Instructions Tribestan film-coated tablets 250 mg No. 60
Composition
active ingredient: creeping anchor grass dry extract (35-45:1);
1 film-coated tablet contains dry extract of Tribulus terrestris herb (Tribulus terrestris herba extractum siccum), (35-45:1), (extractant: methanol 80%) – 250 mg, which corresponds to furostanol saponins in terms of protodioscin – 112.5 mg;
excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, povidone, crospovidone, magnesium stearate, talc;
film coating: Opadry AMV 80W26601 brown (partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), lecithin, xanthan gum, yellow iron oxide (E 172)).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated, brown in color with a specific odor.
Pharmacotherapeutic group
Drugs used in urology.
ATX code G04B X.
Pharmacological properties
Pharmacodynamics.
A natural product obtained using an original technology from the aboveground part of the Tribulus Terrestris L. plant. The drug contains mainly steroidal saponins of the furostanol type, among which protodioscin predominates. The mechanism of action of the drug is due to this component.
Protodioscin is metabolized in the body to dehydroepiandrosterone (DHEA), which has beneficial effects on cell membrane permeability, erectile function, cholesterol metabolism, and immunity. Other active furostanol saponins, which are part of the Tribulus Terrestris L. plant extract, are likely to modulate the effect of protodioscin.
Tribestan has a general tonic effect and stimulates some functions of the reproductive system. In men, it restores and improves libido and erection. It has a stimulating effect on spermatogenesis, increasing the number of spermatozoa and their motility, and increases testosterone levels. In women, Tribestan also improves libido and stimulates ovulation. It has a beneficial effect on vasomotor manifestations in 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 pituitary-gonadal axis hormones without significantly altering levels of adrenal hormones and adrenocorticotropic hormone.
Tribestan has a hypolipidemic effect, and in patients with dyslipoproteinemia it significantly reduces the level of total cholesterol and LDL (low-density lipoproteins), without a significant effect on the level of triglycerides and HDL (high-density lipoproteins) in blood serum.
Tribestan has antihypertensive and diuretic effects.
Pharmacokinetics.
The active substance protodioscin is rapidly excreted from the plasma - already within the third hour its concentration is insignificant. It is excreted mainly with bile. The low percentage of excretion of unchanged protodioscin compared to the dose taken confirms the assumption that it is intensively biotransformed in the body.
Indication
For the prevention and treatment (monotherapy and complex) of sexual disorders in men and women. For erectile dysfunction in men to increase libido, strength and duration of erection. As monotherapy or in complex therapy of certain forms of infertility in men: infertility based on idiopathic oligoasthenoteratospermia (reduction in the number and quality of sperm in the secreted semen); infertility in the absence of improvement in sperm parameters within one year after surgery for varicocele; immunologically determined infertility. For women with climacteric and post-castration syndrome with pronounced neurovegetative and neuropsychiatric manifestations; for endocrine ovarian infertility. For impaired fat metabolism (dyslipoproteinemia) to reduce total cholesterol and LDL.
Contraindication
Tribestan is contraindicated in:
hypersensitivity to the components of the drug;
severe cardiovascular and renal diseases;
prostate adenoma.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Tribestan with drugs that stimulate ovulation leads to mutual enhancement of their effects.
The use of Tribestan may enhance the effects of diuretics and potentiate the hypotensive effect of antihypertensive drugs.
Application features
When treating women with climacteric syndrome, the transition from a therapeutic to a maintenance dose should be gradual. After a sharp reduction or cancellation of the effective dose, a re-appearance of the complex of climacteric symptoms is possible.
Use during pregnancy or breastfeeding
The potential risk to humans is unknown. Due to the lack of clinical studies in pregnant women, Tribestan is contraindicated during pregnancy or breastfeeding.
When pregnancy is established, the drug must be discontinued.
The ability to influence the reaction speed when driving or working with other mechanisms
Method of administration and doses
Take the tablets orally, after meals.
With reduced libido, impotence and infertility.
For men with reduced libido, impotence and infertility, the recommended dosage is 1-2 tablets 3 times a day. The duration of treatment is at least 90 days. The course of treatment can be repeated until a satisfactory therapeutic effect is obtained.
For women with endocrine infertility, the recommended dosage is 1-2 tablets 3 times a day, from the 1st to the 12th day of the menstrual cycle. This course can be repeated periodically until pregnancy occurs.
Dyslipoproteinemia.
2 tablets 3 times a day. Duration of treatment – at least 3 months.
Climacteric and post-castration syndrome in women.
1-2 tablets 3 times a day for 60-90 days. After the condition improves, gradually switch to a maintenance dose of 2 tablets per day for 1-2 years.
Children
The drug is not recommended for use in patients under 18 years of age.
Overdose
To date, no cases of overdose with the drug Tribestan have been observed. There are no reports of overdose with Tribestan. If a large amount of the drug is taken, symptomatic treatment should be carried out.
Side effects
Hypersensitivity reactions are possible.
When taken before meals, the drug may cause irritation to the gastric mucosa.
Expiration date
5 years.
Storage conditions
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Keep out of reach of children.
Packaging
10 film-coated tablets in a blister of PVC film and aluminum foil; 6 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
JSC "Sopharma".
JSC "VITAMINS".
Location of manufacturers and addresses of their place of business.
JSC "Sopharma"
16 Ilienskoe Shose St., Sofia, 1220, Bulgaria.
JSC "VITAMINS"
Ukraine, 20300, Cherkasy region, Uman city, Uspenska st., 31.
