Brand Name
US Brand Name
Androgel
Axiron
First-Testosterone
First-Testosterone MC
Fortesta
Testim
Vogelxo
Description
Testosterone topical gel is used to treat males whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics. This medicine is not for use in female patients.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Gel/Jelly
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of testosterone topical gel in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of testosterone topical gel in the elderly. However, elderly patients may be at an increased risk for developing heart and blood vessel problems, or prostate problems (including enlarged prostate), which may require caution in patients receiving this medicine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Anisindione
- Apixaban
- Azathioprine
- Bupropion
- Dabigatran Etexilate
- Dicumarol
- Edoxaban
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Levoketoconazole
- Mercaptopurine
- Methotrexate
- Paclitaxel
- Paclitaxel Protein-Bound
- Phenprocoumon
- Rivaroxaban
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Licorice
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to alcohol or soy products or
- Breast cancer (males) or
- Prostate cancer, known or suspected—Should not be used in patients with these conditions.
- Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
- Diabetes or
- Enlarged prostate or
- Heart attack, history of or
- Hypercalcemia (high calcium in the blood) or
- Hyperlipidemia (high lipid or cholesterol in the blood) or
- Hypertension (high blood pressure) or
- Lung disease or breathing problems (eg, sleep apnea) or
- Problems with passing urine or
- Stroke, history of—Use with caution. May make these conditions worse.
- Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases (blood clots).
- Heart disease (eg, congestive heart failure) or
- Kidney disease or
- Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.
- Lung disease, chronic or
- Obesity—Use with caution. May increase risk for more side effects.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Androgel® 1.62% is available in two forms: individual packets or multi-dose pump. Fortesta® is available in multi-dose pump. Vogelxo® is available in three forms: individual packets, multi-dose pump, or tube. Testim® is available in tube.
If you are using the gel in foil packets, tear the packet completely open along the perforation. Squeeze the entire contents directly onto the skin where you will apply the gel. You may also empty the packet into the palm of your hand and then apply the medicine. Throw away the empty foil packet in a place where children and pets cannot reach it.
Axiron® is available in two forms:
- Pump actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and press the pump all the way down at least 3 times. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.
- Twist actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and twist the dose dial on the bottle. Rinse the medicine discarded into the sink down the drain. Repeat this two more times. Completely twist (180° turn) the dose dial one time after priming to get your correct dose.
AndroGel® is available in two dosage strengths: AndroGel® 1% and AndroGel® 1.62%. AndroGel® 1% is used differently than AndroGel® 1.62%, even though they are both applied to the skin. Do not change your dose unless your doctor tells you to.
To use the Androgel® 1.62% gel:
- Wash your hands with soap and water before and after you use this medicine.
- If you are using the pump for the first time, you will need to prime the pump. To prime the pump, remove the cap and slowly push the pump all the way down 3 times. Do not use any medicine that comes out while priming. Wash it down the sink.
- If you are using the packets, tear open the packet at the dotted line. Squeeze from the bottom of the packet to the top. Squeeze all the gel out of the packet into the palm of your hand.
- Apply the medicine to a clean, dry, intact skin on your shoulder and upper arms that will be covered by a short sleeve T-shirt. Do not apply to broken skin or other parts of your body (eg, penis, scrotum, or stomach).
- Do not shower, swim, or take a bath for at least 2 hours after applying this medicine.
To use the Fortesta® gel:
- Wash your hands with soap and water before and after you use this medicine.
- If you are using the pump for the first time, you will need to prime the pump. To prime the pump, remove the cap and slowly push the pump all the way down 8 times. Do not use any medicine that comes out while priming. Wash it down the sink.
- Apply the medicine to a clean, dry, intact skin on your front and inner part of your thighs only that will be covered by shorts or pants. Do not apply to the area of the thigh closest to the scrotum. Do not apply to any other parts of your body (eg, penis, scrotum, shoulder, upper arms, or stomach).
- Do not shower, swim, or take a bath for at least 2 hours after applying this medicine.
To use the Testim® gel:
- Wash your hands with soap and water before and after you use this medicine.
- Squeeze all of the gel from the tube into the palm of your hand.
- Apply the medicine to a clean, dry, intact skin on your shoulder and upper arms that will be covered by a short sleeve T-shirt. Do not apply to broken skin or other parts of your body (eg, penis, scrotum, or stomach).
- Do not shower, swim, or take a bath for at least 2 hours after applying this medicine.
To use the Voglexo® gel:
- Wash your hands with soap and water before and after you use this medicine.
- If you are using the pump for the first time, you will need to prime the pump. To prime the pump, remove the cap and slowly push the pump all the way down 3 times. Do not use any medicine that comes out while priming. Wash it down the sink.
- If you are using the tube, remove the cap from the tube and squeeze all of the gel into the palm of your hand.
- If you are using the packets, tear open the packet at the dotted line. Squeeze from the bottom of the packet to the top. Squeeze all the gel out of the packet into the palm of your hand.
- Apply the medicine to a clean, dry, intact skin on your shoulder and upper arms that will be covered by a short sleeve T-shirt. Do not apply to broken skin or other parts of your body (eg, penis, scrotum, or stomach).
- Do not shower, swim, or take a bath for at least 2 hours after applying this medicine.
To use the topical solution:
- Apply an antiperspirant or deodorant spray at least 2 minutes before you apply this medicine.
- Apply Axiron® to each clean, dry, intact skin of your underarm using an applicator. Do not apply this medicine to your stomach, penis, scrotum, shoulders, or upper arms. Do not use the medicine on skin that has a cut, scrape, or other type of injury. Do not drink this medicine.
- Wipe any medicine that drips or runs with an applicator. Do not rub the solution with your fingers or hand.
- Pump actuated metered dose bottle: Rinse the applicator cup with water and pat it dry with a tissue. Put the cup and cap back onto the bottle.
- Twist actuated metered dose bottle: Rinse the applicator with water and pat it dry with a tissue. Put the lid back on the bottle.
- Allow the solution to dry for at least 3 minutes before you cover the area with clothing. Do not shower or swim for least 2 hours.
- If any medicine gets in your eyes, rinse them right away with water and call your doctor. Do not drink the medicine.
The gel or solution form can be transferred to another person if they touch or rub the skin where the medicine was placed or if some of it remains on your hands. To keep this from happening, wash your hands again after applying the medicine. Also, wash the area where you applied the gel with soap and water if you expect to have a skin-to-skin contact with another person.
This medicine is flammable. Let the medicine dry before smoking or going near an open flame.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For hormone replacement:
- For topical dosage form (gel):
- Adults—
- AndroGel® 1%: At first, apply 50 milligrams (mg) (two 25 mg packets or a single 50 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per day.
- AndroGel® 1.62%: At first, apply 40.5 milligrams (mg) (2 pumps or a single 40.5 mg packet) to a clean, dry, intact skin of the shoulder and upper arm once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 81 mg per day.
- Fortesta®: At first, apply 40 milligrams (mg) (4 pumps) to the thighs once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 70 mg per day.
- Testim®: At first, apply 50 milligrams (1 tube) to a clean, dry intact skin of the shoulder and upper arm once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg once a day.
- Vogelxo®: At first, apply 50 milligrams (mg) (1 tube, 1 packet, or 4 pumps) to a clean, dry, intact skin of the shoulder and upper arm once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg once a day.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For topical dosage form (solution):
- Adults—At first, apply 60 milligrams (mg) (1 pump or 1 twist actuation of 30 mg) to each clean, dry, intact skin of your underarm once a day (usually in the morning). Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For topical dosage form (gel):
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms. Throw away the empty pump, tube, or packet in a place where children and pets cannot reach it.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood and urine tests may be needed to check for any problems or unwanted effects.
This medicine should not be used by women, especially those who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Children and women should avoid contact with the unwashed or unclothed area where the testosterone gel has been applied. If another person does accidentally get this medicine on the skin, wash the area with soap and water as soon as possible.
Tell your doctor if your female partner or child starts to have male-like body changes while you are using this medicine. Such changes may include hair growth on the face, a deeper voice, or a significant increase in acne. The changes may also include an enlarged penis or clitoris, early development of pubic hair, increased erections or sexual desire, aggressive behavior, and bone problems.
This medicine may cause blood clotting problems (eg, deep vein thrombosis, pulmonary embolism). Tell your doctor right away if you have anxiety, chest pain, coughing, dizziness or lightheadedness, fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, or trouble breathing.
This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.
This medicine may increase the risk of prostate cancer, especially in older males. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause edema (fluid and sodium retention). Check with your doctor right away if you have a decrease in amount of urine, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain.
This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.
This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.
Hypercalcemia (high calcium in the blood) may occur in patients taking this medicine. Check with your doctor right away if you have stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, or muscle weakness.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blood in the urine
- difficulty urinating
- frequent urination
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- frequent strong or increased urge to urinate
- headache
- nervousness
- pain, redness, or swelling in the arm or leg
- pounding in the ears
- slow or fast heartbeat
- sweating
- swelling of the breasts or breast soreness in both females and males
- tingling of the hands or feet
- unusual weight gain or loss
- waking to urinate at night
Incidence not known
- Aggressive behavior
- anxiety
- bluish lips or skin
- chest pain, discomfort, or tightness
- confusion
- cough
- decrease in testicle size
- development of pubic hair
- difficult or labored breathing
- difficulty in speaking
- dizziness or lightheadedness
- double vision
- enlargement of the clitoris or penis
- fainting
- fast heartbeat
- inability to move the arms, legs, or facial muscles
- inability to speak
- nausea
- pain in the chest, groin, or legs, especially the calves
- pain or discomfort in the arms, jaw, back or neck
- pain, redness, or swelling in the arm or leg
- painful or prolonged erection of the penis
- slurred speech
- sudden, severe weakness or numbness in the arm or leg
- sudden loss of coordination
- trouble breathing
- vision changes
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Blemishes on the skin
- burning, itching, redness, skin rash, swelling, or soreness at the application site
- pimples
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- crying
- decreased interest in sexual intercourse
- depression
- discoloration of the hair
- dry skin
- false or unusual sense of well-being
- hair loss
- inability to have or keep an erection
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- loss of memory
- paranoia
- problems with memory
- quick to react or overreact emotionally
- rapidly changing moods
- thinning of the hair
Incidence not known
- Arm or leg pain
- increased in sexual ability, desire, drive, or performance
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20073444
