Details for: PREMARIN VAGINAL CREAM
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02043440 | PREMARIN VAGINAL CREAM | CONJUGATED ESTROGENS | 0.625 MG / G | CREAM | VAGINAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- To treat vulvar and vaginal atrophy and kraurosis vulvae (itching, burning, dryness in or around the vagina, difficulty or burning on urination) associated with menopause.
- To treat dyspareunia (pain during intercourse) associated with menopause.
Premarin® Vaginal Cream should not be used by women with
intact uteri unless it is prescribed in association with a
progestin.
Premarin® Vaginal Cream 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
When using Premarin® Vaginal Cream women are using a
hormone, estrogen (i.e. conjugated estrogens CSD 0.625
mg/g). Premarin® Vaginal Cream replaces estrogen
specifically in and around the vagina which naturally decreases
at menopause.
Estrogens are female hormones that are produced by a
woman’s ovaries and are necessary for normal sexual
development and the regulation of menstrual periods during
the childbearing years.
When a woman is between the ages of 45 and 55, the ovaries
normally stop making estrogens. This leads to a drop in body
estrogen levels and marks the beginning of menopause (the end of
monthly menstrual periods). A sudden drop in estrogen levels also
occurs if both ovaries are removed during an operation before natural
menopause takes place. This is referred to as surgical menopause.
When the estrogen levels begin dropping, some women develop very
uncomfortable symptoms, such as feelings of warmth in the face,
neck, and chest, or sudden intense episodes of heat and sweating (“hot
flashes”) as well as vaginal symptoms. In some women the
symptoms are mild; in others they can be severe. These symptoms
may last a few months or longer.
When it should not be used
Before using Premarin® Vaginal Cream be sure to tell your doctor if you have any of the following medical problems, as Premarin® Vaginal Cream should not be used under these conditions:
- Known, suspected, or past history of breast cancer.
- Known or suspected hormone-dependent cancer. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take Premarin® Vaginal Cream.
- Unexpected or unusual vaginal bleeding
- Have (or have had) blood clot disorders, including blood clots in the legs or lungs or thrombophlebitis (inflammation of the veins).
- Serious liver disease
- Active or past history of heart disease, heart attacks or stroke.
- If you are allergic to Premarin® Vaginal Cream or any of its ingredients, or have had any unusual reactions to its ingredients (see What the medicinal ingredients are and What the nonmedicinal ingredients are).
- If you are pregnant or suspect you may be pregnant. Since pregnancy may be possible early in pre-menopause while you are still having spontaneous periods, the use of non-hormonal birth control should be discussed with your physician at this time. If you accidentally take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.
- If you have partially or completely lost vision due to blood vessel disease of the eye.
- If you have overgrowth of the lining of the uterus.
- Have known abnormality of the blood clotting system that increases your risk for having a blood clot (e.g. protein C, protein S, or antithrombin deficiency).
- If you experience migraines with or without aura.
What the medicinal ingredient is
Conjugated equine estrogens
What the non-medicinal ingredients are
The cream contains the following inactive ingredients: Cetyl Alcohol, Cetyl Esters Wax, Glycerin, Glyceryl Monostearate, Methyl Stearate, Mineral Oil, Phenylethyl Alcohol, Propyl Glycol Monostearate, Sodium Lauryl Sulfate, Water Purified, White Wax.
What dosage form it comes in
Premarin® Vaginal Cream is available in tubes of 14 g and 30g, each gram containing 0.625 mg of conjugated estrogens CSD. Each tube is accompanied with one (14g tube) or two (30g tube) calibrated plastic applicators.
Warnings and precautions
Serious Warnings and Precautions
The Women’s Health Initiative (WHI) 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 for the 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 postmenopausal 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 selfexamination 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 you 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 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
ungs 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 estrogens by postmenopausal women has been
associated with an increased risk of gallbladder disease
requiring surgery.
Dementia
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.
BEFORE you use Premarin Vaginal Cream talk to your
doctor or pharmacist if you:
- have a history of allergy or intolerance to any medications or other substances
- have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer
- have experienced any unusual or undiagnosed vaginal bleeding
- have a history of uterine fibroids or endometriosis
- have a history of liver disease, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy
- have a history of migraine headache
- have a history of high blood pressure
- have a personal or family history of blood clots, or a personal history of heart disease or stroke
- have a 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 (a disease of blood pigment)
- have a history of high cholesterol or high triglycerides
- are pregnant or may be pregnant
- have had a hysterectomy (surgical removal of the uterus)
- smoke
- have been diagnosed with otosclerosis (hearing loss due to a problem with the bones in your ear)
- 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.
- Premarin® Vaginal Cream may weaken and contribute to the failure of condoms, diaphragms, or cervical cap made of latex or rubber.
Other existing conditions you should discuss with your health professional include lupus, very low calcium levels, thyroid problems, fluid retention, gallbladder disease, depression, and breastfeeding. If you have upcoming surgery or prolonged bedrest, you should also discuss these.
Interactions with this medication
Tell your doctor or pharmacist if you are taking any other
medications, including prescription medications, over-the-counter
medications, vitamins or herbal products (such as St. John’s wort).
Some medications (such as medications for high blood pressure,
diabetes, blood clots, sleeping, anxiety, seizures, pain-relief and
tuberculosis) may affect how Premarin® Vaginal Cream works.
Premarin® Vaginal Cream may also affect how other medicines work.
You should also tell your doctor or pharmacist if you use latex or
rubber diaphragms or cervical caps.
Proper use of this medication
Usual Dose
You should follow the dosage regimen prescribed by your healthcare provider. Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example every 3 to 6 months) about the dose you are taking and whether you still need treatment with Premarin® Vaginal Cream. Do not give Premarin® Vaginal Cream to other people, even if they have the same symptoms you have. It may harm them. Instructions for Use of Applicator:
- Remove cap.
- Screw nozzle end of applicator onto the tube.
- Gently squeeze tube to force sufficient cream into the barrel to provide the prescribed dose.
- Unscrew applicator from tube.
- Place the applicator into the vaginal opening.
- To release medication, press plunger downward.
Overdose
Overdosage with estrogens may cause nausea and
vomiting, breast discomfort, fluid retention, bloating or
vaginal bleeding may occur in women. There is no specific
antidote and further treatment if necessary should be
symptomatic.
Overdosage may result in a period of amenorrhea (lack of
menses) of a variable length and may be followed by irregular
menses for several cycles. No cases of overdosage in male
patients have been reported.
Missed Dose
If you miss a dose, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not use 2 doses at the same time.
Side effects and what to do about them
Side effects may include:
- Breast pain, leaking of milk from the nipple
- Inflammation of the vagina, vaginal itching and/or discharge
- Breakthrough bleeding, spotting, changes in menstrual flow, painful periods
- Joint pain, leg pain
- Hair loss
- Changes in weight (increase or decrease)
- Nausea, vomiting, bloating, abdominal pain
- Dizziness
- Headache (including migraine)
- Changes in libido
- Mood disturbances, irritability
- Rash, itching, hives, tender red nodules on the shins and legs, acne
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Blood clot: Pain or swelling in the leg. | ✔ | ||
| Breast Cancer: Breast lump, unusual discharge. | ✔ | ||
| Edema: Swelling of the hand and/or feet. | ✔ | ||
| High Blood Pressure: headaches, dizziness, vision problems, shortness of breath | ✔ | ||
| Persistent sad mood. | ✔ | ||
| Unexpected vaginal bleeding. | ✔ | ||
| Rare | |||
| Blood clot in the lung: Sharp pain in the chest, coughing blood or sudden shortness of breath. | ✔ | ||
| Stroke: Sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech or weakness or numbness in an arm or leg. | ✔ | ||
| Very Rare | |||
| Blood clot in the eye: Sudden partial or complete loss of vision. | ✔ | ||
| Liver disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | ✔ | ||
| Unknown | |||
| Angioedema and Severe Allergic Reactions: swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalized itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness. | ✔ | ||
| Cerebrovascular insufficiency: visual disturbances, migraines, trouble speaking, paralysis or loss of consciousness. | ✔ | ||
| Gallbladder disorder: severe pain in the upper right abdomen, pain in the back between the shoulder blades, nausea and vomiting. | ✔ | ||
| Heart Attack: Crushing chest pain or chest heaviness, pain in the arm, back, neck or jaw, shortness of breath, cold sweat, nausea, light-headedness. | ✔ | ||
| Heart palpitations | ✔ | ||
| Increased blood sugar: frequent urination, thirst, and hunger. | ✔ | ||
| Worsening of asthma: wheezing, coughing, shortness of breath, difficulty breathing | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Premarin® Vaginal Cream, contact your doctor or pharmacist.
How to store
Store Premarin Vaginal Cream at 15° C to 30° C (room
temperature).
Keep out of reach of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at: http//www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001
-
This leaflet was prepared by
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, QC H9J 2M5