Dibicor® tablets

Registration number:  P N001698/01-120508

Trade name: DIBICOR® 

International non-patented name (INN): Taurine

Drug form: tablets

Composition: taurine 250 mg, 500 mg and excipients: cellulose micro-crystalline  23 mg, potato starch 18 mg, gelatin 6 mg, silicon dioxide colloid (aerosil) 0,3 mg, calcium stearate 2,7 mg.

Description: White or almost white flat cylindric tablets with a line and bevel.

Pharmacotherapeutic group: metabolic drug.

АТХ Code: C01EB

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Pharmacological properties

Pharmacodynamics. Taurine is a natural metabolite of the sulfur-containing amino acids (cysteine, cysteamine, methionine) metabolism. Taurin has an osmo-regulatory and membrane protective actions, has a positive effect on a phospholipid composition of cell membranes, normalizes a calcium and potassium metabolism in cells. Taurine has properties of a braking neurotransmitter, it has an anti-stress effect, it can potentiate a GABA, epinephrine, prolactine  release and to adjusts answers on them.

Dibicor improves metabolic processes in heart, liver and other tissues and organs. In presence of chronis diffuse disease of liver, Dibicor increases a blood flow and decreases a cytolysis. The treatment with Dibicor of cardiovascular insufficiency (CVI) leads to a decrease of stasis effects in a small and large circulation circles: an intracardiac diastolic pressure decreases, a myocardiac contractability increases (a maximal contraction and relaxation speed, contractability and relaxation indexes). The drug moderately decreases an arterial blood pressure in patients with an arterial hypertension, but virtually does not affect it in patients with CVI. Dibicor decreases side effects of a cardiac glycosides and slow Ca-canals blockers over-dosage, increases a workability during hard physical loads.

In the presence of  diabetes mellitus after near 2 weeks of the Dibicor use a triglycerides concentration decreases. It was also noted a prominent decrease of a triglycerides concentration, less prominent – a decrease of a cholesterol level and aterogenicity of plasma lipids. During the prolonged treatment by the drug (near 6 months) an improvement of the eye micro-circulation was noted.

Pharmacokinetics. After the single 500 mg dose of Dibicor its active compound taurine is detected in blood after 15-20 minutes, its maximal concentration is reached after 1,5-2 hours. The drug is totally eliminated after one day.

Indications

• cardiovascular insufficiency of a different etiology;

• intoxacation with cardiac glycozides;

• diabetes mellitus , I type;

• diabetes mellitus , II type (including a combination with relative hypercholesterolemia).

Contraindications

• Individual hypersensitivity to the drug;

• Age under 18 years (effectiveness and safety are not established)).

Method of use and dosages

For the treatment of a cardiac insufficiency Dibicor is used orally by 250-500 mg (1-2 tablets) 2 times a day 20 minutes before meals, the treatment duration -30 days. A dose can be escalated up to 2-3 g (8-12 tablets) per day, or decreased to 125 mg (1/2 of the tablet) per one time use.

For the treatment of a cardiac glycozydes intoxication – not less than 750 mg (3 tablets) per day.

In the complex treatment of I type of diabetes mellitus  – 500 mg (2 tablets) 2 times a day in combination with the insulin therapy during 3-6 months.

In the complex treatment of II type of diabetes mellitus  – 500 mg (2 tablets) 2 times a day as a monotherapy or in combination with other hypoglycemic drugs for internal use. In the complex treatment of II type of diabetes mellitus (including that eith moderate hypercholesterolemia  – 500 mg (2 tablets) 2 times a day , the treatment duration – by a doctor's prescription.

Side effects

Allergic reactions are possible

Over-dosage

Data are absent.

Interaction with other medicines

Dibicor can be used with other medicines, it increases inotropic effect of cardiac glycozydes.

Precautions

On a background of the Dibicor use, a dosage of cardiac glycosides can be decreased (up to one half), in dependence on sensitivity to cardiac glycosides. The similar rule is for “slow” Ca-canals blockers.

Drug form

250 mg tablets. 30 or 60 tablets in orange glass bottles. 10 tablets in blisters. Cans or 3 or 6 blisters are packed into a carton box with an instruction for use.

Keeping conditions

Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiry date.

Selling conditions

Without a prescription.

 Manufacturer

PIQ-PHARMA LLC, 129010 Moscow, Spassky blind alley, 2/1.

Manufactured by:

FSME «Central scientific constructor bureau» (FSME «CSCB»), 109240, Moscow,  Goncharnaya st., 20

or

PIQ-PHARMA PRO LLC, 188663 Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

 Claims have to be sent to

PIQ-PHARMA LLC,. Phone/fax: +7 495 925 57 00.

www.dibikor.ru