Natazia (Estradiol Valerate/Dienogest)

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Natazia (estradiol valerate and estradiol valerate/dienogest) is a combined oral contraceptive prescribed for pregnancy prevention and for treating heavy menstrual bleeding.

Natazia comes in a 28-day blister pack that includes the following tablets for oral administration:

  • 2 dark yellow tablets containing 3 mg of estradiol valerate
  • 5 medium red tablets containing 2 mg of estradiol valerate and 2 mg dienogest
  • 17 light yellow tablets containing 2 mg of estradiol valerate and 3 mg dienogest
  • 2 dark red tablets containing 1 mg of estradiol valerate
  • 2 white tablets that are inactive
Fact Table
Formula Estradiol Valerate: C23H32O3
Dienogest: C20H25NO2
License FDA approved
Bioavailability Estradiol Valerate: Oral bioavailability is variable, but Estradiol has around 5% bioavailability after metabolism.
Dienogest: Approximately 91%
Legal status Prescription only
Chemical Name Estradiol Valerate: [(8R,9S,13S,14S,17S)-13-Methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] pentanoate
Dienogest: (17a)-17-Hydroxy-3-oxo-19-norpregna-4,9-dien-21-nitrile
Elimination half-life Estradiol: Approximately 14 hours
Dienogest: Approximately 9-10 hours
Dosage (Strength) Varies: 1 mg Estradiol Valerate, 2 mg Estradiol Valerate / 2 mg Dienogest, 2 mg Estradiol Valerate / 3 mg Dienogest, 1 mg Estradiol Valerate / 3 mg Dienogest (quadriphasic oral contraceptive regimen)
Pregnancy Not recommended; Category X
Brands Natazia (U.S.), Qlaira (International)
Protein binding Estradiol: 98% (bound to sex hormone-binding globulin)
Dienogest: 90-95%
PubChem CID Estradiol Valerate: 66461
Dienogest: 68849
MedlinePlus a601052 (Estradiol), a602008 (Contraceptive)
ChEBI Estradiol Valerate: 490366
Dienogest: 4715
ATC code G03AB08
DrugBank Estradiol Valerate: DB13950
Dienogest: DB09124
KEGG Estradiol Valerate: D00555
Dienogest: D01771
Routes of administration Oral

Directions

Natazia should be taken as your doctor has instructed. Read the medication guide that comes with your prescription for additional instructions for use.

Recommended dose: Take one tablet by mouth daily at the same time each day. Take the tablets in the order as instructed on the blister pack. Refrain from skipping or delaying your dose by more than 12 hours.

Natazia should be kept out of reach of children and stored at 25°C (77°F).

Do not hesitate to reach out to your doctor or pharmacist with any questions or concerns you have.

Ingredients

Estradiol valerate and estradiol valerate/dienogest are the active ingredients in Natazia.

Contraindications

Natazia should not be given to pregnant patients or patients who are at high risk of arterial or venous thrombotic diseases, have abnormal and undiagnosed uterine bleeding, have breast cancer, or have liver disease or tumors.

Cautions

  • Natazia is associated with the following FDA Boxed Warning:
  • Women who are older than 35 years of age and smoke should not take Natazia.
  • Smoking cigarettes increases the risk of serious cardiovascular events from combined oral contraceptives.
  • Prior to starting Natazia birth control pills, discuss the following with your doctor:
    • All the medications you take, including prescription and nonprescription medications, vitamins, and supplements
    • Your allergies
    • Any existing health concerns
    • Your past medical history
    • If you are pregnant
    • If you are breastfeeding
  • Natazia contains the following warnings and precautions:
    • Vascular conditions
    • Liver disease
    • High blood pressure
    • Lipid metabolic and carbohydrate effects
    • Headache
    • Uterine bleeding
    • CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, St. John’s wort) can impact how well Natazia works; therefore, another combined oral contraceptive should be taken into consideration

Side Effects

Natazia side effects include but are not limited to headache, nausea, breast pain, vomiting, menstrual issues, changes in mood, acne, and weight gain. Call your doctor right away if you experience side effects that are bothersome or persistent.

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Reference

Natazia. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2023.




IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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