Methyltestosterone, Oral

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KEY POINTS

• This medicine is taken by mouth to treat lack of male hormone, to stimulate puberty in male children, and to treat certain breast cancers in women. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: hormone

Generic and brand names: methyltestosterone, oral; Android; Methitest; Testred

What is this medicine used for?

This medicine is a male hormone prescribed when not enough of the hormone is produced naturally by your body. It is also used to stimulate puberty in male children and to treat certain breast cancers in women.

Because of the risk of serious side effects, this medicine should not be used by athletes to improve muscle strength.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Blood clots
• Diabetes
• Heart disease or a heart attack
• High cholesterol
• High levels of calcium in the blood
• Kidney disease
• Liver disease
• Prostate disease or breast cancer in men

Females of childbearing age: This medicine has been reported to cause birth defects. Use an effective birth control method while you are taking this medicine. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than directed. Taking too much of this medicine may increase the risk of side effects.

Check with your healthcare provider before using this medicine in children.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: swelling, nausea.

What should I watch out for?

You may need tests to see how this medicine affects you. Keep all appointments.

This medicine may affect bone growth in young males. Talk with your healthcare provider about this.

Long-term use of this medicine, especially in large doses, may cause enlargement of the breasts in men and growth of facial hair and irregular menstrual cycles in women. Talk with your healthcare provider about this.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may lower sperm count in men, especially with long term use or in large doses. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark urine; black or very light bowel movements; bloody vomit; severe nausea, vomiting, or stomach pain; red spots on your skin or in your mouth; unusual bruising or bleeding; trouble breathing; chest pain; pain, warmth, redness, or swelling in lower leg; unexplained swelling in your ankles or feet; hoarseness or deepening of voice (in women), facial hair growth (in women), breast enlargement (in men), menstrual irregularities; erections that happen too often or last longer than 4 hours; changes in skin color; numbness or tingling.

Other: Hair loss, acne, mild nausea, headache, anxiety, depression, change in sexual desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Saw palmetto
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.