Indication

Contraception

Adult Dose

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

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Renal Dose

Renal Impairment Use caution; monitor blood pressure

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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...

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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

Sex-steroid dependent cancer; past ectopic pregnancy; malabsorption syndromes; functional ovarian cysts; active liver disease, recurrent cholestatic jaundice, history of jaundice 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 of lipoprotein metabolism; patients at risk of venous thromboembolism, breast cancer, preexisting uterine leiomyomata and benign hepatic adenoma; family history of arterial disease in 1st degree relative <45 yr; BP > systolic 140 mmHg and diastolic 90 mmHg; >35 yr; BMI 30-39 kg/m2; migraine without focal aura, controlled with 5HT1; GI...

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Side Effect

>10% Edema,Weakness,Amenorrhea,Breakthrough bleeding,Change in menstrual flow,Spotting,Anorexia Frequency Not Defined DVT,Thrombophlebitis,Depression,Dizziness,Headache,Nervousness,Somnolence,Breast tenderness,Galactorrhea,Abdominal pain,Nausea,Vomiting,Change in weight,Cholestatic jaundice Potentially Fatal: Hepatic tumours; increased risk of thromboembolism.

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Pregnancy Category Note

Pregnancy Category: X Lactation: 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)

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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. Decreased contraceptive effectiveness with anti-HIV protease inhibitors. Increased tacrolimus levels with ethinyl estradiol. May increase theophylline, selegiline and tizanidine levels with oral contraceptives.