PREMARIN VAGINAL CREAM [SIN03229P]

Product Info

PREMARIN VAGINAL CREAM

[SIN03229P]

4.1 Therapeutic indications
Premarin Vaginal Cream is indicated in the treatment of atrophic vaginitis, dyspareunia and kraurosis vulvae.

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). In particular when considering use of estrogen therapy in women without menopausal symptoms, or for long-term use, alternative treatments should be considered.

For many years it has been known that topical or vaginal estrogen therapy would stimulate cell growth and development, improving the epithelial thickness of the vaginal mucosa and increasing secretions. Recent reports have shown that the intravaginal use of topical estrogen creams produces even higher blood estrogen levels than comparable oral doses. Therefore, precautions recommended with oral estrogen administration should also be observed with this route.

4.2 Posology and method of administration
Administered cyclically for short-term use only: For the treatment of atrophic vaginitis, dyspareunia or kraurosis vulvae.

In patients with severe cases of atrophic vaginitis, the mucosa should first be conditioned with a short course of oral therapy – 1.25 mg daily for approximately 10 days. Vaginal treatment should be instituted at the lowest effective dosage, and the requirement for estrogen therapy reassessed regularly. In patients already receiving oral therapy, the oral dosage may be reduced taking into account the potential absorption from the vaginal medication. The degree of atrophy is directly responsible for the level of absorption and should be the guiding factor in dose adjustment.

Usual dosage range: 0.5 to 2 g daily, intravaginally or topically, depending on the severity of the condition. Administration should be cyclic (e.g., three weeks on and one week off).

Appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal uterine bleeding.

Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.

Pediatric use
CE vaginal cream is not indicated in children. Safety and effectiveness in pediatric patients have not been established.

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 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), 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 post-menopausal 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).

4.3 Contraindications

1. Undiagnosed abnormal uterine bleeding.

2. Known, suspected, or history of breast cancer.

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

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

5. Active or chronic liver dysfunction or disease.

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

7. Hypersensitivity to any component of this medication.

8. When pregnancy is known or suspected (see Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).