Conjugated Estrogens - Vaginal (Premarin)

Trade Name : Premarin

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

CREAM

Strength 0.625 mg/g

ESTROGENS, CONJUGATED Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Conjugated Estrogens - Vaginal (Premarin) which is also known as Premarin and Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It is available in strength of 0.625 mg/g per ml. Read more

Conjugated Estrogens - Vaginal (Premarin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Arrayn- Estrogen-Alone Therapy
  • Endometrial Cancer
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding n- Array
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia n- Array
  • The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo n- Array
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg) -alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women .
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Arrayn- Estrogen Plus Progestin Therapy
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia n- Array
  • The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo n- Array
  • The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women n- Array
  • Breast Cancer
  • The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer n
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
  • See full prescribing information for complete boxed warning.
  • Estrogen-Alone Therap
  • Estrogen Plus Progestin Therapy
  • No data
  • PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of estrogens indicated for:
  • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ()
  • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ()
  • 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.
  • 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 .
  • 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 ()
  • 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 ()
  • Twice-weekly administration of 0.5 g intravaginally [for example, Monday and Thursday] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ()
  • Each gram contains 0.625 mg conjugated estrogens, USP.
  • Combination package:
  • Each gram contains 0.625 mg conjugated estrogens, USP ()
  • Combination package:
  • PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions:
  • Undiagnosed abnormal genital bleeding ()
  • Known, suspected, or history of breast cancer (, )
  • Known or suspected estrogen-dependent neoplasia (, )
  • Active DVT, PE, or a history of these conditions (, )
  • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, )
  • Known anaphylactic reaction or angioedema to PREMARIN Vaginal Cream (, )
  • Known liver dysfunction or disease (, )
  • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders ()
  • Known or suspected pregnancy (, )
  • No data
  • Estrogens increase the risk of gallbladder disease ()
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (, , , )
  • Monitor thyroid function in women on thyroid replacement therapy (, )
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions u2265 2 percent are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • No drug interaction studies have been conducted for PREMARIN Vaginal Cream.
  • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ()
  • No data
  • Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ()
  • Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (, )
  • Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of PREMARIN therapy with institution of appropriate symptomatic care.
  • Each gram of PREMARIN (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. PREMARIN Vaginal Cream is applied intravaginally.
  • PREMARIN Vaginal Cream contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, sodium sulfate conjugates, 17 u03b1-dihydroequilin, 17 u03b1-estradiol, and 17 u03b2-dihydroequilin.
  • No data
  • Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
  • No data
  • No data
  • No data
  • See (Patient Information and Instructions for Use).
  • LAB-0498-7.0
  • FDA-Approved Patient Labeling
  • PREMARIN (prem-uh-rin) (Conjugated estrogens) Vaginal Cream
  • Read this PATIENT INFORMATION before you start using PREMARIN Vaginal Cream and read what you get each time you refill your PREMARIN Vaginal Cream prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
  • NDC 0046-0872-21
  • Premarinn tttttt(conjugated estrogens)ttttttvaginal cream
  • 0.625ttttttmg/g
  • Rx only
  • Net Wt. 1.06 oz.tttttt(30 g)
  • NDC 0046-0872-21
  • Premarinn tttttt(conjugated estrogens)ttttttvaginal cream
  • 0.625ttttttmg/g
  • Rx only
  • Pfizer
  • Net Wt. 1.06 oz.tttttt(30 g)
  • This product also containscetyl esters wax, cetylalcohol, white wax, glycerylmonostearate, propyleneglycol monostearate, methylstearate, benzyl alcohol,sodium lauryl sulfate,glycerin, and mineral oil.
  • ttttttt2 Applicators enclosed tttttt
  • For vaginal use only.
  • Usual Dosage: Seeaccompanying information.

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