(conjugated estrogens)
PRECAUTIONS
PRECAUTIONS
A. General
Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into account.
1. Addition of a progestin when a woman has not had a hysterectomy
Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration or daily with estrogen in a continuous regimen have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.
There are, however, possible risks which may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer.
2. Elevated blood pressure
In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen.
3. Hypertriglyceridemia
In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
4. Hepatic impairment and/or past history of cholestatic jaundice
Estrogens may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.
5. Hypothyroidism
Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Women with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
6. Fluid retention
Estrogens may cause some degree of fluid retention. Women with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.
7. Hypocalcemia
Estrogen therapy should be used with caution in individuals with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
8. Exacerbation of endometriosis
A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. For women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.
B. Patient Information
Physicians are advised to discuss the contents of the PATIENT INFORMATION leaflet with patients who are being treated with Premarin Intravenous.
C. Laboratory Tests
Estrogen administration should be guided by clinical response at the lowest dose, rather than laboratory monitoring.
D. Drug-Laboratory Test Interactions
- 1.
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- 2.
- Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- 3.
- Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), SHBG, leading to increased total circulating corticosteroids and sex steroids respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
- 4.
- Increased plasma high-density lipoprotein (HDL) and HDL2 subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglyceride levels.
- 5.
- Impaired glucose tolerance.
E. Carcinogenesis, Mutagenesis, and Impairment of Fertility
(See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)
Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
G. Nursing Mothers
Premarin Intravenous should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogens. Caution should be exercised when Premarin Intravenous is administered to a nursing woman.
H. Pediatric Use
Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established.
Large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short adult stature if treatment is initiated before the completion of physiologic puberty in normally developing children. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration.
Estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. In boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia.
I. Geriatric Use
There have not been sufficient numbers of geriatric patients involved in studies utilizing Premarin to determine whether those over 65 years of age differ from younger subjects in their response to Premarin.
The Women's Health Initiative Studies
In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age. (See CLINICAL STUDIES.)
In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age. (See CLINICAL STUDIES.)
The Women's Health Initiative Memory Study
In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo. (See CLINICAL STUDIES and WARNINGS, Probable Dementia.)
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable Dementia.)
PATIENT INFORMATION
PATIENT INFORMATION
Premarin Intravenous (conjugated estrogens, USP) for injection
Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?
|
What is Premarin Intravenous?
Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.
Premarin Intravenous is used to:
- •
- Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding
Who should not use Premarin Intravenous?
Premarin Intravenous should not be used if you:
- •
- Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
- •
- Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous. - •
- Had a stroke or heart attack
- •
- Currently have or have had blood clots
- •
- Currently have or have had liver problems
- •
- Have been diagnosed with a bleeding disorder
- •
- Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet. - •
- Think you may be pregnant
Tell your healthcare provider:
- •
- If you are breast feeding
- The hormones in Premarin Intravenous can pass into your breast milk.
- •
- About all of your medical problems
- Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- •
- About all the medicines you take
- This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.
What are the possible side effects of Premarin Intravenous?
Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- •
- Heart attack
- •
- Stroke
- •
- Blood clots
- •
- Dementia
- •
- Breast cancer
- •
- Cancer of the lining of the uterus (womb)
- •
- Cancer of the ovary
- •
- High blood pressure
- •
- High blood sugar
- •
- Gallbladder disease
- •
- Liver problems
- •
- Enlargement of benign tumors of the uterus ("fibroids")
- •
- Severe allergic reactions
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- •
- New breast lumps
- •
- Unusual vaginal bleeding
- •
- Changes in vision or speech
- •
- Sudden new severe headaches
- •
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- •
- Swollen lips, tongue and face
Less serious, but common side effects include:
- •
- Headache
- •
- Breast pain
- •
- Irregular vaginal bleeding or spotting
- •
- Stomach or abdominal cramps, bloating
- •
- Nausea and vomiting
- •
- Hair loss
- •
- Fluid retention
- •
- Vaginal yeast infection
These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?
- •
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.
General information about the safe and effective use of Premarin Intravenous
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.
This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the ingredients in Premarin IV?
Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.
Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com. |
LAB-0505-6.0
Revised 02/2024
PATIENT INFORMATION
Premarin
Intravenous
(conjugated estrogens, USP) for injection
Rx only
Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how and when treatment should be used. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Premarin Intravenous (an estrogen mixture)?
|
What is Premarin Intravenous?
Premarin Intravenous is a medicine that contains a mixture of estrogen hormones.
Premarin Intravenous is used to:
- •
- Treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no other cause of bleeding
Who should not use Premarin Intravenous?
Premarin Intravenous should not be used if you:
- •
- Have unusual vaginal bleeding that has not been evaluated by your healthcare provider
- •
- Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Premarin Intravenous. - •
- Had a stroke or heart attack
- •
- Currently have or have had blood clots
- •
- Currently have or have had liver problems
- •
- Have been diagnosed with a bleeding disorder
- •
- Are allergic to Premarin Intravenous or any of its ingredients
See the list of ingredients in Premarin Intravenous at the end of this leaflet. - •
- Think you may be pregnant
Tell your healthcare provider:
- •
- If you are breast feeding
- The hormones in Premarin Intravenous can pass into your breast milk.
- •
- About all of your medical problems
- Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- •
- About all the medicines you take
- This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin Intravenous works.
What are the possible side effects of Premarin Intravenous?
Premarin Intravenous is for short-term use only. However, the risks associated with oral Premarin treatment should be taken into account.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- •
- Heart attack
- •
- Stroke
- •
- Blood clots
- •
- Dementia
- •
- Breast cancer
- •
- Cancer of the lining of the uterus (womb)
- •
- Cancer of the ovary
- •
- High blood pressure
- •
- High blood sugar
- •
- Gallbladder disease
- •
- Liver problems
- •
- Enlargement of benign tumors of the uterus ("fibroids")
- •
- Severe allergic reactions
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- •
- New breast lumps
- •
- Unusual vaginal bleeding
- •
- Changes in vision or speech
- •
- Sudden new severe headaches
- •
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- •
- Swollen lips, tongue and face
Less serious, but common side effects include:
- •
- Headache
- •
- Breast pain
- •
- Irregular vaginal bleeding or spotting
- •
- Stomach or abdominal cramps, bloating
- •
- Nausea and vomiting
- •
- Hair loss
- •
- Fluid retention
- •
- Vaginal yeast infection
These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What can I do to lower my chances of getting a serious side effect with Premarin Intravenous?
- •
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.
General information about the safe and effective use of Premarin Intravenous
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Premarin Intravenous for conditions for which it was not prescribed. Do not give Premarin Intravenous to other people, even if they have the same symptoms you have. It may harm them. Keep Premarin Intravenous out of the reach of children.
This leaflet provides a summary of the most important information about Premarin Intravenous. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Premarin Intravenous that is written for health professionals. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the ingredients in Premarin IV?
Premarin Intravenous for injection contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates: 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Premarin Intravenous for injection also contains lactose, sodium citrate, simethicone, and sodium hydroxide or hydrochloric acid in dry form. The reconstituted solution is suitable for intravenous or intramuscular injection.
Each Premarin Intravenous (conjugated estrogens, USP) for injection package provides 25 mg/vial of conjugated estrogens, USP, in dry form for intravenous or intramuscular use.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com |
LAB-0518-4.0
Rev 12/2021
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