et al, 1991; Konig, 1987).
    4) LIVER DISEASE: 800 milligrams (mg) daily for 7 days (Frezza et al, 1988).
    a) Women treated for estrogen-related liver toxicity received 800 mg of SAMe daily by the oral route (Frezza et al, 1988). In general, the minimum recommended daily dose by mouth is 1600 mg but no dose-finding studies have been done in patients with liver disease. Possibly patients with less well compensated disease will require larger doses (Osman et al, 1993).
    C) PARENTERAL
    1) DEPRESSION: Intramuscular or intravenous injection of 45 milligrams (mg) to 400 mg. The most frequent dose by either route is 200 mg daily (Bressa, 1994).
    2) FIBROMYLAGIA: 200 milligrams daily by intramuscular injection(Tavoni et al, 1987).

Workplace Standards

    A) ACGIH TLV Values for CAS2613-02-7 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) ACGIH TLV Values for CAS23095-97-8 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    C) ACGIH TLV Values for CAS28378-99-6 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    D) ACGIH TLV Values for CAS86522-35-2 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    E) ACGIH TLV Values for CAS86866-89-9 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    F) NIOSH REL and IDLH Values for CAS2613-02-7 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    G) NIOSH REL and IDLH Values for CAS23095-97-8 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    H) NIOSH REL and IDLH Values for CAS28378-99-6 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    I) NIOSH REL and IDLH Values for CAS86522-35-2 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    J) NIOSH REL and IDLH Values for CAS86866-89-9 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    K) Carcinogenicity Ratings for CAS2613-02-7 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    L) Carcinogenicity Ratings for CAS23095-97-8 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    M) Carcinogenicity Ratings for CAS28378-99-6 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    N) Carcinogenicity Ratings for CAS86522-35-2 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    O) Carcinogenicity Ratings for CAS86866-89-9 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    P) OSHA PEL Values for CAS2613-02-7 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

    Q) OSHA PEL Values for CAS23095-97-8 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

    R) OSHA PEL Values for CAS28378-99-6 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

    S) OSHA PEL Values for CAS86522-35-2 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

    T) OSHA PEL Values for CAS86866-89-9 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Pharmacology Toxicology

Pharmacologic Mechanism

    A) SAMe is produced in the body from the amino acid methionine and adenosine triphosphate. It serves as a source of methyl groups in numerous biochemical reactions involving the synthesis, activation, and metabolism of hormones, proteins, catecholamines, nucleic acids, and phospholipids. Release of methyl groups also promotes the formation of glutathione, the chief cellular antioxidant, thereby favoring detoxification processes. SAMe is closely linked with the metabolism of folate and vitamin B12, which accounts for its ability to lower excessive homocystine serum concentrations resulting from a deficiency of one or both of these nutrients (Osman et al, 1993; Bottiglieri et al, 1990).
    B) SAMe is postulated to increase the turnover of the neurotransmitters dopamine and serotonin in the central nervous system. It has been shown to increase the levels of the serotonin metabolite 5-hydroxyindoleacetic acid in the cerebrospinal fluid(Pies, 2000).
    C) Most studies of SAMe have focused on its antidepressive actions and possible efficacy in controlling symptoms of fibromyalgia and osteoarthritis. There is also evidence that SAMe may lessen the severity of chronic liver disease and, in animal studies, prevent liver cancer (Osman et al, 1993; Bottiglieri et al, 1990).

Physicochemical

Molecular Weight

    A) 398.4

References

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