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Norethindrone Acetate and Ethinyl Estradiol
Overview
What is Lomedia 24 Fe?
Lomedia 24 Fe provides 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: povidone, anhydrous lactose, microcrystalline cellulose, polacrilin potassium and magnesium stearate.
Each brown tablet contains ferrous fumarate, pregelatinized starch, anhydrous lactose, crospovidone, magnesium stearate. The ferrous fumarate tablets do not serve any therapeutic purpose.
Ethinyl Estradiol has a molecular weight of 296.40 and a molecular formula of CHO. Norethindrone Acetate has a molecular weight of 340.46 and a molecular formula of CHO.
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 Lomedia 24 Fe look like?
What are the available doses of Lomedia 24 Fe?
Sorry No records found.
What should I talk to my health care provider before I take Lomedia 24 Fe?
Sorry No records found
How should I use Lomedia 24 Fe?
Lomedia 24 Fe tablets are 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.
TABLE 2
Percentage of women experiencing an unintended pregnancy during the first year of typical use
and the first year of perfect use of contraception and the percentage continuing use at the end of
the first year. United States.
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
3
4
5
6
7
8
10
Clinical Studies
In a clinical study, 743 women, 18 to 45 years of age, were treated with Lomedia24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Lomedia24 Fe was 1.82.
To achieve maximum contraceptive effectiveness, Lomedia 24 Fe tablets should be taken exactly as directed and at intervals not exceeding 24 hours. Lomedia 24 Fe tablets may be administered without regard to meals.
Lomedia 24 Fe provides a regimen consisting of 24 white active tablets of 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol 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 possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking Lomedia 24 Fe on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white 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 Lomedia 24 Fe until a white 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 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 nonhormonal 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:
When the patient is switching to Lomedia 24 Fe after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts Lomedia 24 Fe. 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 to Lomedia 24 Fe after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of Lomedia 24 Fe 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 Lomedia 24 Fe the next day. If switching from an implant or injection, the patient should start Lomedia 24 Fe 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 Lomedia 24 Fe is 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 white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy she begins taking the active white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. Therefore, the risk of pregnancy increases with each active (white) tablet missed.
Use after pregnancy, abortion or miscarriage:
Lomedia 24 Fe should be initiated no earlier than 28 days 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.
Lomedia 24 Fe may be initiated after a first-trimester abortion or miscarriage; if the patient starts Lomedia 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 Lomedia 24 Fe?
Sorry No Records found
What are the warnings of Lomedia 24 Fe?
Sorry No Records found
What are the precautions of Lomedia 24 Fe?
Sorry No Records found
What are the side effects of Lomedia 24 Fe?
Sorry No records found
What should I look out for while using Lomedia 24 Fe?
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, and 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 certain inherited thrombophilias, 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 Lomedia 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 Lomedia 24 Fe?
Risperidone tablets USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep out of reach of children.Risperidone tablets USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep out of reach of children.Risperidone tablets USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.Keep out of reach of children.Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00Lomedia 24 Fe is available in blister cards (dispensers) containing 24 white active tablets and 4 brown placebo tablets. Each white, 0.2188" round, 0.092" thick tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol and is debossed with on one side and plain on the other side. Each brown, 0.250" round, 0.095" thick tablet contains 75 mg ferrous fumarate, with on one side and plain on the other side.Cartons of 3 blister cards (dispensers) NDC 65162-316-84Rx onlyKeep this drug and all drugs out of the reach of children. Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].References are available upon request.Manufactured by: Corona, CA 92880 USADistributed by: Glasgow, KY 42141Rev. 04-2015-00
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: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, and 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 certain inherited thrombophilias, 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 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 break-through 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 to 6% of the 743 women using Lomedia 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 Lomedia 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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