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Tabex PDF Print E-mail

Tabex is an original Bulgarian preparation of vegetable origin, destined for treatment of nicotinism. The preparation is developed on the basis of cytisine alkaloid, contained in the plant Cytisus laburnum L., Yellow acacia - disseminated in the southern parts of Central Europe and Italy. The biggest quantity of this alkaloid - up to 3%, is found in the seeds.

Pharmacology

The preparation Tabex, developed on the basis of cytisine, possesses a similar mechanism of action like that of nicotine.
Cytisine:
- Stimulates vegetative nerve ganglia
- Enhances the release of adrenaline from suprarenal glands
- Stimulates reflex-motor center
- Increases arterial blood pressure

Toxicology

In the experiments with different animal species, at peroral administration Tabex is:
Strongly toxic substance

With good resorption index.
In the studies for chronic toxicity it is established that:
- At peroral application to mice, rats and dogs, Tabex does not cause toxic changes in hemopoiesis and viscera.
- Statistically significant increase of transaminases as compared with the control groups at Cytisine dose of 1.35 mg/kg after 90-days administration.
- No changes are noticed in the behaviour of experimental animals and the examined paraclinical indices.
- Pathohistological examinations show different rate of liver dystrophy in mice at doses of 3.3 mg/kg and in dogs at doses of 0.45 mg/kg.

Clinical studies

The preparation Tabex is studied in different designs at 8 multicenter clinical studies in Germany, Bulgaria and Poland.


The summarized results indicate:
Tabex is applied peroral to 1045 persons in comparison to 400 smokers, receiving placebo, and 1500 who administered other anti-smoking preparations. The clinical results show a high percentage of giving up smoking with Tabex, which is higher and statistically trustworthy as compared with placebo and the other preparations. The daily therapeutic dose of Tabex is 1.5 to 9 mg daily, without any adverse effects. Improvement of the general status of smokers is recorded after discontinuance of smoking with Tabex due to interruption of nicotine intoxication with nicotine (I breath freely again). The preparation Tabex is tolerated very well because at therapeutic doses it does not cause lack of appetite, nausea and vomiting.

Clinical efficacy

Tabex - the drug of choice for prevention of socially significant diseases referred to smoking:
- Cardiovascular incidents (infarction, stenocardia, peripheral vascular diseases).
- respiratory system diseases (pulmonary cancer, tracheobronchitis, etc.).
- Digestive tract diseases (gastritis, inflammation of oral mucosa, etc.).
- Psychic and physiological dependence of drug addiction type.

The clinical studies of long years have manifested the advantages of the preparation Tabex and its therapeutic efficacy in different groups of smokers.

High percentage (55-76%) of Tabex treated patients give up cigarettes. Good tolerance and absence of adverse effects at therapeutic doses Good effect on the depressive states and chronic pulmonary lesions accompanying the long-term smoking.

No adverse drug interactions are recorded with neuroleptics, antidepressants and insulin
TABEX, ADMINISTERED IN A SUITABLE SCHEME, ALLOWS GRADUAL GIVING UP OF SMOKING WITHOUT ANY ABSTINENT SYMPTOMS.

Tabex is applied peroral (better under doctor's control) according to the following scheme:
If there is no reluctance for smoking and reduction of cigarettes number in the initial 3 days, the treatment is discontinued and the attempt may be initiated 2-5 months later on. In case of positive result, the treatment continues according to the scheme. Cessation of smoking should be done as at the fifth day from beginning of treatment.
When the therapeutic course is over, goodwill is necessary - do not try to smoke even one cigarette.

Adverse drug reactions:

Changes of taste and appetite, dry mouth, headache, increased irritability, nausea, constipation, tachycardia, slightly elevated blood pressure may appear during administration of Tabex, which disappear within the treatment course.

ATTENTION!!!!!
Tabex should be prescribed only to patients with a serious intention to give up smoking. The patient should know that administration of Tabex simultaneously with smoking may enhance the adverse effects of nicotine.

Prescription of Tabex to patients with ischemic heart disease, heart failure, cerebrovascular lesions. obliterating arterial diseases, hyperthyroidism, diabetes, renal or hepatic failure, should be done after an accurate estimation of the attending physician.