DRUG TITLE

Prometrium (Progesterone)

APPLICATION

This medicine contains the female hormone that is used to protect the endometrium of women on estrogen replacement therapy. Progesterone can lower the risk of endometrial cancer. This drug is also used to treat women who were not menstruating due to lack of the hormone progesterone. This medicine may also be used to treat other diseases, in consultation with the doctor.

MODE OF APPLICATION

Prometrium can be taken by mouth with or without food to avoid an upset stomach. The best way to use the drug is as recommended by your doctor.

There is also a patient information booklet that accompanies the medicine. Read this patient information booklet carefully.

THE MECHANISM OF ACTION

Prometrium is a form of natural progesterone. It is available only by prescription. Prometrium is the only type of progesterone, which can be taken orally.

MISSED DOSE

If you miss a dose of Prometrium and are taking two doses a day, then you may take it as soon as you remember and adjust the remaining doses accordingly. However, if it is nearly time for the next dose then you may skip this dose and continue with the regular dosage. Do not take a double dose to make up for the missed dose.

STORAGE

Store this medication at room temperature at 77 degrees Fahrenheit (25 degrees C) in a tightly closed container, away from heat, moisture and light. No long-term storage of 59 to 86 degrees F (15 ° and 30 ° C) is not allowed.

PRECAUTIONARY MEASURES

Discuss with your doctor about any prior medical condition that you may have including allergies to medicines, food or other substances, including heart problems, circulation problems, high blood pressure, family history of blood clots, womb problems (such as endometriosis), asthma, migraine headaches, any current or previous cancers, bleeding problems, liver problems, kidney problems, history of depression, diabetes, seizure disorders, history of tobacco use, cholesterol or lipid problems, lupus, thyroid problems, high calcium levels in your blood, if you have had a recent miscarriage, any allergies.

Prometrium may cause drowsiness. These effects get aggravated if you take it with alcohol or certain other medications (sleep aids, muscle relaxers). So, do not drive or perform other potentially hazardous tasks until you know how your body reacts to the drug.

Follow your doctor's instructions to perform monthly breast self-examinations and report any lumps immediately.

You must not take if you are allergic to any ingredient in it or if you have a history of blood clots or clotting problems, cancer of the breast, ovary, or uterus, undiagnosed vaginal bleeding, severe liver problems, recent (within the past year) heart attack, or history of stroke.

If you will be having surgery, or be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor beforehand.

If you are pregnant or suspect that you are, then stop using Prometrium and contact your doctor immediately.

It is unknown whether Prometrium is secreted in breast milk. Avoid breast feeding while using the drug.

Certain drugs can interact with Prometrium and hence, mention clearly to your doctor or pharmacist all medicines, dietary supplements and herbal prescriptions that you are taking.

Prometrium may affect your blood sugar level and may make you feel confused, drowsy, or thirsty. Contact your doctor immediately if these symptoms occur.

Prometrium should not be used in children as the safety and effectiveness of the drug have not been confirmed yet.

Prometrium may cause certain lab tests to be incorrect. Ensure that your lab personnel know that you are taking the drug.

Ensure that you inform your doctor and your dentist about before receiving any form of medical treatment or dental treatment or emergency surgery.

Periodic lab tests including blood pressure, breast and pelvic examinations, PAP tests (for endometrial cancer), mammogram, and other tests may be recommended to monitor your health while taking the drug. Ensure that you do not miss any lab tests.

It has been noted that elderly patients are more sensitive to the side effects of the drug (dementia). They might need a dosage adjustment or special monitoring throughout the treatment.

For Women: When combined with estrogen, it can increase the risk of heart disease (including heart attacks), stroke, serious blood clots in the lung (pulmonary embolism) or leg (deep venous thrombosis), cancer of the breast, cancer of the ovary or dementia. These risks are aggravated depending on the length of time that you take these drugs together and the amount of estrogen in each dose. So if you cannot avoid taking these drugs together then use it for the lowest possible time together to maximize its benefit.

SIDE EFFECTS

Some of the common side effects of are sleepiness or tiredness, dizziness, cough, nausea, vomiting, cramps, bloating, worry, irritability, diarrhea, constipation, headache, breast tenderness, stomach upset, acne, or dry mouth. Please contact your doctor if the symptoms persist or become bothersome.

Other severe side effects include experience pain or cramping in the muscles or joints, unexplained weight changes, swelling of hands or feet, fainting, vaginal discharge, difficulty urinating or change in the amount of urine produced, or breast pain. Contact your doctor immediately if you experience fever or chills, calf/leg pain, swelling, or tenderness, unusually fast heartbeat, sharp or crushing chest pain, sudden shortness of breath, sudden leg pain, sudden severe headache, vomiting, dizziness, or fainting, vision problems or changes (including sudden, partial, or full loss of vision), numbness of an arm or a leg, severe stomach pain, one-sided weakness, slurred speech, mental or mood changes (such as severe depression, memory loss, or confusion), coughing up blood, yellowing of eyes/skin, darkening of urine, stomach pain, swelling, or tenderness, abnormal vaginal bleeding, lump in the breast, or seizure. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing.

You must seek medical attention immediately if any of these side effects occur.
 
ADDITIONAL INFORMATION

If you have any questions about the drug, please consult your doctor.
This medicine should be used only on prescription.
If symptoms do not improve or if they become worse, check with your doctor.