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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (E's) » Estrogens Conjugated and Medroxyprogesterone



WARNING

ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN. THIS FINDING REFERS TO ESTROGENS GIVEN WITHOUT PROGESTIN.

Progestins taken with estrogen drugs significantly reduce but do not eliminate this risk. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses.

ESTROGENS/PROGESTINS SHOULD NOT BE USED DURING PREGNANCY.

There is no indication for estrogen therapy during pregnancy or during the immediate postpartum period. Estrogen therapy during pregnancy os associated with an increased risk of congenital defects in the reproductive organs of the fetus, and possibly other birth defects. Estrogens are not indicated for the prevention of partum breast enlargement.

Studies of women who received diethylstilbestrol (DES) during pregnancy have shown that female offspring have an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal cancer later in life. The 1985 DES Task Force concluded that use of DES during pregnancy is associated with subsequent increased risk of breast cancer in the mothers, although a casual relationship remains unproven and the observed level of excess risk is similar to that for a number of other breast cancer risk factors.

Several reports also suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias, 5 to 8 per 1000 male births in the general population, may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses; some of these drugs induce mild virilization of the external genitalia of the female fetus. If the patient is exposed to Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) during pregnancy, or if she becomes pregnant while taking these drugs, she should be apprised of the potential risk to the fetus.

Estrogens are ineffective for the prevention or treatment of threatened or habitual abortion. There is no adequate evidence that progestational agents are effective in preventing habitual abortion when such drugs are given during the first trimester of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum, which progestational agents could not be expected to influence. In addition, the use of progestational agents with their uterine-relaxant properties, in patients with fertilized defective ova, may cause a delay in spontaneous abortion.


DESCRIPTION

Estrogens, conjugated is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components sodium sulfate conjugates 17a-estradiol and 17a-estradiol and 17b-dihydroequilin.

Medroxyprogesterone acetate (MPA) is a derivative of progesterone. It is white to off-white, odorless, crystalline powder, stable in air, melting between 200° C and 210° C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for MPA is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6a)-.

Prempro Therapy Consists of Two Separate Tablets: Premarin brand of conjugated estrogens 0.625 mg tablets, and Cycrin brand of medroxyprogesterone acetate (MPA), 2.5 mg tablets, for oral administration.

Each Premarin tablet for oral administration contains 0.625 mg of conjugated estrogens. Inactive Ingredients: Calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glycerol monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, stearic acid, titanium dioxide, FD&C blue no. 2, D&C red No. 27, FD&C red no. 40.

Cycrin is available in tablet form for oral administration and is given in combination with Premarin at a dose of 2.5 mg. Each white, oval tablet contains 2.5 mg of MPA. Inactive Ingredients: Lactose, magnesium stearate, methylcellulose, microcrystalline cellulose.

Premphase Therapy Consists of Two Separate Tablets: Premarin brand of conjugated estrogens, 0.625 mg tablets which are taken orally for 28 days, and Cycrin brand of medroxyprogesterone acetate (MPA), 5.0 mg tablets which are taken orally with a Premarin tablet on days 15 through 28.

Each Premarin tablet for oral administration contains 0.625 mg of conjugated estrogens. Inactive Ingredients: Calcium phosphate tribasic, calcium sulfate, carnauba wax, cellulose, glycerol monooleate, lactose, magnesium stearate, methylcellulose, pharmaceutical glaze, polyethylene glycol, stearic acid, titanium dioxide, FD&C blue no. 2, D&C red No. 27, FD&C red no. 40.

Cycrin is available in tablet form for oral administration. Each light-purple, oval tablet contains 5.0 mg of MPA. Inactive Ingredients: Lactose, magnesium stearate, methylcellulose, microcrystalline cellulose, D&C red no. 30 and FD&C blue no. 1.

CATEGORIES, BRAND NAMES

CATEGORIES: Menopause; Osteoporosis; Vaginitis, atrophic; Pregnancy Category X; FDA Approved 1994 Dec; Top 200 Drugs

FDA Drug Classes: Estrogens/Progestins

BRAND NAMES:

BRAND NAMES: Climarest plus; Climatrol; Climopax; Menoprem Continuous; Premaril Plus; Premarin MPA; Premarin Pak; Premelle; Prempak; Prempak-MPA; Premphase; Prempro; Provette Continuous
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Climarest plus (Germany)
Climatrol (Peru)
Climopax (Germany)
Menoprem Continuous (Australia; New-Zealand)
Premaril Plus (Israel)
Premarin Pak (Mexico)
Premelle (Hong-Kong; Philippines)
Prempak (Argentina; Bolivia; Brazil; Canada; Chile; CIS; Colombia; Costa-Rica; Dominican-Republic; Ecuador; El-Salvador; Guatemala; Honduras; Hong-Kong; Mexico; Nicaragua; Panama; Paraguay; Peru; Philippines; Thailand; Uruguay; Venezuela)
Prempak-MPA (Colombia)
Provette Continuous (New-Zealand)





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