Activella

Generic Name: conjugated estrogens and medroxyprogesterone (Oral route)

Commonly used brand name(s):

In the U.S.

• Activella
• Angeliq
• Cyclessa
• Estinyl
• Loestrin 1/20
• Loestrin 1.5/30
• Mircette
• Necon
• Ortho-Novum
• Prefest
• Premphase
• Prempro
• Tri-Levlen
• Triphasil

Available Dosage Forms:

• Tablet
• Tablet, Chewable

Uses For Activella

Conjugated estrogens and medroxyprogesterone are estrogen and progestin hormones. Along with other effects, estrogens help females develop sexually at puberty and regulate the menstrual cycle. Progestin lowers the effect of estrogen on the uterus and keeps estrogen-related problems from developing.

Around the time of menopause, the ovaries produce less estrogen. Estrogens are given to:

• Relieve the signs of menopause (vasomotor symptoms of menopause), such as hot flashes and unusual sweating, chills, faintness, or dizziness.
• Treat inflammation of the vagina (atrophic vaginitis) and of the genital area (atrophy of the vulva) by keeping these areas from becoming too dry, itchy, or painful.
• Prevent the loss of bone that begins at the time of menopause. Keeping bones strong decreases the chance of developing weak bones that easily break (osteoporosis). Estrogen use is most effective when it is taken for more than 7 years while you are getting regular exercise and extra calcium. Protection from bone loss can then last for many years after you stop taking the medicine.

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 related to the menopausal symptoms, such as hot flashes.

Progestins are not needed if the uterus has been removed by a surgical method called hysterectomy. In that case, it may be better to receive estrogens alone without the progestin.

Conjugated estrogens and medroxyprogesterone are available only with your doctor's prescription.

Before Using Activella

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Conjugated estrogens and medroxyprogesterone may increase your chance of having a stroke, memory problems, or breast cancer that spreads to other parts of your body.

Pregnancy

Conjugated estrogens and medroxyprogesterone are not recommended for use during pregnancy. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause. Tell your doctor right away if you suspect you are pregnant.

Breast Feeding

Conjugated estrogens and medroxyprogesterone pass into the breast milk. This medicine is not recommended for use during breast-feeding.

Interactions with Medicines

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Felbamate
• Isotretinoin
• Paclitaxel
• Paclitaxel Protein-Bound
• Theophylline
• Tizanidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Epilepsy or
• Heart problems (congestive heart failure) or
• High blood pressure or
• Kidney problems, severe or
• Migraine headaches—Rarely, water retention caused by conjugated estrogens and medroxyprogesterone may make these conditions worse.

• Blood clotting problems, or history of with previous estrogen use or
• Breast cancer, estrogen-dependent, or history of or
• Breast cancer, or history of or
• Deep vein thrombosis (blood clot in the leg), active or history of or
• Heart attack, active or recent (within past year) or
• Liver disease, including jaundice, or history of or
• Pulmonary embolism (clot in the lung), active or history of or
• Stroke, active or recent (within past year) or
• Venous thromboembolism (clot in the veins), or history of—Conjugated estrogens and medroxyprogesterone should not be used in patients with these conditions.

• Bone cancer or
• Endometrial cancer (cancer of the uterus), active or suspected or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of bone cancer, worsen cancer of the uterus, or increase the size of fibroid tumors.

• Changes in genital or vaginal bleeding of unknown causes—Estrogens may make these conditions worse; some irregular vaginal bleeding may be a sign that the lining of the uterus may be growing too much or is a sign of cancer of the uterus lining.

• Changes in vision—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse.

• Diabetes mellitus—Conjugated estrogens and medroxyprogesterone may slightly change the amount of blood sugar for some patients, but for most patients with diabetes, there is no change in blood sugar.

• Endometriosis or
• Gallbladder disease or gallstones, or history of or
• High cholesterol or triglycerides, or family history of or
• Memory loss (dementia) or
• Pancreatitis (inflammation of pancreas) or
• Porphyria (liver problem)—Conjugated estrogens and medroxyprogesterone may make these conditions worse; using estrogens can lower blood cholesterol in many patients with high cholesterol.

• Hypothyroidism (underactive thyroid)—A change in dose of thyroid medication may be needed.

• Low blood calcium, severe—Estrogens should be used with caution in patients with this condition.

Proper Use of conjugated estrogens and medroxyprogesterone

This section provides information on the proper use of a number of products that contain conjugated estrogens and medroxyprogesterone. It may not be specific to Activella. Please read with care.

Conjugated estrogens and medroxyprogesterone usually come with patient directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer period of time than your doctor ordered. The length of time you take the medicine will depend on the medical problem for which you are taking conjugated estrogens and medroxyprogesterone. Discuss with your doctor how long you will need to take these medicines.

If you are taking the estrogen or progestin hormones in a certain order (i.e., conjugated estrogens tablets followed by conjugated estrogens and medroxyprogesterone tablets), be sure you know in which order you need to take the medicines. If you have questions about this, ask your health care professional.

Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

Dosing

The dose medicines in this class 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 these medicines. 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 conjugated estrogens, and conjugated estrogens and medroxyprogesterone
• For oral dosage form (tablets):
  • To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—One tablet (containing 0.625 mg conjugated estrogens) once a day on Days 1 through 14; then, one tablet (containing 0.625 mg conjugated estrogens and 5 mg medroxyprogesterone) once a day on Days 15 through 28. Repeat cycle.

• For conjugated estrogens and medroxyprogesterone
• For oral dosage form (tablets):
  • To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—One tablet (containing 0.3 mg conjugated estrogens and 1.5 mg medroxyprogesterone) once a day for twenty-eight days. Repeat cycle. If vaginal bleeding or spotting continues and it is undesired, your doctor may increase your dose to the next highest strength tablet (0.45 mg conjugated estrogens and 1.5 mg medroxyprogesterone). It should be taken once a day for twenty-eight days. Repeat cycle.

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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Activella

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. Plan on going to see your doctor every year, but some doctors require visits more often.

Although the risk for developing breast problems or breast cancer is low, it is still important that you regularly check your breasts for any unusual lumps or discharge, and report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) and breast examination done by your doctor whenever your doctor recommends it.

If your menstrual periods have stopped, they may start again once you begin taking this medicine. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before having any laboratory test, because some test results may be affected.

You may need to stop taking this medicine before having some kinds of surgery or while your doctor has ordered a long period of bedrest. Talk with your doctor about this.

Activella 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.

Healthy women rarely have severe side effects from taking conjugated estrogens or medroxyprogesterone to replace estrogen.

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

• Itching of the vagina or genital area
• menstrual periods beginning again, including changing menstrual bleeding pattern for up to 6 months (spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or vaginal bleeding completely stopping by 10 months)
• pain during sexual intercourse
• thick, white vaginal discharge

• Blurred vision
• breast lumps
• chest pain
• discharge from breast
• dizziness
• feeling faint, dizzy, or light-headed
• feeling of warmth or heat
• flushing or redness of skin, especially on face and neck
• headache
• heavy nonmenstrual vaginal bleeding
• pounding in the ears
• severe cramping of the uterus
• slow or fast heartbeat
• sweating

• Change in vaginal discharge
• pain or feeling of pressure in pelvis
• pain or tenderness in stomach, side, or abdomen
• yellow eyes or skin

• Abdominal bloating
• acid or sour stomach
• belching
• backache
• full or bloated feeling or pressure in the stomach
• heartburn
• indigestion
• loss of appetite
• pelvic pain
• stomach discomfort, upset or pain
• stomach pain
• swelling of abdominal or stomach are

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:

• Abdominal cramps
• back pain
• body aches or pain
• breast pain or tenderness
• congestion
• chills
• cough
• crying
• depersonalization
• diarrhea
• dryness or soreness of throat
• dysphoria
• enlarged breasts
• euphoria
• feeling faint, dizzy, or light-headedness
• feeling of warmth or heat
• fever
• flushing or redness of skin, especially on face and neck
• general feeling of discomfort or illness
• headache, severe and throbbing
• hoarseness
• increase in amount of clear vaginal discharge
• itching
• joint pain
• lack or loss of strength
• mental depression
• muscle aches and pains
• nausea
• pain
• pain or tenderness around eyes and cheekbones
• painful menstrual periods
• painful or difficult urination
• paranoia
• passing of gas
• quick to react or overreact emotionally
• rapidly changing moods
• runny nose
• shivering
• shortness of breath or troubled breathing
• sneezing
• sore throat
• stuffy nose
• stomach discomfort following meals
• tender, swollen glands in neck
• tightness of chest or wheezing
• trouble sleeping
• trouble in swallowing
• unusual tiredness
• voice changes
• vomiting

• Acne
• bloating or swelling of face, ankles, or feet
• cervix disorder
• crying
• depersonalization
• dysphoria
• euphoria
• increase in sexual desire
• leg cramps
• mental depression
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• sleeplessness
• tense muscles
• trouble sleeping
• unable to sleep
• unusual weight gain or loss

• Abdominal cramping
• bloody or cloudy urine
• bloody vaginal discharge
• difficult, burning, or painful urination
• frequent urge to urinate
• light vaginal bleeding between periods and after intercourse

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.

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