Novatretin

Novatretin Special Precautions

acitretin

Manufacturer:

Douglas

Distributor:

Apex Pharma Marketing
Full Prescribing Info
Special Precautions
NOVATRETIN should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy.
Alcohol (in drinks, food or medicines) must not be ingested during treatment with acitretin by women of childbearing age, as clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and alcohol. The mechanism of this metabolic process has not been defined, so it is not clear whether other interacting agents are also possible. Etretinate is highly teratogenic and has a longer half life than acitretin. Ethanol should be avoided for 2 months after cessation of acitretin therapy.
Hepatic function should be checked before starting treatment with acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. If abnormal results are obtained, weekly checks should be instituted. If hepatic function fails to return to normal or deteriorates further, acitretin must be withdrawn. In such cases it is advisable to continue monitoring hepatic function for at least 3 months.
Serum cholesterol and serum triglycerides (fasting values) must be monitored, especially in high-risk patients (disturbances of lipid metabolism, diabetes mellitus, obesity, alcoholism) and during long-term treatment.
In diabetics, retinoids can either improve or worsen glucose tolerance. Blood-sugar levels must therefore be checked more frequently than usual in the early stages of treatment.
In adults receiving long-term treatment with acitretin, appropriate examinations should be periodically performed in view of possible ossification abnormalities (see Adverse Reactions). If such disorders arise, the continuation of therapy should be discussed with the patient on the basis of a careful risk/benefit analysis.
In children, growth parameters and bone development must be closely monitored.
Decreased night vision has been reported with acitretin therapy. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored (see Adverse Reactions).
Low dosed progesterone preparations (minipills) may be an inadequate method of contraception during acitretin therapy.
It should be emphasized that, at the present time, not all the consequences of life-long administration of acitretin are known.
For male patients treated with acitretin, available data, based on the level of maternal exposure from the semen and seminal fluid indicate a minimal, if any, risk of teratogenic effects.
Psychiatric disorders: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including acitretin. Particular care should be taken in patients with a history of depression. Patients should be monitored for signs of depression and referred for appropriate treatment if necessary. Awareness by family or friends may be useful to detect mental health deterioration.
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