Valena Estradiol 0.01% Vaginal Cream 16g Tube

✔️ Dosage

• Initial Dosage: Typically, 2 to 4 g (marked on the applicator) daily for one or two weeks.
• Tapering Dosage: After one or two weeks, reduce the dosage to half of the initial dose for a similar duration.
• Maintenance Dosage: Once the vaginal mucosa has been restored, a maintenance dosage of 1 g can be used one to three times a week.

✔️ Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection
• Vaginal irritation, burning, or itching

✔️ Administration

1. Wash your hands thoroughly with soap and water.
2. Open the sealed wrapper and remove the applicator.
3. Insert the tip of the applicator into the tube.
4. Squeeze the tube to fill the applicator with the required amount of gel (2–4 g).
5. Remove the applicator from the tube.
6. Gently insert the rounded tip of the applicator into the vagina.
7. Push the plunger to release the gel.
8. After use, remove the applicator and clean it properly for future use.
   ⚠ Always follow the instructions provided by your healthcare provider.

✔️ Overdose Effects

Overdosage may lead to:

• Nausea
• Vomiting
• Breast tenderness
• Abdominal pain
• Drowsiness and fatigue
• Withdrawal bleeding in women.

Treatment: Discontinue Valena therapy and provide appropriate symptomatic care.

✔️ Interactions

• Decreased Estrogen Plasma Levels: Medications like Phenobarbital, Carbamazepine, and Rifampin may reduce the plasma concentration of estrogens, potentially reducing the effectiveness of Valena.
• Increased Estrogen Plasma Levels: Medications such as Erythromycin, Clarithromycin, Ketoconazole, Itraconazole, Ritonavir, and Grapefruit juice may increase plasma estrogen concentrations, potentially leading to side effects.

✔️ Valena Vaginal Cream should not be used in patients with:

• Undiagnosed abnormal genital bleeding.
• Known or suspected breast cancer or estrogen-dependent neoplasia.
• Active deep vein thrombosis (DVT), pulmonary embolism, or a history of these conditions.
• Active or recent arterial thromboembolic disease (e.g., stroke, heart attack).
• Liver dysfunction or disease.
• Hypersensitivity to any of the ingredients.
• Pregnancy (Valena is not indicated during pregnancy).
  ⚠ Consult with a healthcare provider if you have any of these conditions.

✔️ Pregnancy & Lactation

• Pregnancy: Valena should not be used during pregnancy. There is no indication for its use in pregnant women.
• Lactation: Valena is not recommended during breastfeeding due to potential risks of estrogen exposure to the infant.

✔️ Precautions & Warnings

• Progestin Therapy: Patients using an additional progestin alongside Valena may face an increased risk of endometrial hyperplasia, a precursor to endometrial cancer.
• Increased Risk of Breast Cancer: There may be an elevated risk in women using estrogen therapy.
• Other Health Conditions: Caution should be taken in patients with hepatic impairment, cholestatic jaundice, hypothyroidism, hypocalcemia, or endometriosis. Estrogen therapy may also exacerbate asthma, diabetes, epilepsy, migraine, and certain autoimmune disorders.

✔️ Storage Conditions

• Store below 30°C.
• Keep away from light and moisture, and out of reach of children.