Estrogens are hormones produced by the body. Among other things, estrogens help develop and maintain female organs.
When your body is in short supply of this hormone, replacing it can ease the uncomfortable changes that occur in the vagina, vulva (female genitals), and urethra (part of the urinary system). Conditions that are treated with vaginal estrogens include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), and inflammation of the urethra (atrophic urethritis).
Estrogens work partly by increasing a normal clear discharge from the vagina and making the vulva and urethra healthy. Using or applying an estrogen relieves or lessens:
Dryness and soreness in the vagina
Itching, redness, or soreness of the vulva
Feeling an urge to urinate more often then is needed or experiencing pain while urinating
Pain during sexual intercourse
When used vaginally or on the skin, most estrogens are absorbed into the bloodstream and cause some, but not all, of the same effects as when they are taken by mouth. Estrogens used vaginally at very low doses for treating local problems of the genitals and urinary system will not protect against osteoporosis or stop the hot flushes caused by menopause.
Estrogens for vaginal use are available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Indications And Clinical Use
Oestroform Vaginal Cream is prescribed in the treatment of menopausal and post menopausal symptoms.
Oestroform Vaginal Cream should be prescribed with an appropriate dosage of a progestin for women with intact uteri to prevent endometrial hyperplasia/carcinoma.
Oestroform Vaginal Cream is intended for short term use.
Geriatrics ( > 65 years of age): See above INDICATIONS
Pediatrics ( < 16 years of age): Oestroform Vaginal Cream is not indicated for use in children.
Oestroform, one of the major mammalian estrogens, is an aromatized C18 steroid with a 3-hydroxyl group and a 17-ketone. It is produced in vivo from androstenedione or from testosterone via estradiol. It is produced primarily in the ovaries, placenta, and in peripheral tissues (especially adipose tissue) through conversion of adrostenedione. Oestroform may be further metabolized to 16-alpha-hydroxyestrone, which may be reduced to estriol by estradiol dehydrogenase.
Estrogens are usually prescribed in a cyclical regimen of 25 days on drug followed by 5 days off or in a continuous uninterrupted therapy.
The treatment is initiated by the patient at a time of day convenient to the patient. Repeat dosages should coincide with this chosen schedule.
Recommended Dose and Dosage Adjustment
The recommended dose is 2.0 to 4.0 g intravaginally per day, adjusted to the lowest amount that controls symptoms. Oestroform Vaginal Cream is intended for short-term use.
If a dose has been clearly missed it is safer to restart at the time of the next dose. Do not double dose.
Oestroform Vaginal Cream is administered with the use of the supplied vaginal applicator, which consists of a calibrated plunger and a barrel. The applicator is calibrated in half gram increments to measure and deliver 0.5 to 4.0 grams of cream.
Instructions for the proper use of the supplied vaginal applicator: Before piercing the tube, screw the applicator barrel to the tube. Repeat this at least twice to ensure that the applicator screws on with ease.
Fill the applicator by proceeding as follows: use the inversed cap to pierce the tube seal. Screw the applicator barrel firmly to the tube with the plunger fully in. Squeeze the tube to fill cream into the barrel. Measure the required amount of cream by aligning the line calibrator on the plunger to the barrel end.
Inserting the vaginal applicator with cream: patients should be lying on their back. Using either hand, grasp the barrel of the applicator firmly with thumb and middle finger. Do not push the plunger with the index finger until after the applicator is in the proper position in the vagina. Pointing the applicator slightly downward, insert it deeply into the vagina as far as it will comfortably go without using force. Now, push the plunger all the way down to deposit the cream in the vagina. Withdraw the applicator from the vagina when the cream has been deposited
Care of the applicator: Separate the plunger from the barrel by pulling it all the way out. Wash both sections of the applicator thoroughly with mild detergent and warm water, allowing the water to flow through the barrel to rinse well. Sterilisation of the applicator is not necessary and extremely hot water should not be used because it may soften the plastic applicator. Dry the applicator and store it in a clean place.
Caution: the applicator should be used only on the advice of a physician.
Oestroform Vaginal Cream should be prescribed with an appropriate dosage of a progestin for women with intact uteri in order to prevent endometrial hyperplasia/carcinoma. Progestin therapy is not required as part of hormone replacement therapy in women who have had a previous hysterectomy.
Storage And Stability
Store at room temperature between 15°C and 30°C. Avoid freezing as it may cause the cream to separate destroying its properties.
Dosage Forms, Composition And Packaging
Oestroform Vaginal Cream is a vaginal cream containing 0.1% Oestroform. If used continuously then lower the dosage to the lowest amount that controls the symptoms. Oestroform Vaginal Cream comes only in 0.1% w/w concentration of Oestroform.
Non medicinal ingredients are as follows: arlacel 165, isopropyl myristate, methyl paraben, mineral oil, Peg 40 stearate, propyl paraben, sorbitan monostearate, stearic acid, water.
Oestroform Vaginal Cream is available as a 45g size tube and comes complete with 0 to 4 gram applicator calibrated in 0.5g increments. Included in the boxed package are the detailed applicator instructions on its use and its hygienic maintenance.
Interactions for Vitamin B6 (Oestroform)
Amiodarone: Concomitant use of vitamin B6 and amiodarone may enhance amiodarone-induced photosensitivity reactions. Doses of vitamin B6 greater than 5-10 milligrams/day should be avoided by those taking amiodarone Carbamazepine: Chronic use of carbamazepine may result in a significant decrease in plasma pyridoxal 5-phosphate levels Cycloserine: Cycloserine may react with pyridoxal 5-phosphate to form a metabolically inactive oxime, which may result in a functional vitamin B6 deficiency Ethionamide: The use of ethionamide may increase vitamin B6 requirements Fosphenytoin: High doses of vitamin B6 may lower plasma levels of phenytoin. Fosphenytoin is a prodrug of phenytoin Hydralazine: The use of hydralazine may increase vitamin B6 requirements Isoniazid: (isonicotinic acid, INH). Isoniazid reacts with pyridoxal 5-phosphate to form a metabolically inactive hydrazone, which may result in functional vitamin B6 deficiency Levodopa: Concomitant use of levodopa and vitamin B6 in doses of 5 milligrams or more daily may reverse the therapeutic effects of levodopa. Vitamin B6 does not reverse the therapeutic effects of levodopa if levodopa is taken concurrently with the levodopa decarboxylase inhibitor carbidopa. Levodopa is typically administered as a combination product with carbidopa
Oral contraceptives: The use of oral contraceptives may increase vitamin B6 requirements. This was more the case with the older oral contraceptive agents with high-dose estrogen/progestin. It appears to be less the case with the newer low-dose estrogen/progestin products Penicillamine: Penicillamine may react with pyridoxal 5-phosphate to form a metabolically inactive thiazolidine, which may result in a functional vitamin B6 deficiency Phenelzine: Phenelzine may react with pyridoxal 5-phosphate to yield a metabolically inactive hydrazone compound Phenobarbital: High doses of vitamin B6 may lower plasma levels of phenobarbital Phenytoin: High doses of vitamin B6 may lower plasma levels of phenytoin Theophylline: Theophylline may react with pyridoxal 5-phosphate leading to low plasma levels of the coenzyme. This may increase the risk of theophylline-induced seizures Valproic acid: Chronic use of valproic acid may result in a significant decrease in plasma pyridoxal 5-phosphate levels.
Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur.
Nervous system disorders
Aggravation of migraine episodes; headaches; dizziness; neuritis.
Mental depression; nervousness; irritability.
Renal and urinary disorders
Cystitis; dysuria; sodium retention; edema.
Reproductive system and breast disorders
Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; breast swelling and tenderness.
Skin and subcutaneous tissue disorders
Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; haemorrhagic eruption; loss of scalp hair; hirsutism and acne.
Case# 2- Complaint of inflammation and vaginal discharge.
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
Liver dysfunction or disease as long as liverfunction tests have failed to return to normal.
Known or suspected estrogen-dependent or progestin-dependent malignant neoplasia (e.g. endometrial cancer )
Known, suspected, or past history of breast cancer
Undiagnosed abnormal genital bleeding
Known or suspected pregnancy
Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease.)
Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis.
Partial or complete loss of vision due to ophthalmic vascular disease
The mineral oil found in Oestroform Vaginal Cream is not compatible with the latex rubber found in most condoms.
DailyMed. "ESTRONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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