Ogen 2.5

Estropipate is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estropipate is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estropipate may also be used for purposes other than those listed in this medication guide.

There are no restrictions on food, beverages, or activity while using estropipate unless your doctor has told you otherwise.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• pain or swelling in your lower leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes); or

• a lump in your breast.

Other less serious side effects are more likely to occur, such as:

• nausea, vomiting, loss of appetite;

• swollen breasts;

• acne or skin color changes;

• decreased sex drive, impotence, or difficulty having an orgasm;

• migraine headaches or dizziness;

• vaginal pain, dryness, or discomfort;

• swelling of your ankles or feet;

• depression; or

• changes in your menstrual periods, break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Before using estropipate, tell your doctor if you are using any of the following drugs:

• St. John's wort;

• phenobarbital (Luminal, Solfoton);

• phenytoin (Dilantin);

• a blood thinner such as warfarin (Coumadin);

• ritonavir (Norvir);

• cimetidine (Tagamet);

• carbamazepine (Carbatrol, Tegretol);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estropipate or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estropipate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

In the U.S.

• Alora
• Cenestin
• Climara
• Divigel
• Elestrin
• Emcyt
• Enjuvia
• Esclim
• Estinyl
• EstroGel
• Evamist
• Femtrace
• Gynodiol
• Menest
• Menostar
• Minivelle
• Ogen .625
• Ogen 1.25
• Ogen 2.5
• Premarin
• Vivelle
• Vivelle-Dot

In Canada

• Estraderm
• Estradot Transdermal
• Estradot Transdermal Therapeutic System
• Estradot Transdermal Therapeutic System
• Estrogel
• Oesclim
• Rhoxal-Estradiol Derm 50
• Rhoxal-Estradiol Derm 75
• Roxal-Estradiol Derm 100
• Vivelle 100 Mcg
• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet
• Cream
• Patch, Extended Release
• Gel/Jelly
• Spray
• Emulsion
• Tablet, Enteric Coated
• Capsule

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• To help prevent weakening of bones (osteoporosis) in women past menopause.
• In the treatment of selected cases of breast cancer in men and women.
• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription.

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

Check with your doctor immediately if any of the following side effects occur:

• Breast pain (in females and males)
• fast heartbeat
• fever
• hives
• hoarseness
• increased breast size (in females and males)
• irritation of the skin
• itching of the skin
• joint pain, stiffness, or swelling
• rash
• redness of the skin
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• swelling of the feet and lower legs
• tightness in the chest
• troubled breathing or swallowing
• weight gain (rapid)
• wheezing

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
• chest pain
• chills
• cough
• heavy non-menstrual vaginal bleeding
• lumps in, or discharge from, breast (in females and males)
• pains in the stomach, side, or abdomen
• yellow eyes or skin

• Headache (sudden or severe)
• loss of coordination (sudden)
• loss of vision or change of vision (sudden)
• pains in the chest, groin, or leg, especially in the calf of leg
• shortness of breath (sudden and unexplained)
• slurring of speech (sudden)
• weakness or numbness in the arm or leg

• Abdominal or stomach bloating
• abdominal or stomach cramps
• acid or sour stomach
• anxiety
• backache
• belching
• blindness
• blistering, peeling, or loosening of the skin
• blue-yellow color blindness
• blurred vision
• change in vaginal discharge
• changes in skin color
• changes in vision
• chest discomfort
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• dark urine
• decrease in the amount of urine
• decreased vision
• depression
• diarrhea
• difficulty with breathing
• difficulty with speaking
• dimpling of the breast skin
• dizziness
• double vision
• dry mouth
• eye pain
• fainting
• fluid-filled skin blisters
• full feeling in upper abdomen or stomach
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move the arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• indigestion
• inverted nipple
• irregular heartbeats
• light-colored stools
• lightheadedness
• loss of appetite
• loss of bladder control
• lump under the arm
• metallic taste
• migraine headache
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain
• muscle spasm or jerking of all extremities
• muscle weakness
• nausea
• noisy breathing
• numbness or tingling of the hands, feet, or face
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back or neck
• pain or feeling of pressure in the pelvis
• pain, tenderness, swelling of the foot or leg
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• pains in the chest, groin, or legs, especially calves of the legs
• partial or complete loss of vision in the eye
• pelvic pain
• persistent crusting or scaling of nipple
• pinpoint red or purple spots on the skin
• prominent superficial veins over affected area
• red, irritated eyes
• redness or swelling of the breast
• sensitivity to the sun
• severe headaches of sudden onset
• skin thinness
• skin warmth
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach discomfort, upset, or pain
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling of the abdominal or stomach area
• swelling of the fingers or hands
• thirst
• tremor
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• weight loss

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal growth filled with fluid or semisolid material
• accidental injury
• bladder pain
• bloated full feeling
• bloody or cloudy urine
• body aches or pain
• coating or white patches on tongue
• congestion
• cough producing mucus
• decrease in amount of urine
• difficult, burning, or painful urination
• discouragement
• dryness of the throat
• ear congestion or pain
• excess air or gas in the stomach or intestines
• fear
• feeling of warmth
• feeling sad or empty
• frequent urge to urinate
• general feeling of discomfort or illness
• headache, severe and throbbing
• increased clear or white vaginal discharge
• irritability
• itching of the vaginal, rectal or genital areas
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• mild dizziness
• neck pain
• nervousness
• pain
• pain during sexual intercourse
• painful or difficult urination
• pain or tenderness around the eyes and cheekbones
• passing gas
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• skin irritation or redness where skin patch was worn
• shivering
• sleeplessness
• sneezing
• sore mouth or tongue
• stuffy nose
• sudden sweating
• tender, swollen glands in the neck
• thick, white vaginal discharge with no odor or with a mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• voice changes

• Blemishes on the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning or stinging of the skin
• diarrhea (mild)
• difficulty with moving
• dizziness (mild)
• increased hair growth, especially on the face
• lower abdominal or stomach pain or pressure
• mood or mental changes
• muscle stiffness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• pounding in the ears
• problems in wearing contact lenses
• slow heartbeat
• tooth or gum pain
• unusual decrease in sexual desire (in males)
• unusual increase in sexual desire (in females)
• white or brownish vaginal discharge

• Abnormal turning out of cervix
• changes in appetite
• dull ache or feeling of pressure or heaviness in the legs
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• irritability
• large amount of triglyceride in the blood
• leg cramps
• patchy brown or dark brown discoloration of the skin
• poor insight and judgment
• problems with memory or speech
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Dizziness or passing out.
• Change in eyesight.
• Loss of eyesight.
• Bulging eyes.
• Change in how contact lenses feel in the eyes.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Memory problems or loss.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hair loss.
• Upset stomach or throwing up.
• Stomach cramps.
• Bloating.
• Tender breasts.
• Vaginal bleeding or spotting.
• Feeling nervous and excitable.
• Weight gain or loss.
• Joint pain.
• Lowered interest in sex.
• This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.