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
Premarin Intravenous may interfere with laboratory testing.
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

If you think you have been given too much Premarin Intravenous contact healthcare professional, hospital emergency department or regional poison control center immediately, even if there are no symptoms.

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
These are not all the possible side effects you may feel when taking Premarin Intravenous. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects, how often they happen and what to do about them
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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