Premarin

The active ingredient in Premarin Vaginal Cream is conjugated estrogens. It is a type of hormone therapy that works by increasing the estrogen levels in the body. Estrogen is a hormone that plays a crucial role in maintaining the health of the tissue of the vagina. During menopause, estrogen levels naturally decline, leading to vaginal discomfort. By applying Premarin Vaginal Cream directly to the vagina, the conjugated estrogens are absorbed into the tissues, helping to relieve inflammation of the vagina (atrophic vaginitis and kraurosis vulvae), with symptoms such as dryness, irritation, and dyspareunia (difficult or painful sexual intercourse).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Premarin Vaginal Cream. However, the following is a synopsis of the general guidelines for the use of Premarin Vaginal Cream:

• Thoroughly wash your hands with water and soap both before and after applying the cream.
• Detach the cap from the tube and secure the applicator.
• Press the bottom of the tube gently to fill up the applicator with the desired amount of cream. The applicator is marked to help measure the dose correctly.
• Detach the applicator from the tube, lie down on your back, and bend your knees.
• Carefully push the applicator deep into the vagina and push the plunger to release the cream.
• After application, separate the plunger from the barrel and clean both parts with water and mild soap. Avoid hot water to prevent damage to the applicator.
• If you forget to apply a dose, do so as soon as you remember. If it's almost time for your next dose, skip the missed dose.
• You may need an annual mammogram (breast x-ray) or breast exam, along with a pelvic exam, unless advised otherwise by your doctor.
• Rubber or latex condoms, cervical caps, and diaphragms may be weakened and become less effective if they come into contact with Premarin Vaginal Cream.

The most common side effects of Premarin Vaginal Cream seen in clinical trials as compared to placebo include:

• Headache
• Irregular vaginal bleeding or spotting
• This may be a sign of endometrial cancer.
• Irregular vaginal discharge or yeast infection
• Breast pain
• Pelvic pain
• Stomach/abdominal cramps or bloating
• Nausea and vomiting
• Loss of hair
• Fluid retention
• Vaginal burning, itching, and irritation after inserting the cream

Some individuals may experience serious side effects while using Premarin Vaginal Cream. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Endometrial cancer (cancer of the uterus/womb)
• There is an increased risk of developing endometrial cancer while taking medications containing estrogens.
• Let your doctor know if you experience any unusual vaginal bleeding. This could be a sign of endometrial cancer.
• Taking a progestin prescribed by your doctor may help decrease your risk of developing this cancer.
• Gallbladder disease
• Blood clots (sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs)
• Stroke
• Sudden/severe headache
• High blood pressure
• Cancer of the ovaries
• Increased triglycerides
• Dementia, especially in patients 65 years of age or older.
• Enlargement of benign tumors of the uterus (fibroids)
• Jaundice
• Discontinue the use of Premarin Vaginal Cream if this occurs.

These are not all of the possible side effects of Premarin Vaginal Cream. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Premarin Vaginal Cream, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Abnormal or unusual vaginal bleeding
• High blood pressure
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism) or clotting disorders
• Breast cancer, known or suspected
• Heart attack
• High cholesterol
• Hereditary angioedema
• Liver disease or liver problems
• Blood disorders such as porphyria
• Epilepsy
• Stroke
• Tumors (estrogen-dependent), known or suspected
• High levels of calcium in your blood
• Have an allergy or have had an allergic reaction to any of its ingredients
• A pregnancy, think you may be pregnant, planning to become pregnant, or are breastfeeding.
• Underactive thyroid (hypothyroidism) or other thyroid conditions
• Have had a hysterectomy with a history of endometriosis
• You may need to take a progestin in conjunction with Premarin Vaginal Cream.

Boxed warnings

Premarin Vaginal Cream carries a boxed warning. It states that using estrogen by itself can increase the risk of developing cancer of the uterus. It is crucial to let your doctor know if you experience unusual vaginal bleeding immediately while using this product. Vaginal bleeding in postmenopausal women can be a sign of uterine cancer.

Additionally, using estrogens, with or without progestins, may increase the chances of getting heart attacks, breast cancer, strokes, or blood clots. Estrogen alone should not be used to prevent heart disease or dementia.

Taking estrogen-alone may increase your chances of developing:

• Blood clots
• Stroke
• Dementia (found from a study on women 65 years of age or older)

Taking estrogen with progestin may increase your chances of developing:

• Strokes
• Heart attacks
• Breast cancer
• Blood clots
• Dementia (found from a study on women 65 years of age or older)

Estrogens, including Premarin Vaginal Cream, are recommended to be used at the lowest effective dose for the shortest duration needed. Regular communication with your healthcare provider is essential to assess the ongoing need for treatment.

• Known or suspected pregnancy
• Known liver disease or dysfunction
• Known protein S, protein C, or antithrombin deficiency, or any other known thrombophilic disorders
• Current or history of stroke or heart attack
• Known anaphylactic reaction or angioedema to Premarin Vaginal Cream
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE, or a history of these conditions
• Known, suspected, or a history of breast cancer
• Known or suspected estrogen-dependent cancer
• Undiagnosed abnormal genital bleeding

Premarin vaginal cream typically begins to show effects within a few weeks. Many women notice initial relief from symptoms within the first two to four weeks of consistent use, although it may take up to eight to twelve weeks to experience the full benefits, especially if symptoms are more severe. It's important to follow the dosage instructions provided by your healthcare provider, as individual responses to the cream can vary. If you have any concerns about its effectiveness or experience side effects, it’s best to consult your healthcare provider.

When Premarin Vaginal Cream is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking so they can check for drug interactions, including:

• Inducers and/or inhibitors of CYP3A4
• These may affect estrogen drug metabolism
• Example: St. John’s wort
• Similar drugs that contain estrogens including estradiol, Premarin tablets, Estrace, and Prempro
• Though not a drug, you should not eat grapefruit or drink grapefruit juice while taking this medication. There is a chance that it will change how much medication is in your body.

This is not an exhaustive list, and there may be other medications that can interact with Premarin Vaginal Cream. Always consult your healthcare provider or pharmacist for personalized advice based on your specific situation.

Premarin Vaginal Cream comes in a 30g tube containing 0.625mg/g of conjugated estrogens. The cream is typically applied once a day for 21 days then off for 7 days, using a special applicator that comes with the medication. It may also be applied twice weekly if you are using it to treat painful intercourse. It is important to follow the instructions provided by your healthcare provider and the medication's packaging carefully.

• Keep the cream in a closed container at room temperature.
• Protect it from heat, moisture, and direct light.
• Do not freeze the cream.
• Keep Premarin Vaginal Cream out of reach of children.
• Do not keep outdated or unused medication. Follow proper disposal guidelines as advised by your healthcare provider or pharmacist.

Premarin Vaginal Cream is manufactured by Pfizer, Inc.

Currently, there is no FDA-approved generic equivalent for Premarin Vaginal Cream.

To stop using Premarin vaginal cream, it's best to work closely with your healthcare provider to create a plan for gradually reducing your dose. They may suggest tapering off the cream rather than stopping suddenly, which can help minimize any return of menopausal symptoms. They’ll consider factors like how long you've been using the cream, your symptom history, and overall health to guide this process. Make sure to follow their recommendations to ensure a smooth transition.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Estrogen medications, including Premarin Vaginal Cream, may have adverse effects on your unborn baby.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Estrogen medications can potentially affect milk production or composition. There is evidence that Premarin Vaginal Cream can pass into your breast milk. Your healthcare provider will assess the potential risks and benefits and provide guidance tailored to your specific situation.