Medroxyprogesterone Acetate Injectable Suspension USP: Uses, Side Effects and Dosage

What is Medroxyprogesterone Acetate Injectable Suspension USP used for?

• birth control to prevent pregnancy
• treatment of endometriosis

How does Medroxyprogesterone Acetate Injectable Suspension USP work?

Serious Warnings and Precautions

• Low Bone Density (osteoporosis): Medroxyprogesterone Acetate Injectable Suspension

  USP may cause your bones to become less dense. This can lead to osteoporosis or broken bones. It is worse the longer you use the drug. The effect on your bones may not be reversed by stopping the drug. This is of concern because adolescence and young adulthood are times to build bone density for later in life.

• Only use Medroxyprogesterone Acetate Injectable Suspension USP if you and your healthcare professional decide that no other treatment will work for you.
• Use it for the shortest period of time possible.
• Your risks and benefits should be regularly reevaluated by you and your doctor.
• You should not smoke. It increases the risk of serious side effects on the heart and blood vessels.
• Medroxyprogesterone Acetate Injectable Suspension USP DO NOT PROTECT against sexually transmitted infections. This includes HIV/AIDS. Use condoms (latex or polyurethane) to reduce the risk.

• Women considering using Medroxyprogesterone Acetate Injectable Suspension USP should be advised about the concerns that Medroxyprogesterone Acetate Injectable Suspension USP may increase risk of HIV acquisition, about the uncertainty over whether there is a causal relationship, and about how to minimize their risk of acquiring HIV. For birth control: Medroxyprogesterone Acetate Injectable Suspension USP works in 3 ways to make pregnancy unlikely:

  • stops the maturing of the egg in the ovaries
  • changes the lining of the uterus
  • thickens the mucus in the cervix.

Medroxyprogesterone Acetate Injectable Suspension USP is more than 99.7 percent effective in preventing pregnancy.

For treatment of endometriosis: Medroxyprogesterone Acetate Injectable Suspension USP helps shrink endometrium-like tissue found outside the uterus.

What are the ingredients in Medroxyprogesterone Acetate Injectable Suspension USP?

Medicinal ingredient: Medroxyprogesterone acetate.

Non-medicinal ingredients: Methylparaben 1.37 mg and propylparaben 0.15 mg (as preservatives), polyethylene glycol 3350 28.9 mg, polysorbate 80 2.41mg, sodium chloride 8.68 mg, hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.

Medroxyprogesterone Acetate Injectable Suspension USP comes in the following dosage form:

Medroxyprogesterone Acetate Injectable Suspension USP 150 mg/mL is supplied in 1 mL vials, boxes of 1.

LATEX-FREE STOPPER: Stopper contains no dry natural rubber.

Do not use Medroxyprogesterone Acetate Injectable Suspension USP if:

• You are pregnant or think you might be
• Your menstrual periods have not started
• You have unusual vaginal bleeding without a known reason.
• You have blood in your urine
• You have or suspect a cancer. It can be of the breast, uterus or ovaries. It can be a cancer that grows in response to progesterone
• You have breast lumps or breast abnormalities without a known reason
• You have had blood clots in the legs, lungs, eyes or another part of the body, or inflammation of the veins (thrombophlebitis)
• You have problems with your blood clotting system that increase your risk of developing blood clots
• You have had a stroke, heart attack, heart disease or coronary artery disease
• You have severe high blood pressure
• You have very high levels of blood cholesterol or triglycerides
• You smoke and are over age 35
• You have diabetes with complications
• You have had a loss of vision due to blood vessel disease of the eye
• You have migraine headaches or a history of them.
• You have yellowing of the eyes or skin (jaundice), liver disease or a liver tumour

• You are allergic to medroxyprogesterone acetate or to any of the ingredients in

  Medroxyprogesterone Acetate Injectable Suspension USP

If you want to get pregnant in the near future, you should discuss other treatments with your healthcare professional. Medroxyprogesterone Acetate Injectable Suspension USP may not be the right treatment for you.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you get an injection of Medroxyprogesterone Acetate Injectable Suspension USP. Talk about any health conditions or problems you may have, including if you have:

• Breast cancer or family history of breast cancer, abnormal breast exam or mammogram
• Diabetes, or a family history of it
• Seizures, convulsions or epilepsy
• Migraine headaches
• Asthma
• A heart attack or other heart problems
• Stroke or blood clots (coagulation disorder)
• Kidney problems
• High blood pressure, or a family history of it
• Mental depression
• Menstrual periods that are very light or that occur in an irregular pattern
• A history of smoking or are a current smoker
• A scheduled lab test or surgery

Other warnings you should know about:

Sexually Transmitted Infections: Medroxyprogesterone Acetate Injectable Suspension USP may increase the risk of HIV acquisition. Talk to your doctor about how to minimize the risk of getting HIV.

Low Bone Density (osteoporosis): Medroxyprogesterone Acetate Injectable Suspension USP may cause your bones to become less dense. Other risk factors for low bone density are:

• bone disease
• strong family history of osteoporosis
• use of certain steroids or anti-seizure drugs

• drinking a lot of alcohol

• smoking
• low body weight or anorexia nervosa or bulimia (eating disorders)

Talk with your doctor about how:

• to keep your risk as low as possible
• to strengthen your bones

Cancer: Use of this drug has not shown an increased risk of cancer of the liver, breast, ovary, or cervix. There is a decrease risk of cancer of the uterus.

Some women who took Medroxyprogesterone Acetate Injectable Suspension USP got breast cancer. This seems to occur if:

• you were under 35 years old when you took the drug.

AND

• you used the drug in the 4 years before being diagnosed with breast cancer.

Talk to your doctor about breast self-examination.

Blood clots: Talk to your doctor if you develop risk factors for blood clots. These include:

• start smoking
• obesity
• recent major surgery (such as hip or knee replacement)
• immobility due to air travel or other reason
• lupus

Pregnancy: You should not use Medroxyprogesterone Acetate Injectable Suspension USP if you are pregnant, or think that you may be pregnant. It will not prevent the pregnancy from continuing. It may interfere with the normal development of your baby.

When might you get pregnant after stopping the injections?

If you want to become pregnant, tell your healthcare professional. Medroxyprogesterone Acetate Injectable Suspension USP will not make you infertile. It takes time after the last injection for the drug’s effect to wear off. Most women wait six to eight months to start ovulating and have regular periods. This must occur before you can get pregnant.

After their last injection, women get pregnant:

• within 6 months, 54%
• within 1 year, 76%
• within 2 years, 92%

It can take more than 2 years for some women to get pregnant. This does not depend on how long the drug was used.

What if you do NOT want to get pregnant after stopping the injections?

You must start using another method of birth control 3 months after your last injection.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Medroxyprogesterone Acetate Injectable Suspension USP:

• Aminoglutethimide: a drug used to treat Cushing’s syndrome
• Rifampin: a drug used to treat tuberculosis (TB) and some other infections.

How is Medroxyprogesterone Acetate Injectable Suspension USP given to patients?

Medroxyprogesterone Acetate Injectable Suspension USP is given as an injection by your healthcare professional. Medroxyprogesterone Acetate Injection Suspension USP is injected deep into the muscles of your buttock or upper arm.

Usual dose for birth control:

First injection:

• If your period bleeding pattern is not normal for you, have a pregnancy test first.

• Get your first injection within 5 days of starting your period. If this is followed,

  Medroxyprogesterone Acetate Injectable Suspension USP will start working on the day of the injection.

• If the injection is given after the first 5 days of your period, it may not start to protect you from pregnancy for another 3-4 weeks. During these 3-4 weeks you MUST use another non-hormonal birth control method.

Ongoing Injections:

Get an injection every 3 months. If you can’t see your healthcare professional right at 3 months, you can go a week or two early.

After a miscarriage or abortion:

Talk with your healthcare professional about when you may start using Medroxyprogesterone Acetate Injectable Suspension USP.

After having a baby, if you are:

• NOT breastfeeding or NOT planning to breastfeed:

Get your first injection during the 5 days after having your baby. It will start working as soon as you have the injection.

• Breastfeeding or planning to breastfeed:

It is recommended to wait at least 6 weeks after having your baby before you get an injection. A very small amount of drug will go into your milk. The drug should not affect the amount or quality of your milk. Talk with your doctor to determine the risk to the baby or of getting pregnant.

Talk with your doctor about the chance that you may get pregnant during this time. You and your doctor can decide what other birth controls to use, and when you can start the drug.

Usual dose for endometriosis: Treatment should last for at least 6 months with either:

• One 50 mg injection every week
• One 100 mg injection every 2 weeks

Overdose:

If you think you were injected too much Medroxyprogesterone Acetate Injectable Suspension USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you have not had an injection within 13 weeks of your last injection, you should have a pregnancy test before getting any further injections. This is in case you became pregnant in the meantime.

What are possible side effects from using Medroxyprogesterone Acetate Injectable

Suspension USP?

These are not all the possible side effects you may feel when using Medroxyprogesterone Acetate Injectable Suspension USP. If you experience any side effects not listed here, contact your healthcare professional. Please also see the box called “Serious Warnings and Precautions”.

Side effects may include:

• tiredness, problems sleeping
• leg cramps, joint pain, backache
• pain in your pelvic area, lower sex drive, hot flashes, bloating
• acne
• skin reaction, pus collection, pain or tenderness at the injection site
• lump, dent, dimple, scar or change in colour at injection site (may be persistent)
• nervousness, dizziness
• no hair growth or excessive hair growth

You may gain weight because your appetite has increased. If you notice this over a short period of time, tell your healthcare professional to make a plan about what to do.

Change in your periods:

• more or less often
• lighter or heavier

For the first 3 to 6 months after the first injection, bleeding:

• can come and go
• can’t be predicted
• can last much longer than usual

Over the next few months, bleeding:

• usually becomes lighter

After about a year, your periods:

• may stop completely

Medroxyprogesterone Acetate Injectable Suspension USP can cause low bone density. Your doctor will decide when to perform bone density tests and interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Protect from freezing. Store between 15 and 30°C. Shake well before using. Keep out of reach and sight of children.

If you want more information about Medroxyprogesterone Acetate Injectable Suspension USP:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.

Last Revised: April 23, 2018