Estrogel - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Atrophic Urethritis, Atrophic Vaginitis, Postmenopausal Symptoms|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||17β-estradiol, carbopol 980, ethanol, purified water, triethanolamine|
(17β-estradiol, as estradiol hemihydrate)
About this Medication
What the Medication Is Used For
ESTROGEL is approved for use in the following situation:
- replacement of estrogen in menopausal women with symptoms of menopause, which may include hot flushes, disturbed sleep and vaginal dryness.
ESTROGEL should not be used by women who have not had a hysterectomy (surgical removal of the uterus) unless prescribed in association with a progestin medication.
ESTROGEL should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests.
You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HRT.
What It Does
Menopause is not a disease. Menopause is a natural, pre-determined point in a women's life when the ovaries decrease their production of the female hormones, estrogen and progesterone. In most women, this occurs between the ages of 45 and 55 or sooner if the ovaries have been removed by surgery.
The symptoms associated with menopause vary for every woman. The most common symptom is hot flushes/flashes. Other symptoms some women may develop after menopause include insomnia (reduced quality of sleep) and vaginal atrophy (dryness).Your doctor can provide you with further information on menopause.
The active ingredient in ESTROGEL is estradiol, a natural female hormone. In healthy women of childbearing age, estradiol is the main estrogen produced by the ovaries. When using ESTROGEL, two pump pressures will deliver 2.5 gram of gel, which provides 1.5 milligram of the estrogen substance estradiol. The gel should be applied to the skin over a large area (>2000 cm2), such as both arms. It will be quickly absorbed into the underlying layers of the skin. Over time, the estradiol will be slowly released into the bloodstream.
ESTROGEL does not contain progestins.
For information on the dose and how frequently it should be taken, please see PROPER USE OF THIS MEDICATION below.
When It Should not be Used
Do not use ESTROGEL if you:
- have liver disease;
- have a personal history of breast cancer or endometrial cancer (cancer of the uterus);
- have been diagnosed with endometrial hyperplasia (overgrowth of the lining of the uterus);
- have experienced undiagnosed or unexpected vaginal bleeding;
- are pregnant or suspect you may be pregnant;
- are breast-feeding;
- have a history of coronary heart disease (including heart attack) or stroke;
- experience migraine headaches;
- have a history of blood clots;
- have active thrombophlebitis (inflammation of the veins);
- have had partial or complete loss of vision due to blood vessel disease of the eye;
- known or suspected hormone dependant cancer;
- have had an allergic or unusual reaction to ESTROGEL or to any of its ingredients (See information below on medicinal and nonmedicinal ingredients).
What the Medicinal Ingredient Is
The medicinal ingredient in ESTROGEL is 17β-estradiol.
What the Nonmedicinal Ingredients Are
Carbopol 980, ethanol, purified water and triethanolamine.
What Dosage Forms It Comes In
ESTROGEL is packaged in 80 g metered-dose pumps. Each metered-actuation delivers 1.25 g of gel (0.75 mg of 17β-estradiol).
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 postmenopausal 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 postmenopausal women taking oral combined estrogen plus progestin.
The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal 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.
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 postmenopausal 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.
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.
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 postmenopausal 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.
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;
- 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.
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.
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.
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
|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 2,000 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.|
|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.
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 and what to Do About Them
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;
- palpitations (unpleasant sensation of irregular and/or forceful beating of the heart);
- worsening of varicose veins (visible and bulging veins);
- fatigue (tiredness);
- 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.
Serious Side Effects, how often they Happen and what to Do About Them
|Frequency||Symptom/ possible side effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Abnormal increase in blood clotting;||✓|
|Increase in blood pressure;||✓|
|Abdominal pain, nausea or vomiting||✓|
|Crushing chest pain or heaviness||✓|
|Pain or swelling in the leg||✓|
|Persistent sad mood||✓|
|Sharp pain in the chest, coughing blood or sudden shortness of breath||✓|
|Sudden partial or complete loss of vision||✓|
|Sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech or weakness or numbness in an arm or leg||✓|
|Unexpected vaginal bleeding||✓|
|Yellowing of the skin or eyes (jaundice)||✓|
This is not a complete list of side effects. For any unexpected effects while taking ESTROGEL, contact your doctor or pharmacist.
How to Store It
ESTROGEL should be stored with the cap on securely and at room temperature (15-30°C). The date the gel should be used by is printed on the end of the metered-dose pump after the term "Exp." (expiry date).
Keep out of reach of children.
GENERAL THINGS TO REMEMBER
- This medication has been prescribed only for your current medical problem. Do not use it for other medical problems.
- Do not allow other people to use your medications and do not use medications meant for other people.
- Tell any doctor treating you what medications you are taking. Always carry a medical information card stating which medications you are using. This can be very important in case you are involved in an accident.
- Return unused medications to the pharmacy for safe disposal.
- Make sure that other people you live with or who look after you read this information.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
Toll-free phone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
Postage Paid Mail: Canada Vigilance Program
Ottawa, Ontario K1A 0K9
If you want more information about ESTROGEL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada web site www.merck.ca or by calling Merck Canada at 1-800-567-2594
To report an adverse event related to ESTROGEL, please contact 1-800-567-2594.