For medical use of preparation
Active substance: Biotin.
1 tablet contains Biotin 5 mg.
Excipients: Celactose 80, Sodium lauryl sulfate, Sodium croscarmellose, Colloidal silicon dioxide anhydrous, Magnesium stearate, Opadry II 85 G 54348 pink*.
* – Opadry II 85 G 54348 pink: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, Ponceau 4R (E 124), quinoline yellow (E 104).
Pharmaceutical Form.Film coated tablets.
Round biconvex film coated tablets of pink colour.
Plain vitamin preparations. Biotin. Code ATC A11HA05.
Pharmacodynamics: Biotin (vitamin H, vitamin B7) is a water-soluble vitamin of B group. In human organismit plays an important role in metabolism of carbohydrate, fatty acids and proteins, and it is essential for normal cells growth and development. In introduction in organism it works as carboxylases coenzyme, causes insulin-mimetic action and takes part in gluconeogenesis (due to involvement into glucokinase synthesis) and in such way promotes stabilizing of sugar contents in blood, improves the function of nervous system. Biotin is a synergist of other B vitamins group, folic acid, pantothenic acid, and cyanocobalamin. There is data concerning biotin role in purine nucleotides synthesis. Biotin is also the source of sulfur that takes part in collagen protein synthesis and in such way it has a positive influence on the structure of skin and its appendages (hair, nails).
Biotin deficiency may occur due to imbalanced ration, prolonged diets and consuming raw egg whites; due to parenteral nutrition; because of malabsorption syndrome, after resection of the small intestine; while plural carboxylase deficiency associated with biotin; in patients on hemodialysis.
Pharmacokinetics: In organism biotin is rapidly absorbed in small intestine by a passive diffusion, and after that it passes through a portal system into liver and then into system circulation. The level of biotin binding with plasma proteins is 80%. Concentration of free or weakly bound biotin in blood as a rule is from 200 to 1200 mkg/l. Biotin passes through a hematoencephalic and placental barriers. In organism it is metabolized with different metabolites formation. 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 metabolism products. Half-life period depends on the amount of given dose and it is about 26 hours after inner introduction of 100 µg per kg of body weight. In patients with biotinidase deficiency half-life period after administration of the same dose is reduced to 10-14 hours.
Treatment of diseases caused by biotin deficiency: a disease of the skin, nails, hair.
Treatment of genetically caused enzimopaty associated with biotin (multiple carboxylase deficiency)
Hypersensitivity to Biotin or other drug components.
Interaction with other medicinal products and other forms of interaction
If biotin is used with anticonvulsants the concentration of biotin in plasma can be decreased due to the increase of his excretion with urine. Valproic acid reduces activity of biotinidase by diminishing of the mitochondrial function in the hepar.
The albumen of raw egg contains protein avidin, which co-operates with biotin; therefore it is necessary to avoid their simultaneous use. The use of plenty of raw eggs during 2 – 3 weeks can cause the biotin deficiency.
The Pantothenic acid being used in large doses competes with biotin therefore it is necessary to avoid their simultaneous application.
Special warnings and precautions for use
Do not violate the duration of the treatment course prescribed by physician. In a case of interrupted or prematurely stopped treatment the efficacy of the treatment may decrease. Due to good biotin tolerability the treatment can be prolonged for a long time.
The drug contains Ponceau 4R (E 124), therefore it may cause allergic reactions.
Pregnancy and lactation
There is no any data according to medicine application during pregnancy and lactation period.
Effects on ability to drive and use machines
There is no data indicating negative medication influence on psychomotor actions velocity.
Posology and method of administration
The drug Wolvit® is administered orally in adults. It should be taken before meal with a small portion of water.
Diseases of nails, hair and skin: the recommended dose is 5 mg (1 tablet) of biotin per day.
Genetically caused enzymopathies associated with biotin (multiple carboxylase deficiency): assign 2-4 tablets (daily dose - 20 mg biotin) for 1-2 receptions per day.
The duration of treatment course depends on the nature and course of the disease. Usually one continuous treatment course is about one month.
Do not administer the drug for children.
As of today there are no reports of biotin overdosing.
Immune system: allergic reactions are possible, which can be manifested as chest pain, short breath, urticaria, skin rash.
Shelf life.2 years.
Keep at the temperature not more than 25o C.
Keep it out of reach of children
There are 10 tablets in a blister, 3 blisters are in a carton box.
Conditions of supply. Without prescription.
Manufacturer name and address.
KUSUM HEALTHCARE PVT LTD
SP-289 (A), RIICO Industrialarea, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.