Ukraine Product

Wolvit Tablets

Wolvit Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:
Each film-coated tablet contains: Biotin USP …….. 5 mg

Indications and dosage.

INDICATIONS:
THERAPEUTIC INDICATIONS
Complex treatment and prophylaxis of diseases caused by Biotin deficiency in adults and children:  Hair diseases (high hair thinness, hair fragility, hair falling, increased greasiness or dryness of hair, grey hair);
 Skin diseases (dermatitis, seborrhea oleosa, dryness and peeling of skin);
 Nails diseases (fragility, exfoliation, nails growth or structure abnormality);
 Gastro-intestinal tract functional disorders (including malabsorption syndrome);
 Psycho-emotional disorders (expressed irritation and fatigability, somnolence, apathy, muscle weakness).
Biotin deficiency may be in such cases:
 gut organisms disorders (dysbacteriosis) because of prolonged treatment by antibiotics;
 in unbalanced nutrition, malnutrition, long diet;
 in usage of unboiled ovalbumin (it prevents Biotin absorption);
 in parenteral nutrition;
 in patients on hemodialysis;
 in absorption processes disorders (malabsorption syndrome, states after enterectomy).THERAPEUTIC INDICATIONS Complex treatment and prophylaxis of diseases caused by Biotin deficiency in adults and
children:
 Hair diseases (high hair thinness, hair fragility, hair falling, increased greasiness or dryness of hair, grey hair);
 Skin diseases (dermatitis, seborrhea oleosa, dryness and peeling of skin);
 Nails diseases (fragility, exfoliation, nails growth or structure abnormality);
 Gastro-intestinal tract functional disorders (including malabsorption syndrome);
 Psycho-emotional disorders (expressed irritation and fatigability, somnolence, apathy, muscle weakness).
Biotin deficiency may be in such cases:
 gut organisms disorders (dysbacteriosis) because of prolonged treatment by antibiotics;
 in unbalanced nutrition, malnutrition, long diet;
 in usage of unboiled ovalbumin (it prevents Biotin absorption);
 in parenteral nutrition;
 in patients on hemodialysis;
 in absorption processes disorders (malabsorption syndrome, states after enterectomy).

DOSAGE:
Adults:
The recommended dose in the treatment of diseases of nails, hairs and skin, and neurology disorders is 5 mg of Biotin per day. In adults 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. Elderly patients: The same dose range as in younger patients may be used in the elderly. Children:
In malabsorption syndrome the recommended dose is 10 mg. In children with Biotin deficiency symptoms the recommended dose is 5–20 mg per day. In biotinidase deficiency in children the recommended dose is 5–10 mg per day. In case of biotin-dependent enzymes insufficiency caused by genetics (multiple deficiency of carboxylases) the recommended dose is 20 mg per day. The drug may be used for a long period; one continuous treatment course is about one month. Pediatric:
 Infant's birth to 6 months: 5 mcg
 Infants 7 to 12 months: 6 mcg
 Children 1 to 3 years: 8 mcg
 Children 4 to 8 years: 12 mcg
 Children 9 to 13 years: 20 mcg
 Adolescents 14 to 18 years: 25 mcg

Side effects and drug interactions.

Interactions:
Although there is no evidence that biotin interacts with any medication, there are some medications that may deplete biotin levels. If you are being treated with any of the following medications, you should not use biotin without first talking to your health care provider. Antibiotics -- Long-term antibiotic use may lower biotin levels by destroying the bacteria in the gut that produces biotin. Anticonvulsant Medications -- Long-term use of anticonvulsant medications can reduce the body's stores of biotin. Valproic acid can cause biotinidase deficiency, which may be helped by biotin supplements. Anticonvulsant medications include:  Carbamazepine (Carbatrol)
 Phenobarbital
 Phenytoin (Dilantin)
 Primidone (Mysoline)

Warnings and precautions

Pregnancy and lactation:
There is no any data according to medicine application during pregnancy and lactation period.

Children:
Do not administer the drug for children under 12 years old.

PRECAUTIONS:
Do noAllergic reactions are possible in case of individual intolerance to Biotin. Do not administer the drug for children under 12 years old. 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 can be decreased. Because of good Biotin tolerability the treatment can be prolonged for a long time. There is no data indicating negative medication influence on psychomotor actions velocity
PREGNANCY AND LACTATION
Pregnancy
Pregnant women and nursing mothers should avoid supplemental doses of biotin greater than the adequate intakes (AI) recommended by the Food and Nutrition Board, unless higher doses are prescribed by their physicians. The AIs are 30 micrograms/day for pregnant women and 35 micrograms/day for nursing mothers. The use of biotin for the treatment of a biotin-responsive medical conditions requires medical supervision Individual doctor's advice is necessary if the preparation administration is required during pregnancy periods.
 Pregnant females: 30 mcg
Lactation
Individual doctor's advice is necessary if the preparation administration is required during lactation periods.
 Breast feeding females: 35 mcg

Overdosage and Contraindications

Overdose:
By the moment there are no reports of Biotin overdosing even in case of high doses.
CONTRAINDICATIONS:
Hypersensitivity to Biotin or other drug components. Children less than 12 years old.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

PHARMACODYNAMIC PROPERTIES:
Mechanism of action:
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 a portal system into liver and then into system circulation. The level of 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 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. PHARMACOKINETIC PROPERTIES:
The intestine is exposed to biotin from a few sources: the diet, biotin supplements and biotin synthesized by bacteria in the large intestine. Dietary biotin exists in free and protein-bound forms. Protein-bound biotin is digested by proteases and peptidases to biotin-containing oligopeptides and biocytin (epsilon-N-biotinyl-L-lysine). Biocytin and the biotin-containing oligopeptides are converted to biotin via the enzyme biotinidase. Biotin—both dietary-derived biotin and supplementary biotin—is efficiently absorbed from the small intestine. At doses of biotin derived from food, biotin appears to be transported into enterocytes by a sodium dependent carrier. At higher doses of biotin, absorption appears to occur by passive diffusion. Absorption of the biotin produced by the colonic microflora, appears to occur by a carrier mediated process in the proximal large intestine. Biotin is transported to the liver via the portal circulation and by the systemic circulation, to the other tissues of the body. Biotin appears to be transported in the serum in both bound and unbound forms. Uptake of biotin by cells appears to occur by both a sodium-dependent carrier process and by passive diffusion. Transport of biotin across the blood-brain barrier appears to occur by a saturable transport mechanism. Placental transport of biotin appears to occur by a passive process. Within cells, the carboxylases (pyruvate carboxylase, acetyl-CoA carboxylase, methylcrotonyl-CoA carboxylase, propionyl-CoA carboxylase) are biotinylated via holocarboxylase synthetase. Biotin and apo carboxylases are the substrates. ATP and magnesium also participate in the reaction. Biotin is recycled from the holocarboxylases via the action of proteolytic enzymes and biotinidase. Biotin is catabolized to a number of different metabolites, including bisnorbiotin, biotin sulfoxide, biotin sulfone, bisonorbiotin methyl ketone and tetranorbiotin-1-sulfoxide. Biotin is excreted in the urine as biotin, bisnorbiotin, biotin sulfoxide, biotin sulfone, bisnorbiotin methyl ketone and tetranobiotin-1- sulfoxide.

Shelf-life:
36 months.

Storage:
Store below 30ºC.
Keep all medicines out of reach of children.ss

Package:
Alu-Alu blister of 10 tablets, 3 or 10 blisters are packed in a carton.

Conditions of supply:
Without prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575