1 What Is Estarylla?

Brand: Estarylla, MonoNessa, Ortho-Cyclen, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Previfem, Sprintec, Tri-Lo-Sprintec, TriNessa, TriNessa 28, Tri-Previfem, Tri-Sprintec

Generic: Ethinyl estradiol and norgestimate

Estarylla is a hormone combination used as birth control pills to prevent pregnancy. This drug works by interfering with the monthly development of the ova. It contains the hormones progestin and estrogen to prevent the release of an egg during the menstrual cycle. It also prevents the attachment of a fertilized egg by changing the lining of the uterus; a fertilized egg that does not attach to the uterus is passed out of the body. In order to stop the sperm from reaching the egg, it thickens the vaginal fluid. Birth control pills may make periods more regular, decrease blood loss, treat acne, and decrease risk of ovarian cysts. However, this medication does not protect the partner from STDs (sexually transmitted disease) like HIV, gonorrhea, and Chlamydia

2 What to Know Before Using

Before using Estarylla, the risks and benefits should be discussed with your healthcare provider. Inform your doctor of any allergic reactions to these or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reactions or contraindications.

Studies in children regarding the correlation of age to the effects of ethinyl estradiol and norgestimate in combination have not been performed.

Studies in teenagers have not reported any pediatric-specific problems that would limit the utility of this drug. The drug may be used for birth control in teenage females, but should not be used before the start of menstruation.

This medication is contraindicated in elderly women. Infant risk is still undetermined when taking it while breastfeeding. Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

To prevent any interactions, drugs should not be taken together, but in necessary cases, inquire about adjustments in dosage or any other precautions to prevent unwanted side effects.

Inform your healthcare professional if you are taking any other drugs, such as Dasabuvir, Ombitasvir, Paritaprevir, Ritonavir, Tranexamic, Anagrelide, Boceprevir, Bupropion, Carbamazepine, Ceritinib, Clozapine, Crizotinib Dabrafenib Darunavir Donepezil Eliglustat Fentanyl Idelalisib Isotretinoin Lumacaftor Nilotinib, Paclitaxel, Paclitaxel Protein-Bound, Piperaquine, Pirfenidone, Sugammadex, Theophylline, Tizanidine, Ulipristal, Alprazolam, Amprenavir, Aprepitant, Atazanavir, Bacampicillin, Betamethasone, Bexarotene, Bosentan, Clarithromycin, Colesevelam, Cyclosporine, Delavirdine, Efavirenz, Eslicarbazepine Acetate, Etoricoxib, Etravirine, Fosamprenavir, Fosaprepitant, Fosphenytoin, Ginseng, Griseofulvin, Lamotrigine, Licorice, Modafinil, Mycophenolate, Mofetil, Mycophenolic Acid, Nelfinavir, Oxcarbazepine, Parecoxib, Phenobarbital, Phenytoin, Prednisolone, Primidone, Rifabutin, Rifampin, Rifapentine, Ritonavir, Roflumilast, Rosuvastatin, Rufinamide, Selegiline, St John's Wort, Telaprevir, Tipranavir, Topiramate, Troglitazone, Troleandomycin, Valdecoxib, Voriconazole, or Warfarin.

Drug interactions may change the way the medications work for you, or they may increase the risk for serious side effects. Share with your doctor a list of prescription/non-prescription and herbal products that you use. Do not change or stop the dosage of any medicines without first consulting the doctor. Other products that may interact with Estarylla include aromatase inhibitors (anastrozole, exemestane), tamoxifen, tizanidine, ospemifene, and tranexamic acid.  Some drugs cause a decrease in the amount of birth control hormones in the body, thus making the birth control less effective, resulting in pregnancy. They include rifamycin such as rifabutin, drugs used in the treatment of seizures such as barbiturates, felbamate, topiramate, and HIV drugs such as nevirapine.

Inform your doctor if you start any new drug or if any spotting or breakthrough bleeding occurs, as this may indicate the birth control is not working properly. This medication may cause false test results for certain laboratory tests, such as thyroid and blood clotting factors. Inform the laboratory personnel that you are using this medication before undergoing testing.

Intake of specific foods or using alcohol or tobacco with this drug can increase the risk for certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider of any other medical problems, such as abnormal or unusual vaginal bleeding; blood clots; breast cancer; diabetes with kidney, eye, nerve, or blood vessel damage; endometrial cancer; history of heart attack; cardiovascular disease; hypertension; jaundice during pregnancy or from using hormonal therapy in the past; liver disease; major surgery with prolonged periods of immobilization; migraine; history of stroke; cervical cancer; chloasma; depression; edema; epilepsy; gallbladder disease; hereditary angioedema; hyperlipidemia; obesity; or kidney disease

3 Proper Usage

To use Estarylla correctly, you must follow all instructions given by your doctor.

Before using this product, read the patient information leaflet provided by the pharmacist. It contains information about when to take your pills and what to do if you miss a dose. Follow the instructions on the label or as directed by your healthcare professional. This medication is taken by mouth. Determine a time that is easy for you to remember to take the pill each day. To find the first tablet, follow the package instructions and take the pills in the correct order without skipping any doses.

This drug is available in blister packs with a DialpakВ® tablet dispenser or a VeridateВ® tablet dispenser. Each blister pack contains twenty-eight tablets with different colors that need to be taken in the same order as directed on the pack.

Your body will require an adjustment period of at least seven days after initiating treatment before preventing any pregnancy. For the first seven days of your first cycle of pills, use a second form of contraception, such as a condom, spermicide, or diaphragm. Take the drug at the same time each day. Optimal effects can be achieved if the next daily dose is taken within twenty-four hours.

You could become pregnant if you miss a dose. Feeling sick or nauseated, especially during the first few months, is associated with the use of this drug. Call your healthcare professional if your nausea is persistent. Follow the instructions in the patient leaflet or call your healthcare professional if you vomit or have diarrhea within three to four hours of taking the drug.

Dosage will vary for different patients. The directions on the label or prescription by your healthcare professional should be followed strictly. The dosage you take depends on the medical problem for which you are using the drug.

To prevent pregnancy in adults and teenagers, one blue tablet of Ortho-CyclenВ® must be taken at the same time each day for twenty-one consecutive days, followed by one dark green tablet daily for seven days per menstrual cycle. One white, light blue, or blue tablet of Ortho Tri-CyclenВ® must be taken at the same time each day for twenty-one consecutive days followed by one dark green tablet daily for seven days per menstrual cycle. Use and dosage in children must be determined by your healthcare professional.

Adults and teenagers fifteen years of age and older with acne are given one white, light blue, or blue tablet taken at the same time each day for twenty-one consecutive days, followed by one dark green tablet daily for seven days per menstrual cycle. Use and dosage in teenagers and children younger than fifteen years must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed one and go back to your regular dosing schedule if it is almost time for your next dose. If you a miss a dose consecutively, restart your treatment cycle and wait seven days before having unprotected sex.

If you have not switched from another form of hormonal birth control and are using this medication for the first time, take the first dose in the pack on the first Sunday following the beginning of your menstrual period. For the first seven days, use an additional form of non-hormonal birth control. This will give the medicine enough time to work and also prevent pregnancy. You may need a back-up birth control if you experience vomiting or diarrhea, because they can prevent the effectiveness of the pill. If you have an upset stomach or nausea with this medication, it is better to take it after evening meals or at bedtime. However, you can take it at another time decided by you. No matter what dosing schedule you choose, taking this medication daily at the same time is very important. If you want to switch from other forms of hormonal birth control to this product, ask your doctor or pharmacist.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose of any outdated or expired drugs and ask your healthcare professional for proper disposal methods.

Unless instructed, do not flush the medication down the toilet or pour it into a drain. 

4 Precautions to Take

In using Estarylla, you must be careful and take precautions as advised by your doctor.

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. These visits will usually occur every six to twelve months, but some healthcare professionals require them more often.

Your healthcare professional may also want to check your blood pressure while taking this drug. Inform your doctor immediately if you think you have become pregnant while using the drug, since it has teratogenic potential.

Inform your healthcare professional if you have had a baby within four weeks before you start this drug. Continue with your regular dosing schedule if you experience signs of spotting. Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first three months of use.

The bleeding usually stops within one week, but check with your healthcare professional if the bleeding continues for a  longer duration. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. Check with your healthcare professional immediately if you miss a menstrual period.

Talk to your healthcare professional if you miss two periods in a row. You may be advised to undergo a pregnancy test. Taking this drug is not recommended if you smoke cigarettes or if you are over thirty-five years of age. Smoking increases your risk of having a blood clot, heart attack, or stroke, and the risk is even higher if you are over thirty-five, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight.

Consult your healthcare professional about ways to control these factors. Check with your doctor immediately if you have symptoms of clotting problems, such as pain in the chest, groin, or legs, especially the calves; difficulty breathing; a sudden, severe headache; slurred speech; sudden, unexplained shortness of breath; sudden loss of coordination; or vision changes while using this drug.

Increased risk of breast cancer or cervical cancer has been associated with the use of this drug. Check with your healthcare professional immediately if you experience abnormal vaginal bleeding, blurred vision, difficulty reading, or any other change in vision during or after treatment. You may be referred to an ophthalmologist to have your eyes checked. If any side effects occur, such as pain in the chest, jaw, or left arm; fainting; pain, swelling, or warmth in the groin or calf; rapid breathing; lack of coordination; worsening of migraines; or unusual sweating, get medical help right away.

This drug may contain inactive ingredients that may cause allergic reactions, so before starting it, inform the doctor or pharmacist if you are allergic to progestin or estrogen, or if you have any other allergies.

For those with diabetes, this medication may affect blood sugar levels. Get your blood sugar checked regularly and share the results with your doctor. If you experience any symptoms of high blood sugar, such as increased thirst or urination, tell the doctor right away. In such cases, the doctor may adjust diabetes medication, exercise program, or diet.

Inform the doctor if you had or will have surgery, or if you will be confined to bed for a long time, since these conditions may increase the risk of blood clots. In such cases, the medication needs to be stopped for a time or special precautions must be taken.

After you stop taking birth control pills, it may take some time for you to get pregnant. This drug may decrease the production of breast milk. A small amount will also pass into the breast milk, which may cause undesirable effects on the nursing infant. Before breastfeeding, consult your doctor.

Inform your healthcare professional immediately if you have symptoms of liver problems, such as pain or tenderness in the upper stomach, dark urine, pale stools, or yellow eyes or skin. Using this drug may increase your risk for gallbladder surgery. It is recommended to use sunscreen and wear protective clothing, as this drug may increase your skin’s sensitivity to sunlight.

Do not use sunlamps or tanning beds. Inform your healthcare professional if you have a history of dark patches of skin around the forehead, nose, cheeks, or around the mouth, especially during pregnancy. Check with your healthcare professional before refilling an old prescription. Inform any healthcare professional or dentist that you are using this drug, as it may affect the results of some medical tests. You may also need to stop using this drug at least four weeks before and two weeks after having major surgery.

Consumption of grapefruit or drinking grapefruit juice is not recommended while using this drug, as they may interfere with the drug’s absorption. Consult your healthcare professional before you take any other prescription or non-prescription drugs and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Estarylla.

Side effects may vary for each individual, and prompt medical attention should be sought if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms, such as abdominal or stomach pain; absent, missed, or irregular menstrual periods; anxiety; changes in vision or skin color; chest pain or discomfort; chills; clay-colored stools; constipation; cough; dark urine; diarrhea; dizziness or lightheadedness; fainting; fever; headache; hives or welts; itchy skin; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; loss of appetite; medium-to-heavy, irregular vaginal bleeding between regular monthly periods (which may require the use of a pad or a tampon); nausea and vomiting; pain or discomfort in the arms, jaw, back, or neck, pain; tenderness or swelling of the foot or leg; pains in the chest, groin, or legs (especially in the calves); pounding in the ears; rash; redness of the skin; sudden onset of severe headaches; slow or fast heartbeat; sudden loss of coordination; slurred speech; sudden shortness of HYPERLINK ""breath or troubled breathing; sweating; unusual tiredness or weakness; or vomiting of blood.

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persist or are inconvenient, if you notice any others, or if you have any questions about them, consult your healthcare professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

This medication should not be shared with others. Medical and laboratory appointments should be regular as well as all physical exams, such as medical and laboratory tests. This is to monitor progress and look for any side effects.

Remember that this medication has been prescribed by your doctor because he or she has judged the benefits of its use to be greater than the risk of its side effects. A majority of people using this medication do not experience any serious side effects. If the medication raises your blood pressure, get your blood pressure regularly checked by the doctor.

Seek medical help if there are any symptoms of a serious allergic reaction, such as rash; itching; swelling, especially of the face, throat, or tongue; severe dizziness; or trouble breathing. However, such serious allergic reactions are very rare. You may experience other side effects not listed above.

Its use has been approved in women of reproductive age, but not for those who have not yet had their first menstrual period.

Sometimes, the healthcare provider may recommend Estarylla for reasons other than contraception. This is known as “off-label“ use. It can be recommended for conditions such as:

  • Heavy, painful menstrual bleeding
  • Irregular menstrual bleeding
  • Acne
  • Premenstrual dysphoric disorder (PMDD)

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