PREMARIN CREAM 0,625 mg

COMPOSITION:

PREMARIN Cream - each gram contains 0,625 mg Conjugated Oestrogens USP. (Also contains cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, sodium lauryl sulphate, glycerin, mineral oil and 1% benzyl alcohol as the preservative.

PHARMACOLOGICAL CLASSIFICATION:

Category A, 21.8.1 Oestrogens.

PHARMACOLOGICAL ACTION:

PREMARIN Cream provides the local oestrogenic activity of topical oestrogen.

INDICATIONS:

PREMARIN Cream is indicated for the treatment of postmenopausal and senile vulvovaginitis, atrophic vaginitis, pruritus vulvae caused by atrophic changes in the vulval epithelium, dyspareunia associated with an atrophic vaginal epithelium, and for use prior to plastic pelvic surgery in menopausal cases.

CONTRA-INDICATIONS:

Not for use during pregnancy.

PREMARIN Cream is contra-indicated in patients hypersensitive to its ingredients and in patients with known or suspected cancer of the breast, or oestrogen-dependent neoplasia such as endometrial carcinoma.

DOSAGE AND DIRECTIONS FOR USE:

Usual dosage:

Intravaginally or topically, 1 to 2 g daily, depending on the severity of the condition. Do not exceed 4 g per day. In postmenopausal vaginal surgery, therapy is suggested 10 days before and 10 days following intervention. PREMARIN Cream should be administered cyclically (e.g. 3 weeks on and 1 week off).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Hypersensitivity reactions, systemic effects such as breast tenderness and, rarely, withdrawal bleeding.

Diagnostic measures should be taken to eliminate the possibility of neoplasia.

An increased incidence of endometrial uterine carcinoma related to the continuous use of oestrogens in the postmenopausal period has been reported.

The use of PREMARIN Cream does not preclude the use of appropriate antimicrobial therapy in the presence of trichomonal, monilial, or bacterial infection.

Because of salt and water retention associated with oestrogenic anabolic activity, oestrogens should be used with caution in patients with epilepsy, migraine, asthma, cardiac, or renal disease.

Certain liver and endocrine function tests may be affected by oestrogen administration.

Due to the possibility of systemic absorption, the following must be noted:

Other side-effects include venous thromboembolism and pulmonary embolism.

In some epidemiological studies, women on estrogen replacement therapy, given alone or in combination with a progestin, have been reported to have an increased risk of thrombophlebitis, and/or thromboembolic disease, although the evidence is conflicting. The physician should be aware of the possibility of thrombotic disorders (including thrombophlebitis, retinal thrombosis, cerebral embolism, and pulmonary embolism) during estrogen replacement therapy and alert to their earliest manifestations. Should any of these occur or be suspected, estrogen replacement therapy should be discontinued immediately. Patients who have risk factors for thrombotic disorders should be kept under careful observation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Overdosage may result in systemic hyperoestrogenic effects such as abnormal or excessive uterine bleeding, oedema, breast tenderness, or reactivation of endometriosis.

IDENTIFICATION:

PREMARIN Cream is a white cream containing 0,625 mg Conjugated Oestrogens USP per gram, in a nonliquefying base.

PREMARIN (Conjugated Oestrogens USP) is a mixture of oestrogens, obtained exclusively from natural sources, occurring as the sodium salts of water-soluble oestrogen sulphates blended to represent the average composition of material derived from pregnant mares' urine. It contains oestrone, equilin and 17 alpha-dihydroequilin, together with smaller amounts of 17alpha -oestradiol, equilenin, and 17 alpha-dihydroequilenin as salts of their sulphate esters.

PRESENTATION:

Each pack contains a 25g tube with one calibrated applicator.

STORAGE INSTRUCTIONS:

Store in a cool dry place below 25°C.

Keep out of the reach of children.

For external use only.