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Basic Information:Severe extensive psoriasis and disorders of keratinization resistant to all other forms of therapy.
Detailed Information:
CONTRA-INDICATIONS
Pregnancy and Lactation:
Neotigason is teratogenic and must not be used by females who are pregnant or who intend to become pregnant.
Neotigason is contraindicated in women of childbearing potential unless the following precautions are strictly observed:
1. Before therapy with Neotigason is instituted, patients of childbearing potential must be examined for pregnancy, and told clearly and in detail by the physician about the precautions to be taken, the risks involved and the possible consequences should pregnancy occur during the course of treatment or within two years of discontinuing therapy.
2. Having excluded pregnancy, any woman of childbearing potential must practice effective contraception for at least one month before treatment, during the treatment period and for at least two years following its cessation.
3. The same effective and uninterrupted contraceptive measure must be taken every time therapy is repeated, independently of the intervening period, and must be continued for two years afterwards.
4. Should pregnancy occur, in spite of these precautions, during treatment with Neotigason or up to two years after its discontinuation , there is a high risk of severe malformation of the foetus (e.g. exencephaly).
5. The woman is reliable and capable of understanding the risk and complying with effective contraception and confirms that she has understood the warnings.
Neotigason must not be given to nursing mothers.
Neotigason is also contra-indicated in patients with severely impaired liver and kidney functions and in patients with permanent abnormally elevated blood lipid values.
Hypersensitivity to retinoids. Hypervitaminosis A.
Children less than 18 years of age or until bone development is complete.
Treatment for longer than 12 months as limited safety and efficacy data are available.
WARNINGS
The following musculo-skeletal changes have been reported after longterm systemic retinoid treatment: Hyperostosis including vertebral hyperostosis and bridging of vertebral bodies; exostoses; extraskeletal calcifications including soft tissue calcifications; calcification of the anterior spinal ligament and calcification of tendons and ligaments especially ankles, knees and pelvis; peristeal thickening; disk narrowing; cortical bone resorption; osteoporosis; thinning of bones; fractures; premature epiphyseal closure and painless muscle stiffness.
Severe skin reactions, including erythema multiforme and toxic epidermal necrolysis may occur rarely.Patients may experience photosensitivity reactions rarely.
Transient and usually reversible elevation of transaminases and alkaline phosphatases have been observed. Elevation of serum triglycerides and serum cholesterol has occurred, especially in high-risk patients (disturbances of lipid metabolism, diabetes, obesity, alcoholism). An associated risk of atherogenesis cannot be ruled out if these disturbances persist.
Hepatic function should be monitored before and every one to two weeks for the first two months after starting treatment with Neotigason and then every three months during treatment. If pathological values for hepatic function are found, monitoring should be repeated at weekly intervals. If they fail to return to normal or if they deteriorate, Neotigason must be withdrawn. It is then advisable to continue monitoring hepatic function for at least three months.
Serum cholesterol and serum triglycerides (fasting values) must be monitored in high-risk patients (disturbances of lipid metabolism, diabetes, obesity, alcoholism) and in long-term treatment. Benign intracranial hypertension has been reported with Neotigason. Since tetracyclines can also cause an increase in intracranial pressure, their combination with Neotigason should be avoided.
In adults receiving long-term treatment, appropriate examinations should periodically be performed in view of possible ossification abnormalities. In the event of ossification disorders, Neotigason should be discontinued.
Any patient complaining of atypical musculoskeltal symptoms on treatment with Neotigason should be promptly and fully investigated to exclude acitretin induced bone changes or extraskeletal calcification.
The effects of UV light are enhanced therefore excessive exposure to sunlight and the unsupervised use of sunlamps should be avoided.
Patients should not donate blood either during or for at least two years following discontinuation of Neotigason
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