Prometrium

Prometrium is a prescription-only medicine used to prevent uterine abnormalities in post-menopausal women undergoing estrogen treatments, in women who have irregular menstruations or whose menstrual periods stop abnormally (amenorrhea).

Prometrium is available as:

• Liquid Filled capsule
• Capsule

Before using Prometrium, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will provide you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

• Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.
• Pediatric: Progesterone is not used in children.
• Geriatric: No geriatric studies have been conducted yet and understandably, it’s not clear if progesterone causes any problems to older people. Since breast cancer, stroke and dementia are more common in elderly, cautionary use of progesterone in this population group is recommended.
• Pregnancy: This medicine falls under category B for all trimesters B meaning that progesterone is generally safe for use in pregnancy.
• Breastfeeding: No significant negative effects to the infant are observed when used by a nursing mother.
• Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions. Here is a list of the medicines which in general are not recommended to be used with this medicine. Inform your doctor if you are using any of these medicines:

        o Dabrafenib
        o Eslicarbazepine Acetate

• Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.
• Other Medical Problems: Certain medical conditions might influence the effects (both positive and adverse) and action of progesterone. DO NOT forget to inform your doctor about the following conditions:

        o Unusual bleeding from vagina
        o Peanut allergy
        o History of, or current blood problems including deep vein thrombosis, pulmonary embolism)
        o The Past, current or suspected case of breast cancer
        o Liver disease
        o Ongoing or past stroke (Do not use)
        o Asthma
        o Diabetes
        o Edema (fluid accumulation causing swelling)
        o Endometriosis
        o Seizures
        o Heart disease
        o Hypercalcemia (high blood calcium level)
        o Hypercholesterolemia (high blood cholesterol level)
        o High blood pressure
        o Kidney disease
        o Migraine
        o Systemic lupus erythematosus (SLE)
        o Thyroid disorders (Use cautiously)

To use Prometrium properly, you must follow all instructions given by your doctor.

• Strictly follow your doctor’s instructions and don’t:

        o Take more, for longer or more frequently than recommended.

• Read the patient information leaflet carefully and follow accordingly. For any query, consult your doctor.
• It is given along with an estrogen-containing medicine if your menstruation has stopped. Follow your doctor’s recommendations for both medicines.

Dosing:

For best results, follow your doctor to know what amount of medicine you should take in a single dose. The doses of a medicine can differ according to the conditions for which it is being prescribed. Progesterone is used only in female adults.

The doses for capsule are:

• For prevention of enlargement of the endometrium (endometrial hyperplasia) in adults: A single daily dose of 200 milligrams (mg) continuously for 12 days (per 28-day menstrual cycle) to be taken before sleep.
• For treatment of abnormal cessation of menstruation (amenorrhea) in adults: A daily single dose of 400 milligrams (mg) for 10 days to be taken before sleep.

Missed Dose:

Take your missed dose once you remember but avoid it if it’s time to take your next dose, and follow your normal dosing schedule. Avoid taking double doses to make up for the missed dose.

Storage:

• Store in a closed container at room temperature.
• Keep away from heat, moisture, and direct light.
• Do not freeze.
• Keep away from children.
• Discard any unused or expired medicines.

Your progress should be regularly monitored to look for some undesirable side effects
which may also be detected by a pelvic exam, breast exam, and mammogram (breast x-ray), if necessary.

Here are some points to consider:

• Though usually safe, progesterone may harm your baby in the womb. Avoid getting pregnant by using appropriate contraceptive measures. If you suspect of getting pregnant, inform your doctor immediately.
• If you experience any of the followings, promptly discontinue this medicine and inform your doctor:

        o Chest pain or pain in the calves
        o Breathing problems including sudden shortness of breath
        o A sudden, severe headache
        o Speech problems
        o A sudden loss of coordination
        o Vision problems

• Your risk of breast cancer and endometrial (lining of the uterus) cancer is elevated by a slight margin. Inform your doctor about your family history of the cancers, if any.
• Large doses of progesterone for prolonged time or using it along with an estrogen-containing medicine may make you more prone to heart attack, stroke, blood clots, or dementia. Consult your doctor if you are concerned. If you are a smoker and overweight with elevated blood cholesterol level, your risk is even more. Lower your risk by:

        o Quitting smoking.
        o Keeping sugar and cholesterol levels down.
        o Maintaining a healthy weight.

• You may need to avoid this medicine during a surgery (including dental surgery) or emergency treatment. Consult your doctor or dentist beforehand.
• If you experience vision problems such as sudden vision loss during treatment with progesterone, discontinue immediately and consult your doctor.
• Take special care while driving or using machines, as it might cause dizziness or drowsiness.
• Progesterone may interfere with results of some laboratory tests. So, it’s better if you inform the doctor in charge about this.

Make sure you meet with your doctor in using Prometrium to avoid unwanted potential side effects.

Call your doctor immediately if you experience:

More common:

• Chest pain
• Chills
• Symptoms resembling a cold or flu
• A cough or hoarseness
• Fever
• Urinary problems

Less common:

• Clear or bloody discharge from the nipple
• Breast skin appearing like orange peel
• Abnormal nipple
• Abnormal mass in the breast or in the armpit
• Persistent crusting or scaling of the nipple
• Red swollen breast
• Persistent soreness of the breast skin

Incidence not known (side effects that have occurred in some people but have not been studied in a large population)

• Blurred vision
• Abnormal vaginal discharge
• Clay-colored stools
• Confusion
• Darkened urine
• Breathing or swallowing problems
• Tendency to faint
• Hives
• Irregular heartbeat
• Painful, swollen or stiff joints
• Breathing problems
• Numb or tingling sensations in the face, arms, or legs pain
• Abdominal pain that may radiate to the back
• Spontaneous abortion
• Swollen eyelids face, lips, hands, or feet
• Chest discomfort
• Bleeding from vagina
• Vomiting blood

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common:

• Breast pain or tenderness
• Depression
• Muscle or joint pain
• White or brownish vaginal discharge

Incidence not known:

• Blurred or loss of vision
• Balance problems
• Disorientation
• Auditory problems
• Excessive dizziness
• Fainting
• Dizziness
• Derealization or depersonalization
• Hair loss or thinning
• Hives
• Abnormal periods
• Slowed speech
• Swollen tongue
• Suicidal thoughts

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.