- Approval Id
- 980ed4fb86ed0b4f
- Drug Name
- UTROGESTAN CAPSULE 200MG
- Product Name
- UTROGESTAN CAPSULE 200MG
- Approval Number
- SIN15475P
- Approval Date
- 2018-04-30
- Registrant
- PHARMED IMPORT & EXPORT PTE LTD
- Licence Holder
- PHARMED IMPORT & EXPORT 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 300mg divided into one or two intakes, 100mg in the morning or 200mg at bedtime.<br>
In some cases, notably to help pregnancy, the doctor may increase the dose to 600 mg per day, divided into three intakes.<br>
For threatened abortion, 200mg–400mg per day to be taken in the acute phase from the start to 12th week of pregnancy.<br>
For menace for preterm delivery, 400 mg 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 36th 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>
<p><strong>MODE OF ADMINISTRATION</strong><br>
Two routes of administration are possible, oral and vaginal which will be decided individually by the prescribing physician. If the medicine is to be administered orally, swallow the whole capsule with a glass of water preferably in the evening before going to bed or in to three intakes following the doctor's prescription.<br>
If the medicine will be administered vaginally, insert each capsule deeply into the vagina. The duration of the treatment will be specified by the prescribing physician per the needs of the patient. This may be readjusted depending on the indication and efficacy of the treatment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATION</strong><br>
Utrogestan 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 12th 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>
Utrogestan should not be used in individuals with any of the following conditions:</p>
<ul>
<li>Known allergy or hypersensitivity to progesterone or to any of the excipients.</li>
<li>Severe hepatic dysfunction.</li>
<li>Undiagnosed vaginal bleeding.</li>
<li>Known missed abortion or ectopic pregnancy</li>
<li>Mammary or genital tract carcinoma.</li>
<li>Thromboembolic or thrombophlebitis disorders.</li>
<li>Cerebral haemorrhage.</li>
<li>Porphyria.</li>
</ul>
- Atc Code
- G03DA04
- Atc Item Name
- progesterone
- Pharma Manufacturer Name
- PHARMED IMPORT & EXPORT PTE LTD
