Generess Fe
Loading...Generess Fe Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
GENERESS Fe is indicated for use by women to prevent pregnancy.
The efficacy of GENERESS Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
History
There is currently no drug history available for this drug.
Other Information
GENERESS Fe provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:
- 24 light green, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol
- 4 brown, round tablets each containing 75 mg ferrous fumarate
Each light green tablet also contains the following inactive ingredients: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor, sucralose and vitamin E.
Each brown, round tablet contains ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor and sucralose. The ferrous fumarate chewable tablets do not serve any therapeutic purpose. Ferrous fumarate chewable tablets are not USP for dissolution and assay.
The empirical formula of ethinyl estradiol is C20H24O2 and the chemical structure is:
The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,(17α)-]
The empirical formula of norethindrone is C20H26O2 and the chemical structure is:
The chemical name of norethindrone is [17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one]
Sources
Generess Fe Manufacturers
-
Watson Pharma, Inc.
![Generess Fe (Norethindrone And Ethinyl Estradiol And Ferrous Fumarate) Kit [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Generess Fe | Watson Pharma, Inc.
2.1 How to Take GENERESS FeTo achieve maximum contraceptive effectiveness, GENERESS Fe must be taken exactly as directed. Chew and swallow one tablet without water at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling. GENERESS Fe may be administered without regard to meals [see Clinical Pharmacology (12.3)].
2.2 How to Start GENERESS FeInstruct the patient to begin taking GENERESS Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days [see FDA-Approved Patient Labeling]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking GENERESS Fe other than on the first day of her menstrual cycle.
For postpartum women who do not breastfeed or after a second trimester abortion, GENERESS Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives (COCs) are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. The possibility of ovulation and conception before starting COCs should also be considered.
If the patient is switching from a combination hormonal method such as:
Instruct her to take the first light green pill on the day she would have started a new cycle of her previous birth control pack (Day 1). If she previously used a vaginal ring or transdermal patch, she should start using GENERESS Fe on the day she would have restarted the ring or patch. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days.
- Another pill
- Vaginal ring
- PatchIf the patient is switching from a progestin-only method such as:
- Progestin-only pill
Instruct her to take the first light green pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection. Instruct the patient to use a non-hormonal back-up method such as a condom and spermicide for the first 7 days. 2.3 Advice in Case of Gastrointestinal Disturbances
- Implant
- Intrauterine system
- InjectionIn case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a light green tablet, this can be regarded as a missed tablet [see FDA-Approved Patient Labeling].
Login To Your Free Account