Ogen .625 (Oral)

Estropipate is used to treat moderate to severe menopause symptoms. It also helps with changes in and around the vagina (like vaginal dryness, itching, and burning) due to low estrogen levels or menopause. This medicine can also be used to treat certain conditions in women before menopause if their ovaries do not produce enough estrogens naturally, and to prevent osteoporosis after menopause.

Estropipate is an estrogen hormone that helps prevent symptoms such as warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during 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 ensure this medicine is working properly and does not cause unwanted effects. Blood tests, pelvic exams, breast exams, and mammograms (breast x-rays) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

It is unlikely for a postmenopausal woman to become pregnant. However, you should know that using this medicine while you are pregnant could 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 blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol, diabetes, are overweight, or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, inability to move your arms, legs, or facial muscles, or inability to speak.

Using this medicine may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

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

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.

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 will weigh the risks of the medicine against its benefits. Here are some important considerations for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Estropipate is not intended for use in children.

Geriatric

While studies on how age affects the results of estropipate in older adults have not been done, no specific problems for older patients have been noted so far. However, older patients are more likely to have breast cancer, strokes, or dementia, which may require caution when using this medicine.

Breast Feeding

Research suggests that this medication may change milk production or its composition. If you are not prescribed a different medication, you should watch your baby for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should never be taken together, while others can be used together even if interactions might happen. In these cases, your doctor may adjust the dose or take other precautions. When using this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The listed interactions are based on their importance and may not be all-inclusive.

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

• Amifampridine
• Bupropion
• Donepezil
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ginseng
• Levothyroxine
• Licorice
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times, as certain foods may interact with them. Using alcohol or tobacco with specific medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect your use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or
• Breast cancer, known or suspected, or a history of or
• Heart attack, history of or
• Liver disease or
• Protein C, protein S, or other known blood clotting disorders or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma or
• Bone problems or
• Diabetes or
• Edema (fluid retention or body swelling) or
• Endometriosis or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hereditary angioedema (swelling of the face, lips, tongue, or throat) or
• Hypercalcemia (high calcium in the blood) or
• Hypocalcemia (low calcium in the blood) or
• Hypothyroidism (an underactive thyroid) or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver tumors or
• Migraine headache or
• Porphyria (an enzyme problem) or
• Systemic lupus erythematosus (SLE)—Use with caution. May worsen these conditions.

• Heart disease or
• Hypercholesterolemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Obesity, or history of or
• Prolonged periods of immobilization—Use with caution. These conditions may increase the risk of more serious side effects.

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.

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

Incidence not known

• Acid or sour stomach
• anxiety
• backache
• belching
• breast discharge, swelling, or pain
• change in vaginal discharge
• changes in skin color, pain, tenderness
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• constipation
• cough
• cramps
• darkened urine
• diarrhea
• difficulty speaking
• difficulty swallowing
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• fever
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• heavy bleeding
• hives, itching, skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• itching of the vagina or outside genitals
• loss of appetite
• nausea
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back, or neck
• pain or feeling of pressure in the pelvis
• pains in stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow speech
• stomach discomfort, upset, or pain
• sudden shortness of breath or troubled breathing
• sweating
• swelling of the abdominal or stomach area
• tightness in the chest
• unpleasant breath odor
• unusual tiredness or weakness
• unusually heavy or unexpected menstrual bleeding
• vaginal yeast infection
• vaginal bleeding or spotting
• vomiting
• vomiting of blood
• 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. 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:

Incidence not known

• Hair loss
• inability to have or keep an erection
• increased hair growth, especially on the face
• loss in sexual ability, desire, drive, or performance
• patchy brown or dark brown discoloration of the skin
• swelling of the breasts or breast soreness in males
• trouble wearing contact lenses
• weight gain or loss

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.

• Ogen .625
• Ogen 1.25
• Ogen 2.5
• Ortho-Est

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

It is very important that you use this medicine exactly 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 carefully. Ask your doctor if you have any questions.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

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 hot flashes and other symptoms caused by menopause: Adults—One Ogen® 0.625 (0.75 mg estropipate) tablet to two Ogen® 2.5 (3 mg estropipate) tablets per day. Children—Use is not recommended. For treatment of changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause. Adults—One Ogen® 0.625 (0.75 mg estropipate) tablet to two Ogen® 2.5 (3 mg estropipate) tablets per day. Children—Use is not recommended. For female hypogonadism, female castration, or primary ovarian failure: Adults—One Ogen® 1.25 (1.5 mg estropipate) tablet to three Ogen® 2.5 (3 mg estropipate) tablets per day may be given for the first 3 weeks of a cycle, followed by a rest period of 8 to 10 days. Your doctor may adjust your dose as needed and tolerated. Children—Use is not recommended. For prevention of osteoporosis after menopause: Adults—One Ogen® 0.625 (0.75 mg estropipate) tablet for 25 days of a 31-day cycle per month. 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.