Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with the unwashed or unclothed area where the medication has been applied. Tell both of your doctors immediately if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.Who should not take Fortesta transdermal?
This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.
Testosterone helps the body to produce sperm and to develop and maintain the 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 Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using testosterone gel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Learn how to prepare the pump for use. Follow your doctor's instructions on the exact number of pumps for each dose. You may pump this medication into the palm of your hand or directly onto the desired application site. If you are not sure how to use the pump, ask your pharmacist.
Apply the medication as directed to clean, dry skin of the shoulders/upper arms once daily in the morning or as directed by your doctor. Apply only to areas that would be covered if you were to wear a short sleeve t-shirt. Certain products may also be applied to the stomach area (abdomen). Check your product's instructions or ask your pharmacist if your product may be applied to the abdomen. Avoid applying this medication to broken, irritated skin. Do not apply to the genitals (penis or scrotum). Do not let others apply this medication to your body.
Dosage is based on your medical condition and response to treatment.
After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Before dressing, wait a few minutes for the application site to dry completely. Be sure to always wear clothing (such as a t-shirt) to cover the application site until you wash the areas well with soap and water.
To get the best effect, wait several hours (2 to 5 hours depending on the product) before showering/swimming to allow the drug to be absorbed through the skin. Check the manufacturer's information or ask your pharmacist for details. See also Warning and Precautions sections.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.
This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.
Tell your doctor if your condition does not improve or if it worsens.
Nausea, vomiting, headache, dizziness, hair loss, trouble sleeping, change in sexual desire, redness/swelling of the skin, change in skin color, or acne may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: breast pain/enlargement, swelling of the feet/ankles (edema), weight gain, very slow/shallow/difficult breathing (possibly while sleeping), weakness.
Tell your doctor immediately if any of these rare but very serious side effects occur: trouble urinating, mental/mood changes (e.g., depression, agitation, hostility), change in size/shape of the testicles, testicle pain/tenderness, stomach/abdominal pain, dark urine, yellowing of eyes/skin, change in the amount of urine, calf tenderness/swelling/pain.
In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. If you are experiencing these symptoms, consult your doctor. Your doctor may need to adjust your diabetes medications.
For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.
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 (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer (males), prostate cancer.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, prostate problems (e.g., enlarged prostate or BPH), heart problems, kidney problems, diabetes, high cholesterol level, lung disease, obesity, difficulty breathing during sleep (apnea), high blood pressure, bone cancer.
Direct contact with the application site can expose others to this medication. Women and children should avoid contact with the unwashed or unclothed area where the medication has been applied. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. If a woman or child makes contact with the application area, that area on the woman or child should be washed well with soap and water right away.
If this medication accidentally gets into your eyes, rinse the eyes immediately with clean, warm water. Seek medical attention if necessary.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Some men, particularly the elderly, are at a higher risk for developing enlarged prostates 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 should not be used in women. Women accidentally exposed to this medication may have side effects due to testosterone gel. Tell both of your doctors immediately if you notice symptoms in a woman such as changes in body hair or a large increase in acne. Avoid contact with this medication if you are pregnant or breast-feeding. This medication may cause harm to an unborn or breast-feeding baby. Consult your doctor for more details.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: beta blockers (e.g., propranolol), "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone), oxyphenbutazone.
This medication may interfere with certain laboratory tests (including thyroid function tests, creatinine level), possibly causing false test results. Make sure laboratory personnel and your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed. Symptoms of an overdose may include weakness on one side of the body, slurred speech, vision problems, or confusion.
Do not share this medication with others. It is against the law.
Laboratory and/or medical tests (e.g., PSA, cholesterol, hemoglobin, hematocrit, testosterone blood levels, prostate exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
This medication has been prescribed for your current condition only. Do not use it later for another problem unless told to do so by your doctor. A different medication may be necessary in those cases.
Inform all your doctors that you are using or have used this medication.
If you miss a dose, use it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom or near an open flame. Keep all medicines away from children and pets, and throw out used pumps in a secure trash can.
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 for more details about how to safely discard your product.
Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.
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