TriNessa 28 (Oral)

Ethinyl estradiol and norgestimate combination is used to prevent pregnancy. It is a birth control pill that contains two hormones, ethinyl estradiol and norgestimate, and when taken correctly, it can stop pregnancy. It works by preventing a woman's egg from fully developing each month. This means the egg cannot accept sperm, which prevents fertilization (pregnancy).

Ethinyl estradiol and norgestimate combination is also used to treat moderate acne in females (at least 15 years old) who have started their menstrual period and also want to use this medicine for birth control.

No contraceptive method is 100 percent effective. Other birth control methods, such as surgery to become sterile or abstaining from sex, are more effective than birth control pills. Talk to your doctor about your birth control options.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not work as emergency contraception after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors may want to see you more often. Your doctor may also want to check your blood pressure while you are taking this medicine.

Even though you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you may be pregnant while using this medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before starting this medicine.

Do not use this medicine with treatments for hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

This medicine will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner start having sexual intercourse with other people, or if you or your partner tests positive for a sexually transmitted disease. If this worries you, talk with your doctor.

Vaginal bleeding of various amounts may happen between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this happens, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding lasts more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives as directed for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may happen if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you think you may be pregnant, stop taking this medicine immediately and check with your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of blood clots, heart attacks, or strokes. Your risk is even higher if you are over 35, have diabetes, high blood pressure, high cholesterol, or are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol levels.

Using this medicine may increase your risk of blood clotting problems. Check with your doctor right away if you experience 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 changes in vision while using this medicine.

Using this medicine may increase your risk of breast cancer or cervical cancer. Discuss this risk with your doctor. Check with your doctor immediately if you experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Using this medicine may increase your risk for gallbladder surgery. Discuss this risk with your doctor.

This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Inform your doctor if you have a history of dark patches of skin around the forehead, nose, cheeks, and around the mouth, especially during pregnancy.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination, and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of some medical tests. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how ethinyl estradiol and norgestimate combination affects children. However, there are no expected specific problems that would limit the use of this medication in teenagers. This medicine may be used for birth control in teenage females but should not be used before menstruation begins.

Geriatric

There have not been appropriate studies on how ethinyl estradiol and norgestimate combination affects elderly people. This medicine is not indicated for use in elderly women.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. In such cases, your doctor may adjust the dosage or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are selected for their potential significance and may not include every possibility.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide to not treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or how often you use one or both medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Paritaprevir
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary. If both are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Efavirenz
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are selected for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some situations. If used together, your doctor may adjust the dose or how often you use this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Other medical problems may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or a history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• History of heart attack or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or a history of or
• Heart rhythm problems (atrial fibrillation) or
• Uncontrolled hypertension (high blood pressure) or
• Liver disease, including tumors or cancer or
• Major surgery with long periods of immobility or
• New or worse migraine headaches, or a new kind of headache or
• History of stroke—This medicine should not be used in patients with these conditions.

• Inherited angioedema (swelling of the face, tongue, or throat) or
• Cervical cancer or intraepithelial neoplasia or
• History of chloasma gravidarum (skin discoloration of the face during pregnancy) or
• History of cholestasis (bile problem) during pregnancy or
• History of depression or
• Diabetes or
• Uncontrolled dyslipidemia (high cholesterol or fats in the blood) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you might need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fever
• headache
• hives or welts
• itching 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
• 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 of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sudden trouble breathing
• sweating
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Estarylla
• MonoNessa
• Ortho-Cyclen
• Ortho Tri-Cyclen
• Ortho Tri-Cyclen Lo
• Previfem
• Sprintec
• Tri-Lo-Sprintec
• TriNessa
• TriNessa 28
• Tri-Previfem
• Tri-Sprintec

Available Dosage Forms:

• Tablet

Therapeutic Class: Triphasic Contraceptive Combination

Pharmacologic Class: Estrogen

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser or a Veridate® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day with or without food. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

You may have light bleeding or spotting when you first take the pill.

Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, talk with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

• For oral dosage form (tablets): For contraception (to prevent pregnancy): Adults and teenagers— Ortho-Cyclen®: One blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle. Ortho Tri-Cyclen®: One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle. Ortho Tri-Cyclen® Lo: One white, light blue, or dark blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle. Children—Use and dose must be determined by your doctor. For acne: Adults and teenagers 15 years of age and older—One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle. Teenagers and children younger than 15 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• Ortho-cyclen®: If you miss one blue tablet in Week 1, 2, or 3: Take the tablet as soon as possible and take the next tablet at your regular schedule. This means that you may take 2 pills in 1 day. Continue taking one tablet a day until you finish the pack. You do not need to use another form of birth control if you have sex. If you miss two blue tablets in Week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose. If you miss two blue tablets in Week 3 or three or more blue tablets in Week 1, 2, or 3: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Ortho tri-cyclen®: If you miss one blue, light blue, or white tablet in Week 1, 2, or 3: Take the tablet as soon as possible and take the next tablet at your regular schedule. This means that you may take 2 pills in 1 day. Continue taking one tablet a day until you finish the pack. You do not need to use another form of birth control if you have sex. If you miss two blue, light blue, or white tablets in Week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose. If you miss two blue, light blue, or white tablets in Week 3 or three or more blue, light blue, or white tablets in Week 1, 2, or 3: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

You may not have a period for that month if you miss more than one dose or change your schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.