- Approval Id
- ff9524d84980b486
- Drug Name
- CYCLOGEST PESSARY 400 MG
- Product Name
- CYCLOGEST PESSARY 400 MG
- Approval Number
- SIN03626P
- Approval Date
- 1989-07-26
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SUPPOSITORY
- Dosage
- <p><strong>4.2 Posology and Method of Administration</strong><br>
<em>For the treatment of premenstrual syndrome and puerperal depression:</em><br>
200mg daily to 400mg twice a day, by vaginal or rectal insertion.<br>
For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation.<br>
If symptoms are present at ovulation commence treatment on day 12.</p>
<p><em>For luteal phase support as part of an ART treatment:</em><br>
400mg administered vaginally twice a day starting at oocyte retrieval.<br>
The administration of Cyclogest should be continued for 38 days, if pregnancy has been confirmed.</p>
<p><em>Use in special populations:</em> There is no experience with use of Cyclogest in patients with impaired liver or renal function.</p>
<p><em>Paediatric population:</em>There is no relevant use of Cyclogest in the paediatric population.</p>
<p><em>Elderly:</em> No clinical data have been collected in patients over age 65.</p>
<p><em>Method of Administration</em><br>
For rectal or vaginal insertion.</p>
- Route Of Administration
- RECTAL
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong><br>
Cyclogest is indicated for the</p>
<ol class="decimalparen">
<li>Treatment of premenstrual syndrome, including premenstrual tension and depression.</li>
<li>Treatment of puerperal depression.</li>
<li>Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.</li>
</ol>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Undiagnosed vaginal bleeding.</li>
<li>Known or suspected progesterone sensitive malignant tumours.</li>
<li>Porphyria.</li>
<li>Severe hepatic dysfunction or disease</li>
<li>Known missed abortion or ectopic pregnancy.</li>
<li>Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.</li>
</ul>
- Atc Code
- G03DA04
- Atc Item Name
- progesterone
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
