Tribestan

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIBESTAN® (TRIBESTAN®)

Composition:

Active substance: dried extract of Tribulus terrestris herb (35–45:1);

One film-coated tablet contains dried extract of Tribulus terrestris herb (Tribulus terrestris herba extractum siccum), (35–45:1), (extractant: methanol 80%) – 250 mg, corresponding to furostanol saponins calculated as protodioscin – 112.5 mg;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, povidone, crospovidone, magnesium stearate, talc;

Film coating: Opadray AMB 80W26601 brown (partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), lecithin, xanthan gum, iron oxide yellow (E 172)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: brown, round, biconvex, film-coated tablets with a specific odor.

Pharmacotherapeutic group.

Agents used in urology.

ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

The drug is of natural origin, obtained by an original technology from the above-ground part of the plant Tribulus Terrestris L. The medicinal product predominantly contains steroidal saponins of the furostanol type, among which protodioscin predominates. The mechanism of action of the drug is determined by this component.

Protodioscin is metabolized in the body to dehydroepiandrosterone (DHEA), which favorably affects cell membrane permeability, erectile function, cholesterol metabolism, and immunity. Other active furostanol saponins contained in the extract of the plant Tribulus Terrestris L. likely modulate the effect of protodioscin.

Tribestan exerts a general tonic effect and stimulates certain functions of the reproductive system. In men, it restores and improves libido and erection. It exerts a stimulating effect on spermatogenesis, increasing sperm count and motility, and raises testosterone levels. In women, Tribestan also enhances libido and stimulates ovulation. It favorably affects vasomotor symptoms associated with natural and post-castration climacteric syndrome due to its balancing effect on hormonal activity.

Results in healthy volunteers show that Tribestan affects serum levels of hormones of the pituitary-gonadal axis, without significantly altering levels of adrenal hormones and adrenocorticotropic hormone.

Tribestan has a hypolipidemic effect; in patients with dyslipoproteinemia, it significantly reduces total cholesterol and LDL (low-density lipoproteins) levels, without a significant effect on serum triglyceride and HDL (high-density lipoprotein) levels.

Tribestan has antihypertensive and diuretic effects.

Pharmacokinetics.

The active substance protodioscin is rapidly eliminated from plasma—its concentration is already insignificant by the third hour. It is excreted predominantly via bile. The low percentage of unchanged protodioscin excreted compared to the administered dose confirms the assumption that it undergoes intensive biotransformation in the body.

Clinical characteristics.

Indications.

For the prevention and treatment (monotherapy and combination therapy) of sexual disorders in men and women. For erectile dysfunction in men, to enhance libido, strength, and duration of erection. As monotherapy or in combination therapy for certain forms of male infertility: infertility due to idiopathic oligoasthenoteratospermia (reduced number and quality of spermatozoa in ejaculated semen); infertility with no improvement in semen parameters within one year after varicocelectomy; immunologically induced infertility. In women with climacteric and post-castration syndrome presenting with neurovegetative and neuropsychic symptoms; in ovarian endocrine infertility. In lipid metabolism disorders (dyslipoproteinemia) for reduction of total cholesterol and LDL cholesterol.

Contraindications.

Tribestan is contraindicated in cases of:

• hypersensitivity to the components of the medicinal product;
• severe cardiovascular and renal diseases;
• prostate adenoma.

Interaction with other medicinal products and other forms of interactions.

Concomitant use of Tribestan with medicinal products that stimulate ovulation may result in mutual enhancement of their effects.

Administration of Tribestan may enhance the effects of diuretics and potentiate the hypotensive action of antihypertensive agents.

Special precautions for use.

When treating women with climacteric syndrome, transition from the therapeutic dose to the maintenance dose should be gradual. Abrupt reduction or discontinuation of an effective dose may lead to recurrence of climacteric symptoms.

Use during pregnancy or breastfeeding.

The potential risk to humans is unknown. Due to the lack of clinical studies in pregnant women, the drug Tribestan is contraindicated during pregnancy and breastfeeding.

If pregnancy is detected, the drug should be discontinued immediately.

Ability to influence reaction rate while driving or operating machinery.

Tribestan does not affect the ability to drive vehicles or operate machinery.

Method of administration and dosage.

Tablets should be taken orally, after meals.

For reduced libido, impotence, and infertility.

For men with reduced libido, impotence, and infertility, the recommended dosage is 1-2 tablets three times a day. The duration of treatment should be at least 90 days. The treatment course may be repeated until a satisfactory therapeutic effect is achieved.

For women with endocrine infertility, the recommended dosage is 1-2 tablets three times a day, from day 1 to day 12 of the menstrual cycle. This course may be repeated periodically until pregnancy occurs.

Dyslipoproteinemia.

2 tablets three times a day. The duration of treatment should be at least 3 months.

Menopausal and post-castration syndrome in women.

1-2 tablets three times a day for 60-90 days. After improvement of symptoms, gradually switch to a maintenance dose of 2 tablets per day for 1-2 years.

Children.

The use of the drug is not recommended in patients under 18 years of age.

Overdose.

Cases of overdose with the medicinal product Tribestan have not been observed to date. There are no reports of Tribestan overdose. In case of ingestion of a large amount of the drug, symptomatic treatment should be administered.

Side effects.

Hypersensitivity reactions are possible.

When taken orally, the drug may cause an irritating effect on the gastric mucosa.

Shelf life. 5 years.

Storage conditions.

This medicinal product does not require special storage temperature conditions. Store in the original packaging to protect from moisture.

Keep out of reach of children.

Packaging. 10 film-coated tablets in a blister made of PVC film and aluminum foil; 6 blisters per cardboard box.

Availability category.

Over-the-counter.

Manufacturers.

JSC "Sofarma".

JSC "VITAMINS".

Manufacturers' addresses and locations of their business activities.

JSC "Sofarma"

16 Iliensko Shose Str., Sofia, 1220, Bulgaria.

JSC "VITAMINS"

31 Uspenska Str., Umans, Cherkasy region, 20300, Ukraine.