Zenchent FE
Norethindrone and Ethinyl Estradiol · Kit · Oral
Uses
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy.
• Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Dosage and administration
Take one tablet by mouth at the same time every day. Tablets may be chewed or swallowed. ( 2.1 ) Take tablets in the order directed on the blister pack .( 2.1 ) 2.1 How to Start Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are dispensed in a blister card [see How Supplied/Storage and Handling (16) ] . Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 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 Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets (light yellow 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 Zenchent Fe, Norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets 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: Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets active tablets are light yellow (Day 1 to Day 21). Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets placebo tablets are brown (Day 22 to Day 28). Day 1 Start: Take first light yellow active tablet on the first day of menses. Take subsequent light yellow 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 Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. Take subsequent light yellow 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 Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 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 Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets Start Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets: 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 Zenchent Fe, Zenchent Fe, norethindrone and Ethinyl Estradiol Tablets, Chewable and Ferrous Fumarate Tablets after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets may be started immediately. An additional method of contraception is not needed if Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are started within 5 days after termination of the pregnancy. If Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are 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 Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets, 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 Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets.
Dosage forms and strengths
Zenchent Fe, norethindrone and ethinyl estradiol tablets and ferrous fumarate tablets are available are available only in a 28-day regimen. Each package contains 21 light yellow, round, flat face, beveled edge tablets of 0.4 mg norethindrone and 35 mcg ethinyl estradiol, debossed with “ AZ1 ” on one side and plain on the other side. Each natural color brown, round, flat face, beveled edge tablet contains 75 mg ferrous fumarate, debossed with “ AZ2 ” on one side and plain on the other side. Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets consists of 28 tablets in the following order ( 3 ): 21 light yellow tablets (active), each containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol 7 brown tablets (non-hormonal placebo), each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
Contraindications
Zenchent 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] . Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11) ] Hypersensitivity to any of the components. 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 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Warnings and precautions
Thrombotic Disorders and Other Vascular Problems: Stop Zenchent 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 Zenchent Fe if jaundice occurs ( 5.2 ) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop Zenchent Fe if blood pressure rises significantly. ( 5.4 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Zenchent Fe. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.6 ) Headache : Evaluate significant change in headaches and discontinue Zenchent Fe if indicated ( 5.7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea ( 5.8 ) 5.1 Thrombotic Disorders and Other Vascular Problems Stop Zenchent Fe if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Zenchent Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. If feasible, stop Zenchent Fe 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 Zenchent 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 COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after 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). The 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 Zenchent Fe 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 Zenchent Fe if jaundice develops. Liver Tumors Zenchent 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/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. 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 Zenchent Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . Zenchent Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 5.4 High Blood Pressure Zenchent 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 Zenchent 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 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 take Zenchent Fe. COCs may decrease glucose tolerance. Consider alternative contraception for women with uncontrolled dyslipidemia. 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 Zenchent Fe develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Zenchent Fe if indicated. Consider discontinuation of Zenchent Fe in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
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) ] The following adverse reactions are commonly reported by COC users. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions were: irregular uterine bleeding, nausea, breast tenderness, and headache. ( 6 ) 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. 6.2 Post-marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. Figure 1: RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. 1
Drug interactions
Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 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 decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs : Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish 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, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal 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. Colesevelam : Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs : Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20% to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors, such as itraconazole, fluconazole, grapefruit juice, 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 estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). 7.2 Effects of Combined Oral Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, 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 the serum concentration of thyroid-binding globulin increases with use of COCs [see Warnings and Precautions (5.12) ] . 7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Zenchent 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.
Use in specific populations
Nursing mothers: Advise use of another contraceptive method. Zenchent Fe can decrease milk production. ( 8.3 ) 8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not use COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. 8.3 Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. 8.4 Pediatric Use Safety and efficacy of Zenchent Fe have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. 8.5 Geriatric Use Zenchent Fe has not been studied in postmenopausal women and is not indicated in this population. 8.6 Hepatic Impairment The pharmacokinetics of Zenchent Fe has not been studied in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. 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 [see Contraindications (4) and Warnings and Precautions (5.2) ] . 8.7 Renal Impairment The pharmacokinetics of Zenchent Fe has not been studied in women with renal impairment.
Pregnancy
8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not use COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.
Pediatric use
8.4 Pediatric Use Safety and efficacy of Zenchent Fe have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
Geriatric use
8.5 Geriatric Use Zenchent Fe has not been studied in postmenopausal women and is not indicated in this population.
Overdosage
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Description
Zenchent Fe is a combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 light yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are: NORETHINDRONE C 20 H 26 O 2 ETHINYL ESTRADIOL C 20 H 24 O 2 The active light yellow Zenchent Fe tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: calcium phosphate dibasic dihydrate, lactose monohydrate, magnesium stearate, maltodextrin, povidone, D&C yellow #10 (15% to 20%), natural spearmint flavor and sucralose. The inert brown tablets contain 75 mg ferrous fumarate, and compressible sugar, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. NORETHINDRONE ETHINYL ESTRADIOL
Mechanism of action
12.1 Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
How supplied
16.1 How Supplied Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 light yellow, round, flat face, beveled edge tablets of 0.4 mg norethindrone and 35 mcg ethinyl estradiol, debossed with “ AZ1 ” on one side and plain on the other side. Each natural color brown, round, flat face, beveled edge tablet contains 75 mg ferrous fumarate, debossed with “ AZ2 ” on one side and plain on the other side. Norethindrone and ethinyl estradiol tablets, chewable, 0.4 mg/35 mcg are mint flavored. Norethindrone and ethinyl estradiol tablets, chewable, 0.4 mg/35 mcg and ferrous fumarate tablets, 75 mg NDC 69238- 1581-3 Carton of 3 Dispensers each containing 28 tablets 16.2 Storage Conditions Store at 20º C to 25º C (68º F to 77º F); excursions permitted between 15º C to 30º C (59º F -86º F) [see USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children.
Patient information
See FDA-Approved Patient Labeling ( Patient Information and Instructions for Use ) Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ] . Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1) ] . Zenchent Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Zenchent Fe is not to be used during pregnancy; if pregnancy occurs during use of Zenchent Fe, instruct the patient to stop further use [see Warnings and Precautions (5.9) ] . Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed [see Dosage and Administration (2.3) ] . Use a back-up or alternative method of contraception when enzyme inducers are used with Zenchent Fe [see Drug Interactions (7.1) ] . COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3) ] . A woman who starts COCs postpartum and who has not yet had a period should use an additional method of contraception until she has taken a light yellow tablet for 7 consecutive days [see Dosage and Administration (2.2) ] . Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions (5.8) ] .
Label text from the FDA structured product label by Amneal Pharmaceuticals NY LLC (revised May 30, 2022). Long sections are shortened; the complete label is on DailyMed.
Zenchent FE NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69238-1581 | Kit | Amneal Pharmaceuticals NY LLC | ANDA |
Frequently asked questions
What is Zenchent FE used for?
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. • Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
What are the side effects of Zenchent FE?
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) ] The following adverse reactions are commonly reported by COC users. Because these reactions… See the full label for the complete list.
Who makes Zenchent FE?
Zenchent FE is listed by 1 labeler in the FDA NDC directory, including Amneal Pharmaceuticals NY LLC.