Samyr 400 mg. 5 ampoules, 5ml.

Description

Samyr 400 mg, 5 Ampoules, 5 ml

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 unique composition provides hepatoprotective and mood-stabilizing effects. Indications include:

• Chronic liver diseases, such as hepatitis, cholestasis, and cirrhosis.
• Intrahepatic cholestasis in pregnancy or other liver conditions.
• Adjunct therapy for mood disorders, including depression, as it promotes neurotransmitter synthesis.
• Liver dysfunction caused by drugs, alcohol, or toxic substances.

Dosage and Administration

• Administration route: Intravenous (IV) or intramuscular (IM).
• Typical dosage:
  • For liver disorders: 400-800 mg daily, administered intravenously or intramuscularly for the initial phase (2 weeks), followed by oral therapy.
  • For mood disorders: 400-800 mg daily, adjusted based on clinical response.
• Preparation: Reconstitute the lyophilized powder with the accompanying solvent before use. Ensure the solution is clear and free of particles.
• Duration of therapy: Treatment duration depends on the condition being treated and the patient’s response, typically ranging from 2 to 4 weeks for the injectable phase.

Contraindications

Samyr is contraindicated in the following conditions:

• Known hypersensitivity to S-adenosyl-L-methionine or any other components of the formulation.
• Bipolar disorder or manic episodes, as it may exacerbate mania.
• Severe renal dysfunction (use with caution).

Precautions and Warnings

• Use with caution in patients with kidney or liver dysfunction, ensuring regular monitoring of biochemical parameters.
• Patients with depressive disorders should be closely monitored for changes in mood, particularly for signs of mania or hypomania.
• Avoid abrupt discontinuation, as it may lead to a recurrence of symptoms.
• Do not use in patients with known folate or vitamin B12 deficiencies without correction, as these deficiencies may impair S-adenosyl-L-methionine synthesis and function.

Adverse Effects

Samyr is generally well-tolerated. However, the following side effects may occur:

• Gastrointestinal effects: Nausea, diarrhea, or abdominal pain.
• Neurological effects: Insomnia, headache, or dizziness.
• Allergic reactions: Rash, itching, or, rarely, anaphylaxis.
• Injection site reactions: Pain, swelling, or redness at the injection site.

Drug Interactions

• Samyr may interact with serotonergic medications, including SSRIs, increasing the risk of serotonin syndrome. Use cautiously.
• May enhance the effects of antidepressants when used concurrently.
• Consult your healthcare provider for a complete list of potential drug interactions.

Pregnancy and Lactation

Samyr can be used during pregnancy, particularly for intrahepatic cholestasis, under strict medical supervision. Its safety profile during lactation is not fully established; therefore, caution is advised, and the benefit-risk ratio should be carefully assessed.

Overdose

In case of overdose, symptoms such as nausea, diarrhea, and gastrointestinal discomfort may occur. Supportive and symptomatic treatment should be provided. Monitor liver and renal function in case of overdose.

Storage

• Store at a temperature of 15-25°C (59-77°F).
• Protect from direct sunlight and moisture.
• Do not freeze.
• Use immediately after reconstitution. Discard any unused portion.

Patient Information

Patients should be informed about the purpose of the treatment and the importance of adhering to the prescribed regimen. Any unusual symptoms or adverse reactions should be reported to the healthcare provider immediately. Samyr should only be administered under the supervision of a qualified healthcare professional.