Manufacturer

• Produced by: Abbott Laboratories S.A.
• Country of Origin: Spain
• Distributed by: Abbott subsidiaries worldwide

Composition

• Each 5 ml ampoule contains:
  • Active ingredient: 400 mg of S-adenosyl-L-methionine (SAMe) disulfate tosylate.
  • Other ingredients: Sodium hydroxide for pH adjustment and water for injection.

Indications

Samyr is indicated for the treatment of liver and mood disorders. Its dual properties provide hepatoprotective and mood-stabilizing effects.

• Chronic liver diseases (e.g., hepatitis, cholestasis, cirrhosis)
• Intrahepatic cholestasis of pregnancy
• Adjunctive therapy in mood disorders such as depression
• Liver dysfunction due to alcohol, drugs, or toxins

Dosage and Administration

• Route: Intravenous (IV) or intramuscular (IM)
• Typical dosage:
  • Liver disorders: 400–800 mg daily for 2 weeks IV/IM, followed by oral continuation
  • Mood disorders: 400–800 mg daily, adjusted based on clinical response
• Preparation: Reconstitute lyophilized powder with accompanying solvent before use. Ensure solution is clear.
• Duration: Typically 2–4 weeks for injectable phase

Contraindications

• Hypersensitivity to SAMe or excipients
• History of bipolar or manic episodes
• Severe renal dysfunction (use with caution)

Precautions and Warnings

• Monitor renal and hepatic function regularly
• Watch for manic/hypomanic symptoms in patients with depression
• Avoid abrupt discontinuation
• Correct folate or vitamin B12 deficiencies prior to therapy

Adverse Effects

• Gastrointestinal: Nausea, abdominal pain, diarrhea
• Neurological: Insomnia, headache, dizziness
• Allergic: Rash, itching, rare anaphylaxis
• Local: Injection site redness, swelling, pain

Drug Interactions

• Risk of serotonin syndrome when combined with SSRIs or other serotonergic drugs
• May potentiate the effect of antidepressants
• Consult physician for complete drug interaction assessment

Pregnancy and Lactation

• Can be used during pregnancy under supervision (e.g., cholestasis)
• Use during lactation only if benefits outweigh risks

Overdose

Symptoms: Nausea, diarrhea, abdominal discomfort. Treat supportively. Monitor hepatic and renal function.

Storage

• Store at 15–25°C (59–77°F)
• Protect from light and moisture
• Do not freeze
• Use immediately after reconstitution. Discard remainder

Scientific References

• S-Adenosylmethionine in the treatment of depression – PubMed
• S-Adenosylmethionine and its clinical use – NCBI

Patient Information

Samyr should only be administered under medical supervision. Inform patients about the importance of adherence and the need to report unusual symptoms promptly.

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Composition

Each capsule contains Ademetionine 1,4-butanedisulfonate equivalent to 400 mg of S-Adenosyl-L-methionine (SAMe). Excipients include microcrystalline cellulose, magnesium stearate, and colloidal anhydrous silica.

Description

Samyr 400 mg comes in the form of hard gelatin capsules filled with a white to off-white powder. Capsules are packaged in blister strips with 20 units per pack.

Indications

Samyr is indicated for:

• Major depressive disorder (MDD)
• Chronic liver diseases (e.g. intrahepatic cholestasis, cirrhosis)
• Osteoarthritis with inflammatory components
• Supplementation in cases of SAMe deficiency

Mechanism of Action

S-Adenosyl-L-methionine (SAMe) is a naturally occurring methyl donor involved in the synthesis of neurotransmitters (e.g. serotonin, dopamine), phospholipids, and glutathione. It exerts antidepressant and hepatoprotective effects, along with anti-inflammatory activity beneficial in osteoarthritis.

Dosage and Administration

• Standard dose: 400 mg (1 capsule) twice daily on an empty stomach
• Severe depression or hepatic conditions: Up to 800 mg twice daily
• Swallow whole with water; do not crush or chew

Contraindications

• Known hypersensitivity to SAMe or formulation ingredients
• History of bipolar disorder (risk of manic switch)
• Use in children and adolescents under 18 years is not recommended

Precautions

• Monitor liver function during prolonged treatment
• Use with caution in elderly or psychiatric patients
• Inform healthcare provider about gastrointestinal or renal disorders

Side Effects

• Common: Nausea, diarrhea, abdominal pain
• Less common: Insomnia, dizziness, dry mouth
• Rare: Allergic skin reactions (rash, itching)

Overdose

Symptoms may include gastrointestinal discomfort, nausea, and vomiting. In case of overdose, provide supportive treatment and consult a healthcare provider immediately.

Drug Interactions

• Use with serotonergic agents (SSRIs, MAOIs) may increase risk of serotonin syndrome
• May potentiate the effect of other antidepressants
• Discuss all current medications with your doctor before use

Pregnancy and Lactation

• Use during pregnancy only if clearly needed and under medical supervision
• Safety during lactation is not well established; caution is advised

Storage

Store below 25°C (77°F) in a dry place away from moisture and direct sunlight. Keep out of reach of children.

Scientific References

• Ademetionine in major depressive disorder – PubMed
• SAMe in liver disease and depression – NCBI

Disclaimer

This summary is for informational purposes only and does not replace medical advice. Always consult your healthcare provider before starting any medication.

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