Lessina (Oral)

Levonorgestrel and ethinyl estradiol combination is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept sperm, which prevents fertilization (pregnancy).

No contraceptive method is 100 percent effective. Birth control methods like 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 will not prevent HIV infection or other sexually transmitted diseases. It will not work as emergency contraception, such as after unprotected sexual contact.

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

It is very important for your doctor to monitor your progress during regular visits to ensure this medicine is working correctly. Blood and urine tests may be necessary to check for unwanted effects. 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 taking this medicine while you are pregnant could harm your unborn baby. If you think you might be pregnant while using this medicine, tell your doctor immediately. Make sure your doctor knows if you have given birth within 4 weeks before starting this medicine.

If you think you may be pregnant, contact your doctor right away.

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

You might experience light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or if the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. Smoking while using ethinyl estradiol and norgestrel combination increases your risk of developing a blood clot, heart attack, or stroke. Your risk is even higher if you are over 35, have diabetes, high blood pressure, high cholesterol, or if you are overweight. Discuss ways to stop smoking with your doctor. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol levels.

Using this medicine may raise your risk of blood clotting problems. Contact your doctor immediately if you experience chest pain, groin pain, leg pain (especially in the calves), difficulty breathing, a sudden severe headache, slurred speech, sudden loss of coordination, or changes in vision while using this medicine.

Using this medicine may increase your risk of developing breast cancer or cancer of the reproductive organs (such as the endometrium, ovaries, or cervix). Discuss this risk with your doctor. Contact your doctor right away if you notice abnormal vaginal bleeding.

Contact your doctor immediately if you experience stomach pain or tenderness, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

Contact your doctor right away if you have blurred vision, trouble reading, or any other changes in your vision during or after treatment. Your doctor may want you to see an eye doctor (ophthalmologist) for an eye exam.

This medicine may increase your risk of gallbladder disease. Contact your doctor if you experience stomach pain, nausea, and vomiting.

Ensure that any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be influenced by this medicine.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some things to consider for this medicine:

Allergies

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

Pediatric

Studies on how levonorgestrel and ethinyl estradiol combination affects children have not been done. However, there are no expected 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 is no information on how levonorgestrel and ethinyl estradiol combination affects older patients. 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. Weigh the potential benefits against the risks before taking this medication while nursing.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

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

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on 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 cases. If used together, your doctor may change the dose or how often you take this medicine, or give you special instructions about food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical problems might affect the use of this medicine. Be sure to tell 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 history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from using hormonal treatment in the past or
• Liver disease, including tumors or cancer or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Depression, history of or
• Epilepsy, history of or
• Gallbladder disease, history of or
• Hereditary angioedema (swelling of the face, tongue, or throat) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Migraine headache—May worsen these conditions.

• Diarrhea or
• Vomiting—May reduce how much levonorgestrel and ethinyl estradiol combination is absorbed in the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may 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
• bloody stools
• blurred vision
• breast tenderness, enlargement, discharge
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• cough
• dark or cloudy urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficult, burning, or painful urination
• difficulty in speaking
• dizziness or lightheadedness
• double vision
• dull ache or feeling of pressure or heaviness in the legs
• fainting
• fast heartbeat
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache, severe and throbbing
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching of the vagina or outside the genitals
• itching skin near damaged veins
• light vaginal bleeding between regular menstrual periods
• loss of appetite
• nausea
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• pelvic pain
• pounding in the ears
• sensitivity to the sun
• skin thinness
• slow or fast heartbeat
• slow speech
• stomach bloating and cramping
• stomach pain and tenderness
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thick, white curd-like vaginal discharge without odor or with mild odor
• troubled breathing
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

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. Also, your health care professional may 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

• Acne
• changes in appetite
• changes in weight
• decreased interest in sexual intercourse
• decreased milk production
• loss in sexual ability, desire, drive, or performance
• mental depression
• patchy brown or dark brown discoloration of the skin

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.

• Alesse
• Alesse-28
• Altavera
• Amethia
• Amethia Lo
• Aviane
• Camrese
• CamreseLo
• Enpresse
• Introvale
• Jolessa
• Lessina

Available Dosage Forms:

• Tablet
• Tablet, Chewable

Therapeutic Class: Contraceptive

Pharmacologic Class: Progestin

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.

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

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 birth control, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. 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.

Use another form of birth control if you vomit or have diarrhea after taking the pills until you check with your doctor.

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.

• For oral dosage form (tablets):For contraception (to prevent pregnancy): Chateal®: Adults—One white to off-white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle. Children—Use and dose must be determined by your doctor. Triphasil®-28: Adults—One brown, white, light-yellow (in order) (active) tablet taken at the same time each day for 21 consecutive days followed by one light-green (inert) tablet daily for 7 days per menstrual cycle. Children—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.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule. This means you may take 2 pills in 1 day.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill 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 active pills in week 3, or you miss three or more active pills in a row in weeks 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. Sunday start: Continue taking one pill 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.
• You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

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.