Mirvala

How does this medication work? What will it do for me?

Desogestrel - ethinyl estradiol is an estrogen and progestin combination pill used for the prevention of pregnancy. It works by preventing ovulation (the release of an egg from an ovary) and causing changes in the mucus of the cervix that make it difficult for sperm to penetrate and for an egg to implant. It may also be taken to regulate the menstrual cycle.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Mirvala 21
Each round, white tablet, with "MI" and "7" debossed on opposite sides, contains 0.150 mg of desogestrel and 0.030 mg of ethinyl estradiol. Nonmedicinal ingredients: lactose monohydrate, corn starch, povidone K-30, alpha-tocopherol, anhydrous colloidal silica, stearic acid, Hypromellose 2910, triacetin, polysorbate, and titanium dioxide.

Mirvala 28
Each round, white tablet, with "MI" and "7 "debossed on opposite sides, contains 0.150 mg of desogestrel and 0.030 mg of ethinyl estradiol. Each round, green tablet without embossing contains inert ingredients. Nonmedicinal ingredients: lactose monohydrate, corn starch, povidone K-30, alpha-tocopherol, anhydrous colloidal silica, stearic acid, Hypromellose 2910, triacetin, polysorbate, titanium dioxide.

Each inert, green tablet contains the following nonmedicinal ingredients: lactose monohydrate, corn starch, povidone K-30, alpha-tocopherol, anhydrous colloidal silica, stearic acid, Hypromellose 2910, triacetin, polysorbate, titanium dioxide FD&C Blue 2 Aluminium Lake, and yellow iron oxide.

How should I use this medication?

21-day pack: Take one tablet daily for 21 days, then do not take any pills for 7 days, and then begin the next pack.

28-day pack: Take one tablet daily for 21 days, then take one "reminder" pill daily for 7 days, and then begin the next pack.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 of your period. The pills should be taken approximately the same time every day.

It may be advisable to use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use.

Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

If you have vomiting or diarrhea, or if you take some medications such as antibiotics, your pills may not work as well. If you start a new medication while you are taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a back-up method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss pills at any time the risk of becoming pregnant increases. If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills the day you remember and 2 pills the next day, then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you start your pills on Sunday, and you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. You may not have a menstrual period this month.

If you start your pills on Day 1, and you miss 2 pills in a row during the third week of your cycle, or 3 or more pills at anytime during your cycle, safely dispose of the rest of the pill pack and start a new pack that same day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to desogestrel, ethinyl estradiol, or any ingredients of this medication
• are or may be pregnant
• have active liver disease
• have any eye lesion resulting from vascular disease of the eye, such as partial or complete loss of vision or defect in visual fields
• have had a heart attack
• have, have had, or may have a tumour reliant on estrogen
• have, have had, or may have breast cancer
• have or have had signs of thrombosis (e.g., transient ischaemic attack, angina)
• have or have had benign or malignant liver tumors
• have or have had cerebrovascular disorders (e.g., stroke)
• have or have had coronary artery disease or valvular heart disease
• have or have had migraine with focal aura
• have or have had pancreatitis
• have or have had steroid-dependant jaundice, cholestatic jaundice, history of jaundice of pregnancy
• have or have had thrombophlebitis or thromboembolic disorders
• have presence of severe or multiple risk factors for thrombosis
• have diabetes with blood vessel complications (e.g., heart disease, eye disease, kidney disease, foot infections)
• have very high cholesterol or triglyceride levels
• have uncontrolled high blood pressure
• have undiagnosed abnormal vaginal bleeding
• are taking a hepatitis C treatment regimen that contains ombitasvir, paritaprevir, and ritonavir with or without dasabuvir, or the combination of glecaprevir and pibrentasvir

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal cramping or bloating
• acne (usually less common after 3 months of treatment, and may improve if acne already exists)
• back pain
• breast pain, tenderness, or swelling
• diarrhea
• dizziness
• general feeling of being unwell
• headaches
• heartburn
• nausea
• painful menstrual cramps
• unusual tiredness or weakness
• vomiting
• weight gain or loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breast lumps (for women with a history of breast disease)
• changes in the uterine bleeding pattern during or between menstrual periods, such as:
  • breakthrough bleeding or spotting between periods
  • complete stop of menstrual bleeding for several months in a row, or stop of menstrual bleeding that only occurs sometimes
  • decreased bleeding during periods
  • prolonged bleeding during periods
• depression
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
• headaches or migraines (for many users, headaches may lessen but for others, they may increase frequency or severity)
• increased blood pressure
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling, pain, or tenderness in upper abdominal area
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• unusual swelling of the extremities
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worse when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: As with any hormonal contraceptives, there is a risk of developing blood clots. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Let your doctor know if you are planning an upcoming surgery or if you will be immobilized or inactive for a prolonged period of time (i.e., due to accident or illness), as there is an increased risk of blood clot formation when using oral contraceptives

If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision changes or speech changes, sudden severe headache, weakness or numbness in an arm or leg, or are coughing blood, get immediate medical attention as these symptoms could indicate a possible blood clot.

Blood pressure: If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

You may need to visit your doctor more frequently to have your blood pressure checked while using this medication. Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping this medication.

Breast cancer: The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.

Some women who use birth control pills may be at increased risk of developing breast cancer before menopause. These women may be long-term users of birth control pills (more than 8 years) or women who started using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small; however, a yearly breast examination is recommended for all women.

Cervical cancer: Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

Chronic infection with the human papillomavirus (HPV) is believed to be the most important risk factor for cervical cancer. Women who use combination oral contraceptives (COCs) for a long time may have a slightly higher chance of getting cervical cancer. This finding may not be caused by the contraceptive itself but may be related to sexual behavior and other factors.

Cigarette smoking and heart disease: Cigarette smoking is known to increase the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as a woman gets older. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use the birth control pill.

All women are urged not to smoke while taking this medication. Other factors that increase your risk of heart disease include diabetes, high blood pressure, high cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk.

For women who have a low risk of heart disease and do not smoke, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease, regardless of age. These women may continue to use birth control pills up to the age of menopause.

Decreased Effectiveness: The effectiveness of desogestrel – ethinyl estradiol may be decreased as a result of missing doses, conditions that cause digestive tract disturbances such as diarrhea, or other drug interactions that decrease the amount of desogestrel – ethinyl estradiol in the bloodstream.

Depression: Women with a history of depression may find this medication makes the symptoms return or worsen. If you have a history of depression or other emotional problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have a history of depression or other emotional problems you may be more likely to have a recurrence while taking oral birth control medications.

Diabetes: If you have diabetes, or have a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have diabetes, it may be necessary to test your blood sugar more often to detect any worsening of blood sugar control after starting birth control pills.

Eye disorders: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye that may cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

Gallbladder disease: If you use hormonal contraceptives you have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after 4 or 5 years of use. Talk to your doctor if you have any concerns.

Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems, including liver tumours. See your doctor as soon as possible if you develop signs of liver problems such as yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin. This medication should not be used at the same time as certain medications used to treat hepatitis C.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Serious warnings and precautions: The use of oral contraceptive pills is associated with increased risk of several serious conditions including myocardial infarction (heart attack), thromboembolism (blood clot that breaks loose and travels to another part of the body), stroke, liver cancer, and gallbladder disease, although the risk of serious morbidity and mortality is small in healthy women without underlying risk factors.

Sexually transmitted infections (STIs): Birth control pills do not protect against HIV/AIDS and other sexually transmitted infections (STIs; formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with this medication to protect against these infections.

Surgery: If you are having scheduled surgery in the near future, make sure you let all the doctors involved in your care know that you are taking this medication. Being immobile for a period of time, such as when you are recovering from surgery, may increase your risk of developing a blood clot. Your doctor may want you to stop taking this medication for a short time before your surgery and while you are recovering.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: The hormones in this medication pass into breast milk. These hormones may reduce the quantity and quality of the breast milk. Breast-feeding women should use another form of birth control until they are no longer breast-feeding. Talk to your doctor about your options.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between desogestrel - ethinyl estradiol and any of the following:

• ampicillin
• anastrozole
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• bosentan
• bromocriptine
• celecoxib
• certain cancer medications (e.g., asparaginase, cladribine, dacarbazine, pomalidomide, thalidomide)
• cholestyramine
• clofibrate
• cobicistat
• colestipol
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• deferasirox
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• echinacea
• elagolix
• enzalutamide
• estrogens (e.g., estradiol, conjugated/equine, esterified, estropipate)
• exemestane
• fludrocortisone
• glecaprevir and pibrentasvir
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lenalidomide
• lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• mifepristone
• mitotane
• modafinil
• mycophenolate
• nitrofurantoin
• octreotide
• ospemifene
• penicillin
• protein kinase inhibitors (e.g., ceritinib, edrafitinib,  lorlatinib)
• rifabutin
• rifampin
• roflumilast
• St. John's wort
• seizure medications (e.g., carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, rufinamide, topiramate, valproic acid)
• selegiline
• tacrolimus
• tetracyclines
• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
• thyroid replacements (e.g., dessicated thyroid, levothyroxine)
• tizanidine
• tranexamic acid
• tocilizumab
• ulipristal
• ursodiol
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mirvala