March 26, 2017
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Premarin Vaginal Cream

"Medscape Medical News
Tara Haelle
August 18, 2016

Hormone therapy (HT) continues to be the most effective treatment for menopause symptoms such as vasomotor symptoms and urogenital atrophy, according to updated guidelines on"...

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Premarin Vaginal Cream




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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-2×/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group. A 40-week, openlabel 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 percent in the double blind phase are shown below (Table 1) [see Clinical Studies].

Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1 Percent

Body System* /Adverse Reaction Treatment
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 Sys tem        
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)
*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.

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

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.

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.

Read the Premarin Vaginal Cream (conjugated estrogens vaginal cream) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies have been conducted for PREMARIN Vaginal Cream.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.

Read the Premarin Vaginal Cream Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/22/2016

Side Effects
Interactions

Premarin Vaginal Cream - User Reviews

Premarin Vaginal Cream User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Premarin Vaginal Cream sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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