Elestrin 0.06% Gel Pump 2 X 26gm
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Use the medication at the same time every day to maintain a consistent routine.
Before and after applying the medication, wash your hands thoroughly.
Apply the medication to clean, dry, and healthy skin on your upper arm and shoulder. Some products may have specific application areas, so be sure to follow the package insert instructions for guidance.
Do not apply the medication to skin with any problems, such as cuts, wounds, or irritations.
Avoid applying the medication to your face, breast, or vagina.
Precautions and Safety Measures
Before using the pump for the first time, prime it according to the manufacturer's instructions.
Avoid exposure to fire, flames, or smoking until the medication is completely dry on your skin.
Allow the medication to dry completely before covering the area with clothing.
Do not bathe, shower, or swim for at least 2 hours after applying the medication.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms and heat sources.
Protect the medication from heat and open flames.
If using a pump, discard any unused medication after the labeled number of doses has been reached.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
However, if it is almost time for your next scheduled dose (less than 12 hours), skip the missed dose and resume your regular application schedule.
* Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply the gel to clean, dry skin on one arm from the wrist to the shoulder. Do not apply to breasts or irritated skin.
- Allow the gel to dry for at least 5 minutes before dressing.
- Avoid contact with the application site by others for at least one hour after application.
- Wash hands thoroughly after application.
- Do not apply to skin that is broken or irritated.
- Avoid smoking, as it increases the risk of serious side effects like blood clots.
- Maintain a healthy diet and regular exercise.
- Attend all scheduled doctor appointments and screenings (e.g., mammograms, pelvic exams).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Abnormal vaginal bleeding
Depression or other mood changes
Memory problems or loss
Fever
Difficulty urinating or changes in urine output
Pain while urinating
This medication may cause fluid retention or swelling in the body. Inform your doctor if you experience swelling, weight gain, or trouble breathing.
Blood Clots and High Calcium Levels
Seek medical attention immediately if you experience:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing
Signs of high calcium levels: weakness, confusion, fatigue, headache, upset stomach or vomiting, constipation, or bone pain (especially in people with cancer)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Painful periods
Common cold symptoms
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
* Changes in sex interest
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, dizziness, or fainting
- Sudden vision changes (e.g., partial or complete loss of vision)
- Chest pain or heaviness, pain spreading to arm or shoulder, nausea, sweating, general ill feeling
- Sudden cough, wheezing, rapid breathing, coughing up blood
- Pain, swelling, warmth, or redness in one or both legs
- Unusual vaginal bleeding or spotting after menopause
- Lump in your breast
- Yellowing of your skin or eyes (jaundice)
- Severe stomach pain
- Memory problems or confusion (especially if over 65)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, consult with your doctor, as this may increase your risk of developing blood clots. Additionally, if you have diabetes, it is crucial to closely monitor your blood sugar levels.
This medication may cause high blood pressure, so it is essential to have your blood pressure checked regularly, as advised by your doctor. You should also have your blood work and bone density checked as directed by your doctor.
Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor. The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
High triglyceride levels have been associated with this medication, so inform your doctor if you have a history of elevated triglyceride levels. This drug may also cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Smoking increases the risk of heart disease, so it is recommended that you do not smoke. Limit your alcohol consumption, and if you regularly drink grapefruit juice or eat grapefruit, consult with your doctor.
In some cases, this medication may affect growth in children and teenagers, so they may require regular growth checks. Consult with your doctor before using other medications or skin products, including soaps. When using the gel form of this medication, avoid applying sunscreen before or soon after application, and do not use sunscreen on the treated area for 7 consecutive days.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding in women
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism of action in breast cancer treatment.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estradiol levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice) - may increase estradiol levels, increasing risk of adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), leading to increased thyroid hormone requirements.
Moderate Interactions
- Corticosteroids (e.g., prednisone) - estrogens may decrease the clearance of corticosteroids, leading to increased effects.
- Warfarin - estrogens may decrease the anticoagulant effect of warfarin; monitor INR.
- Folic acid - estrogens may increase folic acid requirements.
Minor Interactions
- Not specifically noted for minor interactions with significant clinical impact for transdermal estradiol.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, breast cancer, and endometrial cancer.
Timing: Prior to initiation of therapy.
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy.
Rationale: Estrogens are metabolized by the liver; assess baseline hepatic function.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Annually
Target: Normal for age and health status
Action Threshold: Abnormal findings require further investigation (e.g., new breast lump, abnormal bleeding, significant BP elevation).
Frequency: As clinically indicated, based on age and risk factors (e.g., every 1-2 years)
Target: No suspicious findings
Action Threshold: Suspicious findings require further diagnostic workup.
Frequency: Regularly (e.g., every 3-6 months or as clinically indicated)
Target: <130/80 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require dose adjustment or discontinuation.
Frequency: Ongoing patient education and inquiry at each visit
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate medical evaluation.
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast lumps or changes
- Chest pain, shortness of breath, sudden severe headache
- Sudden vision changes
- Pain, swelling, or tenderness in one leg
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Memory loss or confusion (in older women)
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for estrogen therapy in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
Lactation
Contraindicated during lactation. Estrogens are excreted in breast milk and can reduce the quantity and quality of breast milk. Potential adverse effects on the nursing infant are also a concern.
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Increased risk of probable dementia in women 65 years of age or older. Use the lowest effective dose for the shortest duration. Close monitoring for cardiovascular events and dementia is recommended.
Clinical Information
Clinical Pearls
- Elestrin gel should be applied to a clean, dry, intact area of skin on one arm from the wrist to the shoulder. Do not apply to breasts or face.
- Ensure the gel is completely dry before dressing or allowing skin-to-skin contact with others to prevent transfer.
- For women with a uterus, a progestin must be co-administered to reduce the risk of endometrial hyperplasia and cancer.
- Patients should be educated on the signs and symptoms of serious adverse events, particularly blood clots (DVT, PE, stroke, MI), and instructed to seek immediate medical attention if they occur.
- Regular follow-up, including annual physical exams and mammograms, is crucial for women on HRT.
- Consider the patient's individual risk factors for cardiovascular disease, breast cancer, and VTE before initiating and during therapy.
Alternative Therapies
- Other hormone replacement therapies (e.g., conjugated estrogens, synthetic estrogens)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, avoiding triggers for hot flashes)