Prometrium 100 mg

 
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Best Value On Brand Prometrium 100 mg
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Prometrium 100 mg Prescription Required
100 capsules for $80.82 ($0.81 per capsule)
Prometrium from online pharmacy: India
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Drugs in other countries are sometimes sold using different trade names which will appear on the packaging. This product is sold in other countries as:

  • Naturogest
  • Provera

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About Prometrium

What Prometrium is used for

PROMETRIUM (micronized progesterone) is approved for use in the following situation:

  • In women with an intact uterus (have not had surgery to remove the uterus) who are using estrogen replacement therapy for menopause

Progesterone, as in PROMETRIUM capsules, has a strong influence on the inner lining of the uterus and is used with estrogen therapy during and after menopause. The purpose of using progesterone is to protect the inner lining of the uterus from overgrowth caused by estrogen therapy.

Prometrium should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests.

You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HRT.

What Prometrium does

The active ingredient in PROMETRIUM capsules is progesterone, a natural female hormone. In healthy women of childbearing age, progesterone is produced by the ovaries each month during the second part of the menstrual cycle. Progesterone plays a role in the monthly shedding of the inner lining of the uterus (endometrium) and the menstrual bleeding that follows.

When Prometrium should not be used

Do not use PROMETRIUM (micronized progesterone) if you:

  • have liver disease;

  • have or have had cancer or abnormalities of the breast or uterus;

  • have overgrowth of the lining of the uterus;

  • have undiagnosed or unexpected vaginal bleeding;

  • are pregnant or suspect you may be pregnant;

  • have or have had abnormal increase in blood clotting;

  • have a history of heart disease (including heart attack) or stroke;

  • have migraine headaches;

  • have partially or completely lost vision due to blood vessel disease of the eye;

  • have an allergic or unusual reaction to PROMETRIUM or to any of its ingredients or are allergic to peanuts.

What the medicinal ingredient is

Each PROMETRIUM capsule contains the progestin substance progesterone.

What the important nonmedicinal ingredients for Prometrium are

Non-medicinal ingredients: arachis (peanut) oil, gelatin, glycerin, lecithin, titanium dioxide.

What dosage forms Prometrium comes in

100 mg (milligrams) micronized progesterone capsule.


Warnings and Precautions

Serious Warnings and Precautions

The Women's Health Initiative (WHI) trial assessed the health benefits and risks of oral combined estrogen plus progestin therapy and estrogen-alone therapy in postmenopausal women.

The estrogen plus progestin arm of the WHI trial indicated increased risk of myocardial infarction (heart attack), stroke, invasive breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women receiving treatment with conjugated equine estrogens (an estrogen medication) and medroxyprogesterone acetate (a progestin medication).

The estrogen-alone arm of the WHI trial indicated increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) receiving treatment with conjugated equine estrogens.

Therefore, you should highly consider the following:

  • There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.

  • There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.

  • Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.

  • Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

Breast Cancer

In the estrogen plus progestin arm of the WHI trial, among 10 000 women over a one-year period there were:

  • 8 more cases of invasive breast cancer.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period there was:

  • no meaningful difference in the rate of invasive breast cancer.

Estrogens with or without progestins should not be taken by women who have a personal history of breast cancer. In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting hormone replacement therapy.

Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.

Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

Stroke and Cardiac Disease

In the estrogen plus progestin arm of the WHI trial, among 10 000 women over a one- year period there were:

  • 8 more cases of stroke

  • 7 more cases of coronary heart disease.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10 000 women over a one-year period, there were/was:

  • 12 more cases of stroke

  • no meaningful difference in the rate of coronary heart disease.

Abnormal Blood Clotting

In the estrogen plus progestin arm of the WHI trial, among 10 000 women over a one- year period there were:

  • 18 more cases of blood clots in the lungs and large veins.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10 000 women over a one-year period, there were:

  • 7 more cases of blood clots in the lungs and large veins

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability.

Dementia

The Women's Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial involving women aged 65 and older.

In the estrogen plus progestin arm of the WHIMS, among 10 000 women over a one-year period there were:

  • 23 more cases of probable dementia (loss of memory and intellectual function).

In the estrogen-alone arm of the WHIMS involving women with prior hysterectomy, among 10 000 women over a one-year period there was:

  • no meaningful difference in the rate of probable dementia.

BEFORE you use PROMETRIUM talk to your doctor or pharmacist if:

  • have a history of allergy or intolerance to PROMETRIUM or any of its ingredients (see What the medicinal ingredient is: and What the important nonmedicinal ingredients are:), or are allergic to peanuts or to any other substances or medications;

  • have a history of liver disease or jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy;

  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer);

  • have experienced undiagnosed or abnormal vaginal bleeding;

  • have experienced pressure or pain in your abdomen or pelvis;

  • have a history of heart attack, heart disease or stroke;

  • have a history of migraine headache;

  • have a personal or family history of blood clots or a personal history of active thrombophlebitis (inflammation of the veins);

  • have a partial or complete loss of vision due to blood vessel disease of the eye;

  • are pregnant or may be pregnant;

  • smoke;

  • have a history of high blood pressure;

  • have a history of kidney disease, epilepsy (seizures) or asthma;

  • have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus);

  • have been diagnosed with diabetes;

  • have been diagnosed with porphyria (a disease of blood pigment);

  • have a history of high cholesterol or high triglycerides;

  • have a history of depression.

  • have had a hysterectomy (surgical removal of the uterus)

PROMETRIUM may cause some people to feel dizzy or sleepy, 1-4 hours after ingestion of the capsules. Therefore, before you drive or do anything else that requires alertness, make sure you are not experiencing these side effects.


Interactions With Prometrium

Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products. Some medications (such as certain anti-seizure medications or antibiotics) may affect how PROMETRIUM Capsules work. PROMETRIUM Capsules may also affect how your other medicines work.


Proper Use of Prometrium

Usual dose

Take PROMETRIUM (micronized progesterone) only as directed by your doctor or pharmacist.

Hormone Replacement Therapy for Menopause: The recommended dose is 2 capsules (200 mg) of PROMETRIUM per day for the last 14 days of estrogen treatment each cycle or 3 capsules per day (300 mg) for the last 12-14 days of estrogen treatment each cycle. If you are being treated with 2 capsules (200 mg) a day you should take them both at bedtime. If you are being treated with 3 capsules (300 mg) a day, you should split the daily dose in two parts by taking one capsule in the morning and two at bedtime. PROMETRIUM should be started on the first estrogen cycle.

The length of time that you will take PROMETRIUM will depend of the length of time that you are treated with estrogen. PROMETRIUM should be taken as long as you take estrogen and you have an intact uterus (have not had surgery to remove the uterus).

A few days after completing a PROMETRIUM course of 3 capsules daily, the inner lining of the uterus will usually shed. This is accompanied by vaginal bleeding (resembling a normal monthly period). With a dosage of 2 capsules daily, many women will not have such vaginal bleedings, although the lining of the uterus will also be protected against overgrowth.

Overdose

When someone accidentally takes too much PROMETRIUM (micronized progesterone), the following symptoms may arise: nausea, vomiting, sleepiness, dizziness, depressive mood, tiredness, acne and hairiness.

If someone has accidentally taken PROMETRIUM or has taken several capsules at once, consult a doctor.

Missed Dose

If you are being treated with 2 capsules a day (total dose at bedtime) and you forget to take this dose, you should take one capsule the following morning and continue taking the rest of the capsules as prescribed. If you are being treated with 3 capsules a day and you forget to take a morning or evening dose, you should not take the missed dose.

General Things To Remember

  1. Keep all medication out of the reach of children.

  2. This medication has been prescribed only for your current medical condition. Do not use it for other medical problems.

  3. Do not allow other people to use your medications and do not use medications meant for other people.

  4. Tell any doctor treating you what medications you are taking. Always carry a medical information card stating which medications you are using. This can be very important in case you are involved in an accident.

  5. Return unused medications to the pharmacy for safe disposal.

  6. Make sure that other people you live with or who look after you read this information.


Side Effects for Prometrium and What to Do About Them

Depending on the dosage of PROMETRIUM (micronized progesterone) and the sensitivity of the patient, the following side effects are possible: genital bleeding or spotting (minor vaginal bleeding) in between the normal periods (mainly during the first two months); irregular menstrual periods; dizziness or vertigo; sleepiness; abdominal discomfort (cramps, pressure, pain); nausea (urge to vomit); fatigue (tiredness); aggravation of migraine headaches, headaches or depressive mood; lightheadedness (feeling faint); breast tenderness/swelling; liver disease.

Side effects observed in women taking progestins in general: a severe allergic reaction which may include hives, itchiness, skin redness, swelling, wheezing, increase heart rate and difficulty breathing; rash with or without itching; rare cases of loss of consciousness; hot flashes; impaired concentration; confusion; swelling; and difficulty with speech.

Other side effects that have been observed with estrogen and progestin combinations in general, but not necessarily with PROMETRIUM treatment are:

  • water retention (bloating, swelling);

  • overgrowth of the lining of the uterus;

  • gallbladder disorder, impaired liver function, jaundice (yellowing of the eyes or skin);

  • menstrual cramps;

  • vaginal itching/discharge;

  • pain during sexual intercourse;

  • pain on urination or difficulty urinating;

  • premenstrual syndrome (PMS);

  • inflammation of the bladder;

  • brown, blotchy spots on exposed skin (pregnancy mask);

  • skin rash, tender red lumps or nodules or other skin reactions;

  • loss of hair, hairiness;

  • acne;

  • palpitations (unpleasant sensation of irregular and/or forceful beating of the heart);

  • pain, swelling or redness of the calf or leg which may indicate a blood clot;

  • chest pain or shortness of breath which may indicate a blood clot;

  • increase in blood pressure;

  • depression;

  • nervousness;

  • irritability;

  • visual disturbances, intolerance to contact lenses;

  • changes in appetite and body weight;

  • change in sexual drive;

  • pain in the joints and muscles, usually lasting only 3-6 weeks.

During your first 2-4 months of HRT, you may experience minor unscheduled vaginal bleeding (at times other than when you would expect a normal period). This is a normal response of your body as it adjusts to the return of estrogen and progesterone to the levels that were seen before menopause. Should unscheduled vaginal bleeding persist, you should consult your doctor.

This is not a complete list of side effects. For any unexpected effects while taking PROMETRIUM, contact your doctor or pharmacist.


Technical Information