Estradiol valerate/dienogest

What is Dienogest And Estradiol Valerate?

• Dienogest And Estradiol Valerate (Natazia) is an estrogen/progestin combination oral contraceptive (COC).

What are the uses of this medicine?

• Natazia is a birth control pill.
• It contains two female hormones, an estrogen called estradiol valerate and a progestin called dienogest.
• Estradiol valerate is a synthetic estrogen that is converted to estradiol in your body.

How does this medicine work?

• combination oral contraceptive (COC)s lower the risk of becoming pregnant primarily by suppressing ovulation.
• Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Ever had breast cancer or any cancer that is sensitive to female hormones
• Liver disease, including liver tumors
• Ever had blood clots in your arms, legs, or lungs
• Ever had a stroke
• Ever had a heart attack
• Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• An inherited problem with your blood that makes it clot more than normal
• High blood pressure that medicine can't control
• Diabetes with kidney, eye, or blood vessel damage
• Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
• Smoke and are over 35 years old
• Are pregnant

What drug interactions can this medicine cause?

• Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding.
• Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy.

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

Recommended dosage:

• Take one tablet daily by mouth at the same time every day.
• Tablets must be taken in the order directed on the blister pack.
• Do not skip or delay intake by more than 12 hours.

Administration:

• Take one pill every day at the same time. Take the pills in the order directed on the blister pack.
• Do not skip pills or delay taking your pill by more than 12 hours. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
• If you have trouble remembering to take Natazia, talk to your healthcare provider about how to make pill-taking easier, or about using another method of birth control.
• You may have spotting or light bleeding when you first take Natazia. Spotting or light bleeding is normal at first.
• You may feel sick to your stomach (nauseous), especially during the first few months that you take Natazia. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea doesn't go away, call your healthcare provider.
• If you vomit or have diarrhea within 4 hours of taking your pill, follow the instructions for “What Should I Do if I Miss any Pills.”
• Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: Natazia consists of 28 film-coated, unscored tablets in the following order:

• 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)

This medicine is available in fallowing brand namesː

• Natazia

What side effects can this medication cause?

The most common side effects of this medicine include:

• headaches
• irregular uterine bleeding
• breast tenderness
• nausea/vomiting
• acne
• increased weight

What special precautions should I follow?

• Stop Natazia if a thrombotic event occurs. Stop Natazia at least 4 weeks before and through 2 weeks after major surgery. Start Natazia no earlier than 4 weeks after delivery, in women who are not breastfeeding.
• Discontinue Natazia if jaundice occurs.
• Women who currently have or have had breast cancer should not use COCs because breast cancer is a hormonally-sensitive tumor.
• For women with well-controlled hypertension, monitor blood pressure and stop COCs if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
• Carefully monitor prediabetic and diabetic women who are taking COCs. COCs may decrease glucose tolerance in a dose-related fashion.
• If a woman taking COCs develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue COCs if indicated.
• Breakthrough bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. Evaluate irregular bleeding or amenorrhea.
• Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose Natazia as their oral contraceptive due to the possibility of decreased contraceptive efficacy.

What to do in case of emergency/overdose?

• There have been no reports of serious ill effects from overdose of oral contraceptives.
• Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Can this medicine be used in pregnancy?

• Natazia cannot be used in pregnancy, because there is no reason to use COCs during pregnancy.

Can this medicine be used in children?

• Safety and efficacy of Natazia have been established in women of reproductive age.
• Use of this product before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

Active ingredients: ESTRADIOL VALERATE

Inactive ingredients: FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE POLYETHYLENE GLYCOL 6000 MAGNESIUM STEARATE STARCH, CORN POVIDONE K25 TALC TITANIUM DIOXIDE HYPROMELLOSES

Who manufactures and distributes this medicine?

• Packager: Physicians Total Care, Inc.

What should I know about storage and disposal of this medication?

• Store at 25º C (77º F); excursions permitted to 15–30oC (59–86oF).

• Dailymed label info on Estradiol valerate/dienogest
• FDA Estradiol valerate/dienogest

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