Estrogel Gel (Estrogel)

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Estrogel 0.06%

Product of United Kingdom
Manufactured by: Besins Healthcare
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Estrogel is also marketed as Oestrogel
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Estrogel 0.06%
Product of United Kingdom
Manufactured by Besins Healthcare
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Estrogel 0.06%

Product of Canada
Manufactured by: Merck Sharp & Dohme
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Estrogel 0.06%
Product of Canada
Manufactured by Merck Sharp & Dohme
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Estrogel Gel (Estradiol) Dosage and Side Effects

ESTROGEL is used for a replacement of estrogen in menopausal women with symptoms of menopause, which may include hot flushes, disturbed sleep and vaginal dryness.

Proper Use of this medication

 Do not apply ESTROGEL on the breasts since this may cause unwanted effects and discomfort. Do not apply ESTROGEL to the face or to irritated or damaged skin.

Usual dose:

The recommended dosage of ESTROGEL is two pump pressures (2.5 g) per day on a cyclic schedule from day 1 to day 25 of each calendar month or from day 1 to day 21 of a 28-day cycle. ESTROGEL may be applied either in the morning or evening after washing, but preferably about the same time each day. If your periods have stopped, or are irregular, you can start using ESTROGEL at any time.

Under the supervision of your doctor, the dose of ESTROGEL can be adjusted to meet your individual needs. Attempts to adjust the necessary dosage should be made after two months of treatment. Breast tenderness and/or unexpected bleeding are generally signs that the dose is too high and needs to be lowered. However, if the selected dose fails to control your menopausal symptoms, a higher dose may be prescribed.

You and your doctor should talk regularly about whether you still need treatment with estrogen.

How and When To Apply ESTROGEL:

ESTROGEL Pump:

  • Remove the large pump cover. When you open a new pump, press on the pump once or twice in order to prime the pump and discard these doses.

  • Press firmly on the pump once, collect the gel in your hand and apply the gel on one arm, as illustrated. Repeat and apply the gel on the opposite arm.

  • ESTROGEL should be applied using clean hands onto clean, dry skin. The gel should be spread over a large area of skin (at least 2000 cm2), which corresponds to approximately 4 times the size of your hand. It is recommended to apply ESTROGEL to both arms, as illustrated. Other recommended areas of application are the abdomen or the inner thighs, as illustrated. It is not necessary to rotate the site of administration. Do not apply ESTROGEL on the breasts since this may cause unwanted effects and discomfort. Do not apply ESTROGEL to the face or to irritated or damaged skin.

  • Allow the gel to dry for 2 minutes before covering with clothes. ESTROGEL does not stain and does not smell.

  • The pump contains enough gel for approximately 1 month's use (i.e. 64 metered-doses) at the recommended dose of two pumps/per day (2.5 g). After that, the amount of gel delivered may be lower and thus, it is recommended to change the pump.

  • Always replace the small protective cap back in the tip of the pump as well as the large pump cover after each use, as illustrated.

Overdose:

For management of a suspected drug overdose, contact your regional Poison Control Centre.

When someone accidentally takes too much ESTROGEL, the following symptoms may arise: nausea (urge to vomit), breast discomfort, fluid retention, abdominal cramps, headache, dizziness, bloating or vaginal bleeding in women.

In case of accidental overdosage or ingestion of ESTROGEL, contact your doctor and/or your local Poison Control Centre.

Missed dose:

If a dose of this medication has been missed, it should be taken as soon as possible. However if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double dose. If you are in doubt, contact your healthcare provider.

Side Effects

 Very rarely, skin irritation can occur with ESTROGEL. Depending on the dosage of estrogen and the sensitivity of the patient, the following side effects are possible:
  • genital bleeding or spotting (minor vaginal bleeding) in between the normal periods;

  • headaches or depressive mood;

  • breast tenderness/swelling;

  • water retention (bloating, swelling);

  • endometrial hyperplasia (overgrowth of the lining of the uterus);

  • nausea (urge to vomit), abdominal discomfort (cramps, pressure, pain);

  • gallbladder disorder, impaired liver function;

  • menstrual cramps;

  • vaginal itching/discharge;

  • pain during sexual intercourse;

  • pain on urination or difficulty urinating;

  • premenstrual syndrome (PMS);

  • inflammation of the bladder;

  • brown, blotchy spots on exposed skin (pregnancy mask);

  • skin rash, tender red lumps or nodules or other skin reactions;

  • loss of hair, hairiness;

  • acne;

  • palpitations (unpleasant sensation of irregular and/or forceful beating of the heart);

  • worsening of varicose veins (visible and bulging veins);

  • nervousness;

  • fatigue (tiredness);

  • irritability;

  • intolerance to contact lenses;

  • changes in appetite and body weight;

  • change in sexual drive;

  • pain in the joints and muscles, usually lasting only 3-6 weeks.

For any unexpected effects while taking ESTROGEL, contact your doctor or pharmacist.

Warnings and Precautions

Serious Warnings and Precautions

The Women's Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in post-menopausal women.

The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in post-menopausal women taking oral combined estrogen plus progestin.

The WHI trial indicated an increased risk of stroke and deep vein thrombosis in post-menopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone.

Therefore you should highly consider the following:

  • There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.

  • There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.

  • Estrogens with or without progestins should not be used to prevention of heart disease or stroke.

  • Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

Breast Cancer:

The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated no difference in the risk of breast cancer in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

Estrogens should not be taken by women who have a personal history of breast cancer.

In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting HRT.

Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.

Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

Overgrowth of the lining of the uterus and cancer of the uterus:

The use of estrogen-alone therapy by post-menopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).

If you still have your uterus, you should take a progestin medication (another hormone drug) regularly for a certain number of days of each month to reduce the risk of endometrial hyperplasia.

You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.

If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.

Ovarian Cancer:

In some studies the use of estrogen-alone therapy and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.

Heart Disease and Stroke:

The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.

Abnormal Blood Clotting:

The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo. The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability.

Gallbladder Disease:

The use of estrogen therapy by post-menopausal women has been associated with an increased risk of gallbladder disease requiring surgery.

Dementia (loss of memory and intellectual function): The Women's Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in post-menopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo. The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Contact Sensitization:

Products applied onto the skin may result in sensitization. Although it is extremely rare, skin sensitization may evolve into severe hypersensitivity reaction with continued use of the gel.

BEFORE you use ESTROGEL talk to your doctor or pharmacist if you:

  • have a history of liver disease, liver tumours, or jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy;

  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer;

  • have a history of endometrial hyperplasia (overgrowth of the lining of the uterus);

  • have experienced undiagnosed or unusual vaginal bleeding;

  • have experienced pressure or pain in your abdomen or pelvis;

  • have a history of uterine fibroids (abnormally thick tissue in the uterus) or endometriosis (disorder of the uterine lining);

  • have a history of heart disease or stroke or family history of blood clots;

  • have a history of migraine headaches;

  • have a personal history of active thrombophlebitis (inflammation of veins);

  • have had a partial or complete loss of vision due to blood vessel disease of the eye;

  • are pregnant or may be pregnant;

  • have a history of allergy or intolerance to ESTROGEL or any of its ingredients, or to any medications or other substances;

  • smoke;

  • have a history of high blood pressure;

  • have history of kidney disease, asthma or epilepsy (seizures);

  • have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus);

  • have been diagnosed with diabetes;

  • have been diagnosed with porphyria (disease of blood pigments);

  • have a history of high cholesterol or high triglycerides (a type of fat in the blood);

  • have a history of depression;

  • have had a hysterectomy (surgical removal of the uterus);

  • have been told that you have a condition called hereditary angioedema or if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage), or digestive tract;

  • have been diagnosed with lupus;

  • have been diagnosed with hearing loss due to otosclerosis;

  • breastfeeding.

Interactions with this medication

Drugs that may interact with ESTROGEL include:

Barbiturates, hydantoins, carbamazepine, meprobamate, phenylbutazone or rifampin, atorvastatin, antibiotics, aminoglutethimide, some herbal products (e.g. St. John's wort), phenobarbital, phenytoin, troglitazone, ascorbic acid, acetaminophen, oral contraceptives containing ethinyl estradiol, progestin.

Estrogens may diminish the effectiveness of anticoagulant (substance that prevents coagulation), antidiabetic (drugs treating diabetes mellitus) and antihypertensive agents (drugs treating high blood pressure).

Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.

Other related products

 
 

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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