Each film coated tablet contains: Biotin USP 5 mg.
Excipients/Inactive Ingredients: Cellactose 80, sodium lauryl sulphate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, opadry II 85G 54348 and purified water.
Pharmacotherapeutic Group: Vitamins, other plain vitamin preparations. ATC code: A11HA05.
Pharmacology: Pharmacodynamics: Biotin is traditionally considered to be a vitamin B substance. It is an essential coenzyme in fat metabolism and in other carboxylation reactions. Biotin deficiency may result in the urinary excretion of organic acids and changes in skin and hair.
Deficiency of biotin is very unlikely in man because of its widespread distribution in food. Egg-yolk and offal are especially good sources. Biotin deficiency has been reported however during long-term parenteral nutrition and in patients with biotinidase deficiency, an inherited metabolic disorder. For dosage in biotinidase or isolated carboxylase deficiency see "Dosage & Administration". A combination of biotin and chromium tripicolinate has been promoted as an adjunct for the management of diabetes mellitus. Biotin combines with avidin, a glycoprotein present in raw eggwhite, to form an inactive compound.
Pharmacokinetics: Biotin enters the human organism from food and it is also synthesized by human intestine microflora. In organism Biotin is rapidly absorbed in small intestine by a passive diffusion, and after that it passes through the portal system into liver and then into systemic circulation. Biotin binding with plasma proteins is approximately 80%.
Concentration of free or weakly bound Biotin in blood as a rule is from 200 to 1200 mkg/l. Biotin passes through the hematoencephalic and placental barriers. In human it is metabolized to different metabolites. Biotin is excreted with urine (from 6 to 50 µg per day) and with feces in unchanged form (approximately 50%) and also as biologically inert metabolite. Half-life period depends on the amount of given dose and it is about 26 hours after intake of 100 µg per kg of body weight.
Wolvit is indicated for the prevention and treatment of Biotin deficiency.
Dosage: Older patients may be given 10 mg daily. The usual maintenance dose ranges from 10 to 50 mg daily, though up to 100 mg daily may be needed. For defects of biotin metabolism, 10 mg once daily may be given by mouth, adjusted according to response.
In malabsorption syndrome the recommended dose is 10 mg. In adults and children with Biotin deficiency symptoms the recommended dose is 5-20 mg per day. In biotinidase deficiency in adults and children the recommended dose is 5-10 mg per day.
Method of administration: Wolvit tablets are taken peroral, before meals with a small portion of water.
The recommended dose in the treatment of diseases of nails, hairs and skin, and neurology disorders is 5 mg of Biotin per day. The drug may be used for a long period, one continuous treatment course is about one month.
By the moment there are no reports of Biotin overdosing even in case of high doses.
Wolvit is contraindicated in persons who are hypersensitive to biotin. It should also be avoided in children who are less than 12 years of age.
Follow the duration of the treatment course prescribed by physician. In case of interrupted or prematurely stopped treatment the efficacy of the treatment can be decreased. Because of good Biotin tolerability the treatment can be prolonged for a long time.
Do not give the drug for children under 12 years old.
There is no data regarding safety of use during pregnancy and lactation period.
For reference to life-threatening eosinophilic pleuropericarditis in a patient receiving biotin and pantothenic acid. Allergic reactions are possible in case of individual intolerance to Biotin, which can be exhibited as a chest pain, shortness of breath, urticaria, appearance of skin rash.
If Biotin is used with anticonvulsants the concentration of Biotin in plasma can be decreased due to the increase of Biotin’s excretion with urine. Valproic acid reduces activity of biotinidase by diminishing the mitochondrial function of liver.
The albumen of raw egg contains protein avidin, which is antagonist to biotin, therefore it is necessary to avoid their simultaneous use. The use of plenty of raw eggs for 2 - 3 weeks can cause biotin deficiency. The Pantothenic acid being used in large doses competes with biotin therefore it is necessary to avoid their simultaneous use
Store below 30°C.
Shelf-Life: 36 months.
A11HA05 - biotin ; Belongs to the class of other plain vitamin preparations. Used as dietary supplements.
FC tab 5 mg (pink colored, round, biconvex, plain on both sides) x 3 x 10's, 10 x 10's.