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WYETH/PFIZER
SKU
00046087221

brand premarin vaginal cream-appl

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$345.42 / tube/kit
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Uses

In women, oral conjugated estrogens USP and synthetic conjugated estrogens A are used for the management of moderate to severe vasomotor symptoms associated with menopause and for the management of vulvar and vaginal atrophy (atrophic vaginitis). If estrogens are used solely for the management of vulvar and vaginal atrophy, use of topical vaginal preparations should be considered. Synthetic conjugated estrogens B is used for the management of moderate to severe vasomotor symptoms and for the management of severe vaginal dryness, pain with sexual intercourse, and symptoms of vulvar and vaginal atrophy associated with menopause. Oral conjugated estrogens USP also is used for the management of female hypoestrogenism secondary to hypogonadism, castration, or primary ovarian failure.

Oral conjugated estrogens USP is used adjunctively with other therapeutic measures (e.g., diet, calcium, weight-bearing exercise [including walking, running], physical therapy) to retard further bone loss and the progression of osteoporosis associated with estrogen deficiency in postmenopausal women. While estrogen replacement therapy is effective for the prevention of osteoporosis in women and has been shown to reduce bone resorption and retard or halt bone loss in postmenopausal women, such therapy is associated with a number of adverse effects. If prevention of postmenopausal osteoporosis is the sole indication for therapy with oral conjugated estrogens, alternative therapy (e.g., alendronate, raloxifene, risedronate) should be considered.

Another therapeutic option involves use of conjugated estrogens in combination with an estrogen agonist-antagonist (bazedoxifene) for the management of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis. The combination of conjugated estrogens with bazedoxifene is referred to as a tissue-selective estrogen complex (TSEC).

While results from earlier observational studies indicated that estrogen replacement therapy (ERT) or combined estrogen/progestin therapy (hormone replacement therapy, HRT) was associated with cardiovascular benefit in postmenopausal women, results of the Heart and Estrogen/progestin Replacement Study (HERS) evaluating estrogen/progestin and the Women's Health Initiative (WHI) study evaluating estrogen alone and estrogen/progestin therapy indicate that hormone therapy does not decrease the incidence of cardiovascular disease. The American Heart Association (AHA), American College of Obstetricians and Gynecologists (ACOG), FDA, and manufacturers recommend that hormone therapy not be used to prevent heart disease in healthy women (primary prevention) or to protect women with preexisting heart disease (secondary prevention).

Oral conjugated estrogens USP is used for the palliative treatment of advanced, inoperable, metastatic carcinoma of the breast in postmenopausal women and in men. Estrogens are one of several second-line agents that can be used in certain postmenopausal women with metastatic breast cancer.

Oral conjugated estrogens USP is used for the palliative treatment of advanced carcinoma of the prostate in men; however, the risk of adverse cardiovascular effects of estrogens must be considered.

Conjugated estrogens USP may be administered IM or IV for the treatment of abnormal uterine bleeding caused by hormonal imbalance not associated with organic pathology.

Conjugated estrogens USP may be administered intravaginally for the management of atrophic vaginitis or kraurosis vulvae.

Although in the past oral conjugated estrogens has been used for the prevention of postpartum breast engorgement, the FDA has withdrawn approval of estrogen-containing drugs for this indication since estrogens have not been shown to be safe for use in women with postpartum breast engorgement. Data from controlled studies indicate that the incidence of substantial painful engorgement is low in untreated women, and the condition usually responds to appropriate analgesic or other supportive therapy.

Dosage and Administration

Reconstitution and Administration

Conjugated estrogens USP is usually administered orally, but may also be administered intravaginally or by deep IM or slow IV injection. Synthetic conjugated estrogens A and synthetic conjugated estrogens B are administered orally.

When parenteral administration of conjugated estrogens USP is required, IV injection is preferred because of the more rapid response obtained following this route of administration compared to IM injection. For direct IV injection, the drug should be administered slowly to avoid the occurrence of a flushing reaction.

For parenteral administration, conjugated estrogens USP powder for injection is reconstituted with 5 mL of sterile water for injection. Using aseptic technique, the diluent should then be slowly added, directing the flow against the inner wall of the vial (Secule), while gently agitating the container to facilitate dissolution of the contents; vigorous shaking of the container should be avoided. Premarin solutions should be used immediately after reconstitution.

Oral dosage preparations containing medroxyprogesterone acetate in combination with conjugated estrogens USP as monophasic or biphasic regimens are commercially available in a mnemonic dispensing package that is designed to aid the user in complying with the prescribed dosage schedule. The monophasic combination (Prempro) is available in a 28-day dosage preparation that contains 28 tablets of conjugated estrogens USP (0.625 mg) in fixed combination with medroxyprogesterone acetate (2.5 or 5 mg). The monophasic combination (Prempro) also is available in a 28-day dosage preparation that contains 28 tablets of conjugated estrogens USP (0.3 or 0.45 mg) in fixed combination with medroxyprogesterone acetate (1.5 mg). The biphasic combination (Premphase) is available in a 28-day dosage preparation that contains 14 tablets of conjugated estrogens USP (0.625 mg) and 14 tablets of conjugated estrogens USP (0.625 mg) in fixed combination with medroxyprogesterone acetate (5 mg).

The oral dosage preparation containing conjugated estrogens in fixed combination with bazedoxifene acetate is commercially available in a 30-day package that includes 2 blister packs of 15 tablets each containing conjugated estrogens 0.45 mg in fixed combination with bazedoxifene acetate 22.6 mg (equivalent to 20 mg of bazedoxifene).

Dosage

Dosage of conjugated estrogens USP, synthetic conjugated estrogens A, and synthetic conjugated estrogens B must be individualized according to the condition being treated and the tolerance and therapeutic response of the patient. To minimize the risk of adverse effects, the lowest possible effective dosage should be used. Because of the potential increased risk of cardiovascular events, breast cancer, and venous thromboembolic events, therapy with estrogen, estrogen/progestin, or conjugated estrogens in fixed combination with bazedoxifene should be limited to the lowest effective doses and shortest duration of therapy consistent with treatment goals and risks for the individual woman. Therapy with estrogen, estrogen/progestin, or conjugated estrogens in fixed combination with bazedoxifene should be periodically reevaluated.

Estrogen therapy is administered in a continuous daily dosage regimen or, alternatively, in a cyclic regimen. When estrogens are administered cyclically, the drugs usually are given once daily for 3 weeks followed by 1 week without the drugs or once daily for 25 days followed by 5 days off, and then the respective regimen is repeated as necessary.

While estrogen therapy alone (estrogen replacement therapy, ERT) may be appropriate in women who have undergone a hysterectomy, a progestin generally is added to estrogen therapy (hormone replacement therapy, HRT) in women with an intact uterus. Addition of a progestin for 10 or more days of a cycle of estrogen or daily with estrogen in a continuous regimen reduces the incidence of endometrial hyperplasia and the attendant risk of endometrial carcinoma in women with an intact uterus. Morphologic and biochemical studies of the endometrium suggest that 10-13 days of progestin are needed to provide maximum maturation of the endometrium and to eliminate any hyperplastic changes. As an alternative to progestins, the use of bazedoxifene (an estrogen agonist-antagonist) in fixed combination with conjugated estrogens reduces the risk of endometrial hyperplasia.

When estrogen therapy is used in conjunction with a progestin or in fixed combination with bazedoxifene, the usual precautions associated with progestins or bazedoxifene should be observed. Clinicians prescribing estrogens in conjunction with progestins or conjugated estrogens in fixed combination with bazedoxifene should be aware of the risks associated with these drugs and the manufacturers' labeling should be consulted. Clinical studies indicate that addition of a progestin to estrogen replacement therapy does not interfere with the efficacy of estrogen therapy in the management of vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy, or prevention of osteoporosis. The choice and dosage of a progestin may be important factors in minimizing potential adverse effects.

Exposure to conjugated estrogens USP vaginal cream has been reported to weaken latex condoms. The potential for conjugated estrogens USP vaginal cream to weaken and contribute to the protective failure of latex or rubber condoms, diaphragms, or cervical caps should be considered.

Menopausal Symptoms

Conjugated Estrogens USP

For the management of moderate to severe vasomotor symptoms and/or for the management of vulvar and vaginal atrophy associated with menopause, the usual initial oral dosage of conjugated estrogens USP is 0.3 mg daily. Subsequent dosage adjustment should be based on the patient's response. The drug may be administered in a continuous daily regimen or in a cyclic regimen (25 days on drug followed by 5 days off drug, then this regimen is repeated as necessary). Alternatively, for the management of vulvar and vaginal atrophy, 0.5-2 g of conjugated estrogens USP vaginal cream may be administered intravaginally once daily in the usual cyclic regimen.

When conjugated estrogens USP is used in conjunction with medroxyprogesterone for the management of moderate to severe vasomotor symptoms associated with menopause or for the management of vulvar and vaginal atrophy, conjugated estrogens USP is administered in a continuous daily dosage regimen while medroxyprogesterone may be administered in a continuous daily dosage regimen (Prempro) or cyclically (Premphase). When both drugs are administered in a continuous daily dosage regimen, conjugated estrogens is administered in a daily dosage of 0.3 mg in conjunction with oral medroxyprogesterone acetate in a daily dosage of 1.5 mg. Alternatively, conjugated estrogens is administered in a daily dosage of 0.45 mg in conjunction with medroxyprogesterone acetate in a daily dosage of 1.5 mg, or conjugated estrogens is administered in a daily dosage of 0.625 mg in conjunction with medroxyprogesterone acetate in a daily dosage of 2.5 or 5 mg. When conjugated estrogens USP is administered in a continuous daily dosage regimen and medroxyprogesterone is administered cyclically (Premphase), conjugated estrogens USP is administered in a daily dosage of 0.625 mg, while oral medroxyprogesterone acetate is administered in a daily dosage of 5 mg on days 15-28 of the cycle. Therapy with conjugated estrogens in conjunction with medroxyprogesterone generally should be initiated with the lowest dosage (i.e., conjugated estrogens 0.3 mg in conjunction with medroxyprogesterone acetate 1.5 mg). Subsequent dosage should be adjusted based on the patient's therapeutic response and should be reevaluated periodically. If spotting or bleeding is problematic and has been appropriately evaluated, dosage can be adjusted.

When conjugated estrogens is used in conjunction with bazedoxifene for the treatment of moderate to severe vasomotor symptoms associated with menopause, conjugated estrogens is administered in a daily dosage of 0.45 mg in fixed combination with bazedoxifene 20 mg.

Synthetic Conjugated Estrogens A

For the management of moderate to severe vasomotor symptoms associated with menopause, the usual oral dosage of synthetic conjugated estrogens A is 0.45-1.25 mg daily. The usual initial oral dosage of synthetic conjugated estrogens A is 0.45 mg daily; subsequent dosage adjustment should be based on the patient's response. For the management of vulvar and vaginal atrophy, the usual oral dosage of synthetic conjugated estrogens A is 0.3 mg daily.

Synthetic Conjugated Estrogens B

For the management of moderate to severe vasomotor symptoms associated with menopause, the usual oral dosage of synthetic conjugated estrogens B is 0.3-1.25 mg daily. The usual initial oral dosage of synthetic conjugated estrogens B for this condition is 0.3 mg daily. Subsequent dosage adjustment should be based on the patient's response.

For the management of severe vaginal dryness, pain with sexual intercourse, and vulvar and vaginal atrophy associated with menopause, the usual oral dosage of synthetic conjugated estrogens B is 0.3 mg daily.

Osteoporosis

For the prevention of osteoporosis, the usual initial oral dosage of conjugated estrogens USP is 0.3 mg once daily. Subsequent dosage should be adjusted based on the patient's clinical and bone mineral density responses. The drug may be administered in a continuous daily regimen or in a cyclic regimen (25 days on drug followed by 5 days off drug, then this regimen is repeated as necessary).

When conjugated estrogens USP is used in conjunction with medroxyprogesterone, conjugated estrogens USP is administered in a continuous daily dosage regimen while medroxyprogesterone may be administered in a continuous daily dosage regimen (Prempro) or cyclically (Premphase). When both drugs are administered in a continuous daily dosage regimen, conjugated estrogens USP is administered in a daily dosage of 0.3 mg in conjunction with oral medroxyprogesterone acetate in a daily dosage of 1.5 mg. Alternatively, conjugated estrogens is administered in a daily dosage of 0.45 mg in conjunction with medroxyprogesterone acetate in a daily dosage of 1.5 mg, or conjugated estrogens is administered in a daily dosage of 0.625 mg in conjunction with medroxyprogesterone acetate in a daily dosage of 2.5 or 5 mg. When conjugated estrogens USP is administered in a continuous daily dosage regimen and medroxyprogesterone is administered cyclically, conjugated estrogens USP is administered in a daily dosage of 0.625 mg, while oral medroxyprogesterone acetate is administered in a daily dosage of 5 mg on days 15-28 of the cycle. Therapy with conjugated estrogens in conjunction with medroxyprogesterone generally should be initiated with the lowest dosage (i.e., conjugated estrogens 0.3 mg in conjunction with medroxyprogesterone acetate 1.5 mg). Subsequent dosage should be adjusted based on the patient's clinical and bone mineral density responses. If spotting or bleeding is problematic and has been appropriately evaluated, dosage can be adjusted.

When conjugated estrogens is used in conjunction with bazedoxifene for the prevention of osteoporosis, conjugated estrogens is administered once daily at a dosage of 0.45 mg in fixed combination with bazedoxifene 20 mg.

Female Hypoestrogenism

For replacement therapy in female hypoestrogenism, the usual oral dosage of conjugated estrogens USP is 0.3-0.625 mg daily in a cyclic regimen (3 weeks on drug, 1 week off). Dosage may be adjusted based on symptom severity and responsiveness of the endometrium.

For the management of female castration or primary ovarian failure, the usual initial oral dosage of conjugated estrogens USP is 1.25 mg daily in a cyclic regimen. Subsequent dosage should be adjusted according to the severity of the symptoms and the patient's therapeutic response, using the lowest possible effective maintenance dosage.

Inoperable Carcinoma of the Breast

For the palliative treatment of inoperable, advanced, metastatic carcinoma of the breast in appropriately selected men and postmenopausal women, the usual oral dosage of conjugated estrogens USP is 10 mg 3 times daily. Estrogen therapy is usually continued in these patients for at least 3 months.

Prostate Carcinoma

For the palliative treatment of advanced carcinoma of the prostate, the usual oral dosage of conjugated estrogens USP is 1.25-2.5 mg 3 times daily.

Abnormal Uterine Bleeding

For the emergency treatment of abnormal uterine bleeding caused by hormonal imbalance, the usual IV or IM dose of conjugated estrogens USP is 25 mg. If necessary, the dose may be repeated in 6-12 hours. The use of conjugated estrogens USP for this condition does not preclude the use of other appropriate measures.

Cautions

Conjugated estrogens USP, synthetic conjugated estrogens A, and synthetic conjugated estrogens B share the toxic potentials of other estrogens, and the usual cautions, precautions, and contraindications associated with estrogen therapy should be observed.

Conjugated estrogens is contraindicated in patients who are hypersensitive to the drug or any ingredient in the respective formulation.

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