Estrogens, Conjugated (Premarin)

Trade Name : Premarin

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

TABLET, FILM COATED

Strength 0.3 mg/1

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 Estrogens, Conjugated (Premarin) which is also known as Premarin and Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It is available in strength of 0.3 mg/1 per ml. Read more

Estrogens, Conjugated (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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No data

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy

No data

PREMARIN is a mixture of estrogens indicated for:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ()
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ()
Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ()
Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ()
Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ()
Prevention of Postmenopausal Osteoporosis ()

Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer n
A woman without a uterus does not need 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.
PREMARIN may be taken without regard to meals.

Daily administration of 0.3, 0.45, 0.625, 0.9, and 1.25 mg (, , , , )
Cyclic administration of 0.3, 0.625, and 1.25 mg (, , )

Tablets: 0.3, 0.45, 0.625, 0.9, and 1.25 mg ()

PREMARIN therapy is contraindicated in individuals with any of the following conditions:

Undiagnosed abnormal genital bleeding ()
Known, suspected, or history of breast cancer except in appropriately selected patients being treated for metastatic diseases (, )
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 with PREMARIN ()
Known liver impairment 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 labeling:
Most common adverse reactions (u2265 5 percent) are: abdominal pain, asthenia, pain, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis. ()
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n

Data from a single-dose drug-drug interaction study involving conjugated estrogens and medroxyprogesterone acetate indicate that the pharmacokinetic disposition of both drugs is not altered when the drugs are coadministered. No other clinical drug-drug interaction studies have been conducted with conjugated estrogens.

Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ()

No data

Nursing Mothers: Estrogen administration 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.

PREMARIN (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens purified from pregnant mares' urine and consists of 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 concomitant components as sodium sulfate conjugates, 17u03b1-dihydroequilin, 17u03b1 estradiol, and 17u03b2-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of conjugated estrogens.
PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors:
PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below:

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 FDA-approved patient labeling ().

PREMARIN(prem-uh-rin)
(Conjugated estrogen tablets, USP)
Read this PATIENT INFORMATION before you start taking PREMARIN and read what you get each time you refill your PREMARIN prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.3 MG u2013 LABEL
Pfizer
NDC 0046-1100-81
PREMARIN
0.3 mg
100 Tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.3 MG u2013 CARTON
Pfizer
NDC 0046-1100-91 n n
PREMARIN
0.3 mg
Note: Dispense in tight (USP), child-resistant containers. This package not for household use.
1,000 Tablets

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.3 MG u2013 BLISTER CARD
NDC 0046-1100-51
PROFESSIONAL SAMPLE - NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
0.3 mg
Blister card contains five 0.3 mg tablets
Rx only

PANELPACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.3 MG - POUCHES
NDC 0046-1100-51
PROFESSIONAL SAMPLE u2013 NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
0.3 mg
Visit us at www.PREMARIN.com
Package contains: 1 blister card of 5 tables
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.45 MG u2013 LABEL
Pfizer
NDC 0046-1101-81
PREMARIN
0.45 mg
100 Tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.625 MG u2013 LABEL
Pfizer
NDC 0046-1102-81
PREMARIN
0.625 mg
100 Tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.625 MG u2013 BOTTLE CARTON
Pfizer
NDC 0046-1102-91 n n
PREMARIN
0.625 mg
Note: Dispense in tight (USP), child-resistant containers. This package not for household use.
1,000 Tablets

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.625 MG - BLISTER CARD
NDC 0046-1102-51
PROFESSIONAL SAMPLE - NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
0.625 mg
Blister card contains five 0.625 mg tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.625 MG - POUCHES
NDC 0046-1102-51
PROFESSIONAL SAMPLE u2013 NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
0.625 mg
Package contains: 1 blister card of 5 tablets
Visit us at www.PREMARIN.com
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.625 MG - CARTON
NDC 0046-1102-51
PROFESSIONAL SAMPLE u2013 NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
0.625 mg
Package contains 10 pouches with 1 blister card of 5 tablets each
Visit us at www.PREMARIN.com
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 0.9 MG u2013 LABEL
Pfizer
NDC 0046-1103-81
PREMARIN
0.9 mg
100 Tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 1.25 MG u2013 LABEL
Pfizer
NDC 0046-1104-81
PREMARIN
1.25 mg
100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 1.25 mg Tablet Bottle Carton
Pfizer
NDC 0046-1104-91
PREMARIN
1.25 mg
Note: Dispense in tight (USP), child-resistant containers. This package not for household use.
1,000 Tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 1.25 MG u2013 BLISTER CARD
NDC 0046-1104-51
PROFESSIONAL SAMPLE - NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
1.25 mg
Blister card contains five 1.25 mg tablets
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 1.25 MG - POUCHES
NDC 0046-1104-51
PROFESSIONAL SAMPLE - NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
1.25 mg
Package contains: 1 blister card of 5 tablets
Visit us at www.PREMARIN.com
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 1.25 MG - CARTON
NDC 0046-1104-51
PROFESSIONAL SAMPLE - NOT FOR SALE
PREMARINn
(conjugated estrogens tablets, USP)
1.25 mg
Package contains 10 pouches with 1 blister card of 5 tablets each
Visit us at www.PREMARIN.com
Rx only

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Estrogens, Conjugated (Premarin)

Trade Name : Premarin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Estrogens, Conjugated (Premarin)

Trade Name : Premarin

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?