Transmetil Special Precautions

Ammonia levels should be monitored in patients with pre-cirrhotic and cirrhotic states of hyperammonemia taking oral ademetionine.
Because vitamin B₁₂ and folate deficiencies may decrease ademetionine levels, at risk patients (anemia, liver disease, pregnancy or potential for vitamin deficiencies due to other illnesses or eating habits such as vegans) should have routine blood tests to check the plasma levels. If a deficiency is found, treatment with B₁₂ and/or folate is recommended prior to or concurrently with administration of ademetionine (see Pharmacology: Pharmacokinetics under Actions).
Ademetionine is not recommended for use in patients with bipolar disease. There have been reports of patients switching from depression to hypomania or mania when treated with ademetionine. There has been a single literature report of serotonin syndrome in a patient taking ademetionine and clomipramine. Although a potential interaction is postulated, caution is recommended when administering ademetionine concomitantly with selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (such as clomipramine), and over-the-counter and herbal supplements containing tryptophan. (see Interactions).
The efficacy of ademetionine in the treatment of depression was studied in short-term clinical trials (3 - 6 weeks in duration). The effectiveness of ademetionine in the treatment of depression over longer periods is unknown. There are many medications to treat depression, and patients should consult with their physicians to determine optimal therapy. Patients should be encouraged to inform their physicians if their symptoms do not abate or worsen during ademetionine therapy.
Patients with depression are at risk for suicide and other serious events and therefore should receive continuous psychiatric support during therapy with ademetionine to ensure that the symptoms of depression are adequately addressed and treated.
There have been reports of transient or worsening anxiety in patients treated with ademetionine. In most cases, interruption of therapy was not required. In a few cases, the anxiety resolved after a reduction in dosage or discontinuation of therapy.
Interference with homocysteine immunoassays: Ademetionine interferes with homocysteine immunoassays, which may show falsely elevated levels of plasma homocysteine in patients treated with ademetionine. In patients treated with ademetionine, it is therefore recommended to use non-immunological methods to measure plasma homocysteine.
Effects on Ability to Drive and Use Machines: Some patients may experience dizziness with the use of ademetionine. Patients should be advised not to drive or operate machinery during treatment until they are reasonably certain that ademetionine therapy does not affect their ability to engage in such activities.