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Brand Name :
Tarina FE 1/20, Merzee, Tarina 24 FE, Mibelas 24 FE, Minastrin 24 FE, Junel Fe 1/20, Loestrin Fe 1/20, Loestrin Fe 1.5/30, Loestrin 24 Fe, Lomedia 24 Fe
Synonyms :
norethindrone acetate/ethinyl estradiol/ferrous fumarate
Class :
Contraceptives, Oral
Brand Name :
Tarina FE 1/20, Merzee, Tarina 24 FE, Mibelas 24 FE, Minastrin 24 FE, Junel Fe 1/20, Loestrin Fe 1/20, Loestrin Fe 1.5/30, Loestrin 24 Fe, Lomedia 24 Fe
Synonyms :
norethindrone acetate/ethinyl estradiol/ferrous fumarate
Class :
Contraceptives, Oral
ADULT DOSING
Dosage Forms & Strengths
Tablet, triphasic (Estrostep Fe, Tilia Fe, TriLegest Fe)
1 mg/20 mcg (5 tabs)
1 mg/30 mcg (7 tabs)
1 mg/35 mcg (9 tabs)
Plus 75 mg ferrous fumarate (7 tabs)
Tablet, multiphasic (Lo Loestrin Fe, Lo Minastrin Fe)
1 mg/10 mcg (24 tabs)
Ethinyl estradiol 10 mcg only (2 tabs)
Plus ferrous fumarate 75 mg (2 tabs)
Tablet, monophasic 21-day
1 mg/20 mcg (21 tabs) plus 75 mg ferrous fumarate (7 tabs) (Blisovi Fe 1/20, Larin Fe 1/20, Loestrin Fe 1/20, Junel Fe 1/20, Microgestin Fe 1/20, Tarina Fe 1/20)
1.5 mg/30 mcg (21 tabs) plus 75 mg ferrous fumarate (7 tabs) (Blisovi Fe 1.5/30, Larin Fe 1.5/30, Loestrin Fe 1.5/30, Junel Fe 1.5/30, Microgestin Fe 1.5/30)
Softgel capsule, monophasic 24-day
1 mg/20 mcg (24 caps) plus 75 mg ferrous fumarate (4 caps) (Merzee, Minastrin 24 Fe, Taytulla)
Tablet, monophasic 24-day
1 mg/20 mcg (24 tabs) plus 75 mg ferrous fumarate (4 tabs) (Larin 24 Fe, Loestrin 24 Fe, Lomedia 24 Fe, Junel Fe 24, Blisovi 24 Fe, Melodetta 24 Fe, Mibelas 24 Fe, Tarina 24 Fe)
Oral contraception
For monophasic tablets, one active tablet is taken orally once daily for either 21 or 24 days, followed by one ferrous fumarate tablet daily during the remaining days of the cycle (Days 22-28 for 21-day regimens, Days 25-28 for 24-day regimens).
For multiphasic tablets, 1 mg of norethindrone acetate with 10 mcg of ethinyl estradiol is taken on Days 1-24, ethinyl estradiol alone 10 mcg on Days 25-26, and ferrous fumarate 75 mg on Days 27-28.
For triphasic tablets, 1 mg norethindrone acetate with 20 mcg ethinyl estradiol is taken on Days 1- 5, 1 mg norethindrone acetate with 30 mcg ethinyl estradiol on Days 6-12, and 1 mg norethindrone acetate with 35 mcg ethinyl estradiol on Days 13-21, followed by 75 mg ferrous fumarate on Days 22–28.
PEDIATRIC DOSING
Not recommended
GERIATRIC DOSING
Refer to adult dosing
Action:
Ethinyl Estradiol (EE): Suppresses hypothalamic LHRH release and pituitary gonadotropin secretion; promotes synthesis of DNA, RNA, and proteins in target tissues.
Norethindrone Acetate: A progestin that inhibits pituitary gonadotropin release, prevents follicle maturation and ovulation, and supports mammary tissue growth.
Ferrous Fumarate: Restores and maintains body iron stores.
Frequency defined
>10%
Spotting
Change in menstrual flow
Breakthrough bleeding
Amenorrhea
Anorexia
Weakness
Edema
Frequency Not Defined
Cholestatic jaundice
Weight change
Vomiting
Nausea
Abdominal pain
Galactorrhea
Breast tenderness
Somnolence
Nervousness
Headache
Dizziness
Depression
Thrombophlebitis
Deep vein thrombosis
Black Box Warning
Cardiovascular Risks:
Estrogens, with or without progestins, should not be used to prevent cardiovascular disease. The WHI study showed that postmenopausal women (65 years and older) taking combined estrogen-progestin therapy had higher risks of myocardial infarction, stroke, invasive breast cancer, pulmonary embolism, and DVT. Estrogen alone also increased risks of stroke and DVT.
Dementia Risks:
Estrogens, with or without progestins, should not be used to prevent dementia. WHIMS reported increased risk of probable dementia in women aged ≥65 years taking either combined or estrogen-only therapy. It is unclear if these risks apply to younger postmenopausal women.
Cigarette Smoking:
Smoking increases cardiovascular risks with combination hormonal therapy, especially in women over 35 years or smoking ≥15 cigarettes/day. Such use is contraindicated in this population.
Contraindication/Caution:
Renal impairment
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
Ethinyl Estradiol (EE): Suppresses hypothalamic LHRH release and pituitary gonadotropin secretion; promotes synthesis of DNA, RNA, and proteins in target tissues.
Norethindrone Acetate: A progestin that inhibits pituitary gonadotropin release, prevents follicle maturation and ovulation, and supports mammary tissue growth.
Ferrous Fumarate: Restores and maintains body iron stores.
Pharmacokinetics:
Absorption:
Ethinyl estradiol: Peak plasma concentration reached in 8 hours.
Norethindrone: Peak plasma concentration reached in 1-2 hours.
Distribution:
Ethinyl estradiol: Approximately 80% protein bound.
Norethindrone: Approximately 61% protein bound.
Metabolism:
Both drugs are extensively metabolized in the liver; ethinyl estradiol undergoes significant first-pass metabolism.
Ethinyl estradiol metabolites: Estrone and estriol.
Norethindrone metabolites: Inactive sulfate and glucuronide conjugates.
Excretion and Elimination:
Ethinyl estradiol: Excreted in urine as conjugates; also eliminated via bile with enterohepatic recycling.
Norethindrone: 33-81% excreted in urine, 35-43% in feces.
Norethindrone half-life (oral): 4-13
Administration:
The drug is taken through oral route.
Patient information leaflet
Generic Name: norethindrone acetate/ethinyl estradiol/ferrous fumarate
Why do we use norethindrone acetate/ethinyl estradiol/ferrous fumarate?
This combination is used to prevent pregnancy, regulate menstrual cycles, reduce menstrual pain, and manage acne or endometriosis-related symptoms. The ferrous fumarate component helps prevent or treat iron deficiency anemia by replenishing iron stores, supporting overall health during periods of blood loss or increased iron needs.
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