Premarin

Premarin is an FDA-registered drug product whose active ingredient is ESTROGENS, CONJUGATED. It is labelled by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0046-1100, application NDA004782, label effective 20260604. It is one of 3 FDA drug label records sharing the active ingredient ESTROGENS, CONJUGATED. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ESTROGENS, CONJUGATED are most often described in connection with: treatment moderate, due menopause, palliation only, vaginal atrophy, prevention postmenopausal, severe vasomotor, hypogonadism castration, primary ovarian. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE PREMARIN is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) • Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure 1.4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease 1.5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) 1.6 Prevention of Postmenopausal Osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

2 DOSAGE AND ADMINISTRATION Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer [see Boxed Warning ]. A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.16) ] . Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. PREMARIN may be taken without regard to meals. • Daily administration of 0.3, 0.45, 0.625, 0.9, and 1.25 mg ( 2.1 , 2.2 , 2.3 , 2.5 , 2.6 ) • Cyclic administration of 0.3, 0.625, and 1.25 mg ( 2.1 , 2.2 , 2.3 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. PREMARIN therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by 5 days off drug), as is medically appropriate on an individual basis. 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. PREMARIN therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by 5 days off drug), as is medically appropriate on an individual basis. 2.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure PREMARIN therapy should be initiated and maintained with the lowest effective dose to achieve clinical goals. Female hypogonadism: 0.3 mg or 0.625 mg daily, administered cyclically (e.g., three weeks on and one week off). Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium [ see Clinical Studies (14.4) ]. Female castration or primary ovarian failure: 1.25 mg daily, cyclically. Adjust dosage, upward or downward, according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control. 2.4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease Suggested dosage is 10 mg three times daily, for a period of at least three months. 2.5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) 1.25 mg to 2 × 1.25 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient. 2.6 Prevention of Postmenopausal Osteoporosis PREMARIN therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by 5 days off drug), as is medically appropriate on an individual basis. Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg PREMARIN daily. Subsequent dosage adjustment may be made based upon the individual clinical and bone mineral density responses. This dose should be periodically reassessed by the healthcare provider.

4 CONTRAINDICATIONS PREMARIN therapy is contraindicated in individuals with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2) ] • Breast cancer or a history of breast cancer except in appropriately selected patients being treated for metastatic disease [see Warnings and Precautions (5.2) ] • Estrogen-dependent neoplasia [see Warnings and Precautions (5.2) ] • Active DVT, PE, or a history of these conditions [see Warnings and Precautions (5.1) ] • Active arterial thromboembolic disease (for example stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1) ] • Known anaphylactic reaction or angioedema with PREMARIN [see Warnings and Precautions (5.7 , 5.15 )] • Hepatic impairment or disease [see Warnings and Precautions (5.11) ] • Protein C, protein S or antithrombin deficiency, or other known thrombophilic disorders. • Undiagnosed abnormal genital bleeding ( 4 ) • Breast cancer or history of breast cancer except in appropriately selected patients being treated for metastatic diseases ( 4 , 5.2 ) • Estrogen-dependent neoplasia ( 4 , 5.2 ) • Active DVT, PE, or a history of these conditions ( 4 , 5.1 ) • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4 , 5.1 ) • Known anaphylactic reaction or angioedema with PREMARIN ( 5.7 , 5.15 ) • Hepatic impairment or disease ( 4 , 5.11 ) • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in labeling: • Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] • Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] Most common adverse reactions (≥5%) are: abdominal pain, asthenia, pain, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During the first year of a 2-year clinical trial with 2,333 postmenopausal women with a uterus between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with CE, and 332 were treated with placebo. Table 1 summarizes treatment-related adverse reactions that occurred at a rate of ≥1% in any treatment group. Table 1: Treatment-Related Adverse Reactions at a Frequency ≥1% PREMARIN 0.625 mg (n=348) PREMARIN 0.45 mg (n=338) PREMARIN 0.3 mg (n=326) Placebo (n=332) Body as a whole Abdominal pain 38 (11) 28 (8) 30 (9) 21 (6) Asthenia 16 (5) 8 (2) 14 (4) 3 (1) Back pain 18 (5) 11 (3) 13 (4) 4 (1) Chest pain 2 (1) 3 (1) 4 (1) 2 (1) Generalized edema 7 (2) 6 (2) 4 (1) 8 (2) Headache 45 (13) 47 (14) 44 (13) 46 (14) Moniliasis 5 (1) 4 (1) 4 (1) 1 (0) Pain 17 (5) 10 (3) 12 (4) 14 (4) Pelvic pain 10 (3) 9 (3) 8 (2) 4 (1) Cardiovascular system Hypertension 4 (1) 4 (1) 7 (2) 5 (2) Migraine 7 (2) 1 (0) 0 3 (1) Palpitation 3 (1) 3 (1) 3 (1) 4 (1) Vasodilatation 2 (1) 2 (1) 3 (1) 5 (2) Digestive system Constipation 7 (2) 6 (2) 4 (1) 3 (1) Diarrhea 4 (1) 5 (1) 5 (2) 8 (2) Dyspepsia 7 (2) 5 (1) 6 (2) 14 (4) Eructation 1 (0) 1 (0) 4 (1) 1 (0) Flatulence 22 (6) 18 (5) 13 (4) 8 (2) Increased appetite 4 (1) 1 (0) 1 (0) 2 (1) Nausea 16 (5) 10 (3) 15 (5) 16 (5) Metabolic and nutritional Hyperlipidemia 2 (1) 4 (1) 3 (1) 2 (1) Peripheral edema 5 (1) 2 (1) 4 (1) 3 (1) Weight gain 11 (3) 10 (3) 8 (2) 14 (4) Musculoskeletal system Arthralgia 6 (2) 3 (1) 2 (1) 5 (2) Leg cramps 10 (3) 5 (1) 9 (3) 4 (1) Myalgia 2 (1) 1 (0) 4 (1) 1 (0) Nervous system Anxiety 6 (2) 4 (1) 2 (1) 4 (1) Depression 17 (5) 15 (4) 10 (3) 17 (5) Dizziness 9 (3) 7 (2) 4 (1) 5 (2) Emotional lability 3 (1) 4 (1) 5 (2) 8 (2) Hypertonia 1 (0) 1 (0) 5 (2) 3 (1) Insomnia 16 (5) 10 (3) 13 (4) 14 (4) Nervousness 9 (3) 12 (4) 2 (1) 6 (2) Skin and appendages Acne 3 (1) 1 (0) 8 (2) 3 (1) Alopecia 6 (2) 6 (2) 5 (2) 2 (1) Hirsutism 4 (1) 2 (1) 1 (0) 0 Pruritus 11 (3) 11 (3) 10 (3) 3 (1) Rash 6 (2) 3 (1) 1 (0) 2 (1) Skin discoloration 4 (1) 2 (1) 0 1 (0) Sweating 4 (1) 1 (0) 3 (1) 4 (1) Urogenital system Breast disorder 6 (2) 3 (1) 3 (1) 6 (2) Breast enlargement 3 (1) 4 (1) 7 (2) 3 (1) Breast neoplasm 4 (1) 4 (1) 7 (2) 7 (2) Breast pain 37 (11) 39 (12) 24 (7) 26 (8) Cervix disorder 8 (2) 4 (1) 5 (2) 0 Dysmenorrhea 12 (3) 10 (3) 4 (1) 2 (1) Endometrial disorder 4 (1) 2 (1) 2 (1) 0 Endometrial hyperplasia 16 (5) 8 (2) 1 (0) 0 Leukorrhea 17 (5) 17 (5) 12 (4) 6 (2) Metrorrhagia 11 (3) 4 (1) 3 (1) 1 (0) Urinary tract infection 1 (0) 2 (1) 1 (0) 4 (1) Uterine fibroids enlarged 6 (2) 1 (0) 2 (1) 2 (1) Uterine spasm 11 (3) 5 (1) 3 (1) 2 (1) Vaginal dryness 1 (0) 2 (1) 1 (0) 6 (2) Vaginal hemorrhage 46 (13) 13 (4) 6 (2) 0 Vaginal moniliasis 14 (4) 10 (3) 12 (4) 5 (2) Vaginitis 18 (5) 7 (2) 9 (3) 1 (0) 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of PREMARIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible always to reliably estimate their frequency or establish a causal relationship to drug exposure. Genitourinary system Abnormal uterine bleeding; dysmenorrheal or pelvic pain, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer, leukorrhea. Breasts Tenderness, enlargement, pain, discharge, galactorrhea, fibrocystic breast changes, breast cancer, gynecomastia in males. Cardiovascular Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure. Gastrointestinal Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, enlargement of hepatic hemangiomas, ischemic colitis. Skin Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, rash. Eyes Retinal vascular thrombosis, intolerance to contact lenses. Central nervous system Headache, migraine, dizziness , mental depression, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia, possible growth potentiation of benign meningioma. Miscellaneous Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.

FDA lists 3 drug label records with ESTROGENS, CONJUGATED as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Premarin used for?
1 INDICATIONS AND USAGE PREMARIN is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in …

Who makes Premarin?
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. is the labeler of record for Premarin. 3 FDA label records share the active ingredient ESTROGENS, CONJUGATED, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Premarin come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Premarin prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ESTROGENS, CONJUGATED?
Yes. 3 FDA drug label records list ESTROGENS, CONJUGATED as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Premarin been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.