Generic Ovestin Cream (Evalon Vaginal Cream)

Generic Ovestin Cream (Evalon Vaginal Cream) is used in Hormone Replacement Therapy (HRT) in women. It substitutes for the loss of oestrogen production in menopausal women and alleviates menopausal symptoms.

Chemical Structure (Estriol)

The active pharmaceutical ingredients contained in Generic Ovestin Cream (Evalon Vaginal Cream) is Oestriol (Estriol). Generic Ovestin Cream contains 1 mg of Oestriol (Estriol) in 1gm of the cream.

Active Ingredient

Generic Ovestin Cream is used for the treatment of Atrophy of the lower urogenital tract related to oestrogen deficiency, notably:(a)For the treatment of vaginal complaints such as dyspareunia, dryness and itching.

(b) for the prevention of recurrent infections of the vagina and lower urinary tract.

It is also used in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence and in Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery.

Uses

The usual dose is 0.5g Generic Ovestin Cream (Evalon Vaginal Cream) containing 0.5mg Estriol per day for 2 to 3 weeks. As maintenance dosage, 0.5g of Generic Ovestin Cream twice a week. Pre-surgery Therapy :

One 0.5g Generic Ovestin Cream per day should begin 2 weeks before the operation.

Recommended Dosage

Following Surgery:A period of at least 2 weeks should be allowed before resuming therapy using 0.5g Generic Ovestin Cream twice a week.

Generic Ovestin Cream (Evalon Vaginal Cream) may be started on any day in women not taking HRT or switching from another continuous combined HRT product. In women switching from a cyclic HRT product, Ovestin Cream should be started one week after completion of the cycle

Recommended Dosage

Contraindications

Generic Ovestin Cream (Evalon Vaginal Cream) is contraindicated in patients with the following conditions:

Hypersensitivity to Oestriol (Estriol) or to any inactive ingredient present in the medication.

Pregnancy

Known, past or suspected breast cancer

Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

Undiagnosed genital bleeding

Untreated endometrial hyperplasia

Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

Contraindications

Generic Ovestin Cream (Evalon Vaginal Cream) is contraindicated in patients with the following conditions:

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

Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

Acute liver disease, or a history of liver disease as long as liver function tests failed to return to normal

Porphyria

Side Effects of Generic Ovestin Cream

The most commonly observed side effects associated with the use of Generic Ovestin Cream (Evalon Vaginal Cream) were nausea and vomiting, breast tenderness or pain in the breasts, vaginal bleeding or spotting during or on withdrawal of therapy, excessive production of cervical mucous, headache, application site irritation and pruritus.

Warnings And Precautions

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

If prescribing HRT, the potential for increased cardiovascular, thrombotic and neoplastic adverse events must be considered.

Discontinue treatment if contraindicated, jaundice or a deterioration in liver function occurs, there is a significant increase in blood pressure, a new onset of migraine or pregnancy occurs. If breakthrough bleeding or spotting occurs, the reason should be investigated.

Warnings And Precautions

Patients with some medical conditions including, leiomyoma or endometriosis, a history of or risk factors for thromboembolic disorders, hypertension, liver disorders, diabetes mellitus with or without vascular involvement, cholelithiasis, migraine or (severe) headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, asthma and otosclerosis, will need close supervision particularly when the condition is active, or has occurred previously and/or was aggravated during pregnancy or previous hormone treatment.These conditions may recur or be aggravated during treatment with Generic Ovestin cream.

Patients with cardiac or renal dysfunction or hypertri-glyceridemia should be carefully observed.

Overdose Symptoms and Treatment

Overdosage with Generic Ovestin Cream (Estriol) after vaginal administration is unlikely. However, in cases where large quantities are ingested, nausea, vomiting and withdrawal bleeding in females may occur. No specific antidote is known. Symptomatic treatment can be given if necessary.

Evalon Vaginal Cream manufactured by Organon Pharmaceuticals

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Generic Ovestin Cream

The Swiss Pharmacy, Geneva Switzerland