Prometrium, is it safe ? uses, side effects, dosage

What is Prometrium

Prometrium is a branded proprietary drug manufactured and marketed by Abbvie Inc and is a formulation which is an FDA approved oral bioidentical progesterone and is generally prescribed for the treatment of secondary amenorrhea among other indications.

  1. What are the Generic Name(s)
  2. How does it work ?
  3. What are it’s uses ?
  4. How effective is this medicine ?
  5. What are the Side Effects ?
  6. What is the Dosage ?
  7. What are the precautions I need to take ?
  8. Is it safe to take If I am pregnant ?
  9. Is it safe to take if I am breast feeding ?
  10. Can this medicine be given to Children and Infants ?
  11. Is Prometrium available as over the counter (OTC) product?
  12. Frequently asked questions
  13. Reference

 

Prometrium, is it safe ? Uses, Side effects

Prometrium, is it safe ? Uses, Side effects


What are the Generic Name(s)

Generic name of Prometrium is Progesterone and it is available in the form of 100mg & 200mg capsules,

How does it work ?

This formulation contains progesterone, which is a type of female hormone (progestin) and is similar to the hormone that your body naturally makes. Progesterone stimulates luteal actions, changes in uterus and vagina as seen in early pregnancy.

What are it’s uses ?

Prometrium is prescribed for the treatment of indications such as Secondary amenorrhea, Recurrent miscarriage, abnormal uterine bleeding, palliative treatment of advanced, inoperable endometrial carcinoma.

How effective is this medicine ?

Prometrium is one of the few oral FDA approved Bioidentical hormone formulations which is a progesterone and is very effective when taken in dosage and frequency as suggested by the Doctor.

What are the Side Effects ?

Some of the reported side effects of this medicine include :

  • headache
  • breast tenderness
  • joint pain
  • hot flashes
  • urinary problems
  • night sweats
  • breast pain
  • depression
  • dizziness
  • diarrhea
  • swelling of hands and feet
  • abdominal bloating
  • abdominal pain
  • vaginal discharge
  • nausea
  • vomiting
  • chest pain

Stop using the medicine and seek emergency medical help or consult a doctor immediately if you see any of the adverse effects listed below :

  • swelling of the hands/feet
  • stomach/abdominal pain
  • mental/mood changes
  • dark urine
  • unusual tiredness
  • persistent nausea/vomiting
  • frequent/burning/painful urination
  • yellowing eyes/skin
  • breast lumps
  • unusual vaginal bleeding
  • dark patches on the skin or face

What is the Dosage ?

Tablet - dosage

Tablet – dosage

Harmone Replacement Therapy

In general, the dosage of PROMETRIUM is 200 mg daily for the last 14 days of estrogen treatment per cycle (i.e. from day 8 to day 21 for a 28-day cycle, and from day 12 to day 25 for a 30-day cycle). Estrogens should be administered daily at the lowest effective dose. Patients being treated with high dosages of estrogen (equivalent to 1.25 mg conjugated estrogens or higher) should be administered 300 mg daily for the last 12–14 days of estrogen treatment.

The dosage of this medicine should be proportional to the dosage of estrogen. With adequate adjustment of the dosage, patients should experience either regular withdrawal uterine bleeding or cessation of bleeding (amenorrhea).

What are the precautions I need to take ?

  • Take this medicine only if prescribed by the doctor
  • Take full course of treatment
  • Do not take this medicine, If you are allergic allergic to any of the ingredients of this medicine or any of their excipients
  • Do not take this medicine, If you have certain medical conditions including liver disease, ectopic pregnancy, breast cancer, blood clot events, and hypersensitivity
  • Do not take this medicine after the expiry date stated on the carton package
  • Tell your doctor if you are taking any medicine
  • Tell your doctor if you are suffering from any disease
  • Keep this medicine out of the reach of children
  • Seek emergency medical help or consult a doctor immediately, If the side effects persist or if you observe any of the serious side effects

Prometrium is contraindicated to patients with any of these disorders :

  • hypersensitivity to this drug, soya, peanut or to any ingredient in the formulation of the capsule. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph
  • active hepatic dysfunction or disease, especially of the obstructive type
  • personal history of known or suspected estrogen-dependent or progestin-dependent malignant neoplasia (e.g. breast cancer or endometrial cancer);
  • endometrial hyperplasia
  • undiagnosed abnormal genital bleeding
  • known or suspected pregnancy
  • active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease);
  • classical migraine; active or past history of confirmed venous thromboembolism (such as deep venous thrombosis or pulmonary embolism) or active thrombophlebitis
  • partial or complete loss of vision due to ophthalmic vascular disease

Is it safe to take If I am pregnant ?

Prometrium is classified as Pregnancy category B by FDA, Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Is it safe to take if I am breast feeding ?

Progesterone is reported to affect the quality of the breast milk, so it is suggested that this drug may administered to nursing mothers only when clearly necessary and the potential benefits from administering this drug outweighs the potential risks to the infant.

Can this medicine be given to Children and Infants ?

This drug should be kept out of sight and reach of children and infants.


Is Prometrium available as over the counter (OTC) product?

No, This drug is not available as an over the counter product and requires a prescription from a doctor.

Frequently asked questions

What should I do, if I overdose ?

In case of overdose, Seek emergency medical help or consult a doctor immediately.

Can Prometrium Prevent Miscarriage?

This medicine may help prevent miscarriage, consult a doctor before taking this medicine.

Can I get breast cancer by taking this medicine ?

It is not completely clear if prometrium, increases your risk of breast cancer. There may be a higher risk if you have a history of breast cancer, so make sure to get routine breast exams.

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