Dydrogesterone


Generic Medicine Info
Indications and Dosage
Oral
Recurrent miscarriage
Adult: For cases associated with proven progesterone deficiency: 10 mg bid until the 12th or 20th week of pregnancy.

Oral
Endometrial protection during menopausal hormonal replacement therapy, Mild vasomotor symptoms associated with menopause, Moderate vasomotor symptoms associated with menopause, Prophylaxis of postmenopausal osteoporosis
Adult: In combination with continuous estrogen treatment (continuous sequential therapy): 10 mg daily for 14 consecutive days of a 28-day cycle. In combination with cyclical estrogen therapy (cyclic treatment): 10 mg daily for the last 12-14 days of estrogen treatment. Doses may be adjusted to 20 mg daily depending on clinical response (e.g. endometrial biopsy, ultrasound reveal).

Oral
Threatened miscarriage
Adult: For cases associated with proven progesterone deficiency: Initially, up to 40 mg loading dose, followed by 10 mg 8 hourly until symptoms remit.

Oral
Endometriosis
Adult: 10-30 mg daily from day 5-25 of the cycle, or continuously.

Oral
Infertility due to luteal insufficiency
Adult: 10 mg daily from day 14-25 of the cycle for at least 6 months. Alternatively, 10 or 20 mg daily starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle. Maintain treatment for at least 3 consecutive cycles.

Oral
Dysmenorrhoea
Adult: 10 or 20 mg daily from day 5-25 of the cycle.

Oral
Dysfunctional uterine bleeding
Adult: For arresting a bleeding episode: 10 mg bid for 5-7 days. Alternatively, 20 or 30 mg daily may be given for up to 10 days. For continued prevention: 10 or 20 mg daily from day 11-25 of the cycle. Treatment guidelines may vary between countries as some may recommend dydrogesterone to be used in combination with estrogen. Refer to local detailed product information.

Oral
Secondary amenorrhoea
Adult: In combination with estrogen (endogenous or exogenous) to adequately prime the endometrium: 10 or 20 mg daily from day 11-25 of the menstrual cycle.

Oral
Premenstrual syndrome
Adult: 10 mg bid from day 11-25 of the cycle. Alternatively, 10 mg bid starting on the 2nd half of the menstrual cycle until the 1st day of the next cycle; initial treatment day and duration will depend on the individual cycle length.

Oral
Irregular menstrual cycle
Adult: 10 mg bid from day 11-25 of the cycle. Alternatively, 10 or 20 mg daily starting on the 2nd half of menstrual cycle until the 1st day of next cycle; initial treatment day and duration will depend on the individual cycle length.

Oral
Luteal support during assisted reproductive technology
Adult: 10 mg tid starting at the day of oocyte retrieval and continued for 10 weeks if pregnancy is confirmed. Discontinue treatment upon diagnosis of miscarriage or abortion.
Administration
May be taken with or without food.
Contraindications
Known or suspected progestogen dependent neoplasms (e.g. meningioma), undiagnosed abnormal vaginal bleeding; any contraindications associated with estrogen (when dydrogesterone is used in combination with estrogen). Existing or history of serious liver disorders (as long as liver function is not normalised). Lactation.
Special Precautions
Patient with existing or history of depression, porphyria; diabetes, predisposition to cholestasis; herpes gestationis, otosclerosis; known thrombophilic states, risk factors for venous thromboembolism (e.g. SLE, cancer, major surgery, prolonged immobilisation, obesity [BMI >30 kg/m2]). Hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Breakthrough bleeding and spotting (particularly during the 1st month of therapy); venous thromboembolism (e.g. DVT, pulmonary embolism); increased risk of ischaemic stroke, MI, coronary artery disease, and breast cancer (particularly during combined estrogen-progestogen therapy); CNS effects (e.g. dizziness, drowsiness). Rarely, increased risk of ovarian cancer.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
Hepatobiliary disorders: Abnormal hepatic function.
Investigations: Increased weight.
Nervous system disorders: Migraine, headache.
Psychiatric disorders: Depressed mood.
Reproductive system and breast disorders: Menstrual disorders (including metrorrhagia, menorrhagia, amenorrhoea, oligomenorrhoea, dysmenorrhoea, and irregular menstruation), breast tenderness or pain.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Patient Counseling Information
This drug may cause mild somnolence or dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
Rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding (e.g. endometrial sampling). Screen for complete personal and family medical history prior to initiating and reinstituting hormone replacement therapy. Perform routine physical examination (e.g. breast and pelvic exam, mammogram, blood pressure, Papanicolau smear) periodically before and during treatment.
Drug Interactions
Increased metabolism with CYP enzyme inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, efavirenz, nevirapine).
Food Interaction
Increased metabolism with St. John's wort, ginkgo biloba, or sage.
Action
Description: Dydrogesterone, an orally-active progestogen, is a synthetic retroisomer of progesterone. It produces a complete secretory endometrium in a uterus primed by estrogen, thereby giving protection against the increased risk of endometrium hyperplasia and/or estrogen-induced carcinogenesis. Additionally, it lacks estrogenic, anabolic, androgenic, thermogenic, and corticoid characteristics.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: 0.5-2.5 hours (dydrogesterone); approx 1.5 hours (DHD). Bioavailability: 28%.
Distribution: Plasma protein binding: >90% (dydrogesterone and DHD).
Metabolism: Rapidly metabolised into 20α-dihydrodydrogesterone (DHD).
Excretion: Via urine (63%, as metabolites). Terminal elimination half-life: 5-7 hours (dydrogesterone); 14-17 hours (DHD).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Dydrogesterone, CID=9051, https://pubchem.ncbi.nlm.nih.gov/compound/Dydrogesterone (accessed on Jan. 21, 2020)

Storage
Store below 30°C. Protect from moisture.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
References
Anon. Dydrogesterone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/02/2022.

Buckingham R (ed). Dydrogesterone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.new.medicinescomplete.com. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablet (Abbott Laboratories Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablets (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/02/2022.

Duphaston 10 mg Film-Coated Tablets (Abbott Laboratories [S] Pte Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 04/02/2022.

Duphaston 10 mg Tablets (Abbott Laboratories). MIMS Philippines. http://www.mims.com/philippines. Accessed 04/02/2022.

Disclaimer: This information is independently developed by MIMS based on Dydrogesterone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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