Premarin Vaginal .625 mg/g
conjugated estrogens · CREAM · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Premarin Vaginal is a cream containing conjugated estrogens at .625 mg/g, taken vaginal. Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..
Key Facts
- Brand Name
- Premarin Vaginal
- Generic Name
- conjugated estrogens
- NDC Code (Product)
0046-0872- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Strength
- .625 mg/g
- Dosage Form
- CREAM
- Route
- VAGINAL
- Marketing Status
- Application #
- NDA020216
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 11/01/1978
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer [see Boxed Warning ]. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.3 , 5.15) ] . 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. • Cyclic administration of 0.5 to 2 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 2.1 ) • Cyclic administration of 0.5 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ( 2.2 ) • Twice-weekly administration of 0.5 g intravaginally [for example, Monday and Thursday] for Treatment o…
Contraindications
4 CONTRAINDICATIONS PREMARIN vaginal cream is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.3) ] • Breast cancer or a history of breast cancer [see Warnings and Precautions (5.3) ] • Estrogen-dependent neoplasia [see Warnings and Precautions (5.3) ] • Active DVT, PE, or a history of these conditions [see Warnings and Precautions (5.2) ] • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.2) ] • Known anaphylactic reaction or angioedema to PREMARIN [see Warnings and Precautions (5.16, 5.17) ] • 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 , 5.3 ) • Breast cancer or a history of breast cancer ( 4 , 5.3 ) • Estrogen-dependent neoplasia ( 4 , 5.3 ) • Active DVT, PE, or a history of these conditions ( 4 , 5.2 ) • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4 , 5.2 ) • Known anaphylactic reaction or ang…
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted for PREMARIN vaginal cream. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ( 7.1 ) 7.1 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.
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 day…
Frequently Asked Questions
What is Premarin Vaginal used for?
Premarin Vaginal contains conjugated estrogens. It is a cream taken vaginal. Consult your doctor for specific uses.
Is Premarin Vaginal a controlled substance?
Premarin Vaginal is not classified as a controlled substance by the DEA.
What is the generic name for Premarin Vaginal?
The generic name for Premarin Vaginal is conjugated estrogens. There are 8 other brand versions of conjugated estrogens.
What is the NDC code for Premarin Vaginal .625 mg/g?
The NDC (National Drug Code) for Premarin Vaginal .625 mg/g is 0046-0872, listed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..