PREMARIN TABLET 0.625 MG [SIN04484P]

Product Info

PREMARIN TABLET 0.625 MG

[SIN04484P]

4.1 Therapeutic indications

1. Moderate to severe vasomotor symptoms associated with estrogen deficiency.

2. Prevention and management of osteoporosis associated with estrogen deficiency. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. When prescribing solely for the management of postmenopausal osteoporosis, non-estrogen medications should be first considered.

3. Atrophic vaginitis and atrophic urethritis. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

4. Female hypoestrogenism.

Menopausal hormone therapy (MHT) should not be initiated or continued to prevent coronary heart disease (see section 4.4 Special warnings and precautions for use, Cardiovascular risk – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The benefits and risks of MHT must always be carefully weighed, including consideration of the emergence of risks as therapy continues (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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. In the absence of comparable data, the risks of MHT should be assumed to be similar to all estrogens and estrogen/progestin combinations.

4.2 Posology and method of administration
Administration of Premarin may be continuous (e.g., without a break in therapy) or cyclic (e.g., three weeks on and one week off).

The lowest effective dose should be administered. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.

Since progestogens are administered to reduce the risk of hyperplastic changes of the endometrium, patients without a uterus do not require a progestogen for this purpose.

If an estrogen is prescribed for a postmenopausal woman with a uterus, the addition of a progestin may be appropriate (see section 4.4 Special warnings and precautions for use, Malignant neoplasms – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In some cases, hysterectomized women with a history of endometriosis may need a progestin (see section 4.4 Special warnings and precautions for use, Exacerbation of other conditions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Tablets should be taken whole; do not divide, crush, chew, or dissolve tablets in mouth.

Dosage adjustment may be made based on individual patient response.

Vasomotor symptoms and/or vulvar and vaginal atrophy

• Consider topical vaginal products when treating solely for vulvar and vaginal atrophy.

Female hypoestrogenism

• Administer cyclically (e.g., three weeks on and one week off).

Use in children
Safety and effectiveness in pediatric patients have not been established. Estrogen treatment of prepubertal girls induces premature breast development and vaginal cornification, and may induce uterine bleeding.

Since large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, hormonal therapy should not be started before epiphyseal closure has occurred in order not to compromise final growth.

Use in elderly patients
There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Premarin to determine whether those over 65 years of age differ from younger subjects in their response to Premarin.

The Women’s Health Initiative Study
In the Women’s Health Initiative (WHI) estrogen-alone substudy (daily conjugated estrogens [CE] [0.625 mg] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age (see section 5.1 Pharmacodynamic properties, Women’s Health Initiative Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The Women’s Health Initiative Memory Study
In the Women’s Health Initiative Memory Study (WHIMS) of postmenopausal women 65–79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen alone when compared to placebo. It is unknown whether this finding applies to younger postmenopausal women (see section 4.4 Special warnings and precautions for use, Dementia and section 5.1 Pharmacodynamic properties, Women’s Health Initiative Memory Study – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Usual dosage range
VASOMOTOR SYMPTOMS, ATROPHIC VAGINITIS AND ATROPHIC URETHRITIS ASSOCIATED WITH ESTROGEN DEFICIENCY: 0.3–1.25 mg daily.

OSTEOPOROSIS: 0.3–0.625 mg. Dosage adjustment may be made based upon the individual clinical and bone mineral density responses. This dose should be periodically reassessed by the healthcare provider.

FEMALE HYPOESTROGENISM: 0.3–1.25 mg daily. Administer cyclically (e.g., three weeks on and one week off). Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium. Doses of 0.15 mg have been used in girls and are associated with the onset of development of secondary sex characteristics. Dose should be individualized to achieve optimum patient response.

4.3 Contraindications

1. Known or suspected or history of breast cancer.

2. Known or suspected estrogen-dependent neoplasia (e.g., endometrial cancer, endometrial hyperplasia).

3. Known or suspected pregnancy.

4. Undiagnosed abnormal uterine bleeding.

5. Active or history of arterial thromboembolic disease (e.g., stroke, myocardial infarction) or venous thromboembolism (such as deep venous thrombosis, pulmonary embolism).

6. Known or suspected hypersensitivity to any component of this medication.

7. Active or chronic liver dysfunction or disease.

8. Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency).