Generisches Grisactin

1. Denomination

Grisactin

2. Active Substance

Griseofulvin Fulvicin

3. Indications for Use.

Griseofulvin is one of the main remedies for the treatment of dermatomycoses (skin fungous diseases). It is administered for the treatment of patients suffering from favus (skin fungous disease, mainly of the scalp), trichophytia and microsporia (parasite fungous diseases) of the scalp and smooth skin, epidermophytia (skin diseases provoked by filamentous parasite fungi), smooth skin provoked by Trichophyton (causative fungous of ringworm), likewise patients suffering from the nails damages provoked by pathogenic fungi (fungi-parasites, which provoke such human’s diseases as Trichophyton, red Epidermophyton).

4. Action

Griseofulvin takes anti-fungous action, retarding the growth and procreation of disease-producing fungi. As a consequence, it relieves patients from the symptoms (itching, burn, pains etc.)

5. Posology and Administration

The mode of administration and doses. The tablets are to be taken orally during meal (with one tea spoon of vegetable fat). Suspension (suspended matter of solid particles in fluid) is indicated for children under 3 years of age. The ointment is used independently to cure limited skin lesions and it is combined with an oral intake of the drug.
In microsporia for adults 8 tablets a day is to be administrated, whereas for children it is administrated on the basis of 21-22 mg/kg a day. The drug is to be taken daily up to the first negative fungous analysis, then in the same dosage rate during 2 weeks every other day and 2 weeks twice a week.
In superficial and infiltrative and suppurant form (a form of disease provoking induration of the skin and appearance of abscesses in the skin) forms of Trichophytia and favus adults are administered the same dose, children are to be administered 18 mg/kg (on the same scheme).
In the process of the treatment in Mycoses patients (fungous diseases) of the scalp it is necessary to shave off the hair every week and wash the head with water and soap twice a week. It is recommended to rub into the head’s skin anti-fungal ointments and to smear the lesion focuses with 2-3% spirit of iodine.
In onychomycoses, trichophytias and favus of the scalp a daily dose of Griseofulvin for adults with the body mass less than 50 kg is 5 tablets (625 mg), and in a bigger body mass any 10 kg of additional weight 1 tablet of the drug should be added, but not more than 1 g (8 tablets) daily. Children and adolescents suffering from onychomychoses should be administered 16 mg/kg daily. In onychomycoses the drug should be taken during the first month daily, whereas during the second month every other day, further on – twice a week.
The total treatment should not be less than 8 months.
In onychomycoses it is recommended to combine Griseofulvin therapy with removal of nails with keratolyc remedies (in this case provoking softening and tearing away of the nails) and apply anti-fungal drugs. The ointment is to be smeared with a thin layer in a daily dose of not more than 30 g. on the focuses of disease. The treatment is to be continued not less than 2 weeks after clinical symptoms have disappeared and after three negative results in a microscopic study.

6. Counterindications

Porphyries, systemic lupus erythematosus, lupus syndrome, system blood diseases, organic diseases of liver and kidneys, malignant neoformations, pregnancy.

7. Should Be Taken with Precautions, if…

 Due to a negative influence on reproductive function (both in men and in women) during Griseofulvin therapy one should use efficient non-hormonal contraception methods. Safety of the drug use during lactation is not determined. Patients who are taking Griseofulvin should be advised that alcohol may enhance its performance during Griseofulvin therapy.
The drug should not be administered outpatiently (extra-mural care) to drivers of vehicles, to airmen and to people engaged in elevated jobs.
In diathesis and diabetes suspension should not be administered (due to the sugar containing in it).

8. Interface with Other Medications

Concerning simultaneous administration of medications - take opinion of you doctor to start with.

9. Overdosing

There is no information of overdosing cases. In any case do not use more that it has been ordered by your doctor and in cases of acute manifestation of side effects see your doctor right away.

10. Side Effects

While using Griseofulvin dyspeptic events are possible (digestive upsets), headache, nausea, dizziness, disorientation events (loss of orientation), hives, leucopenia (low level of leucocytes in blood), less frequent leucocytosis (high number of leucocytes in blood). In theses cases it is recommended to make a break in the treatment for 3-4 days; in easy cases it is enough to reduce a daily dose during 4-5 days.

11. Pregnancy and Lactation

The drug is counterindicated in pregnancy. It is not recommended to use while breastfeeding.

12. Driving

The patients of Griseofulvin therapy should refrain from the hazardous activities, which require alertness and quick psychic reaction and motor response.

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