Axiron

The usual recommended dose of testosterone topical solution is 60 mg (2 pump actuations) applied once daily. One pump of solution (30 mg of testosterone) should be applied to clean, dry skin of each underarm and allowed to dry. It should be applied at approximately the same time every day. Depending on the effectiveness of this dose, your doctor may recommend that you increase or decrease the dose. The maximum daily dose is 120 mg (4 pumps). If you are using 4 pumps, apply the solution from the first two pumps to the underarm area and allow the solution to dry on the skin before applying the second two pumps.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you are using a roll-on or stick underarm deodorant or antiperspirant, it should be applied before the testosterone topical solution to avoid contaminating the underarm product.

To apply the solution, hold the container upright and depress the pump fully. This transfers a pre-measured volume of medication into the applicator cup. Keep the applicator upright, place it into the underarm and wipe steadily down, then up into the underarm. Do not rub the solution into the skin with fingers or your hand. If the solution drips, wipe it back up with the applicator.

Repeat this process for the other underarm. Allow the solution to dry on the skin before dressing. Rinse the applicator under running water and pat it dry with a tissue. Put the applicator and cap back on the bottle to store it. Wash your hands with soap and water to avoid transferring any medication to anyone else. Avoid swimming or bathing for at least 2 hours after you apply this medication. Testosterone topical solution is flammable until dry. Make sure it is dry before smoking or going near an open flame.

To avoid exposing others to testosterone topical solution on the skin, it should be applied only to the underarm area. The application site should be covered with clothing (e.g., a shirt) after the solution has dried. If you anticipate skin-to-skin contact with others with the area of application, wash the application site well with soap and water to remove any testosterone that may remain on the skin.

It is important that this medication be used exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Avoid flames, fire or smoking near the package as testosterone topical solution contains alcohol and is flammable.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each 1.5 mL of clear, colourless solution contains testosterone 30 mg. Nonmedicinal ingredients: ethanol, isopropyl alcohol, octisalate, and povidone.

Do not use testosterone topical solution if you:

• are allergic to testosterone or any ingredients of the medication

• have or may have prostate cancer or breast cancer

This medication is not intended to be used by women. Pregnant and breast-feeding women must avoid skin contact with application sites on men.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne

• dizziness

• hair loss

• headache

• skin irritation, redness at the site of application

• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breast enlargement or pain

• changed interest in sexual activity

• fast or irregular heart rate

• increased blood pressure

• increased blood cholesterol

• increased PSA (blood test)

• mood or behaviour changes (e.g., aggression, rage, anxiety or excitation)

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of an enlarged prostate (e.g., change in frequency of urination, difficulty starting urine flow, small amounts of urine)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• sleep disturbances caused by breathing problems

• swelling ankles or legs

Stop taking the medication and seek immediate medical attention if any of the following occur:

• an erection that lasts too long

• increased frequency or inappropriate erections

• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

• signs of stroke (e.g., sudden or severe headache, sudden loss of coordination, vision changes, sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

July 15, 2014

Health Canada has issued new restrictions concerning the use of testosterone products. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Cancer: Long term use of testosterone may cause an increased risk for developing prostate or breast cancer. If this is a concern, discuss the risks and benefits of using this medication with your doctor.

Diabetes: Testosterone may cause an increase in blood sugar levels and glucose tolerance may change. ****People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease and stroke: This medication may increase blood pressure and worsen symptoms of heart disease. It may also increase the risk of blood clots or stroke. If you have heart disease such as high blood pressure, angina, congestive heart failure, or arrhythmia, or a history of heart attack, blood clots, or stroke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. ****

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Additionally, testosterone may reduce liver function and can cause liver failure. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Prostate problems: Men with benign prostatic hypertrophy (BPH), an enlarged prostate gland, may experience an increase in the symptoms. If you have BPH, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sleep disorders: Treatment with testosterone may cause sleep apnea (interruption of breathing during sleep). If you have sleep apnea or risk factors for sleep apnea, such as being overweight or having a chronic lung disease discuss this with your doctor.

Sperm counts: This medication may reduce sperm counts if high doses are used, or if it is used for a prolonged period.

Pregnancy: This medication is not intended to be used by women. Contact with testosterone while pregnant may cause harm to the developing baby. If you come into contact with testosterone, such as directly contacting unwashed clothing or skin, and you are pregnant or may be pregnant, wash the area of contact immediately with soap and water.

**Breast-feeding:**This medication is not intended to be used by women. Contact with testosterone while breast-feeding may cause the testosterone to be absorbed through the skin and into breast milk, affecting the baby. If you come into contact with testosterone, such as directly contacting unwashed clothing or skin, and you are breast-feeding, wash the area of contact immediately with soap and water.

Children: Testosterone topical solution is not intended for use by children or adolescents under the age of 18. Children that have come into contact with testosterone have shown signs of increased testosterone levels, including aggressive behavior, increased acne, and advanced development of sexual characteristics such as development of pubic hair, changes in genital size and interest in sexual activity. If a child comes into contact with unwashed clothes or skin with testosterone topical solution on it, wash the area of contact with soap and water. Signs of unexpected sexual development (early puberty) should be discussed with your child's doctor as soon as possible.

Seniors: Seniors may have an increased risk for prostate enlargement and should be evaluated for prostate cancer before starting testosterone replacement therapy.

There may be an interaction between testosterone topical solution and any of the following:

• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• cyclosporine

• diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)

• dihydroepiandosterone (DHEA)

• insulin

• octreotide

• pasireotide

• somatostatin

• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Axiron