Ethinyl Estradiol / Norethindrone Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Acne

Contraception:
Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)

Initiation of Oral Contraceptive Therapy
This product can be administered in two ways:

When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.

Missed Doses:
If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.

If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)

If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)

Acne:
-Use Estrostep Fe (R) for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
-The timing and initiation of dosing with Estrostep FE (R) should follow the guidelines for use as an oral contraceptive.

Usual Adult Dose for Contraception

Contraception:
Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)

Initiation of Oral Contraceptive Therapy
This product can be administered in two ways:

When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.

Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.

Missed Doses:
If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.

If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)

If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)

Acne:
-Use Estrostep Fe (R) for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
-The timing and initiation of dosing with Estrostep FE (R) should follow the guidelines for use as an oral contraceptive.

Usual Adult Dose for Postmenopausal Symptoms

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for the prevention of osteoporosis is one tablet (5 mcg/1 mg) orally daily.
Comments: When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should be carefully considered, and estrogens and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risk of the drug. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered. The U.S. Preventive Services Task Force (USPSTF) recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for moderate to severe vasomotor symptoms associated with menopause is one tablet (2.5 mcg/ 0.5 mg or 5 mcg/1 mg) orally daily.
Comment: Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is necessary.

Usual Adult Dose for Prevention of Osteoporosis

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for the prevention of osteoporosis is one tablet (5 mcg/1 mg) orally daily.
Comments: When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should be carefully considered, and estrogens and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risk of the drug. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered. The U.S. Preventive Services Task Force (USPSTF) recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for moderate to severe vasomotor symptoms associated with menopause is one tablet (2.5 mcg/ 0.5 mg or 5 mcg/1 mg) orally daily.
Comment: Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is necessary.

Renal Dose Adjustments

Data regarding the pharmacokinetic disposition of some oral contraceptive combinations have been studied in women with end-stage renal disease. In such women, accumulation of the estrogen component may occur after multiple doses. However, the clinical significance of such accumulation is uncertain. In general, if a woman with severe renal insufficiency requires oral contraceptive combinations, low dose products such as desogestrel-ethinyl estradiol or ethinyl estradiol-levonorgestrel are recommended.

Liver Dose Adjustments

Data regarding the pharmacokinetic disposition of oral contraceptive pills in women with liver dysfunction are not available. It is recommended that alternatives be considered and particular caution (careful monitoring of side effects) if these drugs must be used.

Dose Adjustments

Switching from another Hormonal Method of Contraception:
If switching from a combination hormonal method (another pill, vaginal ring, patch):
-Take first white Minastrin 24 Fe (R)tablet on the day the next combination oral contraceptive (COC) would have been taken. Do not continue tablets from previous birth control pack or skip any days between packs.
-If previously used a vaginal ring or patch, start Minastrin 24 Fe (R) tablet on the day the previous product would have been resumed

If switching from a progestin-only method (progestin-only pill, implant, intrauterine system, injection):
-Take the first white Minastrin 24 Fe (R) tablet on the day the next progestin -only pill would have been taken. A non-hormonal method of contraception should be used for 7 consecutive days.

If switching from an implant or injection:
-Start the first white Minastrin 24 Fe (R) tablet on the day the next injection would have been due or on the day of removal of the implant.

If switching from an intrauterine device (IUD):
-Depending on the timing of removal, a back-up contraception may be needed

Dialysis

Data not available

Other Comments

Administration advice:
-Ethinyl estradiol-norethindrone should be taken as directed, in the order directed on the blister pack, the same time every day.
-The chewable tablets should be chewed and swallowed followed by a full glass (8 ounces) of water.
-The tablets should not be skipped or taken at intervals exceeding 24 hours.
-If vomiting or diarrhea occurs within 3 to 4 hours of taking, refer to the "What to Do if You Miss Tablets" section in the manufacturer's product information.

General:
-Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
-Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1).

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