- Approval Id
- ae7af68621718a95
- Drug Name
- INJESTA SOFT CAPSULE 200MG
- Product Name
- INJESTA SOFT CAPSULE 200MG
- Approval Number
- SIN17386P
- Approval Date
- 2025-11-07
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, LIQUID FILLED
- Dosage
- <p><strong>RECOMMENDED DOSAGE</strong><br>
On the average for progesterone deficiencies, the daily dose is 200mg to 300 mg divided into one or two intakes, 100mg in the morning or 200mg at bedtime. In some cases, notably to help pregnancy, the doctor may increase the dose to 600mg per day, divided into three intakes.<br>
For threatened abortion, 200–400mg per day to be taken in the acute phase from the start to 12<sup>th</sup> week of pregnancy.<br>
For menace for preterm delivery, 400mg every 6 to 8 hours depending on the clinical response during the acute phase then a dosage of 3 x 200mg/day as maintenance treatment until the 36<sup>th</sup> week of pregnancy.<br>
In hormone replacement therapy in post menopausal women receiving estrogen therapy, treatment can be prescribed continuously or sequentially for at least 12 days per month.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATION</strong><br>
Injesta is indicated for:<br>
Disorders related to progesterone deficit in particular menstrual irregularities due to ovulation disorders or anovulation, premenstrual disorders, breast pain or by benign breast disorders (mastopathies), bleeding due to fibroma, therapy of menopause (adjunctive use with estrogen in post-menopausal women for prevention of endometrial hyperplasia), menace of preterm delivery and can be used up to 36 week of pregnancy, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12<sup>th</sup> week of pregnancy, treatment of subfertility or primary or secondary infertility related to progesterone insufficiency in particular in In Vitro Fertilization cycles and/or oocyte donation.<br>
For all other progesterone indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to progesterone (somnolence, dizziness).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Injesta should not be used in individuals with any of the following conditions:<br>
* known allergy or hypersensitivity to progesterone or to any of the excipients<br>
* severe hepatic dysfunction</p>
<p>* undiagnosed vaginal bleeding</p>
<p>* known missed abortion or ectopic pregnancy</p>
<p>* mammary or genital tract carcinoma</p>
<p>* thromboembolic or thrombophlebitis disorders</p>
<p>* cerebral haemorrhage</p>
<p>* porphyria.</p>
