norethindrone acetate and ethinyl estradiol and ferrous fumarate
Pharmaranks rates Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is a combination medicine containing Ethinyl Estradiol and Norethindrone Acetate.
Ethinyl Estradiol and Norethindrone Acetate · by Amneal
Generic of Lo Loestrin Fe
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ethinyl Estradiol and Norethindrone Acetate
- Form
- Kit
- Strength
- Ethinyl Estradiol 0.02MG; Norethindrone Acetate 1MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Amneal
- Half-life
- about 8 hours (how long it stays in your system)
- FDA application
- ANDA207514
- Availability
- Discontinued (per FDA)
- FDA boxed warning
- Yes — see the boxed warning
What is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate?
From the FDA label:Melodetta™ 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round tablets each containing 75 mg ferrous fumarate. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Each brown placebo tablet contains ferrous fumarate, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, spearmint flavor and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46. chem structure chem structure 2
How to use
One tablet daily chewed and swallowed or swallowed whole taken at the same time of day. Follow with 8 ounces of water (2.1) Take one tablet by mouth at the same time every day for 28 days (2.1) Take tablets in the order directed on the blister pack (2.1) Tablets may be administered without regard to meals (12.3) 2.1 How to Take Melodetta 24 Fe To achieve maximum contraceptive effectiveness, Melodetta 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time every day. The tablet may be chewed and swallowed or swallowed whole. The patient should drink a full glass (8 ounces) of water immediately after the white tablets are chewed or swallowed whole. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed tablets, [see FDA-approved patient labeling ] . Melodetta 24 Fe may be administered without regard to meals [see Clinical Pharmacology (12.3) ] . 2.2 How to Start Melodetta 24 Fe Instruct the patient to begin taking Melodetta 24 Fe either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Melodetta 24 Fe use, instruct the patient to take one white Melodetta 24 Fe tablet daily, beginning on Day one…
Side effects
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions in clinical trials (greater than or equal to 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data presented in Section 6.1 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Melodetta 24 Fe is bioequivalent to these norethindrone acetate/ethinyl estradiol tablets. Common Adverse Reactions (Greater Than or…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4) ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use Melodetta 24 Fe (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use (4)
Warnings
Important safety information
Vascular risks: Stop Melodetta 24 Fe if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding (5.1) Liver disease: Discontinue if jaundice occurs (5.2) High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease (5.4) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Melodetta 24 Fe. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia (5.5) Headache: Evaluate significant change in headaches and discontinue if indicated (5.6) Uterine bleeding: Evaluate irregular bleeding or amenorrhea (5.7) 5.1 Thromboembolic Disorders and Other Vascular Problems Stop Melodetta 24 Fe if an arterial or deep venous thrombotic event (VTE) occurs. Stop Melodetta 24 Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. If feasible, stop Melodetta 24 Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE. Start Melodetta 24 Fe 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 per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued. Use of COCs also increases the risk of arterial thrombosis 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), although, in general, the risk is greatest in older (greater than 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors. Use COCs with caution in women with cardiovascular disease risk factors. 5.2 Liver Disease Impaired Liver Function Do not use Melodetta 24 Fe in women with acute viral hepatitis or severe (decompensated) cirrhosis of the 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 Melodetta 24 Fe if jaundice develops. Liver Tumors Melodetta 24 Fe is 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 (greater than 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users. 5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Melodetta 24 Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . Melodetta 24 Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 5.4 High Blood Pressure Melodetta 24 Fe is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4) ] . For women with well-controlled hypertension, monitor blood pressure and stop Melodetta 24 Fe if blood pressure rises significantly. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin. 5.5 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC-related cholestasis. 5.6 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who are taking Melodetta 24 Fe. COCs may decrease glucose tolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. 5.7 Headache If a woman taking Melodetta 24 Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Melodetta 24 Fe if indicated. Consider discontinuation of Melodetta 24 Fe in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) [see Contraindications (4) ] . 5.8 Bleeding Irregularities and Amenorrhea Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC. Based on patient diaries from a clinical trial evaluating the safety and efficacy of a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets, 24% to 35% of women experienced unscheduled bleeding per cycle. A total of 10 subjects out of 743 (1.3%) discontinued due to bleeding or spotting. Amenorrhea and Oligomenorrhea Women who are not pregnant and use Melodetta 24 Fe may experience amenorrhea. In the clinical trial with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets and ferrous fumarate tablets, 22% to 36% of the women using norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets and ferrous fumarate tablets experienced amenorrhea in at least one of 6 cycles of use. Some women may experience post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. 5.9 COC Use before or during Early Pregnancy Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction…
Who should not take Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Melodetta 24 Fe is 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: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [ see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5) ] Have headaches with focal neurological symptoms or have migraine headaches with aura All women over age 35 with migraine headache [see Warnings and Precautions (5.6) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7) ] Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.10) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3) ] A high risk of arterial or venous thrombotic diseases (4) Breast cancer (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)
Overdose — what happens if you take too much
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Melodetta 24 Fe. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs (7.1) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations. Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma concentrations of the estrogen and progestin have been noted in some cases of co-administration of HIV/HCV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors. Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. 7.2 Effects of Combined Oral Contraceptives on Other Drugs COCs containing ethinyl estradiol may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs. 7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Melodetta 24 Fe with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.3) ] . 7.4 Interference with Laboratory Tests The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
How long does Ethinyl Estradiol and Norethindrone Acetate stay in your body?
The elimination half-life of ethinyl estradiol and norethindrone acetate is about 8 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life, not a distribution phase: the label states "the mean terminal elimination half-life of norethindrone following single dose administration ... is approximately 8 hours," and its single-dose PK table gives t½ = 7.7 ± 0.5 hours (12 healthy women, 0.35 mg, fasting). Norethindrone itself is the active drug, and the label names no active metabolite that outlasts it — it is extensively reduced and then sulfate/glucuronide conjugated, with less than 5% excreted unchanged. Related point for anyone reading a different label: norethindrone ACETATE is a prodrug that is rapidly converted to norethindrone, so norethindrone is the active moiety in those products too. This label does not characterize how the half-life changes in older adults or in kidney or liver impairment — no such pharmacokinetic data is given, so no number can be quoted for those groups (the label does contraindicate use in women with significant liver disease, but that is a safety statement, not a half-life adjustment).
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CAMILA (norethindrone) 0.35 mg tablets — DailyMed label, Clinical Pharmacology / Pharmacokinetics.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate rated?
- pharmaranks gives Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate. To pay less, Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is marketed by Amneal. You can see Amneal's full profile, rating, and other products on pharmaranks.
- Is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate a brand-name or generic drug?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is a generic medication; its active ingredient is Ethinyl Estradiol and Norethindrone Acetate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate available over the counter?
- No. Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate come in?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate FDA-registered?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate is on record with the U.S. FDA under application number ANDA207514. You can verify this on its official FDA label.
- Has Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate been recalled by the FDA?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate safe?
- There's no single safe-or-not verdict. pharmaranks gives Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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norethindrone acetate and ethinyl estradiol and ferrous fumarate
70/100