Defogen tablet: Each tablet contains 1 milligram of Estriol BP.
Defogen contains the natural female hormone Estriol. Unlike other oestrogens, Estriol is short acting since it has only a short term retention time in the endometrial cells. It substitutes for the loss of estrogen production in menopausal women and alleviates menopausal symptoms. Estriol is particularly effective in the treatment of urogenital symptoms. In case of atrophy of the lower urogenital tract Estriol induces the normalization of the urogenital epithelium and helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the urogenital epithelial cells to infection and inflammation reducing vaginal complaints such as dyspareunia, dryness, itching, vaginal and urinary infections, micturition complaints and mild urinary incontinence.
- Atrophy of the lower urogenital tract related to oestrogen deficiency, notably
For the treatment of vaginal complaints such as dyspareunia, dryness and itching
For the prevention of recurrent infections of the vagina and lower urinary tract
In the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence
- Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery
- Climacteric complaints such as hot flushes and night sweating
- A diagnostic aid in case of a doubtful atrophic cervical smear
- Infertility due to cervical hostility.
Dosage & Administration
The tablet should be swallowed with some water or other drink, preferably at the same time of the day. It is important that the total daily dose is taken at one time.
Atrophy of the lower urogenital tract: 4-8mg per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1-2mg per day) is reached.
Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery: 4-8mg per day in the 2 weeks before surgery; 1-2mg per day in the 2 weeks after surgery.
Climacteric complaints such as hot flushes and night sweating: 4-8mg per day during the first weeks, followed by a gradual reduction. The lowest effective dosage should be used. In case of long-term treatment in women with an intact uterus, monitoring of the the endometrium or, alternatively, concomitant use of a progestagen is recommended (see also Warnings and Precautions section).
A diagnostic aid in case of a doubtful atrophic cervical smear: 2-4mg per day for 7 days before taking the next smear.
Breast tension or pain, nausea, spotting, fluid retention and cervical hypersecretion may occasionally occur. These adverse reactions are usually transient, but may also be indicative of too high a dosage.
In order to prevent endometrial stimulation, the daily dose should not exceed 8 mg nor should this maximum dose be used for longer than several weeks. As for all hormone replacement therapies, yearly medical examination is advisable. With vaginal infections, a concomitant specific treatment is recommended. Patients with any of the following conditions should be monitored; thrombosis, severe liver disorders; porphyria; a history during pregnancy or previous use of steroids of severe pruritus, cholestatic jaundice, herpes gestationis, or otosclerosis.
• Known, past or suspected breast cancer
• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
• Acute liver disease, or a history of liver disease as long as liver function tests failed to return to normal.
Use in Pregnancy & Lactation
During pregnancy: This medicine is contraindicated during pregnancy.
During lactation: Defogen is not indicated during lactation. Estriol is excreted in breast milk and may decrease milk production.
No examples of interactions between estriol and other medicines have been reported in clinical practice. There are, however, indications that estrogens can increase the pharmacologic effects of corticosteroids. If necessary, the dosage of the corticosteroids should be reduced.
Although data are limited it is considered possible that activated charcoal, barbiturates, carbamazepine, griseofuilvin, hydantoins and rifampicin may decrease the effectiveness of estriol.
Conversely, estriol may possibly change the effectiveness of oral anticoagulants, and increase the pharmacologic effects of succinylcholine, theophyllines and troleandomycin.
The acute toxicity of estriol in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting, and withdrawal bleeding in females may develop. No specific antidote is known. Symptomatic treatment can be given if necessary.
Store in a dry & cool place protected from light & moisture. Keep out of reach of children.
Defogen tablet: Each box contains 3 blisters of 10 tablets.