Premarin Vaginal Cream
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Premarin Vaginal Cream
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOX WARNING, WARNINGS AND PRECAUTIONS]
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|
|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|
|Vasodilation||3 (2.1)||2 (2.8)||2 (1.4)||0|
|Muscle Cramp||2 (1.4)||0||0||0|
|Nervous Sys tem|
|Dizziness||1 (0.7)||0||0||1 (1.5)|
|Skin and Appendages|
|Pruritus||2 (1.4)||1 (1.4)||1 (0.7)||0|
|Breast Enlargement||1 (0.7)||1 (1.4)||0||0|
|Breast Pain||7 (4.9)||0||3 (2.1)||0|
|Leukorrhea||3 (2.1)||1 (1.4)||4 (2.9)||5 (7.4)|
|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.|
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.
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.
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.
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
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 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.
Read the Premarin Vaginal Cream Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/22/2016
Additional Premarin Vaginal Cream Information
- Premarin Vaginal Cream Drug Interactions Center: conjugated estrogens vagl
- Premarin Vaginal Cream Side Effects Center
- Premarin Vaginal Cream in detail including Side Effects and Drug Images
- Premarin Vaginal Cream Overview including Precautions
- Premarin Vaginal Cream FDA Approved Prescribing Information including Dosage
Premarin Vaginal Cream - User Reviews
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