Progynova (estradiol Tablets)

Progynova (Estradiol Valerate Tablets) - Product Information

Progynova (Estradiol Valerate Tablets) is used as a Hormone replacement therapy (HRT) for the treatment of signs and symptoms of oestrogen deficiency due to the menopause (whether natural or surgically induced). This medicine is also used for prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of or contraindicated for, other medicinal products approved for the prevention of osteoporosis. This medicine is also used for IVF (In Vitro Fertilization) to increase endometrial thickness and sustain a pregnancy.

Progynova tablets, manufactured by Zydus Healthcare, India are available in strengths 1 mg and 2 mg. We also have in stock Estradiol Vaginal Cream (Evalon Vaginal cream) which is is a prescription medication used to treat moderate to severe dryness, itching, and burning in and around the vagina due to menopause.

Presentation and Marketing of Progynova Tablets

Progynova tablets are manufactured by Zydus Healthcare, India and is offered to the consumer in a blister strip of 28 tablets.

Manufacturer of Progynova Tablets

Zydus Healthcare  
Marketed by Bayer Pharmaceuticals Pvt. Ltd. (Bayer Zydus Pharma)
Website: www.bayer.in

Active Ingredient present in Progynova Tablets

The active ingredient present in Progynova tablets is Estradiol Valerate, also known as Oestradiol Valerate.

How Does Progynova Pill Work?

Progynova replaces the hormone oestradiol that a woman's body no longer makes due to the menopause (whether natural or surgically induced) and prevents or relieves symptoms such as hot flushes, sweats, sleep disturbances, depressive moods, irritability, dizziness, headaches as well as vaginal dryness and burning.

Uses of Progynova Tablets

Progynova tablets are a medical treatment for surgically menopausal (after surgical removal of the ovaries), perimenopausal and postmenopausal women. Progynova alleviates these symptoms by providing relief of symptoms occurring after menopause in case your symptoms seriously hinder your daily life.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Progynova to prevent osteoporosis after menopause. Progynova tablets is also used for the treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease and treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

Progynova (Estradiol Valerate Tablets) - Dosage and Administration

When estrogen (Progynova tablets) is prescribed for a postmenopausal woman with a uterus, a progestogen should also be added Progynova for at least 12 to 14 days each month/28 day cycle. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. The dosage of Progynova (Estradiol Valerate Tablets) for various indications is given below.

Treatment to control menopausal symptoms should be started with Progynova 1 mg. In the case considered necessary, Progynova 2 mg should be used. Once treatment is established the lowest effective dose necessary for relief of symptoms should be used.

For prevention of postmenopausal osteoporosis one tablet of Progynova 2 mg is to be taken daily.

Use of Progynova Tablets in IVF

In assisted as well as natural conception, estrogen helps to grow and maintain your endometrial lining and sustain a pregnancy. It also helps the placenta function, boosts blood flow to your uterus and primes your body for breastfeeding.

In an IVF (In Vitro Fertilization) cycle using your own eggs, Follicle Stimulating Hormone (FSH) medication creates multiple follicles. Estrogen production is then stimulated, causing the uterine lining to thicken.

Some research indicates that estrogen supplements late in an IVF cycle can help improve pregnancy prospects by stabilizing the uterine lining. Oral estrogen tablets such as Progynova are used.

How to start Progynova Tablets

In case the patient has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen, starting with the oestrogen phase, must start on the first day of bleeding. In case the menstrual periods are very infrequent or if amenorrhoea is established, she may start at any time provided, if appropriate, pregnancy has been excluded.

Progynova – Missed or Lost Tablets Instructions

In case the patient forgets to take a tablet at the usual time, she can take it within the following 12 hours. If the woman is more than 12 hours late the missed tablet should not be taken and the remaining tablets taken at the usual time on the right days.

A missed dose could lead to breakthrough bleeding or spotting.

Progynova Overdosage

Serious adverse effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding could occur in females.

Progynova (Estradiol Valerate Tablets) Storage

Store Progynova (Estradiol Valerate tablets) at controlled room temperature (68°F to 77°F, 20°C to 25°C). Keep your tablets in the original packing until it is time to take them. If you take the tablets out of the pack they may not keep well. Keep your tablets in a cool dry place. Protect from light. Do not store Progynova or any other medicine in the bathroom, near a sink, or on a window-sill.

Progynova Tablets Contraindications

Progynova tablets are contraindicated in patients with a hypersensitivity to Estradiol Valerate or any inactive ingredient present in Progynova tablets. Progynova tablets are also contraindicated in the following cases:

• Pregnancy or lactation
• Undiagnosed vaginal bleeding
• Known or suspected cancer of the breast
• Known or suspected premalignant conditions or malignancies, if sex steroid-influenced
• Presence or history of liver tumours (benign or malignant)
• Severe hepatic disease
• Acute arterial thromboembolism (myocardial infarction, stroke) or a recent history of these conditions
• Active deep venous thrombosis, thromboembolic disorders, thrombophlebitis, or a documented history of these conditions
• A high risk of venous or arterial thrombosis
• Hereditary or acquired predisposition to venous thrombosis (e.g. antithrombin III deficiency)
• Severe hypertriglyceridamia

Side Effects of Progynova Tablets

During the first few months of treatment patients could experience some breast tenderness or enlargement. These symptoms are usually temporary and normally disappear with continued treatment. The following side effects have been observed in users of various oral HRT preparations including Progynova :

• signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing
• changes in body weight
• feeling depressed and/or anxious
• changes in sexual drive
• visual disturbances such as partial or complete loss of vision, bulging eyes, double vision
• intolerance to contact lenses
• irregular heartbeat
• muscle cramps
• changes in vaginal bleeding pattern including spotting
• painful menstrual periods
• vaginal secretion
• premenstrual-like syndrome such as mood swings, bloating, breast swelling and tenderness
• breast pain
• indigestion
• nausea
• vomiting
• stomach pain
• increased appetite
• rash
• various skin disorders such as itching, hives, acne, excessive hairiness, hair loss or red, painful lumps
• headache
• migraine
• dizziness
• swelling of the hands, ankles or feet
• feeling tired

You should stop treatment with this medicine at once and consult your doctor in case you have any of the following conditions:

• your very first attack of a migraine (typically a throbbing headache and nausea preceded by visual disturbances)
• worsening of a pre-existing migraine, any unusually frequent or unusually severe headaches
• sudden disturbances of vision or hearing
• swollen veins (phlebitis)
• itching of the whole body
• unusual upper abdominal pain that do not disappear within a short period of time.

If you get a blood clot while you are taking Progynova or there is a suspicion of this you should stop taking it immediately and contact your doctor. Warning signs to look out for are:

• coughing blood
• unusual pains or swelling of your arms or legs
• sudden shortness of breath
• fainting.

Progynova must also be stopped at once if you develop jaundice (yellowing of the skin and/or eyes). Tell your doctor immediately in case either occurs.

Interactions of with Other Drugs

In vitro and in vivo studies have demonstrated that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin could reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.

Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

Warnings and Precautions

Estrogen as well as Estrogen/Progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). In case any of these occur or be suspected, estrogens should be discontinued immediately.

In the Women's Health Initiative (WHI) study, an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo.

In the Women's Health Initiative (WHI) study, an increase in VTE has been observed in women receiving CE compared to placebo.

Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis.

The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12- fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose.

The use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer.

In the Women's Health Initiative Memory Study (WHIMS) with 4,532 generally healthy postmenopausal women 65 years of age and older were studied, it was observed after an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and 21 women in the placebo group (0.9%, n = 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05.

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue administration of this medicine pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or a migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued.

Estradiol Valerate During Pregnancy

Estradiol Valerate (Progynova Tablets) has been classified by the US FDA as Pregnancy Category X. Estradiol Valerate should not be used during pregnancy. There seems to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Progynova Nursing Considerations

Estradiol (Progynova Tablets) has been detected in human breast milk. Estradiol can decrease the quality or quantity of breast milk. A choice should be made whether to stop nursing or to stop use of this medication.
Do not use this medicine without informing your doctor in case you are breast-feeding a baby.

Buy Progynova 1 mg and 2 mg online Tablets Online at only $0.50 per Tablet

You can buy Progynova tablets online from all contraceptives at a cheap price. Progynova 1 mg and 2 mg pills, manufactured by Zydus Healthcare, India and marketed by Bayer Pharmaceuticals Pvt. Ltd. (Bayer Zydus Pharma) are supplied in a blister strip of 28 tablets. The 1 mg tablets cost only $0.50 per unit when you place an order for 280 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.

Shipping Restriction