Contraceptives
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Femcon Fe Dosage

Drug Detail:Femcon fe (birth control) (Ethinyl estradiol and norethindrone (birth control) [ eth-in-il-ess-tra-dye-ole-and-nor-eth-in-drone ])

Generic Name: NORETHINDRONE 0.4mg, ETHINYL ESTRADIOL 0.035mg;

Dosage Form: tablets

Drug Class: Contraceptives Sex hormone combinations

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

2.1 How to Start FEMCON Fe

FEMCON Fe is dispensed in a blister card [see How Supplied/Storage and Handling (16)]. FEMCON Fe may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

2.2 How to Take FEMCON Fe

FEMCON Fe (white active tablets and brown placebo tablets) may be swallowed whole or chewed and swallowed. If the tablet is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing.

Table 1: Instructions for Administration of FEMCON Fe
Starting CHCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)

Important:
Consider the possibility of ovulation and conception prior to initiation of this product.

Tablet Color:
  • FEMCON Fe active tablets are white (Day 1 to Day 21).
  • FEMCON Fe placebo tablets are brown (Day 22 to Day 28).
 Day 1 Start:
  • Take first white active tablet on the first day of menses.
  • Take subsequent white active tablets once daily at the same time each day for a total of 21 days.
  • Take one brown placebo tablet daily for 7 days and at the same time of day that active tablets were taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet).
Sunday Start:
  • Take first active tablet on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of FEMCON Fe.
  • Take subsequent white active tablets once daily at the same time each day for a total of 21 days.
  • Take one brown placebo tablet daily for the following 7 days and at the same time of day that active tablets were taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to FEMCON Fe from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started.
Switching from another contraceptive method to FEMCON Fe Start FEMCON Fe:
  • Transdermal patch
  • On the day when next application would have been scheduled
  • Vaginal ring
  • On the day when next insertion would have been scheduled
  • Injection
  • On the day when next injection would have been scheduled
  • Intrauterine contraceptive
  • On the day of removal
  • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
  • Implant
  • On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

Starting FEMCON Fe after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, FEMCON Fe may be started immediately. An additional method of contraception is not needed if FEMCON Fe is started within 5 days after termination of the pregnancy.
  • If FEMCON Fe is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of FEMCON Fe.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start FEMCON Fe, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of FEMCON Fe. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting FEMCON Fe after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with FEMCON Fe following the instructions in Table 1 for women not currently using hormonal contraception.
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of FEMCON Fe. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

2.3 Missed Tablets

Table 2: Instructions for Missed FEMCON Fe Tablets
  • If one white active tablet is missed in Weeks 1, 2, or 3
 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
  • If two white 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) should be used as back-up if the patient has sex within 7 days after missing tablets.
  • If two white active tablets are missed in Week 3 or three or more white active tablets are missed in a row in Weeks 1, 2, or 3
 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) should be used as back-up if the patient has sex within 7 days after missing 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 should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

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