Delestrogen 20mg/ml Inj,5ml

Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates estrogen receptors (ERα and ERβ) in target tissues, including the reproductive tract, breast, bone, and brain. This binding leads to gene transcription and protein synthesis, mediating the physiological effects of estrogens, such as the development and maintenance of the female reproductive system and secondary sex characteristics. In menopausal women, it replaces declining endogenous estrogen levels.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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, leading to swelling or weight gain. If you experience swelling, weight gain, or trouble breathing, inform your doctor.

Blood Clots and High Calcium Levels

Seek medical attention immediately if you experience signs of a blood clot, such as:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing

High calcium levels have been reported in some people with cancer taking this medication. If you experience signs of high calcium levels, such as weakness, confusion, fatigue, headache, upset stomach or vomiting, constipation, or bone pain, contact your doctor right away.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, 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
* Irritation at the site of administration

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ 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 suspected 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.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity 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 directed by your doctor. You should also have your blood work and bone density checked as recommended 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 to use sunscreen and protective clothing and eyewear.

This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this drug. Smoking can increase the risk of heart disease, so it is recommended that you do not smoke; discuss this with your doctor. 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; discuss this with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use may reduce efficacy of aromatase inhibitors.
• Tranexamic acid - increased risk of thrombosis.

• CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estrogen levels and efficacy.
• CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice) - may increase estrogen levels and adverse effects.
• Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin, potentially increasing thyroid hormone requirements.
• Anticoagulants (e.g., warfarin) - estrogens may decrease the anticoagulant effect of warfarin; monitor INR.

• Corticosteroids - estrogens may increase the half-life of corticosteroids, leading to increased effects.
• Cyclosporine - estrogens may inhibit cyclosporine metabolism, increasing its levels and toxicity.
• Folic acid - estrogens may interfere with folate metabolism.

• Not available

• Signs of thromboembolic events (e.g., sudden chest pain, shortness of breath, leg pain/swelling, sudden severe headache, vision changes)
• Signs of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, trouble walking)
• Signs of myocardial infarction (e.g., chest pain, discomfort in other areas of upper body, shortness of breath)
• Abnormal vaginal bleeding or spotting
• Breast lumps or changes
• Persistent nausea, vomiting, or abdominal pain (may indicate liver issues)
• Jaundice (yellowing of skin or eyes)
• Severe headaches or migraines
• Mood changes, depression

Contraindicated in pregnancy. There is no indication for estrogen therapy during pregnancy, and there is evidence of fetal harm (e.g., genital abnormalities in female fetuses exposed to diethylstilbestrol).

Not recommended 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 unknown but possible.

Use in pediatric patients is generally limited to specific conditions such as primary ovarian failure or hypogonadism, where it is used to induce puberty and maintain secondary sexual characteristics. Dosing must be carefully individualized and monitored by a specialist. Safety and efficacy in children for other indications have not been established.

Women 65 years of age or older have an increased risk of probable dementia when treated with estrogen-alone or estrogen plus progestin therapy. The risks of stroke and deep vein thrombosis are also increased in this population. Use the lowest effective dose for the shortest duration consistent with treatment goals and risks.

• Delestrogen (Estradiol Valerate Injection) provides a sustained release of estradiol, making it suitable for less frequent dosing (typically every 4 weeks) compared to oral or transdermal estrogens.
• Always administer intramuscularly (IM) into a large muscle (e.g., gluteal muscle) to ensure proper absorption and minimize local reactions.
• For women with an intact uterus, progestin therapy must be added to estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.
• Counsel patients extensively on the Black Box Warnings, particularly the increased risks of cardiovascular events, stroke, breast cancer, and dementia.
• Regular follow-up appointments are crucial for monitoring efficacy, adverse effects, and adherence to screening guidelines (e.g., mammograms, pelvic exams).
• Consider alternative routes of estrogen administration (e.g., transdermal patches, gels, vaginal rings) for patients who prefer to avoid injections or who may have specific risk factors where other routes might offer a different safety profile (e.g., lower VTE risk with transdermal).
• This formulation is not typically used for contraception.

• Other estrogen formulations (oral estradiol, conjugated estrogens, transdermal estradiol patches/gels/sprays, vaginal estradiol creams/tablets/rings)
• Selective Estrogen Receptor Modulators (SERMs) for specific indications (e.g., ospemifene for dyspareunia, bazedoxifene/conjugated estrogens for vasomotor symptoms with intact uterus)
• Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs, gabapentin, clonidine)
• Testosterone therapy (off-label for some symptoms of hypoestrogenism)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.