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Side Effects & Adverse Reactions
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Legal Issues
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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
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.
History
There is currently no drug history available for this drug.
Other Information
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert tablets:
- 2 dark yellow tablets each containing 3 mg estradiol valerate
- 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
- 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
- 2 dark red tablets each containing 1 mg estradiol valerate
- 2 white tablets (inert)
Natazia also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red.
The empirical formula of estradiol valerate is C23 H32 O3 and the chemical structure is:
Estradiol Valerate
The chemical name of estradiol valerate is Estra-1,3,5(10)-triene-3,17-diol(17ß)-,17-pentanoate.
The empirical formula of dienogest is C20 H25 NO2 and the chemical structure is:
Dienogest
The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile.
Sources
Natazia Manufacturers
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Physicians Total Care, Inc.
Natazia | Physicians Total Care, Inc.
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2.1 How to take NataziaTo achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one tablet by mouth the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
2.2 How to start NataziaInstruct 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, Natazia may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 9 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 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 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 or spermicide for the first 9 days. 2.3 Advice in case of Gastrointestinal DisturbancesIn 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. [See FDA-Approved Patient Labeling.]
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Bayer Healthcare Pharmaceuticals Inc.
Natazia | Bayer Healthcare Pharmaceuticals Inc.
2.1 How to Take NataziaTo 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 or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
2.2 How to Start NataziaInstruct 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 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 or spermicide for the first 9 days. 2.3 Advice in Case of Gastrointestinal DisturbancesIn 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.
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