Norethindrone Acetate and Ethinyl Estradiol (Page 2 of 9)

2.3 Missed Tablets

Table 2: Instructions for Missed Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets

  • If one active tablet is missed in Weeks 1, 2 or 3

Take the tablet as soon as possible. Take the next pill at the regular time and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed.

  • If two consecutive active tablets are missed in Week 1 or Week 2

Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets.

  • If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time

Day 1 Start: Throw out the rest of the pack and start a new pack that same day.

Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day.

Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing 3 tablets.


2.4 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a white tablet, handle this as a missed tablet [see Dosage and Administration (2.3)].

3 DOSAGE FORMS AND STRENGTHS

Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets are available in blister packs.

Each blister card (28 tablets) contains in the following order:

  • 24 white, flat faced beveled edge round shaped (active) tablets debossed with “AL1” on one side and plain on the other and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.
  • 4 natural color brown, round (non-hormonal placebo) flat face, bevel edge tablets with “AL2” on one side and plain on the other side, each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are contraindicated in females who are known to have or develop the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Disorders and Other Vascular Problems

  • Stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
  • Stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions (6.2)].
  • If feasible, stop norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.
  • Start norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
  • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
  • Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
  • Use COCs with caution in women with cardiovascular disease risk factors.

5.2 Liver Disease

Impaired Liver Function

Do not use norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if jaundice develops.

Liver Tumors

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

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