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Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Overview
What is Microgestin 24 Fe?
Microgestin 24 Feprovides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.
Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
Each white tablet also contains the following inactive ingredients: acacia, lactose, magnesium stearate, starch, confectioner’s sugar, and talc.
Each brown tablet contains ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, mannitol, sucralose and spearmint flavor. The ferrous fumarate tablets do not serve any therapeutic purpose.
The structural formulas for the active hormones are:
Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]
Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]
What does Microgestin 24 Fe look like?
What are the available doses of Microgestin 24 Fe?
Sorry No records found.
What should I talk to my health care provider before I take Microgestin 24 Fe?
Sorry No records found
How should I use Microgestin 24 Fe?
Microgestin 24 Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 2 lists the typical unplanned pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Emergency Contraceptive Pills
Lactational Amenorrhea Method
temporary
Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, . New York, NY: Irvington Publishers, 1998.
typical
perfectly
To achieve maximum contraceptive effectiveness, Microgestin 24 Fe should be taken exactly as directed and at intervals not exceeding 24 hours. Microgestin 24 Fe tablets may be administered without regard to meals.
Microgestin 24 Fe provides a regimen consisting of 24 white active tablets of Microgestin 24 Fe and 4 brown non-hormonal (placebo) tablets of ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
During the first cycle of use:
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: 24 days on white tablets—4 days on 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 white tablet daily for 7 consecutive days.
Switching from another hormonal method of contraception:
If spotting or breakthrough bleeding occurs:
For additional patient instructions regarding missed pills:
DETAILED PATIENT LABELING
provided
Use after pregnancy, abortion or miscarriage:
Microgestin 24 Fe may be initiated after a first-trimester abortion or miscarriage; if the patient starts Microgestin 24 Fe immediately, additional contraceptive measures are not needed.
For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the .
What interacts with Microgestin 24 Fe?
Sorry No Records found
What are the warnings of Microgestin 24 Fe?
Sorry No Records found
What are the precautions of Microgestin 24 Fe?
Sorry No Records found
What are the side effects of Microgestin 24 Fe?
Sorry No records found
What should I look out for while using Microgestin 24 Fe?
Oral contraceptives should not be used in women who currently have the following conditions:
What might happen if I take too much Microgestin 24 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 Microgestin 24 Fe?
Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Microgestin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate. Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature].References are available upon request.Microgestin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate. Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature].References are available upon request.Microgestin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate. Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature].References are available upon request.Microgestin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate. Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature].References are available upon request.Microgestin 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, round tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is imprinted with WC on one side and 530 on the other. Each brown, round tablet contains 75 mg ferrous fumarate. Rx onlyKeep this drug and all drugs out of the reach of children.Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature].References are available upon request.
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
Oral contraceptives should not be used in women who currently have the following conditions:Changes in contraceptive effectiveness associated with co-administration of other products:
a. Anti-infective agents and anticonvulsants
Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered 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.
b. Anti-HIV protease inhibitors
Several of the anti-HIV protease inhibitors have been studied with co-administration 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 co-administration 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 (hypericum perforatum) 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 co-administered drugs:
Co-administration 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 co-administered drugs:
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, 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.
The most common adverse events reported by 2 - 6% of the 743 women using Microgestin 24 Fe were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.
Among the 743 women using Microgestin 24 Fe, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).
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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