Composition
Each package contains-
- 21 active tablets containing 0.3 mg norgestrel & 0.03 mg ethinylestradiol per tablet
- 7 brown inert tablets containing 75 mg ferrous fumarate each.
Indications
Therapeutic Class
Pharmacology
Dosage & Administration
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.
Contraindications
Side Effects
Pregnancy & 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.
Precautions & Warnings
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 1 st degree relative systolic 140 mmHg and diastolic 90 mmHg; >35 yr; BMI 30-39 kg/m2; migraine without focal aura, controlled with 5HT1; Gl upset (vomiting and diarrhoea), missed pills and interaction with other drugs may require additional contraceptive precautions. Should be taken at same time each day.
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
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