Leuprolide and norethindrone

Generic name: Leuprolide And Norethindrone
Drug class: Sex hormone combinations

Usage of Leuprolide and norethindrone

Leuprolide injection and norethindrone tablets are used together to treat pain caused by endometriosis. This combination is also used to prevent the symptoms of endometriosis from occurring again. This medicine should be used no longer than 12 months.

Leuprolide injection is a synthetic (man-made) hormone that is similar to a natural hormone that is produced in the brain. It decreases the amount of estrogen in the body and helps treat endometriosis. Norethindrone is a synthetic (man-made) progestin hormone that is used to treat thinning of the bones caused by leuprolide.

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

Leuprolide and norethindrone 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 or nurse immediately if any of the following side effects occur:

More common

Crying

depersonalization

dysphoria

euphoria

feeling of warmth

mental depression

paranoia

quick to react or overreact emotionally

rapidly changing moods

redness of the face, neck, arms, and occasionally, upper chest

sudden sweating

swelling

Incidence not known

Anxiety

bladder pain

bloody or cloudy urine

blurred vision

chest pain or tightness

confusion

cough

dark urine

difficult, burning, or painful urination

difficulty speaking

difficulty swallowing

dizziness or lightheadedness

double vision

fainting

fast heartbeat

flu-like symptoms

frequent urge to urinate

headache

hives or welts

inability to move the arms, legs, or facial muscles

increased sensitivity of the skin to sunlight

itching

joint or muscle pain or stiffness

lower back or side pain

nausea and vomiting

numbness or tingling in the face, arms, or legs

pain in the groin or genitals

pain, redness, or swelling in the arm or leg

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

severe sunburn

sharp back pain just below the ribs

skin rash

slow or fast heartbeat

slow speech

stomach tenderness

sudden shortness of breath or trouble breathing

sweating

thoughts or attempts at killing oneself

trouble breathing

trouble sleeping

trouble thinking or walking

unusual tiredness or weakness

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:

More common

Acid or sour stomach

being forgetful

belching

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blemishes on the skin

bloated or full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in appetite

decreased interest in sexual intercourse

diarrhea

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

headache, severe and throbbing

heartburn

inability to have or keep an erection

indigestion

lack or loss of strength

loss in sexual ability, desire, drive, or performance

pain or tenderness from the breasts

passing gas

pimples

sensation of spinning

stomach discomfort, upset, or pain

weight gain

Less common

Absent missed or irregular menstrual periods

itching of the vagina or genital area

pain during sexual intercourse

stopping of menstrual bleeding

thick, white vaginal discharge with no odor or with a mild odor

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.

Before taking Leuprolide and norethindrone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Lupaneta Pack® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Lupaneta Pack® is not indicated in postmenopausal women and has not been studied in women 65 years of age and older.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are 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.

Bepridil

Cisapride

Dronedarone

Levoketoconazole

Mesoridazine

Pimozide

Piperaquine

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Tranexamic Acid

Ziprasidone

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

Adagrasib

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amobarbital

Amoxicillin

Ampicillin

Amprenavir

Anagrelide

Apalutamide

Apomorphine

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Armodafinil

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Atazanavir

Azithromycin

Bacampicillin

Bedaquiline

Belzutifan

Betamethasone

Bexarotene

Boceprevir

Bosentan

Buprenorphine

Buserelin

Butabarbital

Butalbital

Carbamazepine

Carbenicillin

Cefaclor

Cefadroxil

Cefdinir

Cefditoren

Cefixime

Cefpodoxime

Cefprozil

Ceftazidime

Ceftibuten

Cefuroxime

Cenobamate

Ceritinib

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clofazimine

Clomipramine

Clothiapine

Cloxacillin

Clozapine

Colesevelam

Crizotinib

Cyclacillin

Cyclobenzaprine

Cyclosporine

Dabrafenib

Darunavir

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Deutetrabenazine

Dexamethasone

Dexmedetomidine

Dicloxacillin

Dipyrone

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Doxycycline

Droperidol

Ebastine

Efavirenz

Elagolix

Elvitegravir

Encorafenib

Entrectinib

Enzalutamide

Eribulin

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Etrasimod

Etravirine

Famotidine

Felbamate

Fexinidazole

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Formoterol

Fosamprenavir

Fosaprepitant

Foscarnet

Fosphenytoin

Fostemsavir

Galantamine

Gatifloxacin

Gemifloxacin

Gepirone

Glasdegib

Gonadorelin

Goserelin

Granisetron

Grazoprevir

Griseofulvin

Guar Gum

Halofantrine

Haloperidol

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibutilide

Iloperidone

Imipramine

Indinavir

Inotuzumab Ozogamicin

Isotretinoin

Itraconazole

Ivabradine

Ivosidenib

Ketoconazole

Lapatinib

Lefamulin

Lenvatinib

Lesinurad

Levofloxacin

Lixisenatide

Lofexidine

Lopinavir

Lorlatinib

Lumacaftor

Lumefantrine

Macimorelin

Mavacamten

Mefloquine

Mephobarbital

Meropenem

Methadone

Methohexital

Methotrimeprazine

Metronidazole

Mifepristone

Minocycline

Mirtazapine

Mitapivat

Mitotane

Mizolastine

Mobocertinib

Modafinil

Moricizine

Moxifloxacin

Mycophenolate Mofetil

Mycophenolic Acid

Nafarelin

Nafcillin

Nelfinavir

Nevirapine

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Osilodrostat

Osimertinib

Oxacillin

Oxaliplatin

Oxcarbazepine

Oxytetracycline

Ozanimod

Pacritinib

Paliperidone

Panobinostat

Papaverine

Paroxetine

Pasireotide

Pazopanib

Penicillin G

Penicillin G Procaine

Penicillin V

Pentamidine

Pentobarbital

Perphenazine

Phenobarbital

Phenylbutazone

Phenytoin

Pimavanserin

Pipamperone

Pitolisant

Ponesimod

Posaconazole

Prednisolone

Prednisone

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Ranolazine

Red Clover

Relugolix

Ribociclib

Rifabutin

Rifampin

Rifapentine

Rilpivirine

Risperidone

Ritonavir

Rufinamide

Saquinavir

Secobarbital

Selpercatinib

Sertindole

Sertraline

Sevoflurane

Simeprevir

Siponimod

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

St John's Wort

Sugammadex

Sulpiride

Sultamicillin

Sultopride

Sunitinib

Tacrolimus

Tamoxifen

Tazemetostat

Telaprevir

Telavancin

Telithromycin

Telotristat Ethyl

Tetrabenazine

Tetracycline

Theophylline

Thiopental

Thioridazine

Ticarcillin

Tigecycline

Tipranavir

Tirzepatide

Tizanidine

Tolterodine

Topiramate

Toremifene

Trazodone

Triclabendazole

Trimipramine

Triptorelin

Troglitazone

Ulipristal

Vandetanib

Vardenafil

Vemurafenib

Venlafaxine

Vilanterol

Vinflunine

Voclosporin

Voriconazole

Vorinostat

Voxilaprevir

Zotepine

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amitriptyline

Atazanavir

Atorvastatin

Clomipramine

Diazepam

Doxepin

Imipramine

Lamotrigine

Licorice

Lorazepam

Parecoxib

Selegiline

Temazepam

Triazolam

Troleandomycin

Valdecoxib

Voriconazole

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased 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 use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

Relate drugs

How to use Leuprolide and norethindrone

Lupaneta Pack® is a kit that contains two medicines: leuprolide injection and norethindrone tablets.

Leuprolide injection is given as a shot into a muscle by a nurse or other trained health professional in a hospital or clinic. It is a long acting form (depot) that may be given once every month or once every 3 months for up to 6 months of treatment.

Norethindrone tablets are to be taken by mouth every day for up to 6 months after you receive your leuprolide injection.

This medicine usually comes with a patient information leaflet. Read the information carefully and make sure you understand them before receiving this medicine. If you have any questions, ask 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.

For oral dosage form (tablets):

For pain due to endometriosis:

Adults—5 mg once a day, for up to 6 months.

Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Warnings

It is very important that your doctor check the your progress at regular visits to make sure that this medicine is working properly.

You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, diaphragm with spermicide, condoms with spermicide, IUD) to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have muscle spasm or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.

This medicine may cause depression. Check with your doctor right away if you have discouragement, feeling sad or empty, irritability, lack or appetite, loss of interest or pleasure, tiredness, trouble concentrating, or trouble sleeping.

Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or a migraine headache.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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