Estradiol and medroxyprogesterone (intramuscular route)


    Brand Name

    US Brand Name

    Lunelle Monthly Contraceptive


    Description

    Contraceptives are designed to prevent pregnancy. The combination of medroxyprogesterone and estradiolare two types of hormones that work by stopping a women's egg from fully developing each month. The egg can no longer accept sperm and fertilization is prevented. Although contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action

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


    Before Using

    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

    This medicine can be used for birth control in teenage females and is not expected to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

    Drug Interactions

    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 taking 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.

    • Fezolinetant
    • Tranexamic Acid

    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.

    • Abametapir
    • Amifampridine
    • Amoxicillin
    • Ampicillin
    • Amprenavir
    • Apalutamide
    • Aprepitant
    • Armodafinil
    • Artemether
    • Avacopan
    • Bacampicillin
    • Belzutifan
    • Betamethasone
    • Bexarotene
    • Bosentan
    • Bupropion
    • Carbamazepine
    • Carbenicillin
    • Cefaclor
    • Cefadroxil
    • Cefdinir
    • Cefditoren
    • Cefixime
    • Cefpodoxime
    • Cefprozil
    • Ceftazidime
    • Ceftibuten
    • Cefuroxime
    • Cenobamate
    • Ceritinib
    • Clarithromycin
    • Clobazam
    • Cloxacillin
    • Colesevelam
    • Conivaptan
    • Cosyntropin
    • Cyclacillin
    • Cyclosporine
    • Dabrafenib
    • Darunavir

    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.

    • Atazanavir
    • Diazepam
    • Ginseng
    • Lamotrigine
    • Levothyroxine
    • Licorice
    • Lorazepam
    • Selegiline
    • Tacrine
    • Temazepam
    • Tipranavir
    • Triazolam
    • Voriconazole

    Other Interactions

    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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

    • Tobacco

    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

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Abnormal changes in menstrual or uterine bleeding
    • Blood clots (or history of) or
    • Gallbladder disease or gallstones (or history of) or
    • Heart or circulation problems or
    • High blood cholesterol or
    • High blood pressure (hypertension) or
    • Liver disease (or history of) or
    • Mental problems—Combination contraceptives may make these conditions worse or, rarely, cause them to occur again.
    • Cancer, including breast cancer— Contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of monthly injectable contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, injectable contraceptives may still be a good choice but you may need to be tested more often
    • Diabetes mellitus (sugar diabetes)—Use of combination contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take.
    • Migraine headaches—Combination contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use contraceptives

    Proper Use

    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 injection dosage form:
      • For contraception
        • Adults—0.5 milliliters (mL) injected into a muscle in the upper arm, upper thigh or in the buttocks every 28 to 30 days.

    Missed Dose

    Call your doctor or pharmacist for instructions.

    If you miss having your next injection by day 33 your doctor will want to rule out pregnancy before the medicine is given to you again. Another method of birth control should be used until your period begins or until your doctor determines that you are not pregnant, and you are able to have the medicine again.


    Precautions

    It is very important that your health care professional check your progress at regular visitsto make sure this medicine does not cause unwanted effects. These physical exams will usually be every 12 months, but you need to visit your doctor every 28 to 30 days to get your injection.

    This medicine does not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).


    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:

    More common

    • Bloating or swelling of face, hands, lower legs and/or feet
    • cough
    • difficulty swallowing
    • dizziness
    • fast heartbeat
    • hives
    • itching
    • loss of appetite and nausea
    • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    • rapid weight gain
    • shortness of breath
    • tightness in chest
    • unusual tiredness or weakness
    • vomiting blood
    • wheezing
    • yellow eyes or skin

    Symptoms of overdose—More common

    • Nausea
    • menstrual irregularities
    • vaginal bleeding
    • vomiting

    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

    • Abdominal pain or enlarged abdomen
    • absent or missed menstrual periods
    • acne
    • allergic rash
    • brown, blotchy spots on skin
    • decreased sex drive
    • depression
    • hair loss/thinning of hair
    • headache
    • increased amount of menstrual bleeding, or normal bleeding that comes earlier
    • lack or loss of strength
    • nervousness
    • quick to react or overact emotionally
    • rapidly changing moods
    • stopping of menstrual bleeding over several months
    • vaginal yeast infection
    • weight change





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