Home / Products

Darstin

Darstin

Darstin

Instructions for use of the drug (for patients)

DARSTIN      10 mg/g gel for local use
DARSTIN

International non-proprietary name:Progesterone 

Composition
The active substance:  1 g of gel contains 10 mg of progesterone.
Auxiliary substances: carbomer, trolamine, 96% ethanol, purified water.

Description
Come transparent.

Pharmacotherapeutic group
Progestagen derivatives of 4-pregnene

ATC code:G03DA04.

Pharmacological properties

Pharmacodynamics
Mechanism of action

Darstin is pure progesterone delivered in an excipient suitable for transdermal use. Its antiestrogenic effect regulates the local imbalance between estrogens and progesterone.
The hormone has a direct effect on the mammary gland. Darstin is generally well tolerated as it does not cause any side effects.
Darstin prevents the vascular and cellular effects of local progesterone deficiency in mammary glands. In this sense, progesterone:

  • Prevents the increase in capillary permeability caused by estrogens.
  • It affects the growth and differentiation of galactophores and acini.
  • Estrogens inhibit the epithelial mitosis cycle.

Pharmacokinetics

Absorption
The absorption coefficient is about 10% of the administered dose.

Biotransformation
About 80% of the drug is metabolized in the mammary gland, only 20% reaches the systemic circulation.

Exclusion
The peak clearance of metabolites occurs after 48 hours.

Instructions for use
Specific treatment of benign diseases of mammary glands.

Mastodynia:

  • in insulated form;
  • After treatment with contraceptives;
  • During premenstrual syndrome;
  • In the early stages of pregnancy;
  • During benign mastopathy.

Contraindications
Hypersensitivity to the active substance or any of the listed auxiliary substances.

Special instructions and precautions
Because it is a water/alcohol solution, it should not be used directly on mucous membranes.
Frequent use can cause skin irritation and dryness.

Interaction with other drugs
Clinically significant interactions were not observed in the studies conducted.

Use during pregnancy and lactation
Available data show that Darstin has no effect on pregnancy.
Since Darstin does not have a systemic effect, it can be used when breastfeeding.

Effects on the ability to drive vehicles and other potentially dangerous mechanisms
Darstin has no or insignificant effect on the ability to drive vehicles and machinery.

Method of use and dosage
Apply 5 g of gel to the mammary glands every day, including during menstruation (one dosing spatula per mammary gland).
The duration of treatment depends on the prescription and is determined individually by the doctor.

Use through the skin
Hold the spatula with one hand and the tube with the other and spread the gel along the length of the spatula. This amount is a suitable dose for one mammary gland (2.5 g).
Repeat this procedure for the other breast.

Side effects
Side effects of Darstin are generally not observed. However, the following may occur:

  • Disorders of the skin and subcutaneous tissues.
  • The incidence of skin irritation and dryness is unknown. 

Overdose
Due to the special pharmacokinetics of this product, there is no risk of overdose.

 Release form
80 g of gel is packaged in a cardboard box with an aluminum tube, a gold-colored interior, one end sealed, a dosing spatula and a leaflet.

Storage conditions
Store below 25ºC and out of the reach of children.
Close the container tightly after each application.

Suitability duration
3 years.
Do not use after the expiration date.

Condition of release from pharmacy
It is released on the basis of a prescription.

Manufacturer
SEID, S.A., Spain.
Ctr. Sabadell-Granollers, Km 15.08185, Lliça de Vall (Barcelona), Spain.

Holder of registration card
LN COMPANY LLC, Republic of Azerbaijan.
Khirdalan city, Baku-Guba highway, 12th km, building 2, No. 3, Republic of Azerbaijan.