Why is this medicine prescribed?
Testosterone nasal gel is used to treat low or no testosterone levels in men caused by certain medical conditions. Testosterone should not be used to treat low testosterone levels in men who have low testosterone due to aging. Testosterone is in a class of medications called androgenic hormones. Testosterone is a male sex hormone responsible for development and functioning of male sexual organs and typical male characteristics. Testosterone works by replacing testosterone that is normally produced by the body.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Testosterone comes as a gel to apply to the inside of the nose using a dispenser pump. It is usually used three times a day in each nostril. To help you remember to apply testosterone nasal gel, apply it at about the same times each day. Space your doses about 6 to 8 hours apart.
Use testosterone nasal gel exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. Do not use more or less of it or take it more often than prescribed by your doctor.
Tell your doctor if you have severe cold symptoms (sneezing, congestion, runny nose). Your doctor may decide to stop your treatment until you are better or change you to another medication.
Before you use testosterone nasal gel for the first time, read the written instructions for use that come with the medicine. This will tell you how to use it. Read it carefully. Ask your doctor or pharmacist if you have any questions on how to use the medicine.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before using testosterone nasal gel,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking while using testosterone nasal gel. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone nasal gel.
- tell your doctor if you have or ever had nose (nasal) problems (allergies, sinus problems, or polyps); nasal or sinus surgery; a broken nose that occurred within the last 6 months; a deviated nasal septum (crooked inside middle section of the nose) caused by a broken nose; urinary problems due to benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep); diabetes; high blood pressure, heart disease, a heart attack, or a stroke; blood clots; higher than normal red blood cell counts; or lung, kidney, or liver disease.
- you should know that testosterone nasal gel is only for use in adult men. Children, teenagers, and women should not use this medication. Testosterone may stop bone growth and cause precocious puberty (early puberty) in children and teenagers. Testosterone may cause deepening of voice, hair growth in unusual places, genital enlargement, decrease in breast size, male-pattern hair loss, and unusual menstrual cycles in women. If testosterone is used by a woman who is pregnant, may become pregnant or is breastfeeding, it may harm the baby.
- you should know that testosterone may cause serious side effects if used at higher doses or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone. Be sure to use testosterone nasal gel exactly as directed by your doctor.
- you should know that testosterone may cause an increase in blood pressure. This may increase your risk of having a heart attack or stroke that may be life-threatening. Tell your doctor if you have or have ever had high blood pressure, heart disease, a heart attack, or a stroke. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; pain in the arms, back, neck, or jaw; slow or difficult speech; dizziness or faintness; or weakness or numbness of an arm or leg. Your doctor may check your blood pressure before starting treatment and regularly while you are using testosterone nasal gel.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra gel to make up for a missed dose.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222
. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Testosterone nasal gel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- cough
- sinus pain
- changed sense of smell
Some side effects can be serious. If you experience any of these symptoms or those listed in SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
- runny nose; nasal congestion; sneezing; dryness, discomfort, irritation, or scabbing in the nose; or nosebleed
- lower leg pain, swelling, warmth, or redness
- difficulty breathing, especially at night
- swelling of the hands, feet, and ankles
- sudden unexplained weight gain
- erections of the penis that happen too often or do not go away
- difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
- yellowing of the skin or eyes, nausea or vomiting, extreme tiredness, pain in the upper right part of the stomach, dark urine
- enlarged or painful breasts
Testosterone nasal gel may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.
Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of using this medication.
Testosterone nasal gel may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Store testosterone nasal gel in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to use testosterone. Your doctor may order certain lab tests to check your body's response to testosterone nasal gel.
Before having any laboratory tests, tell your doctor and the laboratory personnel that you are using testosterone nasal gel. This medication may affect the results of certain laboratory tests.
Do not let anyone else use your medication. Testosterone nasal gel is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.