See Supplemental Patient Information
- Cigarette smokers are more prone to risk of serious cardiovascular side effects due to oral contraceptives. Risk increases with age (women >35 yrs) and heavy smoking (>15 cigarettes/day)
- Advise women who use contraceptives to avoid smoking. Use of oral contraceptives are contraindicated in smokers >35yrs (FDA Black Box Warning)
- Increased risk of thromboembolic and thrombotic disease associated with therapy have occurred; risk of post-operative thromboembolic complications increases on use of use of oral contraceptives. Discontinue use at least 4 weeks prior to and for 2 weeks after elective surgery and during and following prolonged immobilization; initiate use not earlier than 4 to 6 weeks after delivery in women electing not to breast feed
- Increases risk of thrombotic and hemorrhagic strokes
- Decrease in serum HDL associated with an increased risk of ischemic heart disease have occurred
- Individualized dosage in a way that it contains the least amount of estrogen and progestogen is compatible with a low failure rate; start on preparations containing the lowest estrogen content producing satisfactory results. Use 50 mcg estrogen only when medically indicated
- Increased risk of subarachnoid hemorrhage after termination of use of oral contraceptives have occurred
- Increased risk of cardiovascular disease in non-smoking women >40yrs of age has occurred. Initiate therapy with lowest possible dose in all women
- Carcinoma of the breast and reproductive organs may occur
- Rare occasions of fatal benign hepatic adenomas associated with use of oral contraceptives have occurred
- Discontinue use on unexplained partial or complete loss of vision, onset of proptosis, diplopia, papilledema, or retinal vascular lesions
- Avoid using oral contraceptives to induce withdrawal bleeding, to treat threatened or habitual abortion
- Discontinue use on confirmation of pregnancy
- Risk of gallbladder disease exists
- Carefully monitor prediabetic and diabetic women for carbohydrate and lipid metabolic effects of oral contraceptives. Changes in serum triglycerides and lipoprotein levels, hyperinsulinism, less glucose intolerance, increased secretion of insulin and insulin resistance associated with therapy have been reported
- Hypertension may occur; closely monitor women electing to use oral contraceptives. Discontinue use in women with significant elevation of blood pressure
- Discontinue therapy on onset or exacerbation of migraine, development of headache with a new recurrent, persistent or severe pattern
- Bleeding irregularities especially during the first 3 months may occur. Consider non-hormonal and adequate diagnostic measures to rule out malignancy/pregnancy in the event of breakthrough bleeding
- Consider physical examination and follow up in relevance to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and perform relevant laboratory tests
- Carefully monitor women with a strong family history of breast cancer or having breast nodules
- Closely monitor women who are being treated for hyperlipidemias
- Discontinue therapy on occurrence of jaundice
- Carefully monitor patients with conditions aggravating fluid retention
- Discontinue use if depression recurs to a serious degree
Use cautiously in:
Supplemental Patient Information
- Inform patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Instruct patients to take pill exactly as directed and at intervals not exceeding 24 hrs
- Advise women to use an additional method of protection until after the first 7 days of administration in the initial cycle
- Inform patients to start oral contraceptives no earlier than 4 to 6 weeks after delivery due to its association with an increased risk of thromboembolism. On termination of pregnancy, instruct patients to start oral contraceptives immediately or within 7 days after termination
- Advise patients to report physician on spotting or persisting breakthrough bleeding
- On missing one pill, instruct patients to take it as soon as they remember and then to take the next pill at the regular time
- Educate patients that missing a pill would cause spotting or light bleeding, and they may experience gastric irritation if they take the missed pill along with their regularly scheduled pill
- In case of a missed menstrual period, inform patients to consider the possibility of pregnancy, withholding oral contraceptives until pregnancy has been ruled out. Instruct patients to rule out pregnancy before continuing the contraceptive regimen even in patients who have adhered to the prescribed regimen but missed 2 consecutive periods
Pregnancy Category:X
Breastfeeding: Small amounts of oral contraceptive steroids are excreted in milk of nursing mothers and a few adverse effects on the child have occurred, including jaundice and breast enlargement. Oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Manufacturer advises the nursing mother to avoid use of oral contraceptives and the use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
- Norinyl 1+50 28-day
- Necon 1/50
US Availability
Norinyl 1+50 28-day, Necon 1/50 (mestranol/norethindrone)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Norinyl-1 (mestranol/norethindrone)
Australian Trade Name(s)
- Norinyl-1 (21's)
- Norinyl-1 (28's)
Australian Availability
Norinyl-1 (21's), Norinyl-1 (28's) (mestranol/norethindrone)
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