Natesto 5.5 mg/0.122 gram per actuation nasal gel pump

Generic name:
Testosterone gel - nasal

Pronunciation
(tes-TOS-ter-one)

Brand name(s)
Natesto

This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

This drug should not be used by women.

Read the Patient Information Leaflet if available from your pharmacist before you start using testosterone and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Gently blow your nose before using this medication. Follow the instructions on how to properly prime the bottle if you are using it for the first time.

Use this medication in the nose as directed by your doctor, usually 3 times a day (6 to 8 hours apart). After applying the medication into both nostrils, gently squeeze your nostrils together and lightly massage. Do not apply this medication to other areas of your body. If another part of your body comes in contact with this medication, wash the area with warm water and soap.

Do not blow your nose or sniff for 1 hour after using this medication. Wipe the tip of the applicator with a clean, dry tissue after each use.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.

Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Tell your doctor if your condition does not get better or if it gets worse.

Runny/stuffy nose, nosebleed, nasal dryness/irritation/scabbing or changes in smell may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• difficulty urinating
• increased urination (especially at night)
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• swelling hands/ankle/feet
• breast pain/enlargement
• interrupted breathing during sleep
• daytime drowsiness
• frequent erections
• fast/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• nasal problems (such as runny/stuffy nose, swelling of the lining of your nose)
• seasonal allergies
• history of a broken nose within the past 6 months
• a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum)
• sinus problem
• nasal or sinus surgery
• cancer (especially prostate or breast cancer)
• prostate problems (such as enlarged prostate or BPH)
• blood clots (such as in the legs, lungs)
• heart problems (such as heart failure, heart attack)
• stroke
• breathing trouble during sleep (sleep apnea)
• kidney disease
• liver disease
• high cholesterol
• diabetes

If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.

Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.

This medication can affect fertility in males. Ask your doctor for more details.

This medication should not be used by women. Women accidentally exposed to this medication may have side effects due to testosterone gel. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breastfeeding must avoid contact with this medication. This medication may harm an unborn or breastfeeding baby. Consult your doctor for more details.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin)

This medication may interfere with certain lab tests (such as thyroid tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as PSA, cholesterol, hemoglobin/hematocrit, testosterone blood levels, prostate exams) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.