Rephaston

Rephaston10 mg

Tablet

Dydrogesterone

Renata Limited

Product Code : 19544
MRP 350.00
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Medicine overview

Indications of Rephaston 10 mg

Progesterone deficiencies: Treatment of threatened miscarriage Treatment of habitual miscarriage Treatment of dysmenorrhoea Treatment of endometriosis Treatment of secondary amenorrhoea Treatment of irregular cycles Treatment of dysfunctional uterine bleeding ... Read moreProgesterone deficiencies: Treatment of threatened miscarriage Treatment of habitual miscarriage Treatment of dysmenorrhoea Treatment of endometriosis Treatment of secondary amenorrhoea Treatment of irregular cycles Treatment of dysfunctional uterine bleeding Treatment of infertility due to luteal insufficiency Luteal support as part of an Assisted Reproductive Technology (ART) Hormone Replacement Therapy: To counteract the effects of unopposed oestrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus.

Theropeutic Class

Female Sex hormones

Pharmacology

Rephaston 10 mg is a progestogen structurally related to progesterone. However, unlike progesterone, it does not induce an increase in temp nor inhibit ovulation and may be preferred over other progestational agents when contraceptive effect is not required. It does not have oestrogenic or androgenic properties.

Dosage & Administration of Rephaston 10 mg

Recurrent miscarriage: 10 mg bid given cyclically until conception, then continuously until wk 20 of pregnancy, after which dose may be gradually reduced.Infertility: 10 mg bid.Menstrual disorders: 10 mg bid in a cyclical regimen.Endometriosis: 10 mg bid-tid cyclically or continuously.Threatened miscarriage: Initially, 40 mg followed by 10 mg or more every 8 hr, continued for a wk after symptoms are relieved. Reduce dose gradually after that unless symptoms return.Endometrial protection during menopausal hormonal replacement therapy: 10 mg 1-2 times daily in a cyclical regimen or 5 mg daily.

Dosage of Rephaston 10 mg

Always take Presentation 10 mg tablet exactly as your doctor has prescribed. Presentationerone deficiencies: Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit. Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy. Dysmenorrhoea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle. Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously. Dysfunctional bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Presentation should be given with oestrogen. Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Presentation should be given with oestrogen. Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation twice daily from day 11 to day 25 of the cycle. Irregular cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Infertility due to luteal insufficiency: 10 mg (one tablet) 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 month of any pregnancy using the doses stated with respect to habitual miscarriage. Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed. Hormone Replacement Therapy: In combination with continuous oestrogentherapy, take one tablet daily for 14 consecutive days of a 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy. For doctors: If endometrial biopsies or ultrasound reveal inadequate Presentationational response, 20 mg Rephaston 10 mg should be prescribed. For patients: If you are not sure what type of oestrogen therapy you are on, talk to your Doctor before taking Presentation. There is no relevant use of Rephaston 10 mg before menarche. The safety and efficacy of Rephaston 10 mg in adolescents aged 12 to 18 years has not been established.

Interaction of Rephaston 10 mg

Carbamazepine, griseofulvin, phenobarbital, rifampicin enhances the clearance of progestogens.

Contraindications

Known hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms (e.g. meningioma).

Side Effects of Rephaston 10 mg

The most commonly reported adverse drug reactions of patients treated with Rephaston 10 mg in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.

Pregnancy & Lactation

From spontaneous surveillance systems to date, there is no evidence that Rephaston 10 mg can not be used during pregnancy.Rephaston 10 mg is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Rephaston 10 mg should not be used during breast-feeding.There is no evidence that Rephaston 10 mg decreases fertility at therapeutic dose.

Precautions & Warnings

Before initiating Rephaston 10 mg treatment for abnormal bleeding the etiology for the bleeding should be clarified. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be considered. Severe headache, migraine or symptoms that may indicate cerebral ischemia. Marked increase in blood pressure. Occurrence of venous thromboembolism (VTE) In cases of habitual or threatened abortion, the viability of the foetus should be ascertained. It is also necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive. Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with Rephaston 10 mg must be stopped

Overdose Effects of Rephaston 10 mg

Rephaston 10 mg was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic.

Storage Conditions

Store at below 30°C in a dry place protected from light. Keep out of reach of children.

Drug Classes

Female Sex hormones

Mode Of Action

Rephaston 10 mg is an orally-active progestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and carcinogenesis induced by oestrogens. It is indicated in all cases of endogenous progesterone deficiency. Rephaston 10 mg has no oestrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.

Pregnancy

It is estimated that more than 10 million pregnancies have been exposed to Rephaston 10 mg. So far there were no indications of a harmful effect of Rephaston 10 mg use during pregnancy. No data exist on excretion of Rephaston 10 mg in mother's milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother's milk in small quantities. Whether there is a risk to the child is not known. Therefore Rephaston 10 mg should not be used during the lactation period.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.