Generic Medicine Info
Hypersensitivity. Undiagnosed abnormal bleeding, previous or current venous thromboembolism (e.g. DVT, pulmonary embolism); active or recent arterial thromboembolic disease (e.g. MI), suspected or history of breast cancer, known or suspected estrogen-dependent tumours, untreated endometrial hyperplasia, porphyria, thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency). Hepatic impairment. Pregnancy.
Special Precautions
Patient with familial defects of lipoprotein metabolism, asthma, epilepsy, migraine, diabetes, porphyria, SLE, hereditary angioedema, hepatic haemangiomas, history of cholestatic jaundice associated with pregnancy or prior estrogen use; diseases that may be exacerbated by fluid retention (e.g. heart disease). Not intended for the prevention of CV disease or dementia. Renal impairment. Lactation. Monitoring Parameters Assess for risk of breast cancer and CV disease prior to therapy. Monitor blood pressure, serum triglycerides, TSH (in patients taking thyroid replacement). Perform age appropriate breast and pelvic exams during therapy.
Adverse Reactions
Significant: Endometriosis, retinal vascular thrombosis, increased HDL and triglycerides, decreased LDL; increased risk of gallbladder disease. Cardiac disorders: Vasodilation. Eye disorders: Intolerance to contact lenses. Gastrointestinal disorders: Nausea, flatulence, abdominal pain. General disorders and administration site conditions: Oedema, weakness, pain. Infections and infestations: Vaginitis, vaginal candidiasis. Investigations: Changes in weight. Musculoskeletal and connective tissue disorders: Arthralgias, leg cramps, back pain. Nervous system disorders: Dizziness, headache, migraine, anxiety. Psychiatric disorders: Depression, change in libido, mood disturbances, insomnia. Reproductive system and breast disorders: Abnormal uterine bleeding, vaginitis, leucorrhoea, vaginal haemorrhage, breast pain, tenderness, enlargement, discharge. Respiratory, thoracic and mediastinal disorders: Pharyngitis, sinusitis. Skin and subcutaneous tissue disorders: Alopecia, melasma, hirsutism, pruritus, rash. Vascular disorders: Venous thrombosis, pulmonary embolism.
Potentially Fatal: Anaphylaxis, angioedema; increased risk of endometrial cancer.
Drug Interactions
Decreased plasma concentrations with CYP3A4 inducers (e.g. phenytoin, rifampicin). Increased plasma concentrations with CYP3A4 inhubitors (e.g. erythromycin, ritonavir).
CIMS Class
Oestrogens & Progesterones & Related Synthetic Drugs
ATC Classification
L02AA - Estrogens ; Used in endocrine therapy.
G03C - ESTROGENS ; Used in estrogenic hormone preparations.
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