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CYESTRA-35 is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosage Considerations CYESTRA-35 (cyproterone acetate and ethinyl estradiol) should not be prescribed for the purpose of contraception alone. If patient compliance is uncertain and contraception is necessary, then a supplementary non-hormonal contraceptive method should be considered.
Recommended Dose and Dosage Adjustment Each cycle consists of 21 days on medication and a 7-day interval without medication (3 weeks on, 1 week off).
First treatment course:
The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. ) The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets.
The first cycle will be somewhat shorter than usual, whereas all following cycles will last four weeks. The patient should be instructed to take the first tablet from the blister pack out of the section marked with the corresponding day of the week (for example "Mon" for Monday), and swallow it whole with some liquid.
The patient should be instructed to take the tablet at the same time each day.
Subsequent courses:
The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation, regardless of whether or not withdrawal bleeding is still in progress.
Length of use:
The length of use depends on the severity of the symptoms of androgenization and their response to treatment. In general, treatment should be continued for several months, since improvement may not be observed for at least three months.
The need to continue treatment with CYESTRA-35 should be evaluated periodically by the treating physician. CYESTRA-35 should be discontinued 3 to 4 cycles after signs have completely resolved. Should there be a recurrence of symptoms, weeks or months after discontinuation of tablet- taking, treatment with CYESTRA-35 may be resumed.
In case of a restart of CYESTRA-35 (following a 4-week or greater tablet-free interval), the increased risk of VTE should be considered (see WARNINGS AND PRECAUTIONS). Pregnancy should be ruled out before continuing treatment with CYESTRA-35 in patients who have missed a menstrual period.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethinyl Estradiol in Canada.
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If pregnancy is suspected, medication should be discontinued. CYESTRA-35 Product Monograph Page 22 of 48 Missed Dose It is recommended that CYESTRA-35 tablets be taken at the same time each day. If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours.
If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid a premature withdrawal bleeding during this cycle.
A supplementary non- hormonal method of contraception must be employed until the pack is empty to prevent pregnancy which would necessitate immediate discontinuation of CYESTRA-35 treatment. Irregular tablet-taking, vomiting or intestinal infections with diarrhea, very rare individual metabolic disturbances or prolonged simultaneous use of certain medical preparations can affect the contraceptive action (see DRUG INTERACTIONS, Drug-Drug Interactions).
Administration If spotting or breakthrough bleeding occurs during the 3 weeks in which CYESTRA-35 is being taken, the patient is instructed to continue taking the medication. This type of bleeding usually is transient and without significance.
However if the bleeding is persistent or prolonged, the patient is advised to consult her physician. In exceptional cases, menstruation may fail to occur during the 7-day tablet-free interval. The patient is advised not to resume tablet-taking and to consult her physician.
Although the occurrence of pregnancy is highly unlikely if the tablets are taken according to directions, the possibility of pregnancy should be ruled out before continuing treatment with CYESTRA-35 in patients who have missed a period of withdrawal bleeding.
The patient should consult her physician and in the meantime, a supplementary non-hormonal method of contraception should be employed. OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control center.
There have been no reports of overdose with cyproterone acetate and ethinyl estradiol tablets. Symptoms that may occur are nausea, vomiting, and withdrawal bleeding. Withdrawal bleeding may even occur in girls before menarche, if they have accidentally taken the medicinal product.
There are no specific antidotes and treatment should be symptomatic, based on the knowledge of the pharmacological action of the constituents. CYESTRA-35 Product Monograph Page 23 of 48 ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Cyproterone acetate and ethinyl estradiol is a combination antiandrogen-estrogen for use in the treatment of androgen-dependent dermatological conditions in females.
Cyproterone acetate is a steroid compound with potent antiandrogenic, progestogenic and antigonadotrophic activity. It exerts its antiandrogenic effect by blocking androgen receptors. It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary- ovarian systems.
The estrogen component (ethinyl estradiol) of cyproterone acetate and ethinyl estradiol tablets increases levels of sex hormone binding globulin (SHBG) and thus reduces the free circulating plasma levels of androgens. Cyproterone acetate has no tendency to reduce SHBG levels.
If used alone in women, cyproterone acetate leads to menstrual cycle disturbances which are avoided when combined with ethinyl estradiol. When cyproterone acetate and ethinyl estradiol tablets are administered in a cyclic manner it has the added effect of preventing ovulation and possible […]