Same (ademetionine, adenosylmethionine, Adomet, Gumbaral, Heptral, Sadenosyl Lmethionine, sammy, Samyr)

Suggested dosing of ademetionine, adenosylmethionine (SAMe)

 

Depression

Oral: 400-1600 mg PO qDay

IM/IV: 200-400 mg/day

 

Osteoarthritis

Oral: 200 mg PO TId

IV: 400 mg/day IV

 

Liver Disease, Alcohol Related

Oral: 1200-1600 mg PO qDay; no more than 24 months

IV: 200-2000 mg/day IV x 15-30 days

IM: 200 mg/day IM x 30 days

 

Intrahepatic Cholestasis

Oral: 800 mg PO BId

 

Fibromyalgia

800 mg PO qDay

 

AIDS-related Myelopathy (Orphan)

800 mg/day IV x 14 days

Orphan indication sponsor

• Genopia USA, Inc; 90 Gold Street, 6N; New York, NY 10038

 

Suggested uses of ademetionine, adenosylmethionine (SAMe)

AIDS-related myelopathy, Alzheimer's disease, bursitis/tendinitis, depression, fibromyalgia, heart disease, intrahepatic cholestasis, liver disease, migraine headache, osteoarthritis

 

Efficacy

Several studies showed comparable effectiveness to TCAs

Standardization of product not as good in US as in Europe

Oral form has poor bioavailability; pos. studies used parenteral SAMe

Mult clinical trials showed comparable effectiveness to NSAIDS, with fewer side effects

Studies showed possibly effective for the treatment of AIDS-related myelopathy, fibromyalgia,& intrahepatic cholestasis

 

ademetionine, adenosylmethionine (SAMe) adverse (side) effects

Frequency not defined

Anxiety

Diarrhea

Flatulence

Headache

Hypomania/mania

Nausea/vomiting

 

Warnings

Contraindications

MAO inhibitor use within 14 day

 

Cautions

Bipolar disorder

 

Pregnancy and lactation

Pregnancy category: N/A

Lactation: N/A

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of ademetionine, adenosylmethionine (SAMe)

Metabolism: N/A

Excretion: N/A

 

Mechanism of action

Methyl donor in many metabolic reactions