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[.] In the last years the introduction of UVB fototherapy, PUVA therapy, usage of biological products and, in nations of Germanic area, usage of fumaric acid derivatives led to a concept of long term biological modulation in psoriasis. (www.poscare.it/terapia)
Food supplement based on salts of fumaric acid
LIST OF INGREDIENTS ACCORDING TO TYPE AND QUANTITY
1 capsule of PSOCAPS contains: salified fumaric acid (170 mg of fumarate)
Cellulose, Calcium Carbonate, Magnesium chelate, Potassium Carbonate, Anti-caking agent: silicon dioxide, magnesium sterate, zinc oxide, vitamin B6, Glazing Agent: Shellac, castor oil.
Treatment of low/medium forms of psoriasis vulgaris
The product must not be used in case of serious gastrointestinal diseases like gastric ulcer and duodenal ulcer, and in case of serious liver and kidney disease, should not be administered to patients under the age of 12 years.
Although based on experimental data on laboratory animal there is no evidence of teratogenic action, PSOCAPS must not be used during pregnancy and lactation, as there is no experience with pregnant patients and it is not known whether substances pass in breast milk.
At the beginning of treatment are frequent facial flushing and hot flashes, and very rarely stomach pain and diarrhoea. In the course of treatment usually these disorders are reduced. However If they are very pronounced they can lead to discontinuation of treatment.
There are other rare disorders of the digestive tract such as heaviness in the stomach, epigastric pain and meteorism.
Rarely are reported nausea, drowsiness, dizziness and headache. During treatment, these side effects usually disappear. In most cases it is sufficient a reduction of the dose to alleviate the disorders.
However in the event that these side effects are not reduced, the medic decides on the continuation of therapy. In the course of therapy with PSOCAPS as with any product containing fumaric acid derivatives, are often observed mild haemochrome-cytometrical alterations such as leukopenia,
Before you start and at the end of a course of treatment with PSOCAPS is recommended a complete blood count (CBC exam). If the medic advices an overdose, should be carried out the complete blood count (CBC exam) periodically during the treatment.
Similarly, must be analysed, before starting the treatment, the activity of SGOT, SGTP, gamma-GT and the concentration of plasma creatinine, proteins and the urinary sediment to control possible hypersensitivity effects.
Methotrexate, retinoids, psoralen, cyclosporine, immunosuppressive, cytostatic and medicinal products known to have an adverse effect on renal function must not be given concurrently with PSOCAPS.
There are no known incompatibilities until now.
POSOLOGY WITH SINGLE AND DAILY DOSAGE OF PSOCAPS:
Unless otherwise prescription, do the following dosage:We suggest a gradual dosage, in order to obtain an optimal set of efficacy and tolerability.
Must NOT exceed the maximum dose of 3 times 2 gastroresistant capsules of PSOCAPS. However in many cases the maximum daily dose is not necessary. The firsts therapeutic effects are visible mainly after the fourth week of treatment.
After the betterment of skin reactions, the daily dose should be decreased gradually until the maintenance dose of PSOCAPS required case by case.
ROUTE AND DURATION OF ADMINISTRATION
Gastroresistant capsules must be swallowed without masticating them with a good amount of liquid during or immediately after meals. In general, should be taken a sufficient quantity of liquids (1-2 litres) within a day.
The medic must establish the treatment duration. A sufficient experience exists about a treatment duration of 4 months. Even if exists data for treatment duration up to 36 months, we suggest to not extend the treatment up to 6 months.
PHARMACOKINETICS AND BIOAVAILABILITY, TO THE EXTENT THAT SUCH INDICATION ARE NECESSARY FOR THERAPEUTICAL USE
No preclinical studies are available because the absence of proper experimental models in laboratory animals.
Knowledge about the activity mechanism of fumaric acid salts on psoriasis vulgaris therapy are actually based on these scientific data: derivatives of fumaric acid affect on the regulatory site of succinate dehydrogenase on citric acid cycle.
During the treatment with derivatives of fumaric acid, granulocytes and T-helper cells infiltration in the intraepidermal skin is reduced. This event is accompanied by a reduction of acanthosis and hyperkeratosis.
Derivatives affect secretion of cytokines from T-helper cells. An increment of secretion of anti-
inflammatory cytokines IL-4, IL-5 and IL-10.
In case of administration of 26 weeks there is no evidence of hematic or urinary alterations.
Studies in healthy volunteers have shown that the half-life is detectable in the serum and its average is about 80 minutes. Experiments conducted in rats and rabbits, with lower toxic doses for the maternal animal, did not show a teratogenic effect. Only toxic doses for maternal animal leaded to embryo- and fetotoxic effects (delay in development, lethality). Basing on in-vitro and on in-vivo mutagenesis experiments it is possible to exclude a potential mutagenic effect in humans both for mixture and for individual components.
There are no carcinogenicity studies.
In studies on subacute and chronic effects during systemic intake of fumaric acid derivatives (mixture of components) were not detected effects on the immune system.
Contrariwise in sensitization experiments on Guinea pig, fumaric acid esters (mixture of components) have proved sensitizing in case of dermal application.
Pharmacokinetic studies were performed in vitro and in-vivo.
The experiments conducted in rats reveal that, after oral administration of PSOCAPS, the individual components are absorbed almost completely (about 30 minutes - 2 hours).
The maximum blood levels were reached respectively at 15 minutes and 1 hour after administration.
PARTICULAR CONDITIONS OF PRESERVATION
PRESENTATION AND CONTENT OF PSOCAPS
Fumaric acidVitamin B6Zinc and ironArginine
REACTIVATOROF THE KREBS CYCLEIN THE KERATINOCYTE
Technical Information Lutrol® L and April 2010 Supersedes issue dated February 2010 Lutrol F-Grades 03_100102e-03/Page 1 of 8 Poloxamers Ph. Eur., Poloxamer USP/NF Poloxamers for Pharmaceutical Use Pharma Ingredients & Services Chemical nature The Lutrol L and F-block copolymers are synthetic copolymers of ethylene oxide and propylene oxide represented by th
CHAPTER 30 Pharmaceutical Products 1. This Chapter does not cover: (a) Foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters)other than nutritional preparations for intravenous administration (Section IV); Plasters specially calcined or finely ground for use in dentistry (heading 2520); Aqueous distillates or aqueou