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Norethindrone and Ethinyl Estradiol
Overview
What is Zenchent FE?
Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets provide a regimen for oral contraception derived from 21 light yellow tablets composed of norethindrone and ethinyl estradiol followed by 7 natural 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 molecular weights for norethindrone and ethinyl estradiol are 298.42 and 296.40, respectively. The structural formulas are:
The active light yellow norethindrone and ethinyl estradiol tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: dicalcium phosphate dihydrate, lactose monohydrate, magnesium stearate, maltodextrin, povidone, D&C yellow #10 (15% to 20%), natural spearmint and sucralose.
The inert natural 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.
What does Zenchent FE look like?
What are the available doses of Zenchent FE?
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What should I talk to my health care provider before I take Zenchent FE?
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How should I use Zenchent FE?
Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
typical
perfectly
3
4
5
6
7
8
10
To achieve maximum contraceptive effectiveness, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is one light yellow tablet daily for 21 consecutive days, followed by one natural brown tablet, daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (light yellow) is taken that day. One light yellow tablet should be taken daily for 21 consecutive days followed by one natural brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of light yellow tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets until a light yellow tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on light yellow tablets - 7 days on natural brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a light yellow tablet daily for 7 consecutive days.
When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets the next day. If switching from an implant or injection, the patient should start norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets on the day of implant removal or, if using an injection, the day the next injection would be due.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.
For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the . Any time the patient misses two or more light yellow tablets, she should also use another method of non-hormonal back-up contraception until she has taken a light yellow tablet daily for seven consecutive days. If the patient misses one or more natural brown tablets, she is still protected against pregnancy she begins taking light yellow tablets again on the proper day. If breakthrough bleeding occurs following missed light yellow tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled light yellow tablets are missed. The risk of pregnancy increases with each active (light yellow) tablet missed.
Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see “,” “,” and “” concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets may be initiated after a first-trimester abortion; if the patient starts norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets immediately, additional contraceptive measures are not needed.
For additional patient instructions regarding complete dosing instructions, see “HOW TO TAKE THE PILL”section in the .
What interacts with Zenchent FE?
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What are the warnings of Zenchent FE?
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What are the precautions of Zenchent FE?
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What are the side effects of Zenchent FE?
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What should I look out for while using Zenchent FE?
Combination oral contraceptives should not be used in women who currently have the following conditions:
The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.
What might happen if I take too much Zenchent FE?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
How should I store and handle Zenchent FE?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.Zenchent Fe™ Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are available only in a 28-day regimen. Each package contains 21 round, light yellow uncoated tablets of 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, with on one side and on the other. Each natural brown, round tablet contains 75 mg ferrous fumarate, with on one side and on the other. 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 mgNDC 65162-347-84 Carton of 3 Dispensers each containing 28 tabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.*Realityis manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Lo-Ovral and Triphasil are manufactured by Wyeth Pharmaceuticals, Inc. and registered trademarks of Wyeth Corporation; Nordette is manufactured by and a registered trademark of Duramed Pharmaceuticals, Inc.; Levlen and Tri-Levlen are manufactured by and registered trademarks of Bayer Healthcare.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Non-Clinical Toxicology
Combination oral contraceptives should not be used in women who currently have the following conditions:The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.
Changes in contraceptive effectiveness associated with coadministration of other products:
a. Anti-infective agents and anticonvulsants
Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin. Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and tetracyclines. However, clinical pharmacology studies investigating drug interaction between combined oral contraceptives and these antibiotics have reported inconsistent results.
b. Anti-HIV protease inhibitors
Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
c. Herbal products
Herbal products containing St. John’s Wort may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in plasma levels of estradiol associated with coadministered drugs:
Coadministration of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in plasma levels of coadministered drugs:
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone, and theophylline have been reported with concomitant administration of combination oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation have been noted when these drugs were administered with combination oral contraceptives.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see section):
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:
The following adverse reactions have been reported in users of oral contraceptives, and a causal association has been neither confirmed nor refuted:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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