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Histologic changes were all estrogenic in nature with minimal evidence of progestational response. CEO and Co-Founder of Pandia Health, Dr. Sophia Yen discusses the difference between generic brand and name brand birth control and why you should choose generic over name brand! No clinically significant changes were observed in fasting serum or blood glucose levels and associated blood insulin levels of subjects receiving norgestimate and ethinyl estradiol tablets. 0.18 mg norgestimate and 0.035 mg ethinyl estradiol 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 0.25 mg norgestimate and 0.035 mg ethinyl estradiol Suite 407, Concord, ON PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 18 DOSAGE AND ADMINISTRATION ..................................................................................... 25 OVERDOSAGE ....................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 32 STORAGE AND STABILITY ................................................................................................. 33 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 34 PART II: SCIENTIFIC INFORMATION .................................................................................... 35 PHARMACEUTICAL INFORMATION ................................................................................. 35 CLINICAL TRIALS ................................................................................................................. 36 DETAILED PHARMACOLOGY ............................................................................................ 40 TOXICOLOGY ........................................................................................................................ 40 REFERENCES ......................................................................................................................... 48 PART III: CONSUMER INFORMATION .................................................................................. 53 0.18 mg norgestimate and 0.035 mg ethinyl estradiol 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 0.18 mg norgestimate and 0.035 mg ethinyl estradiol 0.25 mg norgestimate and 0.035 mg ethinyl estradiol The treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved History of or actual thrombophlebitis or thromboembolic disorders.History of or actual myocardial infarction or coronary arterial disease.History of or actual prodromi of a thrombosis (e.g., transient ischemic attack, angina pectoris).Active liver disease or history of or actual benign or malignant liver tumours.Use with the Hepatitis C virus (HCV) combination drug regimen ombitasvir, paritaprevir, ritonavir, with or without dasabuvir (see Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss Steroid-dependent jaundice, cholestatic jaundice or history of jaundice of pregnancy.History of or actual pancreatitis if associated with severe hypertriglyceridemia.Presence of severe or multiple risk factor(s) for arterial or venous thrombosis:persistent blood pressure values ≥160 mm Hg systolic or ≥100 mm Hg diastolic hereditary or acquired predisposition for venous or arterial thrombosis, such as Factor V Leiden mutation and activated protein C (APC-) resistance, antithrombin-III- deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia (e.g., due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid-antibodies (anticardiolipin antibodies, lupus anticoagulant) major surgery associated with an increased risk of postoperative thromboembolism Hypersensitivity to this drug or to any ingredient in the formulation or component of embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and immobilization after accidents or confinement to bed during long-term illness). Norgestimate is an active progestin when administered either orally or parenterally and binds to but is not estrogenic itself.

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