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30 X 10 mg
30 X 25 mg
Neotigason capsules are for oral administration.
The capsules should be taken once daily with meals or with milk.
There is a wide variation in the absorption and rate of metabolism of Neotigason. This necessitates individual adjustment of dosage. For this reason the following dosage recommendations can serve only as a guide.
Adults: Initial daily dose should be 25mg or 30mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. Following assessment of the initial treatment period, titration of the dose upwards or downwards may be necessary to achieve the desired therapeutic response with the minimum of side-effects. In general, a daily dosage of 25 – 50mg taken for a further 6 to 8 weeks achieves optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75mg/day.
In patients with Darier’s disease a starting dose of 10mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur.
Therapy can be discontinued in patients with psoriasis whose lesions have improved sufficiently. Relapses should be treated as described above. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.
Elderly: Dosage recommendations are the same as for other adults.
Children: In view of possible severe side-effects associated with long-term treatment, Neotigason is contraindicated in children unless, in the opinion of the physician, the benefits significantly outweigh the risks. The dosage should be established according to bodyweight. The daily dosage is about 0.5mg/kg.
Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35mg/day. The maintenance dose should be kept as low as possible in view of possible long term side-effects.
Combination therapy: Other dermatological therapy, particularly with keratolytics, should normally be stopped before administration of Neotigason. However, the use of topical corticosteroids or bland emollient ointment may be continued if indicated.
When Neotigason is used in combination with other types of therapy, it may be possible, depending on the individual patient’s response, to reduce the dosage of Neotigason.
Severe disorders of keratinization such as erythrodermic psoriasis local or generalized or pustular psoriasis congenital ichthyosis pityriasis rubra pilaris darier’s disease.
Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment.
The use of Neotigason is contra-indicated in women who are breast feeding.
Neotigason is contra-indicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values.
Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated. Supplementary treatment with antibiotics such as tetracyclines is therefore contra-indicated.
An increased risk of hepatitis has been reported following the concomitant use of methotrexate and etretinate. Consequently, the concomitant use of methotrexate and Neotigason should be avoided.
Concomitant administration of Neotigason with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A.
Neotigason is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids.
Owing to the presence of glucose, patients with rare glucose-galactose malabsorption should not take this medicine.
Neotigason is highly teratogenic. The risk of giving birth to a deformed child is exceptionally high if Neotigason is taken before or during pregnancy, no matter for how long or at what dosage. Foetal exposure to Neotigason always involves a risk of congenital malformation.
Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and alcohol. Women of childbearing age must therefore not consume alcohol (in drinks, food or medicines) during treatment with acitretin and for 2 months after cessation of acitretin therapy.
Contraceptive measures and pregnancy tests must also be taken for 2 years after completion of acitretin treatment.
Acitretin has been shown to affect diaphyseal and spongy bone adversely in animals at high doses in excess of those recommended for use in man. Since skeletal hyperostosis and extraosseous calcification have been reported following long-term treatment with etretinate in man, this effect should be expected with acitretin therapy.
Since there have been occasional reports of bone changes in children, including premature epiphyseal closure, skeletal hyperostosis and extraosseous calcification after long-term treatment with etretinate, these effects may be expected with acitretin. Neotigason therapy in children is not, therefore, recommended. If, in exceptional circumstances, such therapy is undertaken the child should be carefully monitored for any abnormalities of musculo-skeletal development and growth parameters and bone development must be closely monitored.
In adults, especially elderly, receiving long-term treatment with Neotigason, appropriate examinations should be periodically performed in view of possible ossification abnormalities.
The effects of UV light are enhanced by retinoid therapy, therefore patients should avoid excessive exposure to sunlight and the unsupervised use of sun lamps.
See prescribing information for full details.
Undesirable effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Neotigason are dose-related and are usually well-tolerated at the recommended dosages.
However, the toxic dose of Neotigason is close to the therapeutic dose and most patients experience some side-effects during the initial period whilst dosage is being adjusted. They are usually reversible with reduction of dosage or discontinuation of therapy.
The skin and mucous membranes are most commonly affected, and it is recommended that patients should be so advised before treatment is commenced. An initial worsening of psoriasis symptoms is sometimes seen at the beginning of the treatment period.
The most frequent undesirable effects observed are symptoms of hypervitaminosis A, e.g. dryness of the lips, which can be alleviated by application of a fatty ointment.
See prescribing information for full details.
Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. However, etretinate formation without concurrent alcohol intake cannot be excluded.
Therefore, since the elimination half-life of etretinate is 120 days the post-therapy contraception period in women of childbearing potential must be 2 years.
Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. An increased risk of hepatitis has been reported following the concomitant use of methotrexate and etretinate.
In concurrent treatment with phenytoin, it must be remembered that Neotigason partially reduces the protein binding of phenytoin. The clinical significance of this is as yet unknown.
Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy. Interactions with combined estrogen/progestogen oral contraceptives have not been observed.
Interactions between Neotigason and other substances (e.g. digoxin, cimetidine) have not been observed to date.
In a study with healthy volunteers, concurrent intake of a single dose of acitretin together with alcohol led to the formation of etretinate which is highly teratogenic. The mechanism of this metabolic process has not been defined, so it is not clear whether other interacting agents are also possible. This should be taken into account when treating women of childbearing age.
Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
Pregnancy and Lactation
Pregnancy: Acitretin is contraindicated in pregnant women.
Breastfeeding: Acitretin must not be given to nursing mothers.
See prescribing information for full details.
In the event of acute overdose, acitretin must be withdrawn at once.
Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Neotigason would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.
Because of the variable absorption of the drug, gastric lavage may be worthwhile within the first few hours after ingestion.