Estradiol valerate/dienogest

Natazia 

Natazia is a versatile medication primarily used for contraception and treating heavy menstrual bleeding. This oral contraceptive is provided in a 28-day pack with different colored tablets, each containing varying strengths of active ingredients. The tablets must be taken in a specific order for optimal effectiveness. Natazia works by preventing ovulation, altering the uterine lining, and thickening cervical mucus to reduce the likelihood of pregnancy. Common side effects include headaches, nausea, and breast tenderness, but severe risks like blood clots and liver issues are also possible. Interactions with certain medications, supplements, and conditions can affect its efficacy, so it’s crucial to consult a healthcare provider. For those seeking alternatives, options include other combination oral contraceptives, progestin-only pills, extended-cycle contraceptives, IUDs, implants, injections, and non-hormonal treatments like tranexamic acid and NSAIDs. Natazia offers an effective solution for contraception and menstrual management, but careful adherence to guidelines and consultation with a healthcare expert is essential for safe use.

Product Overview

Natazia, a combination oral contraceptive featuring estradiol valerate and dienogest, is engineered to prevent pregnancy and manage heavy menstrual bleeding effectively. This contraceptive integrates a dynamic dosing regimen across a 28-day cycle, differentiated by the tablets’ color representing varying hormone concentrations. The pack includes 2 dark yellow tablets containing 3 mg of estradiol valerate, 5 medium red tablets combining 2 mg each of estradiol valerate and dienogest, 17 light yellow tablets with 2 mg estradiol valerate & 3 mg dienogest, 2 dark red tablets with 1 mg estradiol valerate, and 2 placebo white tablets.

For contraception, users take one tablet daily without interruption between packs, starting on the first day of menstrual bleeding. Similar adherence applies to treating heavy menstrual bleeding, emphasizing continuous use. To maintain hormonal balance and efficacy, Natazia requires particular attention to dosing times, ideally at the same hour each day. This contraceptive is not suitable for everyone; it carries significant risks, especially for women over 35 who smoke, as they have increased chances of severe cardiovascular issues like heart attacks and strokes. Other potential side effects include blood clots, high blood pressure, and severe reactions in the liver and gallbladder. Women with a history of depression, diabetes, or blood clotting disorders should use Natazia cautiously and under close medical supervision.

Moreover, Natazia can interact with various medications and substances, including antibiotics and herbal supplements like St. John’s Wort, which might diminish its contraceptive effectiveness. Regular medical consultations are essential to tailor the dosage and manage any arising side effects or interactions. Natazia represents a robust solution for birth control and managing menstrual-related issues, providing a reliable method for women seeking comprehensive reproductive health management.

What Are the Uses of Natazia?

• Contraception
• Treatment of Heavy Menstrual Bleeding

What Are the Forms & Strengths of Natazia?

Natazia is provided as a 28-day oral contraceptive pack that contains a sequence of different colored tablets with varying strengths of the active ingredients estradiol valerate and dienogest:

• 2 dark yellow tablets containing 3 mg estradiol valerate.
• 5 medium red tablets containing 2 mg estradiol valerate and 2 mg dienogest.
• 17 light yellow tablets containing 2 mg estradiol valerate and 3 mg dienogest.
• 2 dark red tablets containing 1 mg estradiol valerate.
• 2 white tablets containing no active hormones (placebos).

What Are the Recommended Dosage of Natazia?

The recommended dosage of Natazia generally follows a standard protocol but may require adjustments based on individual patient needs and conditions. Here are the typical dosing guidelines:

Adult Women for Contraception:

• Take one tablet daily simultaneously, without any breaks between packets. The sequence of different-colored pills in the pack should be strictly followed.

For Treatment of Heavy Menstrual Bleeding:

• The exact dosing schedule for contraception is recommended: one tablet daily, continuously, following the order of the pills in the pack.

Special Considerations:

• Starting Natazia: If there is no previous hormonal contraceptive use, begin on the first day of menstruation. If switching from another form of contraception, specific guidelines regarding the timing vary based on the type of contraception previously used.
• Missed Pills: Instructions for missed pills depend on how many and when they are missed. Typically, if one pill is missed, it should be taken as soon as remembered, and then the next pill should be taken at the regular time (even if it means taking two pills in one day).

Patients with Renal or Liver Impairment:

• Natazia is not recommended for use in women with severe hepatic impairment & should be used with caution in women with renal impairment.

Patients with Other Medical Conditions:

• Women with conditions affected by fluid retention (such as epilepsy, migraine, asthma, or cardiac or renal dysfunction) should be closely monitored.

[Note: It’s essential to seek consultation from a healthcare professional to tailor the dosage according to individual health needs and medical history. Regular follow-ups to assess the effectiveness and tolerability of the treatment are also crucial.]

How to Use Natazia? 

Using Natazia effectively involves following specific instructions to ensure it works as intended and to maintain its effectiveness as a contraceptive. Here’s a concise guide on how to use Natazia:

• Begin taking Natazia on the first day of your menstrual period. This is considered Day 1.
• Take one tablet each day, following the order indicated on the pack. The pack contains tablets of different colors, corresponding to various cycle phases. It is crucial to take them in the correct sequence.
• For best results, take your tablet at the same time every day. This helps maintain consistent hormone levels in your body.
• Do not crush, chew, or break the Natazia tablets. Swallow each tablet whole with water.
• After finishing a pack, start the next pack the following day. There should be no gap between packs.
• Natazia can be taken with or without food. If you experience stomach upset, try taking it with food.
• Routine check-ups with your healthcare specialist are essential while using Natazia, especially if you experience any side effects or unusual symptoms.

[Note: Your doctor will decide the right dosage amount for you as per your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Natazia Work?

Natazia works as a combined oral contraceptive by utilizing a blend of two hormones, estrogen (estradiol valerate) and progestin (dienogest), to prevent pregnancy. Here’s how it functions:

• Ovulation Prevention: Natazia primarily works by inhibiting the release of an egg during the period of menstrual cycle. This is achieved through the actions of the hormones that control the body’s natural cyclical hormones.
• Changes in Uterine Lining: It alters the lining of the uterus (endometrium), making it less suitable for a fertilized egg to attach. If an egg were to become fertilized, this change in the lining often prevents it from successfully implanting.
• Cervical Mucus Modification: Natazia thickens the cervical mucus, which makes it more difficult for sperm to enter the uterus. This decreased sperm mobility significantly reduces the likelihood of fertilization.

Important Safety Information for Using Natazia

What Are the Side Effects of Natazia?

Common Side Effects of Natazia

Natazia can lead to some side effects. These are usually temporary, lasting from a few days to weeks. If these side effects continue beyond this period, bother you, or become intense, it’s important to consult your doctor or pharmacist. Common side effects of Natazia may include:

• Headache
• Breast tenderness or pain
• Nausea
• Menstrual irregularities (spotting, breakthrough bleeding)
• Mood changes (including depression)
• Weight gain
• Acne
• Decreased libido
• Bloating
• Fluid retention
• Vaginal discharge
• Fatigue
• Abdominal pain
• Dizziness
• Back pain

Serious Side Effects of Natazia

Natazia can cause serious side effects, which, although less common, require immediate medical attention if they occur. Here are the severe side effects associated with Natazia:

• Blood Clots: Natazia increases the risk of developing blood clots in the veins & arteries, which can result in deep vein thrombosis, pulmonary embolism, stroke, or heart attack.
• High Blood Pressure: Some women may experience increased blood pressure, which can be severe and require medical management.
• Liver Problems: Signs of liver issues, such as jaundice (yellowing of the skin or eyes), severe abdominal pain, or liver enlargement, can occur and may indicate serious conditions like liver tumors.
• Gallbladder Disease: Use of hormonal contraceptives like Natazia has been linked to an increased risk of gallbladder disease.
• Severe Allergic Reactions: Although rare, allergic reactions such as hives, swelling of the face or lips, or difficulty breathing can occur.
• Cerebral Vascular Events: Such as strokes can happen, particularly in women with other risk factors like smoking, hypertension, or a history of clotting disorders.
• Visual Impairments: Hormonal changes due to the contraceptive might cause blurry vision or other visual disturbances that may indicate a more severe condition.
• Mood Changes: Some users report significant changes in mood, including symptoms of depression. If mood changes are severe, evaluation by a healthcare provider is necessary.

[Note: Remember, this list does not cover all possible side effects of Natazia. Always seek consultation from your healthcare professional for medical advice about medication side effects.]

Are There Any Warnings for Natazia? 

Natazia carries significant health risks, especially for specific individuals. If you have concerns about these risks, discuss alternative medication options with your healthcare expert.

• Cigarette Smoking and Cardiovascular Problems: Women over 35 who smoke and use combined oral contraceptives (COCs) like Natazia face an increased risk of severe cardiovascular issues such as strokes, heart attacks, and blood clots. If you smoke, consult your healthcare provider about safer contraceptive methods.
• Blood Clots and Strokes: Using Natazia can heighten the risk of blood clots buildup, leading to potentially fatal conditions such as pulmonary embolism, deep vein thrombosis, strokes, and heart attacks. If you notice symptoms like severe chest pain, difficulty breathing, leg pain, or sudden changes in vision or speech, immediate medical attention is necessary. It may be advisable to discontinue Natazia before planned surgeries to mitigate clotting risks.
• Cancer Risks: Long-term use of COCs is associated with increased risks of breast & cervical cancers. Natazia should be avoided if you have a history of breast cancer, and symptoms such as unusual lumps or nipple discharge should be checked immediately. Regular screenings for cervical cancer are recommended due to potential risks.
• Liver Health Concerns: Natazia may cause liver problems, including tumors and liver damage, particularly in products with higher estrogen levels. Report symptoms like fatigue, abdominal pain, or jaundice to your healthcare provider promptly.
• High Blood Pressure: Natazia may increase blood pressure. Monitor your blood pressure on a routine basis, especially if you have pre-existing hypertension. Significant increases in blood pressure while using Natazia may require consultation with your healthcare provider about alternative treatments.
• Elevated Blood Sugar and Triglycerides: Natazia can raise blood sugar and triglyceride levels, potentially leading to pancreatitis. If you have diabetes, keep your blood sugar in check and seek immediate care for symptoms like severe abdominal pain.
• Depression: Monitor for new or worsening symptoms of depression while on Natazia. Severe cases may necessitate discontinuation of the medication.
• Drug Interactions: Inform your healthcare expert about all medications you are taking, as certain drugs can reduce Natazia’s effectiveness and lead to unintended pregnancy.
• Exacerbation of Other Conditions: Natazia may worsen hereditary angioedema and chloasma. If prone to these conditions, discuss potential risks with your healthcare provider and consider avoiding sun exposure to prevent chloasma flare-ups.

What Are the FDA Boxed Warning for Natazia?

Natazia does not have a specific FDA-boxed warning unique to this medication. However, like all combined oral contraceptives, it shares common serious risks outlined in general warnings applicable to all estrogen-containing contraceptives. These typically include warnings about:

• Cardiovascular Events: An increased risk of blood clots, strokes, and heart attacks, particularly in women who smoke and are over the age of 35.
• Cancer Risks: Possible increased risk of cervical and breast cancers noted with long-term use of hormonal contraceptives.

What Are the Natazia Precautions?

Before taking Natazia, consider the following precautions to ensure it’s safe for your use:

• Blood Clots and Cardiovascular Risks: Natazia can significantly heighten the risk of developing blood clots, stroke, or heart attack. This risk is heightened if you have conditions such as high blood pressure, diabetes, and high cholesterol or if you’re overweight. The first year of using Natazia or restarting the medication after a break of almost 4 weeks or more carries the highest risk.
• Smoking: Smoking increases the danger of severe cardiovascular side effects from Natazia, especially if you are over 35 years old. It is advised not to use Natazia if you smoke and are over this age.
• Pregnancy: Avoid using Natazia during pregnancy. Discontinue use immediately if you become pregnant or miss two consecutive menstrual periods. If you’ve recently had a baby, wait at least 4 weeks before starting Natazia.
• Other Health Conditions: Inform your doctor if you have a history of depression, diabetes, thyroid disorders, gallbladder disease, seizures, epilepsy, or jaundice caused by pregnancy or birth control pills.
• Breastfeeding: Natazia may reduce breast milk production and can pass into breast milk, causing harm to the nursing baby. Do not use this medication if you are breastfeeding.

What Are the Contraindications of Natazia?

Due to potential safety concerns, Natazia should not be used under the following conditions. Inform your healthcare provider if any of the following apply to you:

• Smoking while over 35 years old.
• Current or family history of deep vein thrombosis (DVT) or pulmonary embolism (PE).
• Coronary artery disease.
• Cerebrovascular disease (issues with blood flow in the brain).
• Specific heart valve or rhythm disorders.
• Blood clotting disorders.
• Uncontrolled high blood pressure.
• Diabetes with vascular complications.
• Specific types of headaches or migraines, particularly if over 35 years old.
• Undiagnosed abnormal uterine bleeding.
• Current or history of breast cancer.
• Liver tumors or liver disease.
• Pregnancy.

What If You Missed a Dose of Natazia?

If you miss a dose of Natazia, the steps you should take depend on how many pills you’ve missed and when they were missed in your cycle:

• If you miss one pill, take it as soon as you remember. If it’s almost time for your next dose, take both pills at the same time. Continue with your regular schedule afterward.
• If you miss two consecutive pills in the first or second week, take two pills as soon as you remember and two pills the next day. Then resume taking one pill per day. Use backup contraception, like condoms, for the next 7 days.
• If you miss two consecutive pills in the third week or if you miss three or more successive pills at any point in the pack:
  • Discard the rest of the pill pack and start a new pack on the same day if you are a Day 1 starter.
  • If you start your pack on Sunday, take one pill daily until Sunday, discard the rest, and start a new pack on the same day.
  • In both cases, use backup contraception for the next 7 days.
• If you miss any of the reminder (non-hormonal) pills in Week 4, discard the missed pills and continue taking the remaining pills on schedule. No additional contraception is needed.

[Note: If you have missed a dosage of Natazia and are unsure regarding the next one, immediately consult your doctor or pharmacist.]

What Happens If You Take Too Much of Natazia?

Taking too much Natazia can increase the risk of side effects associated with hormonal contraceptives. Common symptoms of an overdose may include:

• Nausea
• Vomiting
• Vaginal bleeding

These symptoms are generally not severe, but it’s essential to seek medical advice if an overdose is suspected. There is no specific antidote for an overdose of Natazia, so treatment is supportive and symptomatic. If you’ve taken more Natazia than prescribed and experience any discomfort or unusual symptoms, it’s wise to contact your healthcare expert or seek emergency medical attention to ensure appropriate care is given.

[Note: If you have taken more than the recommended dose of Natazia, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

How to Store a Natazia?

To store Natazia properly, follow these guidelines:

• Keep Natazia at an average room temperature of 20°C to 25°C.
• Store this medicine in a dry place. Avoid keeping medicine in bathrooms or other damp areas.
• Protect Natazia from light. Keep it in its original packaging until you are ready to take it.
• Keep Natazia out of reach of children and pets to prevent accidental ingestion.
• Do not use Natazia if the packaging is damaged or shows signs of tampering.

[Note: Discuss with your healthcare specialist the proper disposal of unused medicine and any questions you may have regarding its storage.]

What Medications Interact with Natazia?

Natazia (estradiol valerate/dienogest) can interact with various medications, affecting their efficacy or increasing the risk of side effects. Here are some fundamental interactions to be aware of:

• Antibiotics:

• • • Rifampin: Can reduce the effectiveness of Natazia.
    • Penicillin and Tetracyclines: These may also reduce the effectiveness of the drug.

• Anticonvulsants:

• • • Carbamazepine
    • Phenytoin
    • Topiramate
    • Barbiturates

• Antifungal Medications:

• • • Griseofulvin
    • Ketoconazole: Can increase the levels of Natazia in the blood.
  • HIV Medications:
    • Ritonavir
    • Nelfinavir

• Hepatitis C Medications:

• • • Ombitasvir/Paritaprevir/Ritonavir: These can increase liver enzyme levels and decrease the effectiveness of Natazia.

• Herbal Supplements:

• • • St. John’s Wort: It can lower the effectiveness of Natazia by increasing its metabolism in the liver.

• Other Medications:

• • • Modafinil: Can reduce the effectiveness of Natazia.
    • Certain anti-diabetic drugs: May require dose adjustments due to changes in blood glucose levels.

• Anticoagulants:

• • • Warfarin: Combined oral contraceptives can alter the effectiveness of warfarin and may require dose adjustments.

• Other Hormonal Contraceptives:

• • Using multiple forms of hormonal contraceptives simultaneously can increase the risk of side effects and is generally not recommended without medical supervision.

What Are the Other Natazia Interactions?

In addition to interactions with specific medications, Natazia (estradiol valerate/dienogest) can interact with various substances and conditions. Here are some notable interactions:

• Other Substances

  • Caffeine: Combined use may increase caffeine levels in your bloodstream, potentially causing jitteriness or insomnia.
  • Alcohol: This may increase the risk of liver issues and can exacerbate side effects like dizziness and nausea.
  • Grapefruit Juice: It can potentially increase the blood levels of estradiol and dienogest, potentially increasing the risk of side effects.
• Dietary Considerations
  • High-Fat Meals: High-fat meals can alter the absorption of Natazia, though this effect is generally not significant enough to require dietary changes.
  • Iron Supplements: Certain oral contraceptives can affect iron levels, so it’s important to maintain a balanced diet or consider supplements if your doctor advises.
• Medical Conditions
  • Liver Disease: Natazia should be used with caution in patients facing liver disease, as it can affect liver function and metabolism of the medication.
  • High Blood Pressure: Use with caution, as Natazia can potentially increase blood pressure. Regular monitoring is recommended.
  • Diabetes: Can affect blood sugar levels. Diabetic patients should routinely monitor their blood sugar levels and adjust medications as necessary.
  • Depression: Hormonal contraceptives can sometimes exacerbate symptoms of depression. Inform your healthcare provider if you have a history of depression.
  • Migraines: Hormonal changes can trigger or worsen migraines in some individuals.
• Laboratory Tests
  • Thyroid Function Tests: Natazia can affect thyroid hormone levels, potentially altering test results.
  • Liver Function Tests: Can cause changes in liver enzyme levels, which might require monitoring during treatment.
• Herbal Supplements
  • Ginseng: May reduce the effectiveness of hormonal contraceptives.
  • Garlic Supplements: Can alter the metabolism of Natazia, potentially reducing its effectiveness.
• Vaccinations
  • Live Vaccines: Hormonal contraceptives do not typically interfere with vaccines, but it’s always best to inform your healthcare expert about your medications and supplements.

[Note: This is not an exhaustive list; other interactions may exist. Always seek supervision from your healthcare provider or pharmacist for comprehensive advice tailored to your situation.]

What Are the Natazia Alternatives?

• Combination Oral Contraceptives (COCs):

  • Yasmin (drospirenone/ethinyl estradiol)
  • Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)
  • Alesse (levonorgestrel/ethinyl estradiol)

• Progestin-only Pills (POPs):

  • Micronor (norethindrone)
  • Camila (norethindrone)

• Extended-Cycle Oral Contraceptives:

  • Seasonique (levonorgestrel/ethinyl estradiol)
  • Lybrel (levonorgestrel/ethinyl estradiol)

• Intrauterine Devices (IUDs):

  • Mirena (levonorgestrel-releasing IUD) is also effective in reducing menstrual bleeding
  • Paragard (Copper IUD), which does not contain hormones

• Implants and Injections:

  • Nexplanon (etonogestrel implant)
  • Depo-Provera (medroxyprogesterone acetate injection)

• Non-Hormonal Options:

  • Tranexamic Acid: For treatment of heavy menstrual bleeding
  • NSAIDs (e.g., ibuprofen): Often used to reduce menstrual pain and bleeding

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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Frequently Asked Questions

Why do the pills in my Natazia pack have different colors?

The varying colors of the pills in your Natazia pack indicate different dosages of hormones. For instance, the dark yellow pills contain 3 mg of estradiol valerate, while the white pills are hormone-free placebos. Each pill’s specific hormone content is designed to work with your body’s natural cycle over 28 days. It’s crucial to take the pills in the precise order outlined in the pack. If you have any concerns or need clarification, it’s best to consult your healthcare professional or pharmacist.

What constitutes heavy menstrual bleeding?

Heavy menstrual bleeding is typically characterized by periods that last more than seven days or by very heavy blood flow, which might require you to change your pad or tampon more frequently than every two hours. If you experience such symptoms, it’s advisable to consult your healthcare provider. Natazia is often prescribed to manage heavy menstrual bleeding, as it helps regulate menstrual cycles and decrease the volume of bleeding.

How do I begin taking Natazia?

To start Natazia, take the first pill from the pack on the first day of your menstrual bleeding. It is essential to use additional non-hormonal contraception, such as condoms or spermicide, during the initial 9 days of taking Natazia to ensure effective birth control while the medication becomes fully active.

Can taking Natazia cause nausea?

Nausea is a common side effect when starting combined oral contraceptives like Natazia, particularly within the first few months of use. The symptoms often improve with time. If you feel like vomiting or experience severe diarrhea within 3-4 hours after taking a colored Natazia tablet. You should take another pill of the same color from a spare blister pack to maintain contraceptive effectiveness. Consult your medical professional or pharmacist for guidance if you do not have an extra pack.

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