Silymarin

Registered South African indications:

• Aid in the treatment of alcohol-induced liver disease

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding

Cautions

• Renal impairment
• Hepatic impairment
• Elderly
• Porphyria
• History of Stevens-Johnson Syndrome
• History of drug-induced phototoxicity

Forms avail. in SA and covered in this monograph: tab, cap

Alcohol-induced liver disease 

• Oral (tab): Initial: 140mg, 8hrly; Maintenance: 70mg, 8hrly
• Oral (cap): 140mg, 8hrly; Max: 420mg/24 hrs

Silymarin is not suitable for treating cases of acute poisoning

The duration of treatment to be decided by the prescribing doctor

The capsules are to be swallowed whole and unchewed with an appropriate amount of liquid

Not indicated for use in children below 12 years

Pregnancy 

• Contraindicated
• There are no adequate data from the use of silymarin in pregnant women. Therefore, in these circumstances silymarin should not be administered

Breastfeeding

• Contraindicated
• There are no adequate data from the use of silymarin in breastfeeding women. Therefore, in these circumstances silymarin should not be administered

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Diarrhoea

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Due to the herbal nature of this product, limited data related to drug interactions are available

• UGT1A1 inhibitor
• UGT1A1 substrates
• UGT1A1 inducers
• Lipid-lowering agents
• HMG CoA reductase inhibitors
• Nonsteroidal anti-inflammatory drug
• Antiepileptic agents
• Immunosuppressants
• Mycophenolate mofetil
• Oestrogens
• Estradiol
• Dolutegravir
• Zidovudine
• Rifampicin
• Probenecid
• Irinotecan
• Furosemide
• Losartan
• Raloxifene
• Levothyroxine

None routine

• The treatment with silymarin does not serve as a substitute for the abstention from the cause of liver damage (e.g. alcohol)
• If icterus (light to dark yellow tinge of the skin, yellow discolouration of the white of the eye) occurs, the doctor is to be consulted

Silymarin (also known as silybin or silibinin) is standardised herbal extract of milk thistle seeds. Silymarin has a membrane-stabilising effect and an RNA-synthesis stimulating effect on hepatocytes.

Silymarin has free radical capturing powers, silymarin possesses antiperoxidative activity. The pathophysiological process of lipid peroxidation which is responsible for the destruction of cell membranes is interrupted or reduced. Furthermore, in liver cells, which have already sustained damage, silymarin stimulates protein synthesis and normalises phospholipid metabolism.

The enhancement of protein synthesis by silymarin is due to its stimulation of RNA polymerase I, an enzyme which is located in the nucleus. This leads to increased formation of ribosomal RNA and structure and function proteins (enzymes) are therefore synthesised in greater amounts.

Tablet 70mg

• Legalon (Xixia Pharmaceuticals) originator

Capsule 140mg

• Legalon Forte (Xixia Pharmaceuticals) originator