Prometrium

The active ingredient in Prometrium is progesterone. Progesterone is a sex hormone that plays an important role in women’s health. The symptoms of certain medical conditions may be due to too little progesterone so Prometrium can increase these levels.

In menopause, hormone replacement therapy (HRT) is used to treat symptoms of hot flashes and night sweats due to a decline in estrogen levels in the body. In women who still have their uterus, HRT with estrogen alone can increase the risk of uterine cancer. Prometrium has a protective effect on the lining of the uterus and can help minimize this risk.

In secondary amenorrhea, there is a loss of menstrual periods due to a decrease in progesterone. Prometrium can help restore a normal menstrual cycle by helping to regulate irregular periods.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prometrium. However, the following is a synopsis of the general guidelines for the use of Prometrium:

• Typically, Prometrium is taken daily at night. Some may use it for days at a time while others for weeks. The duration of use will depend on what is being treated. Consult your healthcare provider for further information.
• Use exactly as prescribed. Do not exceed the recommended dose or duration of use.
• If you have trouble swallowing, take Prometrium with a full glass of water while in an upright position.
• Prometrium can cause excessive drowsiness and dizziness so nighttime dosing is preferred. Exercise caution when driving or operating heavy machinery.
• Patients with risk factors for heart disease (such as high cholesterol, high blood pressure, diabetes, smoking, and obesity) should have these risk factors appropriately managed to reduce the risk of adverse events while using Prometrium.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Prometrium seen in clinical trials include:

• Headaches
• Breast pain or breast tenderness
• Irregular vaginal bleeding or breakthrough bleeding
• Abdominal cramps
• Bloating
• Fluid retention
• Vaginal discharge
• Nausea and vomiting
• Hair loss
• Vaginal yeast infection
• Constipation

Some individuals may experience serious side effects while using Prometrium. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Unusual vaginal bleeding
• Abnormal mood changes
• Extreme dizziness or drowsiness
• Signs of stroke such as slurred speech, facial drooping, sudden/severe headaches, or inability to move your arm
• Signs of a heart attack such as radiating chest pain, shortness of breath, sweating, or lightheadedness
• Signs of a blood clot such as severe leg or chest pain that may be accompanied by shortness of breath or fatigue
• Signs of breast cancer such as breast lumps or any other unusual changes in the appearance of the breasts
• Signs of liver disease such as jaundice or yellowing of the skin or eyes, loss of appetite, right-sided abdominal pain, or dark urine
• Signs of an allergic reaction such as hives, difficulty breathing, rash, or swelling of the face, eyes, or tongue

These are not all of the possible side effects of Prometrium. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prometrium, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Asthma
• Epilepsy or seizures
• Diabetes
• Migraines
• Endometriosis
• Lupus
• Family history of blood clots
• Family history of breast cancer
• Heart problems
• Liver problems
• Thyroid problems
• Kidney disease
• High blood calcium levels
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Do not use progestin therapy and estrogen together to prevent heart disease, heart attacks, or strokes. Research has demonstrated an increased risk of blood clots (such as pulmonary embolism and deep vein thrombosis) as well as stroke and heart attack when these are used together.
• Do not use progestin therapy and estrogen together to prevent dementia. Estrogen plus progestin therapy can increase the risk of dementia if used at 65 years of age or older.
• Estrogen plus progestin therapy may increase the risk of invasive breast cancer.

Do not use Prometrium if you have:

• An allergy to peanuts. The capsules contain peanut oil.
• An allergy to any of the other inactive ingredients found in Prometrium.
• Unusual vaginal bleeding.
• A history or current diagnosis of cancer. The risk of certain kinds of cancers increases when you take Prometrium, especially in combination with estrogen.
• A history of stroke, heart attack, or blood clots.
• Liver problems.
• Are pregnant.

Prometrium will typically start to work within days of taking. However, everybody is different, and, depending on the reason for use, it may take longer to see effects.

When Prometrium is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ketoconazole
• Apixaban
• Warfarin
• Barbiturates like pentobarbital and phenobarbital
• Certain seizure meds like carbamazepine and phenytoin
• Corticosteroids such as dexamethasone and hydrocortisone
• Diabetes medications such as canagliflozin, glyburide, insulin, linagliptin, metformin, and sitagliptin
• Estrogens such as conjugated estrogen, estradiol, and ethinyl estradiol
• HIV medications like efavirenz, etravirine, indinavir, lopinavir, nelfinavir, ritonavir, and saquinavir
• Heparin and low molecular weight heparins like enoxaparin
• Rifamycins such as rifabutin and rifampin

Prometrium capsules are available in the following strengths:

• 100 mg of micronized progesterone
• 200 mg of micronized progesterone

Prometrium should be stored at room temperature away from light and moisture and out of reach of children.

Prometrium is manufactured by the pharmaceutical company Acertis Pharmaceuticals.

Yes, there is a generic version available of the brand name Prometrium.

Depending on your reason for taking Prometrium, you may require a slow taper to prevent negative events that can happen with abruptly stopping. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Prometrium.

Prometrium is typically not used if you are pregnant. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Prometrium can pass into the breast milk and is generally not used during lactation. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.