A pale gel, colorless, with an ethanol smell.
Each gram contains: Drug substance: Progesterone 10.0 mg.
Excipients/Inactive Ingredients: Purified water, ethanol, trolamine, carbomer 980.
Pharmacological Group: Sex hormones, progesterone pregnant (4) derivatives. ATC Code: G03DA04.
Pharmacology: Pharmacodynamics: Mechanism of Action: Darstin contains pure progesterone, dispersed into an appropriate excipient for transdermal absorption. Its estrogen-blocking effect helps balance the local estrogen and progesterone levels.
The drug's mechanism of action directly affects the breast tissue, where hormone concentrations are high. Since Darstin generally does not cause side effects, it is well-tolerated.
Darstin helps prevent the impact on blood vessels and cells caused by local progesterone deficiency in breast tissue. At this concentration, progesterone is indicated to: Prevent capillary permeability increase caused by estrogen.
Counteract the development and differentiation of mammary glands and small exocrine ducts.
Block epithelial cell division caused by estrogen.
Pharmacokinetics: Absorption: The absorption rate is approximately 10% of the prescribed dose.
Metabolism: About 80% of the absorbed drug will be metabolized through the mammary glands, but only 20% will enter the systemic circulation.
Treatment of benign breast diseases.
Mastalgia (breast pain), either isolated or associated with benign breast conditions.
Posology: Apply 2.5 g of gel to the breast (use 1 dose-measuring device for each breast) daily, even during menstruation.
Method of administration: For external use only.
Hold the end of the dose-measuring device with one hand, use the other hand to squeeze the tube, and apply the gel along the length of the device. The amount of medication must be accurate as prescribed for each breast (2.5 g).
Repeat the process for the other breast.
Treatment should be continuous daily for the entire month, including during menstruation.
The average treatment duration is 3-6 months.
The maximum daily dose is 5 g.
This medication should not be used for children.
Due to the unique pharmacokinetics of this medication, there is no risk of overdose.
Contraindicated in patients who are hypersensitive to any component of the medication.
Since the medication is a water/alcohol solution, it should not be applied directly to mucous membranes.
Frequent use may cause skin irritation and dryness.
Effects on the Ability to Drive and Use Machines: Darstin does not affect the ability to operate machinery or drive vehicles.
Pregnancy: Current data indicates that Darstin does not affect pregnant women.
Breast-feeding: Since Darstin does not have systemic effects, it can be used during breastfeeding.
Darstin generally does not cause side effects. However, the following may occur:
Skin and subcutaneous tissue disorders: Unknown frequency (cannot be assessed based on available data): Skin irritation and dryness.
Report any side effects to a doctor.
No clinically significant drug interactions have been reported in studies.
Store in a dry place, protected from light and moisture, below 30°C.
Shelf Life: 36 months from the manufacturing date.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Darstin Gel dùng tại chỗ 1%
80 g x 1's
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