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Natazia

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Natazia

Indications
Dosage
How Supplied

INDICATIONS

Oral Contraception

Natazia® is indicated for use by women to prevent pregnancy. The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m² has not been evaluated.

Heavy Menstrual Bleeding

Natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies].

DOSAGE AND ADMINISTRATION

How to Take Natazia

To achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped orintake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.

How to Start Natazia

Instruct the patient to begin taking Natazia on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). See FDA-Approved Patient Labeling. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days.

For postpartum women who do not breastfeed or after a second trimester abortion, start Natazia no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Natazia postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Natazia for 9 consecutive days. The possibility of ovulation and conception prior to initiation of medication 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 dark yellow pill on the first day of her withdrawal bleed. She should not continue taking the pills from her previous birth control pack. If she does not have a withdrawal bleed, rule out pregnancy before starting Natazia.
  • If she previously used a vaginal ring or transdermal patch, she should start using Natazia on the day the ring or patch is removed.
  • Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.

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

    • Progestin-only pill
    • Implant
    • Intrauterine system
    • Injection
  • Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on t he 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 or spermicide for the first 9 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 colored tablet, this can be regarded as a missed tablet.

HOW SUPPLIED

Dosage Forms And Strengths

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in blister packs.

Each blister pack contains 28 round, biconvex, film-coated tablets in the following order:

  • 2 dark yellow tablets, with an embossed “DD” in a regular hexagon on one side, each containing 3 mg estradiol valerate
  • 5 medium red tablets, with an embossed “DJ” in a regular hexagon on one side, each containing 2 mg estradiol valerate and 2 mg dienogest
  • 17 light yellow tablets, with an embossed “DH” in a regular hexagon on one side, each containing 2 mg estradiol valerate and 3 mg dienogest
  • 2 dark red tablets, with an embossed “DN” in a regular hexagon on one side, each containing 1 mg estradiol valerate
  • 2 white tablets (inert), with an embossed “DT” in a regular hexagon on one side

Storage And Handling

Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in packages of three blister packs (NDC 50419-409-03).

The active and inert film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with the letters DD or DJ or DH or DN or DT.

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

  • 2 round biconvex dark yellow film-c oated tablets with embossed “DD” in a regular hexagon on one side each containing 3 mg estradiol valerate
  • 5 round biconvex medium red film-coated tablets with e mbossed “DJ” in a regular hexagon on one side each containing 2 mg estradiol valerate and 2 mg dienogest
  • 17 round biconvex light yellow film-coated tablets with embossed “DH” in a regular hexagon on one side each containing 2 mg estradiol valerate and 3 mg dienogest
  • 2 round biconvex dark red film-coated tablets with embossed “DN” in a regular hexagon on one side each containing 1 mg estradiol valerate
  • 2 white round biconvex white film-coated tablets with embossed “DT” in a regular hexagon on one side (inert)
Storage

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

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured in Germany. Revised: August 2013

Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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