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Safety Information

PREMARIN TABLETS ®(estrogenic hormones)

Indications and clinical Use:

Premarin (conjugated estrogens sustained release tablets) is indicated for the following:

  • Relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency states including vulvar and vaginal atrophy
  • Prevention of osteoporosis in naturally occurring or surgically induced estrogen-deficiency states
    • When prescribing solely for the prevention of postmenopausal osteoporosis, Premarin should be considered in light of other available therapies and should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered
    • For older women who are not experiencing any more acute symptoms of menopause, use in combination with a progestin should only be considered for women who failed on, or were intolerant of, non-estrogen medication
  • Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
  • Atrophic vaginitis
  • Vulvar atrophy (with or without pruritus)
    • When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered
  • Not indicated for use in pediatric patients (< 16 years of age)

In patients with an intact uterus, Premarin should be prescribed with an appropriate dosage of a progestin for women with intact uteri, in order to prevent endometrial hyperplasia/carcinoma.

Contraindications:

  • Liver dysfunction or disease
  • Known or suspected estrogen-dependent malignant neoplasia
  • Endometrial hyperplasia
  • Known, suspected, or past history of breast cancer
  • Undiagnosed abnormal genital bleeding
  • Known or suspected pregnancy
  • Active or past history of confirmed venous thromboembolism or active thrombophlebitis
  • Active or past history of arterial thromboembolic disease
  • Partial or complete loss of vision due to ophthalmic vascular disease
  • Known thrombophilic disorders
  • Migraine with or without aura

Most serious warnings and precautions:

  • Risk of stroke and deep vein thrombosis:estrogen-alone therapy (mean age 63.6 years).

    Risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis: estrogen plus progestin therapy (mean age 63.3 years).

    Therefore, estrogens with or without progestins:

    • Should not be prescribed for primary or secondary prevention of cardiovascular diseases
    • Should be prescribed at the lowest effective dose and for the shortest period possible for the approved indication

Other relevant warnings and precautions:

  • Possible risk of ovarian cancer
  • Monitor blood pressure with hormone replacement therapy use
  • Caution in women with pre-existing endocrine and metabolic disorders
  • May exacerbate endometriosis
  • May increase pre-existing uterine leiomyomata
  • Abnormal vaginal bleeding
  • Risk of gallbladder diseases
  • May exacerbate systemic lupus erythematosus
  • May induce or exacerbate anaphylactic reaction and angioedema symptoms
  • Risk of developing probable dementia (women >65 years)
  • May exacerbate epilepsy
  • Caution in patients with otosclerosis
  • May cause fluid retention
  • Risk of estrogen-induced hypocalcemia: Caution in individuals with hypoparathyroidism

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.

The product monograph is also available by calling 1-800-463-6001.

PREMARIN ® Pfizer Canada Inc.