Hormoston

Indonesia • Dexa Medica

Indication

Adjunct to estrogen replacement therapy
Including combination with cyclical estrogen therapy

Progesterone deficiencies
Treatment of progesterone deficiencies such as dysmenorrhea, endometriosis, secondary amenorrhea, dysfunctional uterine bleeding, premenstrual syndrome, threatened and habitual abortion associated with proven progesterone deficiency, and infertility due to luteal insuficiency

Composition

Each film coated tablet contains:
Dydrogesterone 10 mg

Package

Box, 1 blister x 20 film-coated tablets

Dosage Forms

Tablet

ATC Classification

G03D

Warning

Machinery
Safe if Prescribed
This item is safe for use while operating heavy machinery.
Pregnancy
Safe if Prescribed
This item is safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.
Precaution
  • Before initiating treatment with dydrogesterone for abnormal bleeding, the etiology for the bleeding should be clarified.
  • Treatment with dydrogesterone has infrequently been associated with alterations in liver function, sometimes accompanied by clinical symptoms. Thus, dydrogesterone should be used with caution in patients with acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal. In cases of severe hepatic impairment, treatment should be discontinued.
  • Breakthrough bleeding may occur in a few patients. This can, however, be prevented by increasing the dosage.

Dosage

Adjunct to estrogen replacement therapy

  • 10 mg daily for 10 to 12 days per month is adequate for most patients.
  • 20 mg daily for 10 to 12 days per month should be used only in the event unacceptable withdrawal bleeding.
  • In combination with cyclical estrogen therapy, one film coated tablet of 10 mg dydrogesterone daily during the last 12-14 days of estrogen therapy.

 

Progesterone deficiencies

  • Dysmenorrhea: 10 mg twice daily starting day 5 to day 25 of the cycle.
  • Endometriosis: 10 mg twice daily from day 5 to day 25 of the cycle or continuously.
  • Secondary amenorrhea: an estrogen once daily from day 1 to day 25 of the cycle, and HORMOSTON 10 mg twice daily from day 11 to day 25.
  • Dosage in abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology (functional bleeding) such as submucous fibroids or uterine cancer.
    • To arrest functional bleeding: 10 to 20 mg (1 to 2 film coated tablets) one or two times a day for five to tend days
    • To prevent further heavy bleeding: 10 to 20 mg (1 to 2 film coated tablets) one or two times a day from the 11th day to 25th day of the menstrual cycle and repeated cyclically as needed.
  • Premenstrual syndrome: 10 mg twice daily from day 12 to day 26 of the cycle.
  • Threatened abortion: 40 mg at once, then 10 mg every eight hours until symptoms remit.
  • Dosage in habitual abortion associated with proven progesterone deficiency. Treatment should be started as soon as possible, preferably before conception. 10 mg dydrogesterone twice daily is to be given from the 11th to the 25th day of the cycle with continuous administration after conception. The treatment must be continued at any rate until the 20th week of pregnancy, then can be reduced gradually.
  • Dosage in infertility due to luteal insuficiency: 10 mg dydrogesterone twice daily from the 11th to the 25th day of the cycle. The treatment is to be continued for at least 6 successive cycles. It is advised to continue this treatment during the first few months of a possible pregnancy, at dosages as are recommended for habitual abortion.
  • HORMOSTON is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
* For detailed product information, see package insert.