Consumer Information for: PREMARIN INTRAVENOUS
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Premarin Intravenous is used for the treatment of abnormal
bleeding caused by hormonal imbalance when your doctor
has found no serious cause of the bleeding.
Premarin Intravenous should not be used by women with
intact uteri unless it is prescribed in association with a
progestin.
Premarin Intravenous 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 Intravenous women are using a
hormone, estrogen (i.e. conjugated estrogens for injection,
C.S.D.). Premarin Intravenous replaces estrogens in your
body, which naturally decrease 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 and abnormal bleeding. In some women
the symptoms are mild; in others they can be severe. These
symptoms may last a few months or longer. Premarin
Intravenous can help treat abnormal bleeding caused by
dropping levels of estrogens.
When it should not be used
Before using Premarin Intravenous be sure to tell your doctor if you have any of the following medical problems, as Premarin Intravenous should not be used under these conditions:
- Have a liver condition that has not returned to normal.
- Have a known, suspected or past history of breast cancer.
- Have a known or suspected hormone dependent cancer (e.g.endometrial cancer).
- Have unusual thickening of the lining of the womb (endometrial hyperplasia).
- You are or may be pregnant.
- You have unusual vaginal bleeding.
- Have or have had blood clot disorders, including blood clots in the legs or lungs, or inflammation of the veins (thrombophlebitis).
- Have active or past history of heart disease, heart attacks or stroke.
- Have partially or completely lost vision due to blood vessel disease of the eye.
- 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).
- Are allergic (hypersensitive) to conjugated estrogens or any of the other ingredients in Premarin Intravenous (including lactose).
- Have been diagnosed with a bleeding disorder.
What the medicinal ingredient is
Conjugated Estrogens, CSD
What the non-medicinal ingredients are
Lactose, simethicone, and sodium citrate.
What dosage form it comes in
Premarin Intravenous is available in vials containing 25mg of powder.
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
self-examination 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 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 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 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.
BEFORE you use Premarin Intravenous 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 or liver tumors, 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 been diagnosed with otosclerosis (hearing loss due to a problem with the bones in your ear)
- have a history of high cholesterol or high triglycerides
- are pregnant or may be pregnant. If pregnancy occurs while taking Premarin Intravenous contact your doctor immediately
- have had a hysterectomy (surgical removal of the uterus)
- smoke
- 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
- other existing conditions include very low calcium levels, thyroid problems, fluid retention and breastfeeding
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. The following may interact with Premarin Intravenous:
- Blood thinners (drugs that prevent or reduce blood clots)
- Medicine to control your diabetes
- Medicine to control high blood pressure
- Barbiturates (class of sedatives)
- Hydantoins (anticonvulsants)
- Carbamazepine (anticonvulsant)
- Meprobamate (drug that treats tension, anxiety, and nervousness)
- Phenylbutazone (nonsteroidal anti-inflammatory drug)
- Rifampicin (antibiotic)
- St. John’s Wort (Hyperticum perforatum)
- Phenobarbital (drug used to control seizures)
- Phenytoin (drug that can treat and prevent seizures)
- Dexamethasone (drug that can treat inflammation)
- Cimetadine (drug that can reduce acid in the stomach to treat ulcers and acid reflux)
- Erythromycin (antibiotic)
- Ketoconazole (drug that can treat fungal infection)
- Clarithromycin (antibiotic)
- Itraconazole (drug that can treat fungal infection)
- Ritonavir (drug used to treat HIV/AIDS)
- Grapefruit juice
Proper use of this medication
Usual Dose
Your healthcare professional will inject Premarin
Intravenous into a vein or a muscle.
You will receive one 25 mg dose. The dose may be
repeated in 6 to 12 hours, if deemed necessary by your
healthcare professional. Following this, your healthcare
professional should begin treating you with lower doses of
the medicine that you can take in pill form.
Overdose
Overdosage with estrogens may cause nausea and vomiting, breast discomfort, dizziness, abdominal pain, drowsiness/fatigue or vaginal bleeding may occur in women.
Side effects and what to do about them
Side effects may include:
- Breast pain
- Vaginal bleeding or spotting
- Bloating, nausea, vomiting, abdominal pain
- Weight gain
- Dizziness
- Headache (including migraine)
- Nervousness
- Rash
| 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 |
|---|---|---|---|
| Rare | |||
| Inflammation of the Large Intestine (ischemic colitis): abdominal pain, tenderness and/or cramping, blood in your stool, diarrhea, feeling of urgency to move your bowls, nausea | ✔ | ||
| Benign (noncancerous) Brain Tumour: headache, seizures, blurred vision, weakness in arms or legs, numbness, trouble speaking | ✔ | ||
| Blood Clot in the Leg: pain, swelling, redness and tenderness in the leg | ✔ | ||
| Blood Clot in the Lung: sharp pain in the chest, coughing blood, sudden shortness of breath. | ✔ | ||
| Injection Site Reaction: pain, swelling, redness, tenderness | ✔ | ||
| Edema: swelling of the hands, ankles and/or feet | ✔ | ||
| Very Rare | |||
| Superficial Thrombophlebitis (blood clot in a vein just under the skin): redness and inflammation along a vein, skin warm to the touch, pain, hardening of the vein | ✔ | ||
| 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 | ✔ | ||
| Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up | ✔ | ||
| Unknown | |||
| Breast Cancer: breast lump, unusual discharge | ✔ | ||
| Heart attack: crushing chest pain or chest heaviness, pain in the arm, back, neck or jaw, shortness of breath, cold sweat, nausea, light-headedness | ✔ | ||
| Persistent sad mood | ✔ | ||
| Blood clot in the eye: sudden partial or complete loss of vision | ✔ | ||
| 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 | ✔ | ||
| Unexpected vaginal bleeding | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| 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 | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Premarin Intravenous, contact your doctor or pharmacist
How to store
Premarin Intravenous will be stored by your health care
professional in the refrigerator between 2-8ºC.
Keep out of reach and sight 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.
Revision Date: May 14, 2019
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