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TARO-CYPROTERONE/ETHINYL ESTRADIOL 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 .......................................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
History of or actual thrombophlebitis or thromboembolic disorders; History of or actual cerebrovascular disorders; History of or actual myocardial infarction or coronary arterial disease; Active liver disease; Previous or existing liver tumours (benign or malignant); History of cholestatic jaundice; Use with the Hepatitis C virus combination drug regimen ombitasvir, paritaprevir, ritonavir, with or without dasabuvir (see WARNINGS AND PRECAUTIONS); Known or suspected carcinoma of the breast; Known or suspected estrogen-dependent neoplasia; Undiagnosed abnormal vaginal bleeding; Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; Concomitant use with other estrogen/progestogen combinations or estrogens or progestogens alone; When pregnancy is suspected or diagnosed; Severe diabetes with vascular changes; A history of otosclerosis with deterioration during pregnancy; Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the DOSAGE FORMS, COMPOSITION and PACKAGING section of the product monograph. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions TARO-CYPROTERONE/ETHINYL ESTRADIOL, as with all estrogen/progestogen combinations, is contraindicated in women with thrombophlebitis, thromboembolic disorders, or a history of these conditions.
Cyproterone acetate and ethinyl estradiol tablets users appear to have an elevated risk of venous thromboembolic events compared to users of levonorgestrel-containing combined oral contraceptives. The risk of venous thromboembolic events with cyproterone acetate and ethinyl estradiol tablets appears to be similar to desogestrel- and drospirenone-containing combined oral contraceptives.
During treatment with TARO- CYPROTERONE/ETHINYL ESTRADIOL, estrogen/progestogen combinations should not be used. TARO-CYPROTERONE/ETHINYL ESTRADIOL should not be prescribed for the purpose of contraception alone. Estrogens or progestogens should not be taken during treatment with TARO- CYPROTERONE/ETHINYL ESTRADIOL.
PrTARO-CYPROTERONE/ETHINYL ESTRADIOL (cyproterone acetate and ethinyl estradiol tablets) Product Monograph Page 5 of 47 General Discontinue Medication at the Earliest Manifestation of the Following: Thromboembolic and Cardiovascular Disorders such as thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and retinal thrombosis.
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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Conditions that predispose to Venous Stasis and to Vascular Thrombosis (eg, immobilization after accidents or confinement to bed during long-term illness). Non-hormonal treatment for acne should be used until regular activities are resumed.
For use of TARO- CYPROTERONE/ETHINYL ESTRADIOL when surgery is contemplated, see WARNINGS AND PRECAUTIONS. Visual Defects - Partial or Complete Papilledema, or Ophthalmic Vascular Lesions Severe Headache of Unknown Etiology, or Worsening of Pre-existing Migraine Headache Onset of Jaundice or Hepatitis Itching of the Whole Body Significant Rise in Blood Pressure Onset of Severe Depression Severe Upper Abdominal Pain or Liver Enlargement o A liver tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement, or signs of intra-abdominal hemorrhage occur in women taking estrogen/progestogen combinations.
Carcinogenesis and Mutagenesis Malignancies may be life-threatening or may have a fatal outcome. Breast Cancer Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity, and late age for first full-term pregnancy.
The identified groups of women that may be at increased risk of developing breast cancer before menopause are long-term users of estrogen/progestogen combinations (more than eight years) The need to continue treatment with TARO-CYPROTERONE/ETHINYL ESTRADIOL should be evaluated periodically by the treating physician.
TARO- CYPROTERONE/ETHINYL ESTRADIOL should be discontinued 3 to 4 cycles after signs have completely resolved. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of TARO-CYPROTERONE/ETHINYL ESTRADIOL.
This risk increases with age and heavy smoking (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use this medication should not smoke. PrTARO-CYPROTERONE/ETHINYL ESTRADIOL (cyproterone acetate and ethinyl estradiol tablets) Product Monograph Page 6 of 47 and starters at early age.
Special judgement should be used in prescribing such medications for women with fibrocystic disease of the breast. Women receiving such medications should be instructed in self-examination of their breasts. Their physicians should be notified whenever any masses are detected.
A yearly clinical breast examination is also recommended, because, if a breast cancer should develop, drugs that contain estrogen may cause a rapid progression if the malignancy is hormone-dependant. Hepatic Cancer Recognized first-line tests of genotoxicity gave negative results when conducted with cyproterone acetate.
However, further tests showed that cyproterone acetate was capable of producing adducts with DNA (and an increase in DNA repair activity) in liver cells from rats and monkeys and also in freshly isolated human hepatocytes. The DNA-adduct level in dog liver cells was extremely low.
This DNA- adduct formation occurred at systemic exposures that might be expected to occur in the recommended dose regimens for cyproterone acetate. One in vivo consequence of cyproterone acetate treatment was the increased incidence of focal, possibly pre-neoplastic, liver lesions in which cellular enzymes were altered in female rats.
The relevance of these findings does not appear to be clinically significant based on the […]