Prempro Low Dose (Oral)

Conjugated estrogens and medroxyprogesterone acetate combination is used to treat moderate to severe hot flashes, dryness in and around the vagina, and other symptoms of menopause. This medicine is also used to prevent osteoporosis (thinning of the bones) after menopause.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects.

It is unlikely for a postmenopausal woman to become pregnant. However, you should know that using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about these risks.

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol level.

Tell the doctor in charge that you are using this medicine before you have any kind of surgery. Your doctor will decide whether you should continue using this medicine.

Check with your doctor right away if you have a severe headache or a sudden loss of vision or any change in vision while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. Anaphylaxis and angioedema can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may cause the amount of medicine in the blood to be too high.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it can provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, check the label or package ingredients carefully.

Pediatric

Conjugated estrogens and medroxyprogesterone acetate combination is not recommended for children.

Geriatric

While there have not been specific studies on how age affects conjugated estrogens and medroxyprogesterone combination in older adults, no specific problems for this age group have been reported so far. However, older patients may be at a higher risk for certain negative effects (like breast cancer, stroke, or dementia), which may require extra caution when taking this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be taken together, while others may be used together even if there is a risk of interaction. In such cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medicine or may change your other medications.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in certain situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Amifampridine
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Belzutifan
• Bexarotene
• Bosentan
• Bupropion
• Carbamazepine
• Cenobamate
• Clobazam
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolic Acid
• Nafcillin
• Nevirapine
• Oxcarbazepine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Tazemetostat
• Telaprevir
• Theophylline
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it might be necessary to use both for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Etoricoxib
• Ginseng
• Levothyroxine
• Licorice
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken close to meal times or with certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions are significant but may not be a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but it may be unavoidable in some situations. If used together, your doctor may adjust the dose or frequency of this medicine, or provide specific instructions regarding food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any additional health issues, particularly:

• Abnormal vaginal bleeding or
• Antithrombin deficiency (blood clotting disorder) or
• Blood clots, or history of or
• Breast cancer, or history of or
• Deep vein thrombosis (blood clot in the leg), or history of or
• Heart attack, or history of or
• Hysterectomy (removal of the uterus), history of or
• Liver disease or
• Protein C deficiency (blood clotting disorder) or
• Protein S deficiency (blood clotting disorder) or
• Pulmonary embolism (blood clot in the lung), or history of or
• Stroke, or history of or
• Tumor (estrogen-dependent)—Should not be used in patients with these conditions.

• Asthma or
• Congestive heart failure or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hereditary angioedema (swelling of the face, mouth, or throat) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high fats in the blood) or
• Hypothyroidism (an underactive thyroid) or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine
• Blurred vision
• Chest pain
• Clear or bloody discharge from the nipple
• Cough or hoarseness
• Dimpling of the breast skin
• Dizziness
• Fast, irregular, pounding, or racing heartbeat or pulse
• Feeling faint, dizzy, or lightheaded
• Feeling of warmth or heat
• Fever or chills
• Flushing or redness of the skin, especially on the face and neck
• Headache
• Inverted nipple
• Lower back or side pain
• Lump in the breast or under the arm
• Nervousness
• Pain during sexual intercourse
• Painful or difficult urination
• Persistent crusting or scaling of the nipple
• Pounding in the ears
• Redness or swelling of the breast
• Severe cramping of the uterus
• Sore on the skin of the breast that does not heal
• Sweating
• Thick, white vaginal discharge with no odor or with a mild odor
• Tingling of the hands or feet
• Unusual weight gain or loss
• Unusual and heavy vaginal bleeding
• Vaginal or genital itching
• Vaginal yeast infection

Incidence not known

• Absent, missed, or irregular menstrual periods
• Acid or sour stomach
• Anxiety
• Backache
• Breast pain or tenderness
• Confusion
• Constipation
• Darkened urine
• Decreased vision or other changes in vision
• Difficulty with speaking
• Double vision
• Fainting
• Heartburn
• Inability to move the arms, legs, or facial muscles
• Inability to speak
• Indigestion
• Loss of appetite
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Pain or feeling of pressure in the pelvis
• Pain, redness, or swelling in the arm or leg
• Painful or tender cysts in the breasts
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Slow speech
• Sudden shortness of breath or troubled breathing
• Unexpected or excess milk flow from the breasts
• Vomiting
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Depression
• Excess gas in the stomach or intestines
• Lack or loss of strength

Less common

• Blemishes on the skin
• Body aches or pain
• Congestion
• Depersonalization
• Diarrhea
• Difficulty with moving
• Dry skin
• Dryness of the vagina
• Dysphoria
• Euphoria
• Excessive muscle tone
• Feeling paranoid
• Flu-like symptoms
• Fullness or swelling of the breasts
• Hair loss or thinning of the hair
• Severe and throbbing headache
• Leg cramps
• Loss of bladder control
• Longer or heavier menstrual periods
• Muscle pain or stiffness
• Joint pain
• Pain or tenderness around the eyes and cheekbones
• Pimples or acne
• Quick to react or overreact emotionally
• Rapidly changing moods
• Rash
• Sleeplessness
• Sore mouth or tongue
• Stuffy or runny nose
• Tender, swollen glands in the neck
• Tightness of the chest or wheezing
• Trouble with sleeping
• Trouble with swallowing
• Vaginal discharge that is clear or white
• Voice changes
• White patches in the mouth or on the tongue

Incidence not known

• Changes in appetite
• Hives or welts
• Inability to have or keep an erection
• Increased hair growth, especially on the face
• Increased interest in sexual intercourse
• Irritability
• Loss in sexual ability, desire, drive, or performance
• Loss of scalp hair
• Pain in the ankles or knees
• Painful, red lumps under the skin, mostly on the legs
• Patchy brown or dark brown discoloration of the skin
• Redness of the skin
• Weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Premphase
• Prempro
• Prempro Low Dose

Available Dosage Forms:

• Tablet

Therapeutic Class: Estrogen/Progestin Combination

Pharmacologic Class: Estrogen

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of menopause symptoms and prevention of osteoporosis: Adults— Premphase®: One tablet once a day for 28 days, then repeat the cycle. The maroon colored tablet is taken on days 1 to 14, and the light blue tablet is taken on days 15 to 28. Prempro®: One tablet once a day for 28 days, then repeat the cycle. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.