CYPROTERONE ACETATE 2 MG + ETHINYLESTRADIOL 0.035 MG TABLET

BRAND NAME-FEMIWISE-35 TABLETS

COMPOSITION: CYPROTERONE ACETATE 2 MG + ETHINYLESTRADIOL 0.035 MG TABLET

PACKING: 10*2*21 BLISTER

CYPROTERONE ACETATE


Cyproterone acetate is a steroid used in combination with ethinyl estradiol to treat women with severe acne and symptoms of androgenization. Also used alone at much higher doses for palliative treatment of patients with prostate cancer


CYPROTERONE is An anti-androgen that, in the form of its acetate (cyproterone acetate), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females.

MECHANISM OF CYPROTERONE ACETATE

Cyproterone is an antiandrogen. It suppresses the actions of testosterone (and its metabolite dihydrotestosterone) on tissues. It acts by blocking androgen receptors which prevents androgens from binding to them and suppresses luteinizing hormone (which in turn reduces testosterone levels).

ETHINYLESTRADIOL

Ethinylestradiol is a man-made form of the naturally occurring female hormone called oestrogen. It is prescribed to treat period (menstrual) problems, and also to help ease menopausal symptoms. It is usually prescribed alongside another female hormone called a progestogen.

Ethinylestradiol is used to supplement or replace the body’s natural oestrogen. It helps to relieve many of the problems associated with the menopause, such as hot flushes, night sweats and vaginal dryness. It can also help to protect against ‘thinning’ of the bones (osteoporosis) although other treatments are usually preferred for this.

CONTRACEPTIVE EFFECT OF ETHINYLESTRADIOL

Ethinylestradiol is a synthetic estrogen that decreases luteinizing hormone to decrease endometrial vascularization, and decreases gonadotrophic hormone to prevent ovulation.It has a long duration of action as it is taken once daily, and a wide therapeutic index as overdoses are generally not associated with serious adverse effects

Posology and method of administration of FEMIWISE-35 Tablets

Femiwise-35 tablets inhibits ovulation and thereby prevents conception. Patients who are using Femiwise-35 tablets should not therefore use anadditional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessaryfor effective contraception.


First treatment course:
One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).


Subsequent courses:
Each subsequent course is started after 7 tablet-free days have followed the preceding course.


When the contraceptive action ofFemiwise-35 tablets is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.
When changing from an oral contraceptive and relying on the contraceptive action of Femiwise-35 tablets, follow the instructionsgiven below:


Changing from 21-day combined oral contraceptives:
The first tablet of Femiwise-35 tablets should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.


Changing from a combined Every Day pill (28 day tablets):
Femiwise-35 tablets should be started after taking the last hormone containing tablet from the Every Day Pill pack. The first Femiwise-35 tablet is taken the next day. Additional contraceptive precautions are not then required.


Changing from a progestogen-only pill (POP):
The first tablet ofFemiwise-35 tablets should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.


Post-partum and post-abortum use:
After pregnancy, Femiwise-35 tablets can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets.

Lactation is contra-indicated with Femiwise-35 tablets. After a first-trimester abortion, Femiwise-35 tablets may be started immediately in which case no additional contraceptive precautions arerequired.


Duration of Use
Time to relief of symptoms is at least three months. The need to continue treatment should be evaluated periodically bythe treating physician.

INDICATIONS OF FEMIWISE-35 TABLETS

1) ANDROGEN- DEPENDENT ACNE, ACCOMPANIED BY SEBORRHOEA OR FORMATION OF INFLAMED NODES (Acne Papulo Pustulosa & Acne Nodulocystica)

2) HIRSUTISM ll SYMPTOMS OF PCOS

3) ORAL CONTRACEPTION IN WOMEN REQUIRING ANTIANDROGEN THERAPY

4) ANDROGEN DEPENDANT ALOPECIA

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