Vagifem

Vagifem is an FDA-approved prescription medication used to treat symptoms of perimenopause and menopause, such as vaginal dryness, burning, and irritation. Estradiol hemihydrate, its active ingredient, helps restore the normal structure and function of the vaginal tissues. It comes in the form of a vaginal tablet and is available in strengths of 4 mcg and 10 mcg. Patients are advised to begin Vagifem 10 mcg treatment by inserting it deeply into the vagina using the preloaded, single-use applicator daily for the initial two weeks, followed by a maintenance dose of twice weekly on consistent days, ensuring a three to four-day interval between doses. For personalized advice and guidance, consult a licensed healthcare professional.

Product Overview

Vagifem is a prescription medication containing estradiol, a form of estrogen, designed specifically for the treatment of moderate to severe postmenopausal symptoms such as vaginal dryness, irritation, and burning. By delivering estrogen directly to vaginal tissues, Vagifem helps restore the normal structure and function of the tissues, alleviating discomfort.

Available in vaginal tablet form, Vagifem comes in strengths of 4 mcg and 10 mcg. The recommended initial dosage is 10 mcg, inserted deeply into the vagina using a preloaded, single-use applicator. The typical regimen starts with daily administration for the first two weeks, followed by a weekly maintenance dose. Vagifem can be used by postmenopausal women experiencing symptoms of atrophic vaginitis, with dosage timings flexible for convenience, though consistent dosing times are advised.

Potential side effects include stomach cramps, nausea, weight changes, and more serious conditions like mood changes and unusual vaginal bleeding. Patients should discuss their medical history and any concurrent medications with their healthcare provider to mitigate risks. If a dose is missed, it should be taken as soon as remembered or skipped if close to the next scheduled dose. Store Vagifem at room temperature, away from moisture and direct sunlight. Patients are advised to follow specific disposal instructions to avoid environmental harm.

Uses of Vagifem

It is used to:

• Provide relief from moderate to severe symptoms that occur after menopause, such as burning, irritation, and dryness in and around the vagina. 

How to Use Vagifem?

Dosage

Vagifem is available in the form of a vaginal tablet. It comes in the strength of:

• 4 mcg
• 10 mcg

Recommended Dosage for Vagifem

• Insert Vagifem 10 mcg deep into the vagina using the preloaded, single-use applicator. 
• It is to be used daily for the first two weeks, followed by one maintenance dose twice weekly, as directed by your healthcare provider.
• Generally, women should be started at a dosage strength of 10 mcg. 
• You can use the Vagifem tablet at any time of the day as per your convenience, but it should be taken around the same time every day. 
• For example, you can choose Tuesday and Friday as your dosing days.  
• Leave three or four days between each dose. 

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

You can follow our step-by-step guide to insert the Vagifem tablet for safe and efficient use:

• Vagifem is for vaginal insertion only. Do not take it by mouth. 
• Tear off a single blister pack. 
• Separate the plastic wrapper and remove the single-use applicator from the plastic wrap. Keep your hands completely dry and clean while administering the medication. 
• Ensure that the insert has not come out of the applicator or fallen out of the package. If it has, then put it back into the applicator for insertion. 
• Hold the applicator using your middle finger and thumb. Keep your index finger free to press the plunger. 
• Select the most comfortable position for vaginal insertion. You can lie down with your knees bent or stand up.
• Using the other hand, carefully insert the applicator into the vagina as far as it will comfortably go through the vaginal opening or until half of the applicator is inside your vagina, whichever is less. Stop when you feel some resistance. 
• Once the applicator is properly inserted, gently depress the plunger to eject the insert inside your vagina. 
• Vagifem will stick to the wall of your vagina, and it will dissolve by itself in a couple of hours. 
• After the insertion is done, gently remove the applicator from your vagina and dispose of it safely. 
• The tablet will not fall out if you stand or walk. 
• Carefully follow the dosage schedule prescribed by your doctor or healthcare provider. 

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Vagifem Work?

Vagifem functions by delivering estrogens directly to the vaginal tissue, which helps to alleviate symptoms associated with atrophic vaginitis in postmenopausal women. The vaginal route of administration allows the estrogen to bypass first-pass metabolism in the liver, resulting in more direct and localized effects. This targeted approach helps to restore the vaginal tissue’s normal structure and function, reducing symptoms such as dryness, irritation, and discomfort. 

Important Safety Information

Side Effects

Common side effects of Vagifem may include:

• Stomach cramps
• Vomiting 
• Nausea 
• Weight changes
• Diarrhea 
• Bloating 
• Skin color changes
• Swelling or tenderness of breast
• Vaginal itching or discharge
• Nipple discharge
• Headache 
• Dizziness 
• Flu symptoms
• Acne 
• Spotting or bleeding between periods 
• Swelling of your ankles or feet
• Increased facial hair
• Mental changes or depression 
• Changes in your menstrual periods

Mild side effects of Vagifem may include:

• Irregular vaginal bleeding or spotting
• Breast pain
• Stomach cramps or bloating
• Nausea/vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

Adverse side effects of Vagifem may include:

• Breast lumps
• Mood changes such as depression and memory loss
• Unusual vaginal bleeding, such as breakthrough bleeding, spotting, prolonged or recurrent bleeding
• Severe stomach or abdominal pain
• Increased or new genital itching, odor, irritation or discharge
• Persistent nausea or vomiting
• Yellowing eyes or skin
• Increased urination or thirst
• Dark colored urine
• Swelling in hands, ankles, and feet

[Note: This list may not cover all possible side effects. Always consult with your healthcare provider for medical advice about side effects.]

Warnings

• Estrogen therapy is not recommended for the prevention of dementia or cardiovascular disease.
• The use of estrogens can increase the risk of endometrial cancer. Combining estrogen with progestin as prescribed may reduce this risk. Report any unusual vaginal bleeding to your doctor immediately.
• Estrogens can increase the risk of ovarian cancer, stroke, dementia, and serious blood clots in postmenopausal women. If your doctor prescribes, you can take progestin to decrease the risk. 

Boxed Warning 

• Estrogen-Alone Therapy and Endometrial Cancer Risk: The use of unopposed estrogens increases the risk of endometrial cancer in women with a uterus. Combining estrogen with progestin reduces this risk. Diagnostic measures should be taken to rule out malignancy in women with abnormal vaginal bleeding.
• Cardiovascular Disorders and Probable Dementia: Estrogen-alone therapy is not recommended for the prevention of dementia or cardiovascular disease. Oral conjugated estrogens have been linked to increased risks of deep vein thrombosis and stroke in postmenopausal women aged 50 to 79. Additionally, an increased risk of probable dementia has been reported in women 65 years and older during treatment with conjugated estrogens.
• Estrogen Plus Progestin Therapy: This therapy should also not be used to prevent cardiovascular disease or dementia. It has been associated with increased risks of deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, and probable dementia in postmenopausal women aged 50 to 79.
• Breast Cancer Risk: An increased risk of invasive breast cancer has been noted with estrogen plus progestin therapy. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration, consistent with treatment goals and individual risk assessments.

Precautions

• Before using Vagifem, inform your doctor or pharmacist about any allergies, particularly to estradiol or other allergies you may have. This product may contain inactive ingredients that can cause allergic reactions.
• Discuss your medical history with your healthcare provider, particularly if you have had:
  • Vaginal bleeding of unknown cause
  • Gallbladder disease, asthma, seizures, migraine headaches
  • Lupus, hypothyroidism, or mineral imbalances
  • Cancers such as breast, uterine, or ovarian cancer
  • Blood clots or stroke
  • High blood pressure, diabetes, high cholesterol/triglyceride levels, or obesity
  • Heart disease, including past heart attacks
  • Liver or kidney disease
  • A family history of breast lumps, cancer, or blood clots
  • A personal or family history of angioedema
  • Blood clotting disorders such as protein S or protein C deficiency
  • Hormone problems such as hypoparathyroidism
  • Uterine problems like fibroids or endometriosis
  • Mental/mood disorders, including dementia or depression
  • Porphyria, a specific blood disorder
• Avoid smoking or using tobacco, as combining these with estrogen can increase the risk of stroke, blood clots, high blood pressure, and heart attack, particularly in women over 35.
• Notify your doctor if you will be undergoing surgery or will be immobilized (e.g., during long flights), as these conditions can increase the risk of developing blood clots.
• Use caution when sun exposed, as this medication may cause blotchy, dark areas on your face and skin (melasma). Use sunscreen and protective clothing when outdoors.
• If you are nearsighted or wear contact lenses, monitor for vision problems or difficulty wearing your contacts and consult an eye doctor if issues arise.
• Do not use this medication during pregnancy. If pregnancy occurs while using this medication, inform your doctor immediately.
• Estradiol can pass into breast milk and may affect milk production. Discuss the risks with your doctor before breastfeeding.
• Consult your doctor before discontinuing Vagifem. Discuss the effects of stopping and explore alternative treatments.
• Use estrogen alone or combined with progestogen at the lowest effective dose and for the shortest duration based on treatment goals and individual risk factors.
• Periodically reevaluate the necessity of continued hormone treatment in postmenopausal women.
• Discuss the risks and benefits of hormone therapy with your healthcare provider, as severe side effects, although rare, can occur.
• When used for up to 7 years, estrogens alone do not significantly increase the risk of breast cancer. However, when combined with progestin, the risk of heart disease, stroke, blood clots, dementia, and cancers of the breast and ovaries may increase.
• Regularly consult with your healthcare provider to evaluate the continued need for estrogen therapy, ideally every 3 to 6 months.
• For long-term users, annual physical exams are recommended as part of ongoing monitoring.
• Inform your surgeon if you are using Vagifem before any planned surgery. To decrease the risk of blood clots, you may need to discontinue use approximately 4 to 6 weeks before surgery.
• Consult your healthcare provider about when it is safe to resume Vagifem® following surgery.
• For additional information or concerns regarding the use of this medication, consult your doctor or pharmacist.

Contraindications 

Vagifem is not recommended for use in women with any of the following conditions: 

• A known hypersensitivity to Vagifem or any of its ingredients.
• Undiagnosed abnormal vaginal bleeding
• Has or have breast cancer or is suspected of having it
• Active DVT, PE, or a family or personal history of these conditions. 
• Hepatic impairment or related disease. 
• Have untreated endometrial hyperplasia
• Blood clotting disorder
• Have an inherited blood disorder known as porphyria
• Have a history of heart, liver, and kidney-related diseases. 

Missed Dose

• To achieve the best results from the medication, it is crucial to take it around the same time every day. 
• If you forget to take a dose of Vagifem, take it as soon as you remember.
• However, if it is almost time to take your next dose, you may skip the missed dose and return to your regular dosing schedule. 
• Do not take two or more doses of the same medication to compensate for the missed dose. 
• You can set a reminder on your phone to avoid forgetting your dose. 

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Do not take Vagifem more than recommended by your doctor. Overdose of estrogen may lead to unwelcome symptoms such as vomiting, nausea, breast tenderness, stomach pain, dizziness, fatigue, and withdrawal bleeding from the vagina in women. If someone has taken the insertion more than prescribed, they should discontinue taking the medication and seek symptomatic treatment. 

[Note: If you consumed more than the recommended dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Keep this medication at a controlled room temperature ranging from 20°C to 25°C (68°F to 77°F). 
• Keep this product away from direct sunlight, excess heat, and moisture.
• Keep all medications, including Vagifem, away from the sight and reach of children and pets. 
• Do not keep medicines that are outdated or no longer needed. 
• Do not discard the medication in your garbage bin or throw it in wastewater. 
• Do not flush the medications unless instructed, as it may cause risk to the aquatic environment. 
• If you have doubts about the safe disposal of the medication, consult your pharmacist. 

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

Vagifem Interactions

Vagifem may interact with the following drugs and affect how it may work. 

• Anastrozole 
• Anti-diabetes medications 
• “Azole” antifungals
• Carbamazepine 
• Celecoxib 
• Clarithromycin 
• Clozapine 
• Cobicistat 
• Corticosteroids 
• Efavirenz 
• HIV protease inhibitors 
• HIV NNRTIs
• Lenalidomide 
• Melatonin 
• Mifepristone 
• Modafinil 
• Rifabutin 
• Rifampin 
• St. John’s wort
• seizure medications 
• Tacrolimus  
• Theophylline 
• Thyroid replacements
• Tizanidine 
• Tranexamic acid
• Ursodiol 

[Note: This isn’t a complete list, and there could be other drugs that interact with Vagifem. Tell your doctor about prescription, over-the-counter medicines, and herbal products.]

Vagifem Alternatives

• Premarin (conjugated estrogens)
• Estrace (estradiol)
• Imvexxy (estradiol)
• Estring Vaginal Ring (estradiol)
• Femring (estradiol acetate)
• Osphena (ospemifene)
• Intrarosa (prasterone)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

What are the recommended dosing guidelines for Vagifem, and how should it be administered?

Vagifem should be administered using the preloaded, single-use applicator to insert the tablet deeply into the vagina. The initial treatment involves daily administration for the first two weeks, followed by a maintenance dose twice weekly on consistent days such as Tuesday and Friday, ensuring a three to four-day interval between doses. Always follow your healthcare provider’s instructions for the most accurate dosing schedule.

Can Vagifem be used by all postmenopausal women experiencing vaginal symptoms?

Vagifem is specifically designed for postmenopausal women experiencing symptoms such as vaginal dryness, irritation, and burning. However, it may not be suitable for women with certain health conditions, such as undiagnosed vaginal bleeding, a history of breast or uterine cancer, or those who are susceptible to blood clots. A thorough consultation with a healthcare provider is essential to determine if Vagifem is appropriate for your health profile.

What are the potential side effects of Vagifem, and what should I do if I experience them?

Common side effects of Vagifem include stomach cramps, nausea, weight changes, and more serious effects like mood changes and unusual vaginal bleeding. If you experience any side effects, particularly the more severe ones, it is crucial to contact your healthcare provider immediately. They can guide you on managing side effects and adjusting your treatment if necessary.

How should Vagifem be stored and safely disposed of to ensure environmental safety?

Vagifem should be stored at controlled room temperature, between 20°C to 25°C (68°F to 77°F), away from direct sunlight and moisture. Dispose of expired or unused Vagifem by following the specific disposal instructions provided by your pharmacist and avoiding household garbage bins and wastewater systems to prevent environmental harm. Always check with your healthcare professional for proper disposal methods.

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