Generic
Norgestrel + Ethinyl Estradiol + Ferrous Fumarate
Pharmacology
Combination oral contraceptives (COC) act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Dosage Administration
21 active tablets containing 0.3 mg norgestrel & 0.03 mg ethinylestradiol per tablet 7 brown inert tablets containing 75 mg ferrous fumarate each.
Contraindications
Pregnancy, undiagnosed vaginal bleeding, severe arterial disease (or family history of atherogenic lipid profile); liver adenoma; porphyria; after evacuation of hydatidiform mole; history of breast cancer; hepatic impairment; thrombophloebitis or thromboembolic disorders; breast carcinoma except in selected patients being treated for metastatic disease; oestrogen-dependent tumour; smoking >40 cigarettes daily; >50 yr; diabetes complications present; BMI >39 kg/m2; migraine with typical focal aura, lasting >72 hr despite treatment or migraine treated with ergot derivatives; BP >160 mmHg systolic and 100 mmHg diastolic; transient ischaemic attacks without headaches; SLE; gallstones; history of haemolytic uraemic syndrome, pruritis during pregnancy; cholestatic jaundice; chorea or deterioration of otosclerosis pemphigoid; breast feeding during 1 st 6 mth after delivery.
Side Effects
Edema, Weakness, Amenorrhea, Breakthrough bleeding, Change in menstrual flow, Spotting, Anorexia, DVT, Thrombophlebitis, Depression, Dizziness, Headache, Nervousness, Somnolence, B reast tenderness, Galactorrhea, Abdominal pain, Nausea, Vomiting, Change in weight, Cholestatic jaundice
Pregnancy And Lactation
Extensive epidemiological studies have revealed no increased risk of birth defects in infants born to women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral-contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral-contraceptive use should be discontinued if pregnancy is confirmed.
Over The Counter Products
