Duphaston – Uses, Dosage, Side effects, Precautions

Duphaston is a synthetic derivative of a female hormone progesterone. It is used to treat menstrual irregularities in people more than 18 years of age. It is also used to prevent miscarriage and abortions. It contains active ingredient didrogesterone.

Used for Dysmenorrhea, threatened abortions, menstrual abnormalities, infertility problems, uterine bleeding and hormone replacement therapy
Dosage forms Tablets
Available Strengths 10mg, 20 mg and 30 mg
Method of administration Taken during night time after dinner
Prescription Required
Alternatives Dabroston, Terolut, Dufaston
Pharmacokinetics Onset of action: occurs within 0.5 to 2.5 hours of drug administration
Duration of action: within 24 hours

Uses

Prescribed for the following conditions

  • Dysmenorrhea (irregular menstrual cycles)
  • Endometriosis (Shedding of endometrium)
  • Secondary amenorrhea (lack of menstruation)
  • Premenstrual syndrome
  • Threatened and Habitual Abortions
  • Infertility treatment
  • Hormone replacement therapy

A systematic review Duphaston tablets for the treatment of threatened miscarriages.

A randomized clinical trial was conducted in 660 pregnant women. The objective of this study was to assess whether the orally acting progesterone tablets lowers the incidence of miscarriage in pregnant women. This study shows that there is a decrease of 47% miscarriages in women receiving Duphaston.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3518297/

Duphaston in regularization of menstrual cycle

A clinical trial was conducted in India, where 91.6% of women achieved regular menstrual cycle by using Duphaston 10 mg tablets from 11th day to 25th day of cycle. They achieved this within three cycles of therapy with Duphaston. In this study there was also a decrease in the amount and duration of menstrual bleeding in women participated in this study.

https://clinicaltrials.gov/ct2/show/NCT01525563

Dosage

The dosage of this tablet may vary depending on the condition and the clinical use.

For Dysmenorrhea: 10 or 20 mg tablet per day continuously from day 5 to day 25 of menstrual cycle.

For endometriosis: 10 to 30 mg tablet per day from day 5 to day 25 of menstrual cycle.

For dysfunctional uterine bleeding: To stop bleeding 20 or 30 mg tablet per day for 10 days.

 If bleeding occurs regularly and for continuous treatment 10 or 20 mg tablet should be taken during second half of menstrual cycle.

For Secondary amenorrhea: 10 or 20 mg tablet per day for 14 days during second half of cycle.

For premenstrual syndrome: 10 mg twice daily starting on second half of menstrual cycle till first day of next period.

For irregular cycles and Infertility problems: 10 or 20mg per day during second half of cycle and should be continued until first day of next cycle.

For threatened abortions: Initial dose up to 40 mg followed by 20 or 30 mg per day until symptoms stops.

Misuse:

Misuse of this drug leads to fetal death and spontaneous abortions. Effects such as unwanted hair on face of fetus, birth defects like cleft palate and heart defects occurs on misuse of this drug.

If you forgot to take this tablet??

If you forgot to take todays tablet and if it is less then 12 hours late, take it as soon as you remember and next day dose will be as usual dose. If you miss a dose you can see some bleeding and spotting.

Over dosage

It is well tolerated when taken orally and the maximum daily dosage is up to 360mg. If your prescribed dose is high and if you cannot swallow the tablet you can take it as divided doses for the day. Symptoms of overdose include nausea, vomiting, lethargy and dizziness.

If you take more than the prescribed dose, the drug can be removed (i.e if it is within 2 or 3 hours) from the stomach by specific treatment.

Missed a dose??? You should take the missed dose of tablet as soon as you remember, don’t take the tablet if it is nearer time of your next dose. Skip the missed dose and take the as usual dose the next day

Different brands of Duphaston:

Brand name
Manufacturer
Dabroston Abott
Terolut Solvay Pharmaceuticals
Duphaston Abott
Gestasure Mankind Pharmaceuticals
Jigest Sanzyme Ltd

How does it work?

It acts directly on the uterus and activates progesterone receptors.

It works by regulating the growth and normal shedding of the womb lining.

Interactions

  • It interacts with drugs like phenytoin, phenobarbital, nevirapine, carbamazepine, Rifampicin and Ritonavir

Side effects

Here are some common side effects with Duphaston.

  • Nausea
  • Abdominal pain
  • Vomiting
  • Diarrhea
  • Dry mouth
  • Indigestion
  • Dizziness
  • Headache
  • Breast pain
  • Drowsiness
  • Depression
  • Anemia
  • Hypersentivity reactions
  • Swelling of breasts
  • Weight gain

Warnings and Precautions

  • This medicine is not recommended for undiagnosed abnormal vaginal bleeding.
  • This medicine is not recommended for pregnant women unless it is required.
  • This medicine is not recommended for breast feeding women.
  • This should not be used in patients with history of liver diseases as it increases the risks of liver diseases. Patients should be closely monitored for liver function tests if this medicine was used.
  • This medicine is not recommended for children below 18 years of age.
  • One should ensure that the treatment course is completed and do not stop this medicine without consulting doctor.
  • This medicine may cause drowsiness and dizziness so it advised not to drive vehicles or operate heavy machinery when you experience such symptoms.
  • If you experience severe headache, migraine or if you have increased blood pressure discontinue this medicine.
  • If you have depression you must be closely monitored and if severe depression reoccurs this treatment should be discontinued.

Pharmacokinetics

Absorption

After oral administration it is absorbed rapidly within 0.5 to 2.5 hours

Distribution

90% of it is bound to plasma proteins.

Elimination

It is metabolized by liver enzymes (CYP 450) to active metabolite and eliminated in the urine.

Within 72 hours its excretion is completed and its half -life is about 5 to 7 hours.

FAQ’S

Can Duphaston be used during pregnancy??

Yes, can be used during if the pregnancy is assisted by IVF or any reproductive techniques or in case of repeated miscarriages.

Does Duphaston stop bleeding during pregnancy?

Some women experience bleeding during few months and after using this medicine bleeding can be stopped and have normal pregnancy.

Can Duphaston delay the periods?

No, it cannot delay the periods. In fact, it is used to regularize the periods who don’t have regular menstrual cycles.

Is Duphaston safe for breastfeeding women?

It shouldn’t be taken by breastfeeding women.

Why doctors prescribe Duphaston during first trimester of pregnancy?

It is because the placenta will not be fully functional yet and cannot produce enough hormones required for the growth of the baby. So, doctors prescribe Duphaston during first trimester of pregnancy and after 12 weeks there will be no issue. You can stop using Duphaston.

Can Duphaston cause weight gain if it is used for treatment of ovarian cysts?

Yes, it can cause weight gain if it is used for long time.

Is Duphaston a steroid?

Yes, it has a steroidal structure similar to female hormone progesterone produced in the body.

References

https://pubchem.ncbi.nlm.nih.gov/compound/dydrogesterone#section=Drug-Warning

https://www1.ndmctsgh.edu.tw/pharm/pic/medinsert/005DUP05E.pdf

https://www.drugbank.ca/drugs/DB00378

https://data.health.gov.il/drugs/alonim/Duphaston_dr_1410193172635.pdfhttps://www.hpra.ie/img/uploaded/swedocuments/2175418.PA2007_005_001.bd3a6f94-b7ef-4f48-9c4b-854f88ae579c.000001Product%20Leaflet%20Approved.161213.pdf

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