Pediatric Medication

Brand Names: US

Androderm; AndroGel; AndroGel Pump; Aveed; Axiron; Depo-Testosterone; First-Testosterone; First-Testosterone MC; Fortesta; Natesto; Striant; Testim; Testopel; Vogelxo; Vogelxo Pump

Brand Names: Canada

Andriol; Androderm; AndroGel; Axiron; Delatestryl; Depo-Testosterone; Natesto; PMS-Testosterone; Taro-Testosterone; Testim


Testosterone undecanoate:

  • A very bad lung problem has happened with this drug. Allergic reactions have also happened with this drug. Sometimes, allergic reactions have been life-threatening. These reactions have happened while this drug was given and right after. These reactions can happen with any dose of this drug.
  • Your child will be watched closely by the doctor for 30 minutes after each dose. Call the doctor right away if your child has chest pain, coughing, dizziness, passing out, shortness of breath, sweating, or throat tightness.
  • You can only get this drug through the Aveed REMS Program.

What is this drug used for?

All injection products:

  • It is used to treat low testosterone levels.
  • It may be given to your child for other reasons. Talk with the doctor.

Testosterone enanthate:

  • It is used in certain children when puberty is delayed.

All skin products:

  • This drug is not approved for use in children. Talk with the doctor.
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is male and has breast or prostate cancer.
  • If your child has heart problems.
  • If your child has any of these health problems: Kidney disease or liver disease.

If your child is pregnant or breast-feeding a baby:

  • Do not give this drug to your child if she is pregnant.
  • Be sure your child does not breast-feed a baby while taking this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • There may be a higher chance of prostate cancer. Talk with the doctor.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • This drug may affect sperm in males. This may affect being able to father a child later in life. Talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it.
  • Some drugs may be used in children. Use care if this drug is given to a child. Talk with the doctor to see if this drug may be used in children. Talk with the doctor if you have questions about giving this drug to a child.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

If your child is or may be sexually active:

  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Shortness of breath, a big weight gain, swelling in the arms or legs.
  • Passing urine more often.
  • Not able to pass urine or change in how much urine is passed.
  • Mood changes.
  • Enlarged breasts.
  • Breast pain.
  • Upset stomach or throwing up.
  • Any unexplained bruising or bleeding.
  • Trouble breathing when sleeping.
  • Feeling very sleepy.
  • Very bad headache.
  • Chest pain or pressure.
  • Coughing up blood.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, or blurred eyesight.
  • Change in color of skin.
  • Change in size or shape of testicles.
  • Very bad irritation where the shot was given.
  • For females, a deep voice, facial hair, pimples, or period changes.
  • For males, erections (hard penis) that happen often or that last a long time.
  • If your child has an enlarged prostate, his signs can get worse while using this drug. Call the doctor if this happens to your child.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Pimples (acne).
  • Headache.
  • Loose stools (diarrhea).
  • Emotional ups and downs.
  • Feeling tired or weak.
  • Not able to sleep.
  • Pain where the shot was given.
  • Irritation where the shot is given.

If your child is or may be sexually active:

  • Lowered interest in sex.
  • Change in sex ability.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All injection products:

  • It is given as a shot into a muscle.

Testosterone undecanoate:

  • Your child’s doctor will give this drug.

All other shot products:

  • Your child’s doctor may teach you how to give this drug.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if my child misses a dose?

Testosterone undecanoate:

  • Call your child’s doctor to find out what to do.

All other products:

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

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