Gynodian Depot Overdose

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Consists of Estradiol, Prasterone

What happens if I overdose Estradiol (Gynodian Depot)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Estradiol (Gynodian Depot):

Store Estradiol (Gynodian Depot) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom or near an open flame. Do not use Estradiol (Gynodian Depot) after the expiration date. Keep Estradiol (Gynodian Depot) out of the reach of children and away from pets.

Overdose of Estradiol (Gynodian Depot) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Patients who have taken more Estradiol (Gynodian Depot) than recommended should consult a physician or pharmacist. An overdose of Estradiol (Gynodian Depot) could make patients feel sick or vomit.

What should I avoid while taking Estradiol (Gynodian Depot)?

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using Estradiol (Gynodian Depot).

Grapefruit may interact with Estradiol (Gynodian Depot) and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid using creams, lotions, or powders on the skin where you apply the patch, or it may not stick to your skin.

Estradiol (Gynodian Depot) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

1. Induction of Malignant Neoplasms. Some studies have suggested a possible increased incidence of breast cancer in those women taking estrogen therapy at higher doses or for prolonged periods of time. The majority of studies, however, have not shown an association with the usual doses used for estrogen replacement therapy. Women on this therapy should have regular breast examinations and should be instructed in breast self-examination. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater than in nonusers and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with the use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use with increased risks of 15- to 24-fold for 5 to 10 years or more. In 3 studies, persistence of risk was demonstrated for 8 to over 15 years after cessation of estrogen treatment. In 1 study, a significant decrease in the incidence of endometrial cancer occurred 6 months after estrogen withdrawal. Concurrent progestin therapy may offset this risk, but the overall health impact in postmenopausal women is not known. Estrogen therapy during pregnancy is associated with an increased risk of fetal congenital reproductive tract disorders. In female offspring, there is an increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and clear cell vaginal cancer later in life; in males, urogenital and possibly testicular abnormalities. Although some of these changes are benign, it is not known whether they are precursors of malignancy.

2. Gallbladder Disease. Two studies have reported a 2- to 4-fold increase in the risk of surgically confirmed gallbladder disease in postmenopausal women receiving oral estrogen replacement therapy, similar to the 2-fold increase previously noted in users of oral contraceptives.

3. Cardiovascular Disease. 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.

These risks cannot necessarily be extrapolated from men to women. However, to avoid the theoretical cardiovascular risk to women caused by high estrogen doses, the dose for estrogen replacement therapy should not exceed the lowest effective dose.

4. Elevated Blood Pressure. Occasional blood pressure increases during estrogen replacement therapy have been attributed to idiosyncratic reactions to estrogens. More often, blood pressure has remained the same or has dropped. Postmenopausal estrogen use does not increase the risk of stroke. Nonetheless, blood pressure should be monitored at regular intervals with estrogen use, especially if high doses are used. Ethinyl Estradiol (Gynodian Depot) and conjugated estrogens have been shown to increase renin substrate. In contrast to these oral estrogens, transdermally-administered Estradiol (Gynodian Depot) does not affect renin substrate.

5. Hypercalcemia. Administration of estrogen may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If this occurs, the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

What should I discuss with my healthcare provider before taking Estradiol (Gynodian Depot)?

Some medical conditions may interact with Estradiol (Gynodian Depot). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Estradiol (Gynodian Depot). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol (Gynodian Depot) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Estradiol (Gynodian Depot) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Before taking Estradiol (Gynodian Depot): Medical History and Regular Check-ups: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. In case of premature menopause, the risks of using HRT may be different. Please talk to the doctor.

Before starting (or restarting) HRT, the doctor should ask about the patient’s and her family’s medical history. The doctor may decide to perform a physical examination. This may include an examination of the breasts and/or an internal examination, if necessary.

Once on Estradiol (Gynodian Depot) therapy, the patient should see the doctor for regular check-ups (at least once a year). At these check-ups, discuss with the doctor the benefits and risks of continuing with Estradiol (Gynodian Depot). Go for regular breast screening, as recommended by the doctor.

When to take special care with Estradiol (Gynodian Depot): Tell the doctor if the patient has a history of any of the following problems, before starting the treatment, as these may return or become worse during treatment with Estradiol (Gynodian Depot). If so, the patient should see the doctor more often for check-ups: fibroids inside the womb; growth of womb lining outside the womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia); increased risk of developing blood clots as follows); increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer); high blood pressure; a liver disorder, such as a benign liver tumour; diabetes; gallstones; migraine or severe headaches; a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE); epilepsy; asthma; a disease affecting the eardrum and hearing (otosclerosis); a very high level of fat in the blood (triglycerides); fluid retention due to cardiac or kidney problems.

Stop taking Estradiol (Gynodian Depot): Stop taking Estradiol (Gynodian Depot) and see a doctor immediately if the patient notices any of the following when taking HRT: any of the conditions mentioned in Contraindications; yellowing of the skin or the whites of the eyes (jaundice) as these may be signs of a liver disease; a large rise in the blood pressure (symptoms may be headache, tiredness, dizziness); migraine-like headaches which happen for the first time; if the patient becomes pregnant; signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, and difficulty in breathing.

For more information, see Blood Clots in a Vein (Thrombosis) as follows.

Note: Estradiol (Gynodian Depot) is not a contraceptive. If it has been less than 12 months since the last menstrual period or if under 50 years old, the patient may still need to use additional contraception to prevent pregnancy. Talk to the doctor for advice.

HRT and Cancer: Excessive Thickening of the Lining of the Womb (Endometrial Hyperplasia) and Cancer of the Lining of the Womb (Endometrial Cancer): Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestagen in addition to the oestrogen for at least 12 days of each 28 day cycle protects from this extra risk. The doctor will prescribe a progestagen separately if the patient still has the womb. If the womb was removed (a hysterectomy), discuss with the doctor whether Estradiol (Gynodian Depot) can be safely taken without a progestagen.

Compare: In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.

Unexpected Bleeding: The patient will have a bleed once a month (so-called withdrawal bleed) while taking Estradiol (Gynodian Depot). But, if the patient has unexpected bleeding or drops of blood (spotting) besides the monthly bleeding, which: carries on for more than the first 6 months, starts after the patient has been taking Estradiol (Gynodian Depot) more than 6 months, carries on after the patient has stopped taking Estradiol (Gynodian Depot), see the doctor as soon as possible.

Breast Cancer: Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long the patient takes HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.

For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.

Compare: Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestagen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. 4 to 6 extra cases).

Regularly check the breasts. See the doctor if the patient notices any changes such as: dimpling of the skin, changes in the nipple, any lumps the patient can see or feel.

Ovarian Cancer: Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

Women aged 50 to 69 who are not taking HRT, on average, about 2 women in 1,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for over 5 years, there will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra case).

Effect of HRT on Heart and Circulation: Blood Clots in a Vein (Thrombosis): The risk of blood clots in the veins is about 1.3- to 3-times higher in HRT users than in non-users, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.

The patient is more likely to get a blood clot in the veins as she gets older and if any of the following applies. Inform the doctor if any of these situations applies: unable to walk for a long time because of major surgery, injury or illness; seriously overweight (BMI >30 kg/m²); any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots; if any of the close relatives has ever had a blood clot in the leg, lung or another organ; systemic lupus erythematosus (SLE); cancer.

For signs of a blood clot, see Stop taking Estradiol (Gynodian Depot) previously mentioned, and see a doctor immediately.

Compare: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.

For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. 5 extra cases).

For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case).

Heart Disease (Heart Attack): There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.

For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.

Stroke: The risk of getting stroke is about 1.5-times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

Compare: Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).

Other Conditions: HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Talk to the doctor for advice.

Important information about some of the ingredients of Estradiol (Gynodian Depot): Estradiol (Gynodian Depot) contains lactose monohydrate. If the patient has an intolerance to some sugars, contact the doctor before taking Estradiol (Gynodian Depot).

Laboratory Tests: If the patient needs a blood test, tell the doctor or the laboratory staff that Estradiol (Gynodian Depot) is being taken, because this medicine can affect the results of some tests.

Driving and Using Machines: Estradiol (Gynodian Depot) has no known effect on the ability to drive or use machines.

What happens if I miss a dose of Estradiol (Gynodian Depot)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Call your doctor for instructions if you miss an appointment for your Estradiol (Gynodian Depot) injection.

What happens if I overdose Prasterone (Gynodian Depot)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prasterone (Gynodian Depot):

Store Prasterone (Gynodian Depot) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Most herbal products are not packaged in childproof containers. Keep Prasterone (Gynodian Depot) out of the reach of children and away from pets.

Overdose of Prasterone (Gynodian Depot) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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No information provided.

What should I avoid while taking Prasterone (Gynodian Depot)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Prasterone (Gynodian Depot) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Current or Past History of Breast Cancer

Estrogen is a metabolite of Prasterone (Gynodian Depot). Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. Prasterone (Gynodian Depot) has not been studied in women with a history of breast cancer.

What should I discuss with my healthcare provider before taking Prasterone (Gynodian Depot)?

Some medical conditions may interact with Prasterone (Gynodian Depot). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Prasterone (Gynodian Depot). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prasterone (Gynodian Depot) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Prasterone (Gynodian Depot) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Current Or Past History Of Breast Cancer

Estrogen is a metabolite of Prasterone (Gynodian Depot). Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. Prasterone (Gynodian Depot) has not been studied in women with a history of breast cancer.

Patient Counseling Information

Advise the patient to read FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).

Vaginal Discharge

Inform postmenopausal women that vaginal discharge may occur with Prasterone (Gynodian Depot).

Abnormal Pap Smear Findings

Inform postmenopausal women that abnormal Pap smear findings may occur with Prasterone (Gynodian Depot).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Long-term studies in animals to evaluate carcinogenic potential have not been conducted with Prasterone (Gynodian Depot). Two metabolites of Prasterone (Gynodian Depot), testosterone and Prasterone (Gynodian Depot), are carcinogenic in animals.

Mutagenesis

Prasterone (Gynodian Depot) was not genotoxic in the in vitro bacterial mutagenesis assay (Ames test), the in vitro chromosomal aberrations assay with human peripheral blood lymphocytes, and in vivo in the mouse bone marrow micronucleus assay.

Fertility

Fertility studies were not conducted with Prasterone (Gynodian Depot).

Use In Specific Populations

Pregnancy

Risk Summary

Prasterone (Gynodian Depot) is indicated only in postmenopausal women. There are no data with Prasterone (Gynodian Depot) use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with Prasterone (Gynodian Depot).

Lactation

Risk Summary

Prasterone (Gynodian Depot) is indicated only in postmenopausal women. There is no information on the presence of Prasterone (Gynodian Depot) in human milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

Geriatric Use

Of the 1522 Prasterone (Gynodian Depot)-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.

Renal Impairment

The effect of renal impairment on the pharmacokinetics of Prasterone (Gynodian Depot) has not been studied.

Hepatic Impaitment

The effect of hepatic impairment on the pharmacokinetics of Prasterone (Gynodian Depot) has not been studied.

What happens if I miss a dose of Prasterone (Gynodian Depot)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

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.



References

  1. DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DrugBank. "estradiol". http://www.drugbank.ca/drugs/DB00783 (accessed September 17, 2018).
  3. MeSH. "Estrogens". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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