InsuVit

 

TRADE NAME

InsuVit

 

INTERNATIONAL NON-PROPRIETARY NAME

−

 

PHARMACEUTICAL FORM

Capsules.

Description: hard gelatin capsules, size 0, with light green body and cap, containing powder as a mixture of white and light brown particles.

 

COMPOSITION

1 capsule contains

Active ingredients:

Vitamin B12 (cyanocobalamin)	1.2 μg
Vitamin H (biotin)	15 μg
Vitamin PP (niacinamide)	7 mg
Benfotiamine	0.5 mg
Zinc (as zinc citrate trihydrate)	2 mg
Chromium (as chromium picolinate)	6 μg
Selenium (as sodium selenite)	5 μg
Cinnamon bark dry extract (Cinnamonum zeylanicum)	50 mg
Momordica fruit dry extract (Momordica charantia)	25 mg

Excipients: maltodextrin, magnesium stearate.

Capsule shell composition: Patent Blue V, yellow iron oxide, titanium dioxide, gelatin.

 

ATC CODE OF THE DRUG   А11ЕХ

 

PHARMACOTHERAPEUTIC GROUP

Complex of B vitamins with other agents.

 

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

InsuVit is a complex of B vitamins, minerals and herbal extracts for prophylactic use and treatment of diabetes mellitus, metabolic syndrome, and obesity, as well as for use in weight loss programs. It promotes normalization of protein, lipid and carbohydrate metabolism, decrease of insulin resistance in tissues, and blood glucose stabilization. The drug reduces body weight in obesity, attenuates manifestations of diabetic neuropathy, and improves the condition of blood vessels and capillaries.

Vitamin B₁₂ participates in nucleotide synthesis. It is as an essential factor of normal growth, hematopoiesis and development of epithelial cells. It takes part in production of myelin which forms neurilemma; enhances tissue regeneration ability and attenuates manifestations of diabetic neuropathy.

Vitamin Н has an essential role in carbohydrate, protein, and lipid metabolism. Increasing glucokinase synthesis, vitamin H promotes glucose metabolism and enhances gluconeogenesis. It promotes blood glucose stabilization and participates in degradation of fatty acid and utilization of fat.

Vitamin РР prevents disintegration of insulin-producing pancreas cells and development of type 1 diabetes. It reinforces blood vessel walls and improves energy metabolism.

Benfotiamine normalizes carbohydrate metabolism, promotes normalization of the nervous system function, and protects nervous cells from damaging action of hyperglycemia. It participates in metabolism, nervous and reflex regulation, and influences transmission of nervous excitation in cholinergic synapses. Benfotiamine plays an important part in carbohydrate and energy metabolism in nervous and muscular tissue.

Chromium takes part in blood glucose regulation and increases insulin effect in all metabolic processes.

Zinc is a part of numerous enzymes; it is involved in all types of metabolism. It enhances insulin action. Zinc takes part in cell division and differentiation, stimulates skin regeneration processes and hair growth, and produces immunomodulating effect. It participates in photochemical reactions of vision and in endocrine gland activity.

Selenium increases insulin production, improves tissue uptake of glucose and reduces cellular energy starvation.

Cinnamon bark dry extract increases tissue sensitivity to glucose and reduces plasma glucose level in hyperglycemia. It produces antioxidant action and normalizes body weight in obesity.

Momordica fruit dry extract gradually decreases blood glucose level with its subsequent regulation, reduces body weight in obesity, decreases cholesterol level in hypercholesterolemia and normalizes arterial pressure in hypertension.

PHARMACOKINETICS

The action of InsuVit is determined by the cumulative properties of its components. Performance of kinetic observations is impossible, as the combined components cannot be traced with markers or biostudies. Metabolites of the drug cannot be recovered due to the same reason.

 

therapeutic indicationS

- prevention and complex treatment of type 1 and 2 diabetes mellitus and its complications;

- metabolic acidosis (in complex therapy);

- obesity (in complex therapy);

- in weight loss programs.

 

Dosage and administration

InsuVit is administered orally.

Children over 12 years old take 1 capsule daily, adults – 1-2 capsules daily.

The dose may be increased upon the recommendation of the doctor in diabetes mellitus and metabolic syndrome.

 

CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- pregnancy;

- lactation.

 

SIDE EFFECTS

Allergic reactions are possible.

 

SPECIAL INDICATIONS

In case of allergic reactions discontinue InsuVit. Administration of lower doses of the drug is possible.

 

INFLUENCE ON ABILITY TO DRIVE AND OPERATE OTHER MECHANISMS

No warnings for drivers and people working with potentially dangerous mechanisms are available.

 

Pregnancy and lactation

Administration of InsuVit during pregnancy and lactation is contraindicated.

 

PEDIATRIC USE

The dose for children with diabetes mellitus is determined by the doctor.

 

DRUG INTERACTIONS

Penicillamine and isoniazid reduce the effectiveness of benfotiamine, increasing its excretion.

 

OVERDOSE

No reports of overdose have been made to date.

 

PACKAGING

Hard gelatin capsules.

100 capsules in a plastic bottle with a screw cap and protective film.

A bottle together with an enclosed leaflet in a carton box.

 

STORAGE CONDITIONS

Store in a protected from moisture and light place at temperature not exceeding 25°С.

Keep out of reach of children!

 

SHELF LIFE

3 years from the date of manufacture.

Do not apply after the expiry date.

 

SALES TERMS

Sold without prescription.

 

MANUFACTURER

The holder of trade mark and marketing authorization is

“INSUPHAR LABORATORIES İLAÇLARI LİMİTED ŞİRKETİ”, TURKEY.

Manufactured by

“KENDY LTD”, 8 Gurmazovsko shose, 2227 Bozhurishte, Bulgaria.