Valestra 1mg Tablet

Uses:

• Hormonal Replacement Therapy:
  • Hypoestrogenism (estrogen deficiency)
  • Symptoms associated with menopause (itching, dryness in the vagina, hot flashes)
• Osteoporosis (thinning of bones)
• Prevention of osteoporosis

How does Valestra 1mg Tablet work?

• Valestra 1mg Tablet replaces the natural Estradiol hormone in the body.
• It serves as a precursor of ovarian hormones, responsible for menstruation and reproduction in women.
• Maintains an adequate level of circulating hormones.

Side Effects of Valestra 1mg Tablet

• Headache
• Bloating
• Hair loss
• Nausea
• Breast pain
• Weight gain
• Irregular vaginal bleeding (in some cases)

Quick Suggestions:

• The dosage of Estradiol varies based on the condition being treated.
• The administration route includes oral and vaginal forms.
• For specific conditions such as prostate cancer, menopausal symptoms, and osteoporosis prevention, different dosages and regimens are prescribed.
• Follow the prescribed dosage and regimen provided by your healthcare provider.
• Regular medical follow-ups may involve attempts to discontinue or taper the medication based on your response and medical condition. Always consult your doctor regarding any changes in your medication.

Indications:

Valestra 1mg Tablet is designed for hormone replacement therapy, specifically addressing symptoms associated with post-menopausal changes. It plays a role in maintaining hormonal balance and alleviating discomfort caused by vasomotor symptoms. It's essential to follow the prescribed dosage and recommendations from your healthcare provider for optimal benefits and safety. If you have any concerns or experience unusual reactions, consult your doctor promptly.

Pharmacology

Valestra 1mg Tablet is a naturally occurring estrogen. Estrogens are responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. They modulate the pituitary secretion of gonadotrophins, LH, and FSH through a negative feedback system.

Dosage & Administration:

Oral:

• Prostate Cancer: 10 mg three times/day for at least 3 months.
• Menopausal Vasomotor Symptoms: 1-2 mg/day on a cyclical or continuous regimen.
• Prevention of Postmenopausal Osteoporosis: 0.5 mg/day in a cyclical regimen.
• Hypogonadism: 1-2 mg/day in a cyclic regimen.

Vaginal:

• Vulvar and Vaginal Atrophy:
  • Insert 2-4 g/day for 2 weeks.
  • Maintenance: 1 g 1-3 times/week.
• Postmenopausal Vaginal Atrophy; Urogenital Symptoms:
  • Insert a ring and keep it in place for 90 days.
• Atrophic Vaginitis:
  • Insert 1 tablet once daily for 2 weeks.
  • Maintenance: 1 tablet twice weekly.

General Recommendations:

• Attempt to discontinue or taper medication at 3-6 monthly intervals.

Important Information on Hormone Therapy

• Hormone therapy should only be continued as long as the benefit in alleviation of severe symptoms outweighs the risk.
• A complete medical history should be taken and a physical examination conducted before the initiation or reinstitution of HRT (Hormone Replacement Therapy). These assessments should be repeated periodically.
• The frequency and nature of examinations should be based on established practice guidelines. Generally, 6-monthly reviews are considered appropriate. Examinations should include pelvic organs, routine cervical cytology, abdomen, breasts, and blood pressure.
• The need for continued therapy should be reconsidered at each review.
• Unless otherwise prescribed by the doctor, 1 tablet of Valestra 1mg Tablet is taken daily, swallowed whole with some liquid.
• Treatment is continuous, with each pack covering 30 days. The next pack follows immediately without a break.
• The timing of tablet intake doesn't matter as long as the patient chooses a particular time and sticks to it every day.
• If a tablet is forgotten at the usual time, it may be taken within the following 12 to 24 hours. Prolonged discontinuation may lead to irregular bleeding.
• Treatment can be initiated at any time, provided pregnancy has been excluded.
• High-dosed and long-term use of unopposed estrogens during the climacteric may increase the incidence of endometrial carcinoma. Progestogen should be added for the last 10-14 days of each month of therapy to avoid endometrial hyperplasia.
• As a general rule, Valestra 1mg Tablet treatment should be discontinued every 6 months to verify the persistence of complaints requiring treatment.
• Adherence to the prescribed dosage and keeping appointments for gynecological check-ups is essential.

Pediatric Uses:

• Pediatric use:  Valestra 1mg Tablet is not indicated for use in children and adolescents.

Patients with Hepatic Impairment:

• Valestra 1mg Tablet has not been studied in hepatic-impaired patients.
• Valestra 1mg Tablet is contraindicated in women with severe hepatic disease.

Overdose Effects of Valestra 1mg Tablet

• Acute toxicity studies indicate that even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected.
• Overdose may cause nausea and vomiting, and withdrawal bleeding may occur in some women.
• Management of acute overdose should be supportive.

Pregnancy:

• Pregnancy category B3. Gynova 2 mg is contraindicated during pregnancy.
• If pregnancy occurs during medication with Valestra 1mg Tablet, treatment must be discontinued immediately.
• In animal studies, maternal administration of high doses of synthetic estrogens produced urogenital malformations in the offspring. However, the relevance of the animal findings for the clinical use of 17b-o Valestra 1mg Tablet is uncertain.

Lactation:

• Valestra 1mg Tablet is contraindicated during lactation.

Drug-Drug Interaction:

• Anti-epileptic medicines: Estradiol may interact with anti-epileptic medicines such as carbamazepine and phenytoin.
• Medicines for infections: Interactions may occur with medicines for infections, including griseofulvin and rifampicin.
• Medicines for viral infections: Estradiol may interact with medicines for viral infections, including efavirenz, ritonavir, and nelfinavir.
• High blood pressure: Interaction with bosentan, a medicine for high blood pressure.
• Blood thinner: Interaction may occur with aspirin, a blood thinner.

Drug-Food Interaction:

• Estradiol is known to interact with grapefruit juice.
• Interaction may occur with St. John’s wort, a natural remedy for depression.

Drug-Disease Interaction:

Inform your doctor if you have a history or current diagnosis of:

• Breast cancer: Estradiol may have implications in patients with breast cancer.
• Vaginal bleeding: Inform your doctor if you have a history of unusual vaginal bleeding.
• Blood clot in the leg (deep venous thrombosis), lungs (pulmonary embolism), and vein (thrombosis): Patients with a history of blood clotting disorders should be cautious.
• Cancer of the endometrium (womb lining): ESTRADIOL may have implications in patients with a history of endometrial cancer.
• Any blood clotting disorder: Caution is advised in patients with blood clotting disorders.
• Recent heart attack: Patients with a recent heart attack should inform their doctor.
• Liver or kidney disease: Estradiol should be used with caution in patients with liver or kidney disease.
• Porphyria: Caution is advised in patients with porphyria, a group of liver diseases.
• High blood pressure: Patients with high blood pressure should inform their doctor.

HRT (Hormone Replacement Therapy) Contraindications:

HRT should not be initiated in the presence of any of the following conditions:

• Pregnancy and Lactation: HRT is contraindicated during pregnancy and lactation.
• Undiagnosed Vaginal Bleeding: If a woman experiences undiagnosed vaginal bleeding, HRT should not be started.
• Known or Suspected Cancer of the Breast: HRT is contraindicated in individuals with known or suspected breast cancer.
• Known or Suspected Premalignant Conditions or Malignancies: HRT should not be used in individuals with known or suspected premalignant conditions or malignancies, especially if sex steroid-influenced.
• Presence or History of Liver Tumors: Individuals with the presence or history of benign or malignant liver tumors should not use HRT.
• Severe Hepatic Disease: HRT is contraindicated in individuals with severe liver disease.
• Acute Arterial Thromboembolism: HRT should not be used in individuals with acute arterial thromboembolism, such as myocardial infarction or stroke.
• Active Deep Vein Thrombosis (DVT) or Thromboembolic Disorders: Individuals with active DVT or a history of thromboembolic disorders should avoid HRT.
• High Risk of Venous or Arterial Thrombosis: Individuals at a high risk of venous or arterial thrombosis should not use HRT.
• Severe Hypertriglyceridemia: HRT is contraindicated in individuals with severe hypertriglyceridemia.
• Idiopathic Cholestatic Jaundice of Pregnancy or Prior History with Oral Contraceptives/HRT: Individuals with idiopathic cholestatic jaundice during pregnancy or a history of jaundice with prior oral contraceptive or HRT use should avoid HRT.
• Otosclerosis with Deterioration During Pregnancy: HRT is contraindicated in individuals with otosclerosis that deteriorates during pregnancy.
• Severe Diabetes with Vascular Changes: HRT should not be used in individuals with severe diabetes accompanied by vascular changes.
• Known Hypersensitivity: Individuals with a known hypersensitivity to any of the components of Gynova 2 mg should not use this medication.

Drug Warnings:

• Allergy: Do not take Estradiol if you are allergic to any of its ingredients.
• Breast cancer: Inform your doctor if you have a history of breast cancer.
• Vaginal bleeding: Notify your doctor in case of a history of unusual vaginal bleeding.
• Blood clot disorders: Inform your doctor if you have a history of blood clot disorders, including deep venous thrombosis, pulmonary embolism, or vein thrombosis.
• Cancer of the endometrium: Caution is advised in patients with a history of cancer of the endometrium (womb lining).
• Blood clotting disorder: Inform your doctor if you have any blood clotting disorder.
• Recent heart attack: Patients with a recent heart attack should notify their doctor.
• Liver or kidney disease: Estradiol should be used with caution in patients with liver or kidney disease.
• Porphyria: Caution is advised in patients with porphyria, a group of liver diseases.
• High blood pressure: Patients with high blood pressure should inform their doctor.
• Pregnancy and breast-feeding: Estradiol is contraindicated in pregnancy. Inform your doctor if you are pregnant or breastfeeding.
• Smoking: Avoid smoking as it greatly increases the risk of blood clots, stroke, and heart attack while taking Estradiol.
• Interactions with grapefruit juice and St. John’s wort: These substances should not be taken along with Estradiol.

Storage Conditions

Store in a cool (below 30°C) and dry place, away from light & children.