Depo-Provera

Generic Name: medroxyprogesterone (Intramuscular route)

me-drox-ee-proe-JES-ter-one AS-e-tate

Intramuscular route(Suspension)

Women who use medroxyprogesterone acetate injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. Medroxyprogesterone acetate should not be used as a long-term birth control method (ie, longer than 2 years) unless other birth control methods are considered inadequate .

Commonly used brand name(s)

In the U.S.

• Depo-Provera


• Depo-Provera Contraceptive

Available Dosage Forms:

• Injectable


• Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Medroxyprogesterone

Uses For Depo-Provera

Medroxyprogesterone injection is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

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

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Depo-Provera

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 on the relationship of age to the effects of medroxyprogesterone injection have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of medroxyprogesterone injection have not been performed in the geriatric population. This medicine should not be used in elderly women.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 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.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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.

• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Griseofulvin


• Lamotrigine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Telaprevir


• Tetracycline


• Topiramate


• Troglitazone


• Troleandomycin


• 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

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 or unusual vaginal bleeding or


• Blood clots, or history of or


• Breast cancer, known or suspected or


• Liver disease, significant or


• Pregnancy or


• Problems with circulation or blood clots, now or in the past or


• Stroke, history of—Should not be used in patients with these conditions.

• Asthma or


• Depression, history of or


• Fluid retention (edema or body swelling) or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Migraine headaches (severe headache)


• Osteoporosis, current or risk factors for—Use with caution. May make these conditions worse.

Proper Use of medroxyprogesterone

This section provides information on the proper use of a number of products that contain medroxyprogesterone. It may not be specific to Depo-Provera. Please read with care.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient information insert. Read them carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles (usually in the buttocks or upper arm).

Your doctor must make sure you are not pregnant before you start treatment with this medicine. For most women, this means you must receive your first shot during the first 5 days of a normal menstrual period. You will need to receive this medicine every 3 months (12 to 14 weeks). Be sure to keep all appointments with your doctor to receive your injections.

If you plan to start this medicine after having a baby, you should receive your first shot within 5 days after your baby is born. If you plan to breastfeed your new baby, talk to your doctor about when to get your first shot. Some doctors may suggest waiting 6 weeks before getting your first shot, but others may suggest getting the shot sooner after the baby is born. If you wait 6 weeks, talk to your doctor about using an alternative form of birth control.

If you are switching from another method of birth control, carefully follow your doctor’s instructions about when to have your first injection of this medicine.

You need to have enough calcium and vitamin D in your diet. Your doctor might suggest that you take supplements.

Missed Dose

Call your doctor or pharmacist for instructions.

You must have this shot every 12 to 14 weeks to prevent pregnancy. If you do not get another shot after 14 weeks, talk with your doctor. You may need to use another form of birth control and wait until your next menstrual period before starting the shots again.

Precautions While Using Depo-Provera

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 3 months, but some doctors require them more often. Your doctor will check your blood pressure once a year.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause your bones to lose calcium, which can lead to osteoporosis (thin or weak bones). This calcium loss could continue the whole time you are receiving this medicine. Your bones should start to rebuild calcium after you stop using this medicine. This is more of a concern if you are a teenager, smoke or drink alcohol regularly, have other bone problems, anorexia nervosa (an eating disorder), a family history of osteoporosis, or use other medicines that also affect your bones (such as steroids or medicine to treat seizures).

You will need to talk with your doctor if you want to use this medicine for more than 2 years. You might need to be tested to make sure your bones are not losing too much calcium.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using this medicine.

Check with your doctor immediately if you have blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

There is a very slight chance that this medicine could increase risk of breast cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after receiving this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

Most women have changes in their menstrual periods while using this medicine. You might have irregular bleeding, spotting, or heavier or lighter periods. Many women stop having periods. Call your doctor if you have very heavy or nonstop bleeding.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires 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 after receiving this medicine.

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause fluid retention (edema) and weight gain in some patients. Tell your doctor right away if you have bloating or swelling of face, arms, hands, lower legs, or feet; tingling of hands or feet; or unusual weight gain or loss.

If you plan to have children after you stop using this medicine, it may take up to year or longer before you can become pregnant. However, do not depend on this medicine to prevent pregnancy for more than 13 weeks.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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 (e.g., St. John's wort) or vitamin supplements.

Depo-Provera 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

• Absent, missed, or irregular menstrual periods


• menstrual changes


• stopping of menstrual bleeding

Less common

• Breast pain


• cramps


• heavy bleeding


• increased clear or white vaginal discharge


• itching of the vagina or genital area


• pain during sexual intercourse


• swelling


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

Incidence not known

• Abdominal or stomach pain


• anxiety


• black, tarry stools


• blood in the stools


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


• changes in skin color


• chest pain


• chills


• clay-colored stools


• clear or bloody discharge from the nipple


• cough


• dark urine


• decrease in height


• difficult or labored breathing


• difficulty with breathing


• difficulty with swallowing


• dimpling of the breast skin


• dizziness or lightheadedness


• dull ache or feeling of pressure or heaviness in the legs


• fainting


• fast, pounding, or irregular heartbeat or pulse


• fever


• headache


• hives


• increased thirst


• inverted nipple


• itching


• itching skin near damaged veins


• loss of appetite


• lump in the breast or under the arm


• nausea


• no sensation in the legs


• noisy breathing


• pain in the back, ribs, arms, or legs


• pain, redness, tenderness, or swelling of the arm, foot, or leg


• pale skin


• persistent crusting or scaling of the nipple


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


• rash


• redness or swelling of the breast


• shortness of breath


• skin rash


• sore on the skin of the breast that does not heal


• sudden shortness of breath or troubled breathing


• swollen feet and ankles


• tightness in the chest


• troubled breathing with exertion


• unable to move the legs


• unpleasant breath odor


• unusual bruising or bleeding


• unusual tiredness or weakness


• vomiting of blood


• wheezing


• 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

• Abdominal or stomach discomfort


• decreased interest in sexual intercourse


• inability to have or keep an erection


• increased weight


• loss in sexual ability, desire, drive, or performance


• nervousness

Less common

• Backache


• blemishes on the skin


• bloating


• depression


• difficulty with moving


• feeling of warmth


• hair loss or thinning of the hair


• lack or loss of strength


• leg cramps


• muscle pain or stiffness


• pain in the joints


• pimples


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


• sleeplessness


• sudden sweating


• trouble sleeping


• unable to sleep

Incidence not known

• Brown, blotchy spots on the exposed skin


• changes in appetite


• diarrhea


• drowsiness


• dry skin


• hoarseness


• increased hair growth, especially on the face


• increased in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• increased sweating and body odor


• indigestion


• loss of appetite


• pain at the injection site


• passing of gas


• patchy brown or dark brown discoloration of the skin


• stomach pain, fullness, or discomfort


• swelling of the armpits


• unexpected or excess milk flow from breasts

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.

See also: Depo-Provera side effects (in more detail)

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More Depo-Provera resources

• Depo-Provera Side Effects (in more detail)
• Depo-Provera Use in Pregnancy & Breastfeeding
• Depo-Provera Drug Interactions
• Depo-Provera Support Group
• 110 Reviews for Depo-Provera - Add your own review/rating

• Depo-Provera Prescribing Information (FDA)


• Depo-Provera Injectable Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Depo-Provera Consumer Overview


• Depo-SubQ Provera 104 Prescribing Information (FDA)


• Medroxyprogesterone Prescribing Information (FDA)


• Medroxyprogesterone MedFacts Consumer Leaflet (Wolters Kluwer)


• Medroxyprogesterone Acetate Monograph (AHFS DI)


• Provera Prescribing Information (FDA)


• depo-subQ provera 104 Injectable Suspension (Subcutaneous) MedFacts Consumer Leaflet (Wolters Kluwer)

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