Premarin (Intravenous)

Conjugated estrogens is a medicine that contains a mix of estrogen hormones. Conjugated estrogens injection is used to treat unusual bleeding from your uterus caused by hormonal imbalance when your doctor has determined there is no other reason for the bleeding. This medicine is meant for short-term use only, to quickly and temporarily raise your estrogen levels.

This medicine must be given only by or under the direct supervision of a doctor.

It is very important that your doctor check you closely to make sure this medicine is working properly and does not cause unwanted effects. A pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent becoming pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk for dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, are overweight, or smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs, or facial muscles, or an inability to speak.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. Anaphylaxis and angioedema can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before you have surgery or if you need to stay in bed for an extended time. This medicine may affect the results of certain medical tests.

Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a choice for you and your doctor to make. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been done to determine how age affects the effects of Premarin® injection in children. Its safety and effectiveness have not been established.

Geriatric

Although studies on how age affects the effects of Premarin® injection have not been conducted in older adults, there have been no specific problems documented for this age group. However, older patients are more likely to have breast cancer, stroke, or dementia, which may require extra caution when using this medicine.

Breast Feeding

Studies indicate that this medication may affect milk production or composition. If you are not given an alternative to this medication, you should monitor your infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be taken together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are highlighted based on their potential importance and do not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some instances. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Etoricoxib
• Ginseng
• Levothyroxine
• Licorice
• Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with certain foods due to possible interactions. Consuming alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), either current or in the past
• Breast cancer, known or suspected, or a history of it
• Heart attack, history of it
• Liver disease
• Protein C, protein S, or other known blood clotting disorders
• Stroke, history of it
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma
• Cancer, history of it
• Diabetes
• Edema (fluid retention or body swelling)
• Endometriosis
• Epilepsy (seizures)
• Gallbladder disease
• Heart disease
• Hereditary angioedema (swelling of the face, lips, tongue, or throat)
• Hypercalcemia (high calcium in the blood)
• Hypertension (high blood pressure)
• Hypertriglyceridemia (high triglycerides or fats in the blood)
• Hypocalcemia (low calcium in the blood)
• Hypothyroidism (an underactive thyroid)
• Jaundice during pregnancy or from past hormonal therapy
• Liver tumors
• Migraine headache
• Porphyria (an enzyme issue)
• Systemic lupus erythematosus (SLE)—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach cramps, pain, or tenderness
• anxiety
• backache
• blistering, peeling, or loosening of the skin
• bloody or clay-colored stools
• changes in skin color
• chest pain or discomfort
• chills or fever
• clear or bloody discharge from the nipple
• cough or sore throat
• darkened urine
• difficulty with speaking
• dizziness, lightheadedness, or confusion
• double vision
• fainting
• fast heartbeat
• fluid-filled skin blisters
• headache, severe and throbbing
• heartburn or indigestion
• heavy bleeding
• inability to move the arms, legs, or facial muscles
• irregular heartbeats
• joint or muscle pain
• loss of appetite
• loss of bladder control
• lump in the breast or under the arm
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasm or jerking of all extremities
• nausea, vomiting, or diarrhea
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• rash, hives or welts
• rectal bleeding
• red, irritated eyes
• redness or swelling of the breast
• sensitivity to the sun
• sore on the skin of the breast that does not heal
• sores, ulcers, or white spots in the mouth or on the lips
• stomach discomfort or upset
• sudden loss of consciousness
• sudden shortness of breath or troubled breathing
• sweating
• swelling of the foot or leg
• tremor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Brown, blotchy spots on exposed skin
• decreased interest in sexual intercourse
• difficulty of wearing contact lenses
• hair loss in the scalp
• increase or decrease in weight
• increased hair growth, especially on the face
• mental depression
• muscle pain or stiffness
• pain or swelling at the injection site
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Premarin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given into a vein or into a muscle. This medicine is not for long-term use.

This medicine comes with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.