- Approval Id
- 9b3eb7b85a350242
- Drug Name
- DUPHASTON TABLET 10 mg (Film-coated)
- Product Name
- DUPHASTON TABLET 10 mg (Film-coated)
- Approval Number
- SIN11255P
- Approval Date
- 2000-01-10
- Registrant
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Licence Holder
- ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Dosages, treatment schedule and duration of treatment may be adapted to the severity of the dysfunction and the clinical response.</p>
<p>Symptomatic relief of mild to moderate vasomotor symptoms associated with menopause; prevention of postmenopausal osteoporosis;</p>
<ul class="dash">
<li>Continuous sequential therapy: An oestrogen is dosed continuously and one tablet of 10 mg dydrogesterone is added for the last 14 days of every 28 day cycle, in a sequential manner.</li>
<li>Cyclic therapy: When an oestrogen is dosed cyclically with a treatment-free interval, usually 21 days on and 7 days off. One tablet of 10 mg dydrogesterone is added for the last 12 – 14 days of oestrogen therapy.<br>
If ultrasound or endometrial biopsies would reveal inadequate progestational response, 20 mg dydrogesterone should be prescribed.</li>
</ul>
<p>Dysmenorrhoea:</p>
<ul class="nobull">
<li>10 mg twice daily from day 5 to day 25 of the menstrual cycle.</li>
</ul>
<p>Endometriosis:</p>
<ul class="nobull">
<li>10 mg two or three times daily from day 5 to day 25 of the cycle or continuously.</li>
</ul>
<p>Dysfunctional bleeding (to arrest bleeding):</p>
<ul class="nobull">
<li>10 mg twice daily for five to seven days. Duphaston® should be given with oestrogen.</li>
</ul>
<p>Dysfunctional bleeding (to prevent bleeding):</p>
<ul class="nobull">
<li>10 mg twice daily from day 11 to day 25 of the cycle. Duphaston® should be given with oestrogen.</li>
</ul>
<p>Amenorrhoea:</p>
<ul class="nobull">
<li>An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg dydrogesterone twice daily from day 11 to day 25 of the cycle.</li>
</ul>
<p>Irregular cycles:</p>
<ul class="nobull">
<li>10 mg twice daily from day 11 to day 25 of the cycle.</li>
</ul>
<p>Threatened miscarriage:</p>
<ul class="nobull">
<li>40 mg at once, then 10 mg every eight hours until symptoms remit.</li>
</ul>
<p>Habitual miscarriage:</p>
<ul class="nobull">
<li>10 mg twice daily until the twentieth week of pregnancy.</li>
</ul>
<p>Infertility due to luteal insufficiency:</p>
<ul class="nobull">
<li>10 mg daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first months of any pregnancy using the doses stated with respect to habitual miscarriage.</li>
</ul>
<p>Luteal support as part of an Assisted Reproductive Technology (ART) treatment</p>
<ul class="nobull">
<li>10 mg three times daily (30 mg daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.</li>
</ul>
<p>There is no relevant use of dydrogesterone before menarche. The safety and efficacy of dydrogesterone in adolescents aged 12 to 18 years has not been established. Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><u>Method of administration</u><br>
For oral use.<br>
For administration of higher dosages, the tablets should be taken evenly distributed over the day.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutics Indications</strong></p>
<ul class="dash">
<li>Symptomatic relief of mild to moderate vasomotor symptoms associated with menopause.</li>
<li>Prevention of postmenopausal osteoporosis, if other treatments are unsuitable.</li>
</ul>
<p><strong>Progesterone deficiencies</strong></p>
<ul class="dash">
<li>Treatment of dysmenorrhoea.</li>
<li>Treatment of endometriosis.</li>
<li>Treatment of secondary amenorrhoea.</li>
<li>Treatment of irregular cycles.</li>
<li>Treatment of dysfunction uterine bleeding.</li>
<li>Treatment of threatened miscarriage.</li>
<li>Treatment of habitual miscarriage.</li>
<li>Treatment of infertility due to luteal insufficiency.</li>
<li>Luteal support as part of an Assisted Reproductive Technology (ART) treatment.</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Known hypersensitivity to the active substance or to any of the excipients.</li>
<li>Known or suspected progestogen dependent neoplasms (e.g. meningioma).</li>
<li>Undiagnosed vaginal bleeding.</li>
<li>Treatment for luteal support as part of an Assisted Reproductive Technology (ART) treatment should be discontinued upon diagnosis of abortion/miscarriage.</li>
<li>Contraindications for the use of estrogens when used in combination with dydrogesterone.</li>
<li>Existence of serious liver disorders, or serious liver disorders in the medical history as long as the liver function values have not normalised.</li>
</ul>
- Atc Code
- G03DB01
- Atc Item Name
- dydrogesterone
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
