Indications

Indication: Femastin cream is indicated for the deficiency of estrogen. During menopause, the amount of estrogens produced by a woman's body gradually drops. Shortage of estrogens causes the vaginal wall to become thin and dry which leads to painful sexual intercourse. Femastin cream is used to relieve painful sexual intercourse. This is used in postmenopausal women with at least 12 months since their last natural period. If the ovaries are removed surgically (ovariectomy) before menopause, the decrease in estrogen production occurs very abruptly.

Pharmacology

Mechanism of Action: Estriol Cream is a Hormone Replacement Therapy (HRT). It contains the female hormone estriol (an estrogen). During menopause Estriol is used in vagina which is slowly released and absorbed into the surrounding area and into the bloodstream.

Therapeutic Effect: Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. In comparison to other estrogens, estriol is short acting. In the years just before and after the menopause (which can be natural or surgically induced) estriol can be used in the treatment of symptoms and complaints related to estrogen deficiency. Estriol is particularly used in the treatment of urogenital symptoms.

Dosage

General Advice: Estriol cream should be used as per physician's advice. Each dose of cream contains 0.5 mg estriol.

Vulvo-vaginal Complaints: For vulvo-vaginal complaints associated with menopause, initially one dose of cream per day for 3 weeks. Later you may only need one dose of cream twice a week.

Surgical & Diagnostic Prep: Before surgery, one dose of cream daily 2 weeks before the operation. When having a Pap smear your doctor may recommend a daily application of cream for 7 days.

Administration

Application Method: Remove cap from the tube, invert it, and use the sharp point to open the tube. Pull the plunger up to the ring. Now attach it to the opening of the tube. Squeeze the tube slowly to fill the applicator to the ring-mark (where the plunger stops). Remove the tube. To apply the cream, lie down, insert the applicator deep into the vagina, and slowly push the plunger all the way in until the applicator is empty.

Cleaning and Maintenance: After use, pull the plunger out of the barrel beyond the point of resistance and wash both parts in warm, soapy water. Do not use detergents. Rinse well and dry afterwards. Do not put the applicator in hot or boiling water. The applicator can be re-assembled by fully inserting the plunger into the barrel beyond the point where resistance is felt. Discard the applicator once the tube is empty.

Timing and Missed Dose: Take Estriol cream before taking rest or going to sleep. If you forget a dose, use it as soon as you remember. But if you remember your missed dose at the time of your next dose, do not use an extra dose. Do not use a double dose to make up for the missed dose. This may increase the chance of you getting an unwanted side effect.

Interaction

Drug Interactions: Interaction is found with Anticoagulants, corticosteroid hormones, succinylcholine, theophyllines, and medicines for epilepsy, medicines for fungal or bacterial infections, viral infections, and herbal preparations containing St John's Wort. As a result irregular bleeding may occur.

Contraindications

Absolute Contraindications: Do not use Estriol cream if you have or have ever had breast cancer, or if you are suspected of having it, ovarian cancer, heart attack, stroke, angina, liver disease, thrombosis, pulmonary embolism, or vaginal cancer.

Additional Conditions: Do not use if you are pregnant or think you may be pregnant.

Medical History Risks: Do not use if you have any unexplained vaginal bleeding, blood clotting disorder, endometrial hyperplasia, porphyria, and various kind of allergic reaction.

Symptomatic Warnings: Do not use in cases of jaundice, migraine pain, high blood pressure, and breathing problems.

Hypersensitivity: Do not use if you have had an allergic reaction to estriol, or any of the other ingredients of estriol.

Side Effects

Common Reactions: Local irritation or itching of vagina, swelling and increased tenderness of the breasts, increased vaginal discharge, nausea, and fluid retention in the tissues, usually marked by swollen ankles or feet. In most patients these side effects will disappear after the first weeks of treatment. Tell your doctor if vaginal bleeding occurs or if any side effect becomes troublesome or persists.

Severe Risk Factors: Other side effects which may occur with HRT are benign and malignant hormone-dependent tumors such as endometrial cancer, heart attack and stroke, gall bladder disease, skin problems such as rashes, discoloration or red patches on the skin, various skin diseases with blisters and nodules or bleeding into the skin, venous thromboembolism or deep leg or pelvic venous thrombosis, and pulmonary embolism. Using HRT for several years slightly increases the risk of breast cancer.

Pregnancy & Lactation

Usage Warning: This medicine is contraindicated during pregnancy & lactation.

Precautions & Warnings

Clinical Monitoring: Patients should keep under doctor’s observation for any Hormone Replacement Therapy (HRT). Same role is applicable for the application of Femastin cream. Doctor will give continuous advice regarding risks & benefits of the drug.

Discontinuation Triggers: In case of jaundice, sudden high blood pressure, migraine, severe headache or pregnancy, the use of Femastin cream will be stopped immediately.

Age Restriction: Children are not allowed to use Femastin cream.

Therapeutic Class

Classification: Drugs for Infertility, Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones.

Storage Conditions

Storage Instructions: Store below 25°C. Protect from light and moisture. Keep out of reach of children.