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PROGYNOVA (Estradiol Valerate) 1mg

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PROGYNOVA is manufactured by GERMAN REMEDIES
Price From: $9.00

PROGYNOVA (Estradiol Valerate) 1mg

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What is PROGYNOVA (Estradiol Valerate) ?
PROGYNOVA (Estradiol Valerate)  (estradiol) is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.PROGYNOVA (Estradiol Valerate)  is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. PROGYNOVA (Estradiol Valerate)  is sometimes used as part of cancer treatment in women and men.PROGYNOVA (Estradiol Valerate)  may also be used for other purposes not listed in this medication guide.


Important information about PROGYNOVA (Estradiol Valerate) 
PROGYNOVA (Estradiol Valerate)  can harm an unborn baby or cause birth defects. Do not use PROGYNOVA (Estradiol Valerate)  if you are pregnant. You should not take PROGYNOVA (Estradiol Valerate)  if you have abnormal vaginal bleeding, liver disease, breast or uterine cancer, hormone-dependent cancer, a recent history of heart attack or stroke, if you are pregnant, if you have ever had a blood clot (especially in your lung or your lower body), or if you are allergic to any medicines or food dyes. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you smoke, or if you are overweight.Long-term PROGYNOVA (Estradiol Valerate)  treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using PROGYNOVA (Estradiol Valerate)  long-term. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.Taking progestin while using PROGYNOVA (Estradiol Valerate)  may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using PROGYNOVA (Estradiol Valerate) .PROGYNOVA (Estradiol Valerate)  should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using PROGYNOVA (Estradiol Valerate) .
 


Before using PROGYNOVA (Estradiol Valerate) 
You should not take PROGYNOVA (Estradiol Valerate)  if you are allergic to estradiol, or if you have:liver disease; abnormal vaginal bleeding that a doctor has not checked;any type of breast, uterine, or hormone-dependent cancer;a recent history of heart attack or stroke;if you are pregnant;if you have ever had a blood clot (especially in your lung or your lower body); orif you are allergic to any medicines or food dyes.Taking hormones, such as PROGYNOVA (Estradiol Valerate)  can increase your risk of blood clots, stroke, or heart attack, especially if you have risk factors such as diabetes, high blood pressure, high cholesterol or triglycerides, smoking, or being overweight.If you have any of these other conditions, your doctor may need to adjust your PROGYNOVA (Estradiol Valerate)  dose or order special tests:heart disease;kidney disease; family history of blood clots;a history of jaundice caused by pregnancy or taking hormones;endometriosis;lupus;porphyria;gallbladder disease;underactive thyroid;asthma;epilepsy or other seizure disorder;migraines;low levels of calcium in your blood; orif you have had your uterus removed (hysterectomy).FDA pregnancy category X. PROGYNOVA (Estradiol Valerate)  can harm an unborn baby or cause birth defects. Do not use PROGYNOVA (Estradiol Valerate)  if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Estradiol can pass into breast milk and may harm a nursing baby. PROGYNOVA (Estradiol Valerate)  may also slow breast milk production. You should not breast-feed while you are taking estradiol. PROGYNOVA (Estradiol Valerate)  should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.


How should I use PROGYNOVA (Estradiol Valerate) ?
Take PROGYNOVA (Estradiol Valerate)  exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.Long-term PROGYNOVA (Estradiol Valerate)  treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using PROGYNOVA (Estradiol Valerate)  long-term.Taking progestin while using PROGYNOVA (Estradiol Valerate)  may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using PROGYNOVA (Estradiol Valerate) .Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using PROGYNOVA (Estradiol Valerate) . Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking PROGYNOVA (Estradiol Valerate) .


Store PROGYNOVA (Estradiol Valerate)  at room temperature away from moisture, heat, and light.


What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention or call the Poison Help line .Overdose can cause nausea, vomiting, or vaginal bleeding.


What should I avoid while using PROGYNOVA (Estradiol Valerate) ?
Do not smoke while using PROGYNOVA (Estradiol Valerate) . Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens.


Side effects of  PROGYNOVA (Estradiol Valerate) 
Get emergency medical help if you have any of these signs of an allergic reaction to PROGYNOVA (Estradiol Valerate) : hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using PROGYNOVA (Estradiol Valerate)  and call your doctor at once if you have a serious side effect such as:unusual vaginal bleeding (especially if you are past menopause);chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;sudden numbness or weakness, especially on one side of the body;sudden severe headache, confusion, problems with vision, speech, or balance;stabbing chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;pain, swelling, warmth, or redness in one or both legs;nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;a lump in your breast;feeling like you might pass out;pain, swelling, or tenderness in your stomach; orjaundice (yellowing of the skin or eyes).Less serious PROGYNOVA (Estradiol Valerate)  side effects may include:mild nausea, vomiting, bloating, stomach cramps;breast pain, tenderness, or swelling;freckles or darkening of facial skin;loss of scalp hair;vaginal itching or discharge; orchanges in your menstrual periods, break-through bleeding.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 


What other drugs will affect PROGYNOVA (Estradiol Valerate) ?
Tell your doctor about all other medicines you use, especially:a blood thinner such as warfarin (Coumadin);cimetidine (Tagamet);carbamazepine (Carbatrol, Tegretol);phenobarbital (Luminal, Solfoton);phenytoin (Dilantin);rifampin (Rifadin, Rifater, Rifamate, Rimactane); orritonavir (Norvir);St. John's wort;an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab); orantifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal).This list is not complete and other drugs may interact with PROGYNOVA (Estradiol Valerate) . Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.


Generic Name Estradiol Valerate
Search Name Estrace Brand 1mg TAB
Supply Name PROGYNOVA
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage TAB
USA Brand Estrace
Manufacture GERMAN REMEDIES
Strength 1mg
Search Terms Estrace ,PROGYNOVA ,Estradiol
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet

Other dosage forms:

transdermal emulsion, transdermal gel/jelly, transdermal patch extended release, transdermal spray
Along with its needed effects, estradiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

Less common
- Vaginal yeast infection

Incidence not known
- Change in vaginal discharge
- clear or bloody discharge from the nipple
- decrease in the amount of urine
- dimpling of the breast skin
- fast heartbeat
- fever
- hives
- hoarseness
- inverted nipple
- irritation
- itching
- joint pain, stiffness, or swelling
- lump in the breast or under the arm
- noisy, rattling breathing
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- persistent crusting or scaling of the nipple
- rash
- redness of the skin
- redness or swelling of the breast
- shortness of breath
- sore on the skin of the breast that does not heal
- swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
- tightness in the chest
- troubled breathing at rest
- troubled breathing or swallowing
- vaginal bleeding

Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Abdominal or stomach pain
- back pain
- headache
- itching or pain of the vagina or genital area
- thick, white vaginal discharge with mild or no odor
- weight gain

Less common
- Body aches or pain
- chills
- cough
- diarrhea
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness

Incidence not known
- Feeling sad or empty
- headache, severe and throbbing
- hives or welts
- irritability
- itching
- lack of appetite
- tiredness
- trouble concentrating
- trouble sleeping
USUAL ADULT DOSE FOR POSTMENOPAUSAL SYMPTOMS

Oral:
0.45 mg to 2 mg orally once a day.

Parenteral:
1 to 5 mg of estradiol cypionate IM every 3 to 4 weeks or 10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
0.05 mg/day (2 foil pouches of transdermal emulsion) applied topically to both legs each morning.
0.25 mg unit dose packet (0.1% transdermal gel) applied topically once daily to the upper right or left thigh at the same time daily.
1.25 g (one spray) EstroGel (0.75 mg/1.25 gm - 0.06% transdermal gel) applied topically to the arms at the same time daily.
1.53 mg (one spray) Evamist (1.53 mg/spray transdermal spray) applied topically to the forearm at the same time daily.
0.87 g (one spray) Elestrin (0.52 mg/1.087 g - 0.06% transdermal gel) applied topically to the upper arm at the same time daily.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms should be limited. Treatment for one to five years is generally sufficient. However, long-term therapy (for the treatment/prophylaxis of osteoporosis and for risk reduction of cardiovascular disease) may be considered during the time in which the patient is being treated for postmenopausal symptoms.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

USUAL ADULT DOSE FOR ATROPHIC URETHRITIS

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
1.25 g/day (estradiol gel) applied topically at the same time daily. If used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

USUAL ADULT DOSE FOR ATROPHIC VAGINITIS

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
1.25 g/day (estradiol gel) applied topically at the same time daily. If used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

USUAL ADULT DOSE FOR HYPOESTROGENISM

Oral:
1 to 2 mg orally once a day.

Parenteral:
1.5 to 2 mg of estradiol cypionate IM once a month or 10 to 20 mg estradiol valerate IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Dosages should be titrated according to patient response. Therapy should be maintained with the minimum dosage that will achieve the desired clinical effect.

USUAL ADULT DOSE FOR OOPHORECTOMY

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

USUAL ADULT DOSE FOR PRIMARY OVARIAN FAILURE

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

USUAL ADULT DOSE FOR BREAST CANCER-PALLIATIVE

10 mg orally 3 times a day for at least 3 months. Estrogen therapy for breast cancer should be considered only for palliation in the treatment of metastatic disease in select patients

USUAL ADULT DOSE FOR OSTEOPOROSIS

Oral:
0.5 mg orally once a day.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Systems should not be applied to the breasts.
14 mcg/day weekly (transdermal film) applied topically once a week.

Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm.

In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.

Long-term therapy (for more than 5 years) is generally necessary in order to obtain substantive benefits in reducing the risk of bone fracture. Maximal benefits are obtained if estrogen therapy is initiated as soon after menopause as possible. The optimal duration of therapy has not been definitively determined.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should carefully be considered, and estrogen and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risks of the drug.

USUAL ADULT DOSE FOR PROSTATE CANCER

Oral:
1 to 2 mg orally 3 times a day.

Parenteral:
Estradiol valerate 30 mg IM every 1 to 2 weeks.

An apparent response should be noted within 3 months of initiation of therapy. Estrogen therapy for prostate cancer should be considered only for palliation in the treatment of metastatic disease in select patients.

RENAL DOSE ADJUSTMENTS

Data not available

LIVER DOSE ADJUSTMENTS

Hepatic metabolism of estrogens may be impaired in patients with liver disease and caution is recommended in patients receiving estradiol therapy.

PRECAUTIONS

The FDA has notified healthcare professionals and patients that it is reviewing reports of adverse effects from estradiol transdermal spray (Evamist). Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.

DIALYSIS

Data not available