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Generess Fe

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Generess Fe

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

How to Take GENERESS Fe

To 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].

How to Start GENERESS Fe

Instruct 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:

    • Another pill
    • Vaginal ring
    • Patch
  • 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.

If the patient is switching from a progestin-only method such as:

  • 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.

Advice in Case of Gastrointestinal Disturbances

In 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.]

HOW SUPPLIED

Dosage Forms And Strengths

GENERESS Fe is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

  • 24 light green, round tablets (active) imprinted with “WC” on one side and “483” on the other and each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol.
  • 4 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate.

The ferrous fumarate chewable tablets do not serve any therapeutic purpose.

Storage And Handling

GENERESS Fe is available in cartons of 3 blister cards (dispensers) (NDC 52544-204-31).

Each blister card (28 tablets) contains in the following order:

  • 24 light green, round tablets (active) imprinted with “WC” on one side and “483” on the other and each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol.
  • 4 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate.

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].

Keep this drug and all drugs out of the reach of children.

Address medical Inquiries to: WATSON, Medical Communications, P.O. Box 1953 Morristown, NJ 07962-1953. Manufactured By: Warner Chilcott Compay, LLC, Fajardo, PR 00738. Revised: January 2011

Last reviewed on RxList: 7/15/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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