Activella

Activella LD Drug Information

• Activella Overview

  an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). Activella is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in Activella helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using Activella to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. Activella may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.

• Activella Warnings

  Estrogens, either used alone or with a progestin, have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens and progestins should not be used to prevent heart disease or dementia. In postmenopausal women, estrogen when used with a progestin can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries. The risk for serious side effects may depend on the dose of estrogen and the length of time Activella is used. Therefore, Activella should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of Activella with your doctor regularly (for example, every 3 to 6 months) to see if you still need to use it. If you will be using Activella long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

• How to Use Activella

  Read the Patient Information Leaflet if available from your pharmacist before you start using Activella and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take Activella by mouth with or without food as directed by your doctor, usually once daily. You may take it with food or right after a meal to prevent stomach upset. The Dosage of Activella is based on your medical condition and response to treatment. Take Activella regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow your dosing schedule carefully. Do not increase your dose or take Activella more often or for a longer time than directed. Tell your doctor if your condition does not improve or if it worsens.

• Activella Precautions

  Before taking Activella, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Activella may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using Activella, tell your doctor or pharmacist your medical history,vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots), family or personal history of a certain swelling disorder (angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high blood cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression). Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35. Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop Activella for a time or take special precautions. Activella may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. Activella must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. Activella passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

• Activella Misdose

  If you miss a dose of Activella, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

• Activella Interactions

  Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.aromatase inhibitors (such as anastrozole, exemestane, letrozole), fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir). Activella may interfere with certain laboratory tests (including metyrapone test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use Activella.

• Activella Side Effects

  What are Activella side effects?

  Side effects are physical, mental or emotional symptoms which occur in addition to or outside of the desired effect of a therapeutic treatment such as an over-the-counter or prescribed drug or medication. Side effects from Activella may occur at the beginning or at the end of treatment and may also depend on the length of time an individual remains on the treatment. Side effects, also known as adverse effects, are generally more likely to occur when starting treatment. Individuals may also experience side effects from Activella as a result of an interaction with other medications.

  Side Effects of Activella

  The side effects of Activella may vary in number and intensity for many different reasons. Factors such as age, weight, gender and ethnicity may influence the side effects of Activella. Also, an individual’s state of general physical health and seriousness of the disease or illness as well as an increase or decrease in dosage may lead to side effects. Further, side effects from Activella may also occur as a result of an interaction with certain herbal supplements, foods or drinks.

  Prescription drug side effects can be serious and may cause patients to stop the treatment. However, when side effects from the use of a prescription drug, such as Activella, do occur a patient should consult their physician. A physician may prescribe an additional treatment in order to control the symptoms or an adjustment in the dosage may be made. In addition, changes to diet, exercise or other lifestyle activities may help to lessen the side effects of Activella.

  By understanding side effects and the factors which may influence the occurrence of side effects patients are empowered to take an active role in their care. Patients who have specific questions about the side effects of Activella, or any other medication, should contact their physician. General information about Activella and the side effects associated with Activella are described in the following:

  Common Activella Side Effects

  Severe

  • irregular menstrual periods
  • abnormal vaginal bleeding
  • abdominal distension

  Less Severe

  • fatigue
  • edema
  • weight loss
  • appetite changes
  • headache disorder
  • myalgias
  • vaginitis
  • sinusitis
  • gynecomastia
  • mastalgia
  • peripheral edema
  • anorexia
  • weight gain
  • nausea
  • breast milk flow decreased
  • abdominal pain with cramps
  • vulvovaginal candidiasis
  • dysmenorrhea
  • abdominal distension

  Less Frequent Activella Side Effects

  Severe

  • gastroenteritis
  • endometrial hyperplasia

  Less Severe

  • dizziness
  • irritability
  • dyspepsia
  • hypertonia
  • vaginal discharge
  • mood changes
  • libido changes
  • migraine
  • bronchitis
  • vaginal discharge
  • dizziness
  • headache disorder
  • vomiting
  • diarrhea

  Rare or Very Rare Activella Side Effects

  Severe

  • depression
  • retinal thrombosis
  • optic neuritis
  • thromboembolic disorder
  • thrombophlebitis
  • hepatitis
  • cystitis
  • galactorrhea not associated with childbirth
  • erythema multiforme
  • erythema nodosum
  • pruritus of skin
  • back pain
  • skin rash
  • chest pain
  • anaphylaxis
  • pancreatitis
  • abnormal hepatic function tests
  • angioedema
  • obstructive hyperbilirubinemia
  • pulmonary thromboembolism
  • malignant neoplasm of the ovary
  • ectopic pregnancy
  • ovarian cyst
  • menorrhagia
  • hypersensitivity drug reaction
  • thrombotic disorder
  • neoplasm of breast
  • hypertension
  • acute myocardial infarction
  • pulmonary thromboembolism
  • cerebrovascular accident
  • thromboembolic disorder
  • influenza
  • hepatitis
  • gallbladder obstruction
  • unspecified lump in breast
  • involuntary muscle movement
  • endometrial carcinoma
  • urticaria
  • retinal thrombosis
  • change in corneal curvature
  • malignant neoplasm of the ovary

  Less Severe

  • mastalgia
  • erosion of cervix
  • cervical discharge
  • alopecia
  • hirsutism
  • acne vulgaris
  • chloasma
  • insomnia
  • weight gain
  • nausea
  • constipation
  • amenorrhea
  • urticaria
  • drowsy
  • fever
  • hyperglycemia
  • body fluid retention
  • migraine
  • nervousness
  • limb pain
  • upper respiratory infection
  • nipple discharge
  • amenorrhea
  • menorrhagia
  • abnormal vaginal bleeding
  • back pain
  • chest pain
  • body fluid retention

• Activella Storage

  Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard Activella when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.