Femhrt Lo (Oral)

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two hormones, ethinyl estradiol and norethindrone, and when taken correctly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept sperm, so fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods like surgery to become sterile or not having sex are more effective than birth control pills. Talk with your doctor about your options for birth control.

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 that this medicine is working correctly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors may require them 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 be aware that using this medicine while pregnant could harm your unborn baby. If you think you might be pregnant while using this medicine, tell your doctor right away. Make sure your doctor knows if you have given birth within 4 weeks before starting this medicine.

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 may experience vaginal bleeding of varying amounts between your regular menstrual periods during the first 3 months of use. This may be slight spotting or heavier breakthrough bleeding.

• If this happens, continue taking your medicine as directed.
• The bleeding usually stops within 1 week. Talk to your doctor if the bleeding lasts longer than 1 week.
• If the bleeding continues after taking hormonal contraceptives regularly for more than 3 months, consult your doctor.

Contact your doctor immediately if you miss a menstrual period. Missed periods may happen if you skip one or more tablets or do not take your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before taking any more pills.

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

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. Smoking while using norethindrone and ethinyl estradiol combination increases your risk of blood clots, heart attack, or stroke. Your risk is higher if you are over 35, have diabetes, high blood pressure, high cholesterol, or are overweight. Talk to your doctor about ways to quit 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 raise your risk of blood clotting problems. Contact your doctor immediately if you experience chest pain, pain in the groin or legs (especially calves), trouble 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 or reproductive organ cancers (e.g., endometrium, ovaries, cervix). Discuss this risk with your doctor. Consult your doctor immediately if you experience abnormal vaginal bleeding.

Contact your doctor immediately if you wear contact lenses and 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 your eyes or skin. These could be signs of a serious liver problem.

This medicine may increase your risk of gallbladder disease. Consult your doctor if you start having stomach pains, nausea, or vomiting.

Speak 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.

Ensure that any doctor or dentist treating you knows that you are using this medicine. Some medical test results may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after major surgery.

Do not take any 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. Here are some things to consider 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 if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on the effects of ethinyl estradiol and norethindrone combination in children have not been done. However, there are no known problems that would limit the use of this medicine 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 available information on the effects of ethinyl estradiol and norethindrone combination in older adults.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. You should weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is important for your healthcare professional to know if you take any of the following medicines. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of 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 take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of 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
• 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 for your treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• 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 around mealtimes, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant but 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 adjust the dose or give you specific instructions regarding food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Other medical conditions may affect how this medicine works. Make 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
• Endometrial cancer 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) that is not well controlled, or
• Jaundice during pregnancy or from previous hormonal therapy or
• Liver disease, including tumors or cancer or
• Major surgery with long periods of immobility or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase the risk of more serious side effects.

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
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• 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
• sweating
• troubled breathing
• 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. 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

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside 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.

• Femhrt 1/5
• Femhrt Lo
• Gildess 1.5/30
• Jevantique
• Jinteli
• Junel 1/20
• Junel 1.5/30
• Larin 1/20
• Loestrin 1/20
• Loestrin 1.5/30
• Microgestin 1/20
• Microgestin 1.5/30

Available Dosage Forms:

• Tablet, Chewable
• Tablet
• Capsule, Liquid Filled

Therapeutic Class: Contraceptive

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. 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, 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 (with meals or at bedtime). 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.

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.

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, check 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.

• For oral dosage form (tablets):For contraception (to prevent pregnancy): Adults and teenagers— Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets. Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle. Modicon®: One 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. Ortho-novum®: One white or peach 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.

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

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.