Drug name: Activella (Oral)
Description:
Activella (Oral)
Generic name: estrogen and progestin combination (OVARIAN HORMONE THERAPY) (oral route)
Drug class: Sex hormone combinations
Commonly used brand name(s)
In the U.S.
- Activella
- Alesse
- Angeliq
- Estinyl
- Hemocyte
- Loestrin 1/20
- Mircette
- Myfembree
- Ortho-Cyclen
- Ortho-Novum
- Premphase
Available Dosage Forms:
- Tablet
- Tablet, Chewable
- Capsule
Uses for Activella
Estrogens and progestins 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. Progestins help to regulate the effects of estrogens.
Estrogens are prescribed for several reasons:
- to provide additional hormone when the body does not produce enough of its own, such as during menopause. They can also help to relieve a genital skin condition called vaginal or vulvar atrophy.
- to help prevent weakening of bones (osteoporosis) in women past menopause.
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 and progestins 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
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of estrogens and progestins in the elderly with use in other age groups.
Pregnancy
Estrogens and progestins are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.
Breastfeeding
Estrogens and progestins pass into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
- Boceprevir
- Cyclosporine
- Dasabuvir
- Eltrombopag
- Gemfibrozil
- Levoketoconazole
- Ombitasvir
- Paritaprevir
- Ritonavir
- Tranexamic Acid
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.
- Abametapir
- Adagrasib
- Alprazolam
- Amifampridine
- Amiodarone
- Amoxicillin
- Ampicillin
- Amprenavir
- Anagrelide
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Bacampicillin
- Belzutifan
- Betamethasone
- Bexarotene
- Boceprevir
- Bosentan
- Bupropion
- Capmatinib
- Carbamazepine
- Carbenicillin
- Carvedilol
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Clarithromycin
- Clavulanic Acid
- Clobazam
- Cloxacillin
- Clozapine
- Cobicistat
- Colesevelam
- Conivaptan
- Cyclacillin
- Cyclosporine
- Dabrafenib
- Darolutamide
- Darunavir
- Desogestrel
- Dexamethasone
- Dicloxacillin
- Dienogest
- Digoxin
- Donepezil
- Doxycycline
- Dronedarone
- Drospirenone
- Efavirenz
- Elagolix
- Eliglustat
- Elvitegravir
- Enasidenib
- Encorafenib
- Enzalutamide
- Erdafitinib
- Erythromycin
- Eslicarbazepine Acetate
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Etravirine
- Fedratinib
- Fexinidazole
- Finerenone
- Flibanserin
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Fostemsavir
- Gestodene
- Glecaprevir
- Griseofulvin
- Guar Gum
- Idelalisib
- Indinavir
- Iron
- Isotretinoin
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lapatinib
- Leflunomide
- Lemborexant
- Lesinurad
- Levonorgestrel
- Lixisenatide
- Lopinavir
- Lorlatinib
- Lumacaftor
- Mavacamten
- Medroxyprogesterone
- Mestranol
- Midazolam
- Midostaurin
- Minocycline
- Mitapivat
- Mitotane
- Mobocertinib
- Modafinil
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nafcillin
- Nefazodone
- Nelfinavir
- Netupitant
- Nevirapine
- Nirmatrelvir
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Octreotide
- Omeprazole
- Oxacillin
- Oxcarbazepine
- Oxytetracycline
- Paclitaxel
- Paclitaxel Protein-Bound
- Penicillin G
- Penicillin G Procaine
- Penicillin V
- Phenobarbital
- Phenylbutazone
- Phenytoin
- Pibrentasvir
- Piperaquine
- Pitolisant
- Pixantrone
- Posaconazole
- Prednisone
- Primidone
- Quinidine
- Ranolazine
- Red Clover
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Rosuvastatin
- Rufinamide
- Saquinavir
- Secobarbital
- Segesterone
- Sirolimus Protein-Bound
- St John''s Wort
- Sugammadex
- Sultamicillin
- Tacrolimus
- Tazemetostat
- Telaprevir
- Telithromycin
- Teriflunomide
- Tetracycline
- Theophylline
- Ticarcillin
- Tigecycline
- Tirzepatide
- Tizanidine
- Topiramate
- Troglitazone
- Ubrogepant
- Ulipristal
- Valproic Acid
- Vemurafenib
- Venetoclax
- Verapamil
- Voriconazole
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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
- Calcium, too much or too little in blood or
- Diabetes mellitus (sugar diabetes)
- Epilepsy (seizures) or
- Heart problems or
- Kidney problems or
- Liver tumors, benign or
- Lupus erythematosus, systemic or
- Migraine headaches or
- Porphyria—Estrogens may worsen these conditions.
- Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.
- Breast cancer or
- Bone cancer or
- Cancer of the uterus or
- Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.
- Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.
- Endometriosis or
- Gallbladder disease or gallstones (or history of) or
- High cholesterol or triglycerides (or history of) or
- Liver disease or
- Pancreatitis (inflammation of pancreas)—Estrogens may worsen these conditions; while estrogens can improve blood cholesterol, they may worsen blood triglycerides for some people.
- Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.
- Vision changes, sudden onset including
- Bulging eyes or
- Double vision or
- Migraine headache or
- Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).
Proper use of Activella
This section provides information on the proper use of a number of products that contain estrogen and progestin combination (ovarian hormone therapy). It may not be specific to Activella. Please read with care.
Estrogens and progestins usually come with patient information or 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 or use it for a longer time than your doctor ordered. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.
For patients taking estrogens and progestins by mouth:
- 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 17 beta-estradiol and norgestimate
- For oral dosage forms (tablets):
- For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
- Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
- For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
- For ethinyl estradiol and norethindrone
- For oral dosage forms (tablets):
- For treating vasomotor symptoms of menopause:
- Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
- For treating vasomotor symptoms of menopause:
- For estradiol and norethindrone
- For oral dosage forms (tablets):
- For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
- Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
- For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
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. These visits will usually be every year, but some doctors require them more often.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.
Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.
Activella side effects
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, and no need to take an estrogen and progestin combination.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
More common
- Breast pain or tenderness
- dizziness or light-headedness
- headache
- rapid weight gain
- swelling of feet and lower legs
- vaginal bleeding
Rare
- Breast lumps
- change in vaginal discharge
- discharge from nipple
- nausea and vomiting
- pains in chest, groin, or leg, especially calf
- pains in stomach, side, or abdomen
- pain or feeling of pressure in pelvis
- severe or sudden headache
- sudden and unexplained shortness of breath
- sudden loss of coordination
- sudden slurred speech
- sudden vision changes
- weakness or numbness in arm or leg
- 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:
More common
- Back pain
- bloating or gas
- dizziness
- general feeling of tiredness
- flu-like symptoms
- mental depression
- muscle aches
- nausea—taking tablet with food may decrease
- vaginitis
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.
More about conjugated estrogens / medroxyprogesterone
- Check interactions
- Reviews (66)
- Side effects
- Dosage information
- During pregnancy
- Drug class: sex hormone combinations
- En español
Patient resources
- Drug Information
- Conjugated estrogens and medroxyprogesterone Oral (Advanced Reading)
- Estrogens (Conjugated/Equine) and Medroxyprogesterone
Other brands
Prempro, Premphase
Professional resources
- Prescribing Information
Related treatment guides
- Atrophic Urethritis
- Atrophic Vaginitis
- Oophorectomy
- Osteoporosis
- Postmenopausal Symptoms
- Primary Ovarian Failure
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Activella (Oral)
Generic name: estradiol and norethindrone (oral route) [ es-tra-DYE-ol, nor-ETH-in-drone-AS-e-tate ]
Drug class: Sex hormone combinations
Medically reviewed by Drugs.com. Last updated on Sep 2, 2022.
Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable DementiaThe Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily conjugated estrogen (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast CancerThe WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not know. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen-Alone TherapyEndometrial CancerThere is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Cardiovascular Disorders and Probable DementiaThe WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogen (0.625 mg)-alone, relative to placebo.The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogen (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. With out such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman .
Commonly used brand name(s)
In the U.S.
- Activella
- Lopreeza
- Mimvey
Available Dosage Forms:
- Tablet
Therapeutic Class: Estrogen/Progestin Combination
Pharmacologic Class: Estrogen
Related/similar drugs
estradiol, Premarin, Estrace, Prempro, Yuvafem, Premarin Vaginal, ethinyl estradiol / norethindroneUses for Activella
Estradiol and norethindrone combination is used to treat moderate to severe symptoms of menopause (eg, feelings of warmth in the face, neck, and chest, sudden strong feelings of heat and sweating [hot flashes], and vaginal problems). This medicine is also used prevent osteoporosis after menopause.
This medicine is available only with your doctor''s prescription.
Before using Activella
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of estradiol and norethindrone combination in the pediatric population. Use of estradiol and norethindrone combination is not indicated for use in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of estradiol and norethindrone combination in the geriatric population. However, elderly patients are more likely to have breast cancer, strokes, or dementia, which may require caution in patients receiving estradiol and norethindrone combination.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Tranexamic Acid
Using this medicine 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.
- Abametapir
- Amifampridine
- Amoxicillin
- Ampicillin
- Amprenavir
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Bacampicillin
- Belzutifan
- Betamethasone
- Bexarotene
- Bosentan
- Bupropion
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Clavulanic Acid
- Clobazam
- Cloxacillin
- Colesevelam
- Conivaptan
- Cyclacillin
- Cyclosporine
- Dabrafenib
- Darunavir
- Dexamethasone
- Dicloxacillin
- Donepezil
- Doxycycline
- Efavirenz
- Elagolix
- Elvitegravir
- Encorafenib
- Enzalutamide
- Eslicarbazepine Acetate
- Etravirine
- Fedratinib
- Fexinidazole
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Griseofulvin
- Guar Gum
- Isotretinoin
- Ivosidenib
- Lesinurad
- Lixisenatide
- Lorlatinib
- Lumacaftor
- Mavacamten
- Minocycline
- Mitapivat
- Mitotane
- Mobocertinib
- Modafinil
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nafcillin
- Nelfinavir
- Netupitant
- Nevirapine
- Octreotide
- Oxacillin
- Oxcarbazepine
- Oxytetracycline
- Penicillin G
- Penicillin G Procaine
- Penicillin V
- Phenobarbital
- Phenylbutazone
- Phenytoin
- Pitolisant
- Pixantrone
- Prednisone
- Primidone
- Red Clover
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Rufinamide
- Secobarbital
- St John''s Wort
- Sugammadex
- Sultamicillin
- Tazemetostat
- Telaprevir
- Tetracycline
- Theophylline
- Ticarcillin
- Tigecycline
- Tirzepatide
- Tizanidine
- Topiramate
- Troglitazone
- Ulipristal
- Valproic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amitriptyline
- Atazanavir
- Clomipramine
- Diazepam
- Doxepin
- Ginseng
- Imipramine
- Lamotrigine
- Levothyroxine
- Licorice
- Lorazepam
- Parecoxib
- Prednisolone
- Selegiline
- Tacrine
- Temazepam
- Tipranavir
- Triazolam
- Troleandomycin
- Valdecoxib
- Voriconazole
- Warfarin
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.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Bleeding problems or
- Blood clots (eg, deep vein thrombosis, pulmonary embolism), active or history of or
- Breast cancer, known or suspected, or a history of or
- Dementia or
- Heart attack, history of or
- Heart or blood vessel disease or
- Liver disease or
- Protein C, protein S, or antithrombin deficiency, or other known blood clotting disorders or
- Stroke, history of or
- Tumors (estrogen-dependent, including cancer of the uterus), known or suspected—Should not be used in patients with these conditions.
- Asthma or
- Cancer, history of 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
- Hypercholesterolemia (high cholesterol or fats in the blood) or
- Hypertension (high blood pressure) or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Jaundice during pregnancy or from using hormonal therapy in the past or
- Kidney disease or
- Liver tumors or
- Migraine headache or
- Obesity or
- Porphyria (an enzyme problem) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
Proper use of Activella
This section provides information on the proper use of a number of products that contain estradiol and norethindrone. It may not be specific to Activella. Please read with care.
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.
This medicine sometimes comes in a special dispenser pack with a calendar reminder dial.
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.
To use:
- To use this dispenser, first turn the inner disc so the current day of the week is lined up with the plastic tab. Pull the plastic tab up and break if off. Tip out the first tablet.
- To get the next tablet out (on the next day), turn the outer transparent dial one space clockwise as shown by the arrow.
- The transparent dial can be turned only after the tablet in the opening has been removed. This will help you to remember to take one tablet every day.
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 moderate to severe hot flashes:
- Adults—One tablet once a day. Each tablet contains 1 milligram (mg) of estradiol and 0.5 mg of norethindrone or 0.5 mg of estradiol and 0.1 mg of norethindrone.
- Children—Use is not recommended.
- For moderate to severe vaginal problems or dryness:
- Adults—One tablet once a day. Each tablet contains 1 milligram (mg) of estradiol and 0.5 mg of norethindrone.
- Children—Use is not recommended.
- For prevention of osteoporosis after menopause:
- Adults—One tablet once a day. Each tablet contains 1 milligram (mg) of estradiol and 0.5 mg of norethindrone, or 0.5 mg of estradiol and 0.1 mg of norethindrone.
- Children—Use is not recommended.
- For moderate to severe hot flashes:
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.
Precautions while using Activella
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Blood or urine tests, pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
It is unlikely that a postmenopausal woman may become pregnant. But, 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 for having 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 in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine for a long period of time 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 your experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.
Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Tell your doctor or dentist who treats you knows that you are using this medicine before any kind of surgery (eg, surgery that will require inactivity for a long time) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also 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 (eg, St. John''s wort) or vitamin supplements.
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.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- chills or fever
- cold or flu-like symptoms
- difficulty breathing
- headache
- itching of the vagina or genital area
- non-menstrual vaginal bleeding
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
- unusual tiredness or weakness
Incidence not known
- Blistering, peeling, or loosening of the skin
- breast tenderness
- change in vaginal discharge
- change in vision
- chest pain, discomfort, or tightness
- clay-colored stools
- clear or bloody discharge from the nipple
- confusion
- dark urine
- difficulty speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- inability to move the arms, legs, or facial muscles
- inability to speak
- joint or muscle pain
- loss of appetite
- lump in the breast or under the arm
- nausea and vomiting
- noisy breathing
- 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, redness, or swelling in the arm or leg
- painful, red lumps under the skin, mostly on the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- problems with memory or speech
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness or swelling of the breast
- skin rash, hives, or itching
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- sweating
- trouble breathing
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
- unexpected or excess milk flow from the breasts
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:
More common
- Back pain
- cramps
- crying
- euphoria
- mental depression
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- trouble sleeping
- weakness
- weight gain
Incidence not known
- Changes in appetite
- changes in sexual ability, desire, drive, or performance
- excess air or gas in the stomach or intestines
- increased hair growth, especially on the face
- patchy brown or dark brown discoloration of the skin
- trouble wearing contact lenses
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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Further information
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