Premarin Vaginal Cream
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Premarin Vaginal Cream
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Endometrial Cancer [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
Clinical Study 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 ≥ 5 percent are shown below (Table 1) [see Clinical Studies].
Table 1: Number (%) of Patients Reporting Treatment Emergent
Adverse Events ≥ 5 Percent Only
|PVC 21/7 21/7 (n=143)||Placebo (n=72)||PVC 2x/wk
|Number (%) of Patients with Adverse Event|
|Any Adverse Event||95 (66.4)||45 (62.5)||97 (69.3)||46 (67.6)|
|Body As A Whole|
|Abdominal Pain||11 (7.7)||2 (2.8)||9 (6.4)||6 (8.8)|
|Accidental Injury||4 (2.8)||5 (6.9)||9 (6.4)||3 (4.4)|
|Asthenia||8 (5.6)||0||2 (1.4)||1 (1.5)|
|Back Pain||7 (4.9)||3 (4.2)||13 (9.3)||5 (7.4)|
|Headache||16 (11.2)||9 (12.5)||25 (17.9)||12 (17.6)|
|Infection||7 (4.9)||5 (6.9)||16 (11.4)||5 (7.4)|
|Pain||10 (7.0)||3 (4.2)||4 (2.9)||4 (5.9)|
|Vasodilatation||5 (3.5)||4 (5.6)||7 (5.0)||1 (1.5)|
|Diarrhea||4 (2.8)||2 (2.8)||10 (7.1)||1 (1.5)|
|Nausea||5 (3.5)||4 (5.6)||3 (2.1)||3 (4.4)|
|Arthralgia||5 (3.5)||5 (6.9)||6 (4.3)||4 (5.9)|
|Insomnia||6 (4.2)||3 (4.2)||4 (2.9)||4 (5.9)|
|Cough Increased||0||1 (1.4)||7 (5.0)||3 (4.4)|
|Pharyngitis||3 (2.1)||2 (2.8)||7 (5.0)||3 (4.4)|
|Sinusitis||1 (0.7)||3 (4.2)||2 (1.4)||4 (5.9)|
|Skin And Appendages||12 (8.4)||7 (9.7)||16 (11.4)||3 (4.4)|
|Breast Pain||8 (5.6)||1 (1.4)||4 (2.9)||0|
|Leukorrhea||3 (2.1)||2 (2.8)||4 (2.9)||6 (8.8)|
|Vaginitis||8 (5.6)||3 (4.2)||7 (5.0)||3 (4.4)|
|a Body system totals are not necessarily the sum of the individual adverse events, since a patient may report two or more different adverse events in the same body system.|
The following adverse reactions have been reported with 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.
Abnormal uterine bleeding/spotting, dysmenorrhea/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.
Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.
Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.
Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria, anaphylactic reactions, 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 »
No formal drug interaction studies have been conducted for PREMARIN Vaginal Cream.
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.
Last reviewed on RxList: 6/7/2011
This monograph has been modified to include the generic and brand name in many instances.
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