Indication

Contraception

Adult Dose

Contraception\r\nStart on day 1 of menstrual cycle \r\n1 hormonally active tablet PO for 21 days, then 7 inert (iron) tablets; repeat cycle\r\n\r\nInitiating after Pregnancy\r\nInitiating after vaginal birth: Wait at least 3 weeks\r\nInitiating after caesarean section birth: Wait at least 6 weeks\r\nWomen with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives\r\n\r\nHepatic Impairment\r\nDo not administer

Renal Dose

Renal Impairment\r\nUse caution; monitor blood pressure

Contraindication

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 1st 6 mth after delivery.

Mode of Action

Norgestrel is a progestogen derived from nortestosterone while ethinylestradiol is a synthetic oestrogen. When used together, they inhibit ovulation, and affect other changes such as changes in the cervical mucus and the endometrium, which makes conception unfavourable.

Precaution

Side Effect

10%\r\nEdema,Weakness,Amenorrhea,Breakthrough bleeding,Change in menstrual flow,Spotting,Anorexia\r\n\r\nFrequency Not Defined\r\nDVT,Thrombophlebitis,Depression,Dizziness,Headache,Nervousness,Somnolence,Breast tenderness,Galactorrhea,Abdominal pain,Nausea,Vomiting,Change in weight,Cholestatic jaundice\r\n\r\nPotentially Fatal: Hepatic tumours; increased risk of thromboembolism.

Pregnancy Category Note

Pregnancy Category: X\r\n\r\nLactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)

Interaction

Reduced contraceptive effectiveness with antibiotics, anticonvulsants and drugs that may increase contraceptive steroids clearance (e.g. bosentan, rifampicin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, griseofulvin, aprepitant). Severe pruritus and jaundice with troleandomycin, avoid concurrent use. Decreased effectiveness of ursodeoxycholic acid by increasing the elimination of cholesterol in bile. Effects of danazol or gestrinone and hormonal contraceptives might be altered or reduced by concurrent use, avoid concomittant use. \r\n\r\nDecreased contraceptive effectiveness with anti-HIV protease inhibitors. Increased tacrolimus levels with ethinyl estradiol. May increase theophylline, selegiline and tizanidine levels with oral contraceptives.