Concise Prescribing Info
Contents
21 yellow tab each containing Levonorgestrel 150 mcg, ethinylestradiol 30 mcg, 7 brown tab each containing Fe fumarate 75 mg
Indications/Uses
Contraception & abnormal menstrual bleeding. Fe fumarate is for the prophylaxis & treatment of Fe deficiency anemia.
Dosage/Direction for Use
1 yellow tab daily for 21 days starting on day 5 of cycle, then 1 brown tab for the next 7 days.
Administration
May be taken with or without food.
Contraindications
Impaired liver function or cholestasis, Dubin-Johnson or Rotor syndromes, hepatic adenoma, breast or endometrial cancer, CV disease, previous or current thromboembolic disorders, arterial disease or multiple risk factor for it, disorders of lipid metabolism, undiagnosed vag bleeding, possible pregnancy, history of pruritus or cholestatic jaundice during pregnancy, chorea, herpes gestationis, pemphigoid gestationis or deteriorating osteosclerosis, severe or focal migraine.
Special Precautions
Age, smoking, obesity, HTN, hypercholesterolemia, diabetes, history of preeclamptic toxemia, MI, thromboembolic disorders, ocular lesions, optic neuritis; cervix, vag & liver cancer; hepatic tumors, gallbladder disease, bleeding irregularities; mental depression, fluid retention, headache. Lactation.
Adverse Reactions
Thrombophlebitis, arterial thromboembolic disorders, pulmonary embolism, MI, cerebral hemorrhage & thrombosis, HTN, gallbladder disease, hepatic adenoma or benign liver tumors. Nausea, vomiting, GI upsets, breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhea, melasma. Breast changes, wt change, change in cervical erosion & secretion. Cholestatic jaundice, migraine, rash, mental depression, reduced tolerance to carbohydrates, vag candidiasis, change in corneal curvature, intolerance to contact lenses.
Drug Interactions
Rifampin, ampicillin, penicillin V, tetracyclines, neomycin, chloramphenicol, sulfonamides, nitrofurantoin, barbiturates, phenylbutazone, meprobamate, phenacetin, pyrazolone-containing analgesics, chlorpromazine, dihydroergotamine, chlordiazepoxide; antihypertensives, anticonvulsants, oral anticoagulants, hypoglycemic agents; theophyllines, phenothiazines, corticosteroids, β-adrenergic antagonists, TCAs, caffeine, cyclosporin. Increased sedative effect w/ diazepam & chlordiazepoxide.
MIMS Class
Oral Contraceptives
ATC Classification
G03FB09 - levonorgestrel and estrogen ; Belongs to the class of progestogens and estrogens in sequential preparations.
Presentation/Packing
Form
Femme FC tab
Packing/Price
1 × 28's
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