Premarin Vaginal
Generic: CONJUGATED ESTROGENS
Basic Information
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
96609623-528e-4aba-cabe-7254aed816d5
Indications & Usage
1 INDICATIONS AND USAGE PREMARIN (conjugated estrogens) vaginal cream is a mixture of estrogens indicated for: • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 1.1 ) • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ( 1.2 ) 1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae 1.2 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.2) ] • Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.3) ] In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions ≥ 2% are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder ( 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 Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a 12-week, randomized, double-blind, placebo-controlled trial of PREMARIN vaginal cream (PVC), a total of 423 postmenopausal women received at least 1 dose of study medication and were included in all safety analyses: 143 women in the PVC-21/7 treatment group (0.5 g PVC daily for 21 days, then 7 days off), 72 women in the matching placebo treatment group; 140 women in the PVC-2x/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group.
A 40-week, open-label extension followed, in which a total of 394 women received treatment with PVC, including those subjects randomized at baseline to placebo.
In this study, the most common adverse reactions ≥ 1% in the double blind phase are shown below (Table 1) [see Clinical Studies (14.1) ] .
Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1% Only Treatment Body System Body system totals are not necessarily the sum of individual adverse events, since a patient may report two or more different adverse reactions in the same body system.
/Adverse Reaction PVC 21/7 N=143 Placebo 21/7 N=72 PVC 2×/week N=140 Placebo 2×/week N=68 Number (%) of Patients with Adverse Reaction Body As A Whole Abdominal Pain 1 (0.7) 1 (1.4) 0 1 (1.5) Headache 5 (3.5) 1 (1.4) 3 (2.1) 1 (1.5) Moniliasis 2 (1.4) 1 (1.4) 1 (0.7) 0 Pain 2 (1.4) 0 1 (0.7) 0 Pelvic Pain 4 (2.8) 2 (2.8) 4 (2.9) 0 Cardiovascular System Migraine 0 0 0 1 (1.5) Vasodilation 3 (2.1) 2 (2.8) 2 (1.4) 0 Musculoskeletal System Muscle Cramp 2 (1.4) 0 0 0 Nervous System Dizziness 1 (0.7) 0 0 1 (1.5) Skin and Appendages Acne 0 0 2 (1.4) 0 Erythema 0 1 (1.4) 0 0 Pruritus 2 (1.4) 1 (1.4) 1 (0.7) 0 Urogenital System Breast Enlargement 1 (0.7) 1 (1.4) 0 0 Breast Pain 7 (4.9) 0 3 (2.1) 0 Dysuria 2 (1.4) 0 0 0 Leukorrhea 3 (2.1) 1 (1.4) 4 (2.9) 5 (7.4) Metrorrhagia 0 0 0 2 (2.9) Urinary Frequency 0 1 (1.4) 0 0 Urinary Tract Infection 0 1 (1.4) 0 0 Urinary Urgency 1 (0.7) 1 (1.4) 0 0 Vaginal Hemorrhage 2 (1.4) 0 1 (0.7) 1 (1.5) Vaginal Moniliasis 2 (1.4) 0 0 0 Vaginitis 2 (1.4) 1 (1.4) 3 (2.1) 3 (4.4) Vulvovaginal Disorder 4 (2.8) 0 3 (2.1) 2 (2.9) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PREMARIN vaginal cream.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary System Abnormal uterine bleeding or spotting, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis (including vaginal candidiasis), change in cervical secretion, cystitis-like syndrome, application site reactions of vulvovaginal discomfort, (including burning, irritation, and genital pruritus), endometrial hyperplasia, endometrial cancer, precocious puberty, leukorrhea.
Breasts Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.
Cardiovascular Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increase in blood pressure.
Gastrointestinal Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.
Skin Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.
Eyes Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia.
Miscellaneous Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.
Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a 12-week, randomized, double-blind, placebo-controlled trial of PREMARIN vaginal cream (PVC), a total of 423 postmenopausal women received at least 1 dose of study medication and were included in all safety analyses: 143 women in the PVC-21/7 treatment group (0.5 g PVC daily for 21 days, then 7 days off), 72 women in the matching placebo treatment group; 140 women in the PVC-2x/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group.
A 40-week, open-label extension followed, in which a total of 394 women received treatment with PVC, including those subjects randomized at baseline to placebo.
In this study, the most common adverse reactions ≥ 1% in the double blind phase are shown below (Table 1) [see Clinical Studies (14.1) ] .
Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1% Only Treatment Body System Body system totals are not necessarily the sum of individual adverse events, since a patient may report two or more different adverse reactions in the same body system.
/Adverse Reaction PVC 21/7 N=143 Placebo 21/7 N=72 PVC 2×/week N=140 Placebo 2×/week N=68 Number (%) of Patients with Adverse Reaction Body As A Whole Abdominal Pain 1 (0.7) 1 (1.4) 0 1 (1.5) Headache 5 (3.5) 1 (1.4) 3 (2.1) 1 (1.5) Moniliasis 2 (1.4) 1 (1.4) 1 (0.7) 0 Pain 2 (1.4) 0 1 (0.7) 0 Pelvic Pain 4 (2.8) 2 (2.8) 4 (2.9) 0 Cardiovascular System Migraine 0 0 0 1 (1.5) Vasodilation 3 (2.1) 2 (2.8) 2 (1.4) 0 Musculoskeletal System Muscle Cramp 2 (1.4) 0 0 0 Nervous System Dizziness 1 (0.7) 0 0 1 (1.5) Skin and Appendages Acne 0 0 2 (1.4) 0 Erythema 0 1 (1.4) 0 0 Pruritus 2 (1.4) 1 (1.4) 1 (0.7) 0 Urogenital System Breast Enlargement 1 (0.7) 1 (1.4) 0 0 Breast Pain 7 (4.9) 0 3 (2.1) 0 Dysuria 2 (1.4) 0 0 0 Leukorrhea 3 (2.1) 1 (1.4) 4 (2.9) 5 (7.4) Metrorrhagia 0 0 0 2 (2.9) Urinary Frequency 0 1 (1.4) 0 0 Urinary Tract Infection 0 1 (1.4) 0 0 Urinary Urgency 1 (0.7) 1 (1.4) 0 0 Vaginal Hemorrhage 2 (1.4) 0 1 (0.7) 1 (1.5) Vaginal Moniliasis 2 (1.4) 0 0 0 Vaginitis 2 (1.4) 1 (1.4) 3 (2.1) 3 (4.4) Vulvovaginal Disorder 4 (2.8) 0 3 (2.1) 2 (2.9) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PREMARIN vaginal cream.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary System Abnormal uterine bleeding or spotting, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis (including vaginal candidiasis), change in cervical secretion, cystitis-like syndrome, application site reactions of vulvovaginal discomfort, (including burning, irritation, and genital pruritus), endometrial hyperplasia, endometrial cancer, precocious puberty, leukorrhea.
Breasts Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.
Cardiovascular Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increase in blood pressure.
Gastrointestinal Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.
Skin Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.
Eyes Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia.
Miscellaneous Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.
Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.