FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY
CREAM For intravaginal use only
Composition
Each gram contains Estriol BP 1 mg
Characteristics
Pharmacodynamic properties
Evalon cream contains the natural female hormone estriol. 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 effective in the treatment of urogenital symptoms. In case of atrophy of the lower urogenital tract, est 1 lot 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.
Unlike other estrogens, estriol is short-acting since it has only a short retention time in the nuclei of endometrial cells. Therefore, no endometrial proliferation is to be expected when the total recommended daily dose is taken at one time. Hence, cyclic administration of a progestogen is not necessary, and postmenopausal withdrawal bleedings do not occur.
Pharmacokinetic properties
Intravaginal administration of estriol ensure optimal availability at the site of action. Estriol is also absorbed into the general circulation, as is shown by a sharp rise in the plasma levels of unconjugated estriol. Peak plasma levels are reached 1 -2 hours after application. Nearly all (90%) estriol is bound to albumin in the plasma and in contrast with other estrogens, hardly any estriol is bound to sex hormone-binding globulin. The metabolism of estriol consists principally of conjugation and deconjugation during the enterohepatic circulation. Estriol, being a metabolic end product, is mainly excreted via the urine in the conjugated form. Only a small part (± 2%) is excreted via the faeces, mainly as unconjugated estriol. Indications
• Atrophy of the lower urogenital tract related to estrogen 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 miction complaints (such as frequency and dysuria) and mild urinary incontinence.
- Pre and postoperative therapy in postmenopausal women undergoing vaginal surgery.
- A diagnostic aid in case of doubtful atrophic cervical smear. Dosage
- For atrophy of the lower urogenital tract:
1 application per day for 2-3 weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 application twice a week) is reached.
- As pre and postoperative therapy in postmenopausal women undergoing vaginal surgery:
1 application per day in the 2 weeks before surgery; lapplication twice a week in the 2 weeks after surgery.
- As a diagnosticaid in case of doubtful atrophic cewical smear: 1 application on alternate days in the week before taking the next smear.
A missed dose should be administered as soon as remembered, unless the missed dose is noticed at the day of the next dose. In the latter case the missed dose should be skipped and the regular dosing scheme continued. Two doses must never be administered on the same day.
Administration
Evalon cream should be administered intravaginally by means of a calibrated applicator before retiring at night. 1 application (applicator filled to the ring mark) contains 0.5 g of Evalon cream which corresponds with 0.5 mg estriol.
Contraindications
- Pregnancy
- Known or suspected estrogen-dependent tumours.
- Undiagnosed vaginal bleeding Pregnancy and lactation
This medicine is contraindicated during pregnancy. There are insufficient data on the use of this medicine dunng breast-feeding to assess potential harm to the infant. It is known, however, that estriol is excreted in breast milk and may decrease milk production.
Warnings and precautions
- In order to prevent endometrial stimulation, the daily dose should not exceed 1 application (0.5 mg estriol) 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 liverdisorders; porphyria,
a history dunng pregnancy or previous use of steroids of severe pruritus, cholestatic jaundice, herpes gestationis or otosclerosis.
Interactions
No examples of interactions between Evalon 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 barbiturates, carbamazepine, griseofulvin, 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.
Effects on ability to drive and use machines
As far as is known Evalon has no effect on alertness and concentration.
Adverse reactions
As with any product that is to be applied to mucosal surfaces, Evalon cream may occasionally cause local irritation or itching. Breast tension or pain may occasionally occur. These adverse reactions are usually transient, but may also be indicative of too high a dosage.
Overdose
The acute toxicity of estriol in animals is very low. Overdose with Evalon cream after vaginal administration is unlikely. However, should large quantities be ingested, nausea, vomiting and withdrawal bleeding in females may develop. No specific antidote is known. Symptomatic treatment can be given if necessary.
Instructions for use for the patient
1. Apply the vaginal cream before retiring at night.
2. Remove cap from the tube, invert it and use the sharp point to open the tube.
4. Squeeze tube to fill the applicator with the cream until the plunger stops.
5, Unscrew applicator from tube and replace cap on tube.
6. To apply cream, lie down, insert end of applicator deep into the vagina and slowly push plungerallthewayin
After use, pull plunger out of barrel and wash both in warm, soapy water.
Do not use detergents, Rinse well afterwards.
DO NOT PUT THE APPLICATOR IN HOT OR BOILING WATER
Manufactured by ORGANON ( INDIA) LIMITED
At 182, Acharya Jagadish Chandra Bose Road 5
Kolkata-700 014 3
DESTROY CONTAINER/CARTON TO PREVENT MISUSE.
EVC/PI/1207/4