FEMICON Tablet - Lomus Pharmaceuticals Pvt. Ltd.

FEMICON TabletDosage Forms/CompositionEach pink uncoated tablet contains levonorgestrel 0.15mg and ethinyl estradiol 0.03mgEach brown uncoated tablet contains ferrous fumarate 75mg.Pharmacological IndexOral contaceptive pillINDICATIONContraceptionPregnancy Risk FactorXContraindicationsPregnancy, undiagnosed vaginal bleeding, severe arterial disease (or family history ofatherogenic lipid profile); liver adenoma; porphyria; after evacuation of hydatidiformmole; history of breast cancer; hepatic impairment; thrombophloebitis orthromboembolic disorders; breast carcinoma except in selected patients being treatedfor metastatic disease; oestrogen-dependent tumour; smoking ≥40 cigarettes daily; >50yr; diabetes complications present; BMI >39 kg/m2; migraine with typical focal aura,lasting >72 hr despite treatment or migraine treated with ergot derivatives; BP >160mmHg systolic and 100 mmHg diastolic; transient ischaemic attacks withoutheadaches; SLE; gallstones; history of haemolytic uraemic syndrome, pruritis duringpregnancy; cholestatic jaundice; chorea or deterioration of otosclerosis pemphigoid;breast feeding during 1st 6 mth after delivery.Warnings/PrecautionsSex-steroid dependent cancer; past ectopic pregnancy; malabsorption syndromes;functional ovarian cysts; active liver disease, recurrent cholestatic jaundice, history ofjaundice in pregnancy; history of CV or renal impairment; DM; asthma; epilepsy;migraine; depression; lactation; conditions exacerbated by fluid retention;hypercalcaemia; CV and gall bladder diseases; lipid effects; familial defects oflipoprotein metabolism; patients at risk of venous thromboembolism, breast cancer,preexisting uterine leiomyomata and benign hepatic adenoma; family history of arterialdisease in 1st degree relative systolic 140 mmHg and diastolic 90 mmHg;>35 yr; BMI 30-39 kg/m2; migraine without focal aura, controlled with 5HT1; GI upset(vomiting and diarrhoea), missed pills and interaction with other drugs may requireadditional contraceptive precautions. Should be taken at same time each day.Adverse ReactionsMenstrual irregularities; headache, dizziness; breast discomfort; gynaecomastia;depression; disturbance of appetite; wt changes; fluid retention; oedema; changes inlibido; hair loss or hirsutism; GI disturbances (nausea and vomiting); genitourinarychanges; haematologic disorders; endocrine and metabolic disorders; cholestatic

jaundice; local skin reactions; chorea; contact lens intolerance; steeping of cornealcurvature; pulmonary thromboembolism; carbohydrate and/or glucose intolerance;depression; chloasma; BP increase, liver impairment; reduced menstrual loss, 'spotting'in early cycles, absence of withdrawal bleeding; rarely photosensitivity; increased riskin breast cancer; elevation of plasma bound iodine, cortisol and thyroid binding,erythrocyte sedimentation may be accelerated; increases in plasma copper, iron andalkaline phosphatase; may affect serum triglyceride and lipoprotein levels; retinalvascular thrombosis.Potentially Fatal: Hepatic tumours; increased risk of thromboembolism.Drug InteractionsCYP3A4 inducers may decrease levels/effects eg aminoglutethimide, carbamazepine,nafcillin, nevirapine, atazanavir,nelfinavir, phenobarbital, phenytoin, lamotrigine,rifamycins, griseofulvin and ritonavir; ampicillin, tetracycline and other antibiotics mayreduce efficacy; oestrogens may antagonise anticoagulant effect of coumarins; mayinhibit metabolism ofprednisolone and ciclosporin; may reduce clearanceof alprazolam, chlordiazepoxide, diazepam; may increase clearanceoflorazepam, oxazepam, temazepam.Mechanism of ActionCombination of hormonal contraceptives inhibits ovulation by modulating pituitarysecretion of gonadotrophins, luteinising hormone and follicle stimulating hormonethrough a negative feedback system. They reduce sperm penetration if ovulation doesoccur by altering the cervical mucus; cause changes in the endometrium which reducethe risk of nidation and may change the tubal transport of the ova through the fallopiantubes.Pharmacodynamics/KineticsAbsorption: Absorbed by GI tract. Bioavailability: ethinyl estradiol: 38-48%;levonorgestrel: 100%.Distribution: Distribution: Ethinyl estradiol: 4.3 L/kg; Levonorgestrel: 1.8 L/kg.Protein binding: Ethinyl estradiol: 95-97%; Levonorgestrel: 97-99% bind to sexhormone-binding globulin and albumin.Metabolism: Slowly metabolised. Estradiol: hepatic via oxidation and conjugation in GItract; hydroxylated via CYP3A4 to metabolites; first-pass effect; enterohepaticrecirculation; reversibly converted to estrone and estriol. Levonorgestrel: hepaticinvolving CYP3A4; undergoes reduction and conjugation followed by hydroxylation;forms metabolites.Excretion: Half life elimination: estradiol: 12-23 hr; levonorgestrel: 22-49 hr.Excretion: levonorgestrel: urine (40-68% parent drug and metabolites) and faeces (16-48% as metabolites); estradiol: through urine as metabolites estrone and estriol, alsothrough faeces in small quantities as glucuronide and sulphate conjugates.Usual DosageFor best result, the therapy should be started within 5 th days of menstruation. 1 pinktablet/day to be taken for 21 consecutive days followed by 1 brown tablet/day for 7consecutive days. Therapy should be continued with the new packet in the similar way.

LOMUS Drug Information CenterLomus Pharmaceuticals Pvt. Ltd.P.O. Box No 4506, Lomus House (Corporate office),Kailash Chour, Lazimpat, Kathmandu, NepalPh: 4436396 (Hunting Line). Fx: 977-1-4436395E-mail: druginfo@lomus.com.np