Generic Ovestin Tablets

Generic Ovestin Tablets (Evalon) are prescribed for menopausal symptoms due to the loss of oestrogen production by your body.

Chemical Structure

Generic Ovestin Tablets (Evalon) are used to treat atrophy of the lower urogenital tract related to oestrogen deficiency, notably for the treatment of vaginal complaints such as dyspareunia, dryness and itching, for the prevention of recurrent infections of the vagina and lower urinary tract, in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence.

Indications

It is also used for Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery, Climacteric complaints such as hot flushes and night sweating, as a diagnostic aid in case of a doubtful atrophic cervical smear and to treat infertility due to cervical hostility.

Indications

The active pharmaceutical ingredient contained in Generic Ovestin Tablets is Estriol (also called Oestriol or E3).

Active Ingredient

The recommended dosage for the treatment of various indications is given below:Atrophy of the Lower Urogenital Tract: The recommended dosage is 4mg to 8mg per day for the first weeks, followed by a gradual reduction, based on response to the treatment, until a maintenance dosage (e.g. 1mg to 2mg per day) is reached.

Pre- and Postoperative Therapy in Post Menopausal Women Undergoing Vaginal Surgery: 4mg to 8mg per day in the 2 weeks before surgery; 1mg to 2mg per day in the 2 weeks after surgery.

Recommended Dosage

Recommended Dosage

Climacteric Complaints such as Hot Flushes and Night Sweating: The recommended dosage is 4mg to 8mg per day during the first weeks, followed by a gradual reduction. The lowest effective dosage should be used. In case of long-term treatment in women with an intact uterus, monitoring of the endometrium or, alternatively, concomitant use of a progestagen is recommended.

A Diagnostic Aid in case of a Doubtful Atrophic Cervical Smear: 2mg to 4mg per day for 7 days before taking the next smear.

Recommended Dosage

Infertility due to Cervical Hostility:The recommended dosage is in general 1mg to 2mg per day on days 6 to 15 of the menstrual cycle. However, for some patients dosages as low as 1mg per day are sufficient, whereas others may need up to 8mg per day. Therefore, the dosage should be increased each month until an optimal effect on the cervical mucus is obtained.

Contraindications

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

Hypersensitivity to Estriol or any inactive component of this 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

Porphyria

Contraindications

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

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

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Side Effects of Generic Ovestin Tablets

The most common side effects of Generic Ovestin Tablets (Evalon) are Breast discomfort and pain, Vaginal bleeding, Increased vaginal discharge, Nausea, Fluid retention in the tissues, usually marked by swollen ankles or feet. In most patients these side effects will disappear after the first weeks of treatment.

Side Effects of Generic Ovestin Tablets

Other side effects which may occur with Hormone Replacement Therapy (HRT):

Benign and malignant hormone-dependent tumors such as endometrial cancer

Heart attack and stroke

Gall bladder disease

Skin problems such as rashes, discolouration or red patches on the skin

Venous thromboembolism or deep leg or pelvic venous thrombosis and pulmonary embolism

Using HRT for several years slightly increases the risk of breast cancer.

Warnings And Precautions

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life

Before initiation or reinstituting HRT, a complete personal and family medical history should be taken

Use of divided daily doses and long-term use of high doses of oestriol (more than 8mg daily) may lead to endometrium stimulation

HRT may increase mammographic density which may complicate the radiological detection of breast cancer.

Warnings And Precautions

HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.

Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomized women has been associated with an increased risk of ovarian cancer.

Overdose Symptoms

As the acute toxicity of Oestriol (Generic Ovestin Tablets) in animals is very low as per trials conducted, toxic symptoms are not expected to occur if several tablets are taken simultaneously.In cases of acute overdose, nausea, vomiting, and withdrawal bleeding in females may develop. No specific antidote is known. Symptomatic treatment can be given if necessary.

Estriol Tablets

Evalon Tablets manufactured by Organon, a subsidiary of Schering-Plough Corporation

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Generic Ovestin Tablets

The Swiss Pharmacy, Geneva Switzerland