Active ingredients: Promestriene
COLPOTROPHINE 1% vaginal cream
Colpotrophine package inserts are available for pack sizes:- COLPOTROPHINE 1% vaginal cream
- COLPOTROPHINE 10 mg vaginal capsules
Why is Colpotrophine used? What is it for?
Pharmacotherapeutic group
Unassociated semisynthetic estrogens.
Therapeutic indications
- Vulvo-cervico-vaginal atrophic and dystrophic states (estrogen deficiency vaginitis, senile vulvo-vaginitis, vulvar itching, vulvar craurosis, etc.).
- Delays in cervico-vaginal and vulvar healing in post-partum, in gynecological surgery, etc.
Contraindications When Colpotrophine should not be used
Known or suspected breast or endometrial cancer, or other estrogen dependent neoplasms; endometriosis; vaginal bleeding of unknown origin; severe liver, kidney and heart disease; thrombophlebitis, thrombosis or thromboembolic processes in place or in the anamnesis, ascertained or presumed pregnancy, hypersensitivity to the components or to other closely related substances from a chemical point of view. Generally contraindicated during breastfeeding.
Precautions for use What you need to know before taking Colpotrophine
Before starting therapy, carry out a thorough medical and gynecological examination, with palpation of the breasts and rule out the presence of a pregnancy
Caution is advised when prescribing promestriene to women with a family history of breast cancer and fibrocystic mastopathy.
A Papanicolau smear should be performed and suspected or confirmed cases of dysplasia should be excluded.
The use of estrogens requires caution in case of asthma, epilepsy, heart disease, hypertension, nephropathy or severe depression in current or previous history. Treatment must be suspended immediately upon the appearance of the first signs of thrombotic or embolic disorders, of hypertension in a previously normal patient. - o hypotension, of hypercalcaemia in women with breast cancer, of colostatic jaundice in patients with a history of jaundice gravidarum In diabetic women, appropriate precautionary measures should be taken as estrogens can reduce glucose tolerance.
In case of concomitant vaginal infection, the use of specific preparations or anti-inflammatory drugs is recommended.
Interactions Which drugs or foods can modify the effect of Colpotrophine
None.
Warnings It is important to know that:
- Use under medical supervision.
- The use, especially if prolonged, of the product can give rise to sensitization phenomena. In this case, suspend the treatment and start a suitable therapy. To avoid prolonged stimulation of the effector organs, it is advisable to administer Colpotrophine in cycles spaced by an adequate period of suspension. In the case of prolonged therapies, carry out careful checks every 6 months (including endometrial biopsy). Products containing estrogens can exert anabolic effects and determine salt and water retention and hyperglycemia. The onset of a metrorrhagia requires a careful review of the case including a " possible biopsy to exclude the existence of a malignant neoplasm of the uterus.
- In women who are breastfeeding, it is necessary to decide whether to give up breastfeeding the infant or, vice versa, to continue breastfeeding without administering the drug.
- Topical preparations containing estrogen can cause oozing, vaginal candidiasis, changes in the cervical secretion; worsening of a possible endometriosis, mastodynia, breast enlargement or discharge, colostatic jaundice, increase in previous allergic rashes or itching.
Dosage and method of use How to use Colpotrophine: Dosage
Apply on the area to be treated 1-2 times a day 1 g of cream for treatment cycles of 20 days.
In the external application follow a light massage, in the endovaginal application use the reusable applicator attached to the package.
Instructions for using the applicator
Screw the applicator onto the open tube.
Fill the applicator by applying light pressure on the tube until the plunger stops at the mark. In this way the applicator will be filled with 1 g of cream.
Unscrew the applicator and insert it deeply into the vagina: then empty it by applying firm pressure on the plunger.
After use, carefully wash the applicator with lukewarm water, taking care to remove the plunger from the body of the applicator itself, pushing it from the opposite side to the filling one.
Overdose What to do if you have taken too much Colpotrophine
There are no known effects attributable to overdose of Colpotrophine
Side Effects What are the side effects of Colpotrophine
Slight burning sensation in the vaginal area, accompanied or not by transient redness, especially after prolonged use in particularly sensitive patients.
Any occurrence of any undesirable effect not described in this leaflet during treatment must be promptly reported to the treating physician or pharmacist.
Expiry and Retention
Warning: do not use the medicine after the expiry date shown on the package.
Do not store above 25 ° C.
Composition and pharmaceutical form
Composition
Promestriene 1%.
Excipients:
mixture of mono- and diglycerides of saturated fatty acids, polyglycol ether of saturated fatty alcohols, decyl ester of oleic acid, triglycerides of saturated fatty acids with a length between C8 and C10, glycerin, methyl sodium p-hydroxybenzoate, propyl sodium p-hydroxybenzoate, purified water.
Pharmaceutical form and packaging
Vaginal cream. 30g tube and reusable applicator.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
COLPOTROPHINE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vaginal cream:
100 g of cream contains 1 g promestriene.
Vaginal capsules:
Each capsule contains 10 mg promestriene.
03.0 PHARMACEUTICAL FORM
Vaginal cream
Vaginal capsules
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Vulvo-cervico-vaginal atrophic and dystrophic states (estrogen deficiency vaginitis, senile vulvo-vaginitis, vulvar itching, vulvar craurosis, etc.). Delays in cervico-vaginal and vulvar healing in post-partum, in gynecological surgery, etc.
04.2 Posology and method of administration
Colpotrophine vaginal cream: apply on the area to be treated 1-2 times a day 1 g of cream for treatment cycles of 20 days. In the external application, follow a light massage; in the endovaginal use, use the special calibrated applicator to contain 1 g of cream.
Instructions for using the applicator:
Screw the applicator onto the open tube.
Fill the applicator by applying light pressure on the tube until the plunger stops at the mark. In this way the applicator will be filled with 1 g of cream.
Unscrew the applicator and insert it deeply into the vagina: then empty it, applying firm pressure on the plunger.
After use, carefully wash the applicator with lukewarm water, taking care to remove the plunger from the body of the applicator itself by pushing on the opposite side to the filling one.
After use, the applicator must be disassembled and washed with warm water.
Colpotrophine vaginal capsules: 1 capsule per day introduced deeply into the vagina for 20-day treatment cycles.
04.3 Contraindications
Known or suspected breast or endometrial cancer, or other estrogen dependent neoplasms; endometriosis; vaginal bleeding of unknown origin; severe liver, kidney and heart disease; thrombophlebitis, thrombosis or thromboembolic processes in progress or during anamnesis; ascertained or presumed pregnancy; hypersensitivity to the components or to other closely related substances from a chemical point of view. Generally contraindicated during lactation.
04.4 Special warnings and appropriate precautions for use
Before starting therapy, carry out a thorough medical and gynecological examination, with palpation of the breasts, and rule out the presence of a pregnancy.
Caution is advised when prescribing promestriene to women with a family history of breast cancer and fibrocystic mastopathy.
A Papanicolau smear should be performed and suspected or confirmed cases of dysplasia should be excluded.
The use of estrogens requires caution in case of asthma, epilepsy, heart disease, hypertension, kidney disease or severe depression in place or in the past. Treatment must be suspended immediately upon the appearance of the first signs of thrombotic or embolic disorders, of hypertension in a previously normal patient. - or hypotension, of hypercalcaemia in women with breast cancer, of cholestatic jaundice in patients with a history of jaundice gravidarum In diabetic women, appropriate precautionary measures should be taken as estrogens can reduce glucose tolerance.
In case of concomitant vaginal infection, the use of specific preparations or anti-inflammatory drugs is recommended.
The use, especially if prolonged, of the product can give rise to sensitization phenomena. In this case, suspend the treatment and start a suitable therapy. To avoid prolonged stimulation of the effector organs, it is advisable to administer Colpotrophine in cycles spaced by an adequate period of suspension. In case of prolonged therapies, carry out careful checks every 6 months (including endometrial biopsy). The onset of metrorrhagia requires a careful re-examination of the case including any biopsy to exclude the existence of a malignant neoplasm of the uterus.
Topical preparations containing estrogen can cause oozing, vaginal candidiasis, changes in the cervical secretion; worsening of any endometriosis, mastodynia, breast enlargement or discharge, cholestatic jaundice, increased previous allergic rashes or itching.
04.5 Interactions with other medicinal products and other forms of interaction
Drug interactions and incompatibilities with other drugs are neither known nor foreseeable.
04.6 Pregnancy and lactation
Use in pregnancy is contraindicated.
In women who are breastfeeding, it is necessary to decide whether to give up breastfeeding the infant or, vice versa, to continue breastfeeding without administering the drug.
04.7 Effects on ability to drive and use machines
The product does not cause any interference.
04.8 Undesirable effects
Slight burning sensation in the vaginal area, accompanied or not by transient redness, especially after prolonged use in particularly sensitive patients.
04.9 Overdose
Products containing estrogen can exert anabolic effects and determine salt and water retention and hyperglycemia.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Promestriene is a synthetic estrogen used exclusively for local application; it exerts a marked trophic activity at the level of the genital mucosa without exerting systemic hormonal effects.
05.2 "Pharmacokinetic properties
After skin application less than 1% of the amount of promestriene applied reaches the systemic circulation; the biological half-life is less than 24 hours. Promestriene does not give rise to accumulation phenomena.
05.3 Preclinical safety data
Promestriene is to be considered practically devoid of acute toxicity: it was not possible to determine a LD50 value after topical administration in mice and rats of quantities between 2.5 g / kg and 13.3 g / kg and after oral administration of 1 , 2 - 2.0 g / kg. Prolonged intravaginal administration for 60 days of 500 mg / kg / day in rats and dogs did not show toxic phenomena.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Vaginal cream
Mixture of mono- and diglycerides of saturated fatty acids; polyglycol ether of saturated fatty alcohols; decyl ester of oleic acid; triglycerides of saturated fatty acids having a length between C8 and C10; glycerin; sodium methyl p-hydroxybenzoate; sodium propyl p-hydroxybenzoate; purified water.
Vaginal capsules
Perhydrogenated polyisobutene; Vaseline; sorbitol sesquioleate; anhydrous colloidal silica; sodium methyl p-hydroxybenzoate; sodium propyl p-hydroxybenzoate; jelly; glycerol; silicone oil 1000; purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
Vaginal cream: 5 years
Vaginal capsules: 4 years
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Colpotrophine vaginal cream: flexible aluminum tube internally protected by a layer of "Araldite" (epoxy resin-based paint added to small quantities of phenolic, melanin and urea resins) and closed with a polypropylene screw cap.
Tube with 30 g of cream with applicator calibrated to 1 g
Colpotrophine vaginal capsules: 2 PVC blisters; each blister contains 10 vaginal capsules.
06.6 Instructions for use and handling
Colpotrophine vaginal cream: vaginal use must be carried out using the special calibrated applicator to contain 1 g of cream.
07.0 MARKETING AUTHORIZATION HOLDER
Ratiopharm Italia S.r.l - Viale Monza, 270 - 20128 Milan
Dealer for sale
Teva Italia S.r.l. - Via Messina, 38 - 20154 Milan
08.0 MARKETING AUTHORIZATION NUMBER
20 vaginal capsules 10 mg AIC n. 026613051
Vaginal cream 30 g + AIC applicator n. 026613048
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Capsules 30.07.1987 / 01.06.2010
Cream 08.07.1988 / 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
July 2014
