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Terms Of Use

TESTOSTERONE

Brand Name(s) : Intrinsa, Nebido, Restandol Testocaps, Sustanon, Testim, Testogel, testosterone, Tostran
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

TESTOSTERONE WARNINGS

Testosterone undecanoate capsules (Restandol Testocaps) should be used with caution in:

  • Elderly men
  • Men with bone cancer, lung cancer or kidney cancer (hypernephroma)
  • Men with high blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
  • Men with kidney or liver problems
  • Men with long standing lung diseases such as chronic bronchitis or emphysema
  • Men who stop breathing temporarily during sleep (sleep apnoea)

They should not be used in :

  • Known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
  • In males before puberty
  • Pregnant or breast feeding women
  • Men with male breast cancer
  • Men with prostate cancer or an enlarged prostate gland
  • Men who have or have had liver tumours

Testosterone 300 µg patches (Intrinsa) should be used with caution in:

  • Women with high blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
  • Women with kidney or liver problems
  • Women with diabetes

They should not be used in:

  • Known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
  • Women with a natural menopause
  • Women with a surgically induced menopause over 60 years old, children or adolescents
  • Women who have or have had breast cancer or other oestrogen dependent cancers
  • Women taking a type of oestrogen known as conjugated equine estrogens (used as hormone replacement therapy (HRT) and in some oral contraceptives)

Testosterone given by IM injection (Nebido) should be used with caution in:

  • Men who have or who have ever had cancer
  • Men with high blood calcium (hypercalcaemia)
  • Men with high blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
  • Men with kidney or liver problems
  • Men with epilepsy (fits) or migraine
  • Men who stop breathing temporarily during sleep (sleep apnoea)
  • Men with diabetes

It should not be used in:

  • Known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
  • Women
  • Children and adolescents (under 18 years old)
  • Men who have or have had male breast cancer
  • Men who have or have had prostate cancer or an enlarged prostate gland
  • Men who have or have had liver tumours

Testosterone given by IM injection (Sustanon) should be used with caution in:

  • Elderly
  • People with bone cancer
  • People with high blood pressure or heart problems and problems with heart blood flow (ischaemic heart disease)
  • People with kidney problems
  • People with epilepsy (fits) or migraine
  • People with a soya allergy
  • Men who stop breathing temporarily during sleep known as sleep apnoea

It should not be used in:

  • People with a known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication including peanut allergy as the medication conations peanut (arachis oil)
  • Pregnant or breast feeding women
  • Men who have or have had prostate cancer
  • Men who have or have had male breast cancer

Testosterone enanthate given by IM injection should be used with caution in:

  • Elderly
  • People who have or who have ever had cancer
  • People with high blood pressure or heart problems and problems with heart blood flow (ischaemic heart disease)
  • People with kidney or liver problems
  • People with epilepsy (fits) or migraine
  • People with diabetes
  • Women who notice a deepening of their voice or increased growth of hair on their face or body
  • It should not be used in:

    • People with a known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
    • Pregnant or breast feeding women
    • Men who have or have had prostate cancer
    • Men who have or have had male breast cancer
    • Women who have or have had liver tumours (in advanced mammary carcinoma in the female only) if these are not due to metastases

    Testosterone implants should be used in caution in:

    • Women
    • Elderly men
    • In males before puberty
    • People with bone cancer
    • People with high blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
    • People with kidney or liver problems
    • People with epilepsy (fits) or migraine
    • People with diabetes

    It should not be used in:

    • People with a known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
    • Pregnant or breast feeding women
    • Men who have or have had prostate cancer
    • Men who have or have had male breast cancer

    Testosterone gels (Tostran, Testogel, Testim) should be used with caution in:

    • Elderly men
    • Men who have difficulty urinating due to an enlarged prostate gland
    • Men with bone cancer
    • Men with high calcium levels in the blood and urine (hypercalcaemia and hypercalciuria)
    • Men with high blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
    • Men with kidney or liver problems
    • Men with epilepsy (fits) or migraine
    • Men with diabetes
    • Men with long standing lung diseases such as chronic bronchitis or emphysema or who are overweight
    • Men who stop breathing temporarily during sleep known as sleep apnoea

    They should not be used in:

    • People with a known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication
    • Women
    • Children under 18 years old
    • Men with male breast cancer
    • Men with prostate cancer or an enlarged prostate gland

    Also see list of precautions and interactions

    STORAGE

    Testosterone undecanoate capsules (Restandol Testocaps)
    Do not store above 30°C.
    Do not refrigerate or freeze.
    Keep the blister in the outer carton. Testosterone 300 µg patches (Intrinsa)
    Do not store above 30°C.
    Do not refrigerate or freeze.

    Testosterone for IM injection (Nebido)
    This medicinal product does not require any special storage conditions.

    Testosterone for IM injection (Sustanon)
    Do not store above 25°C.
    Do not refrigerate or freeze.
    Store the ampoules in the outer carton

    Testosterone enanthate for IM injection
    Protect from the light.

    Testosterone propionate for IM injection (Virormone)
    Do not store above 25°C.
    Protect from light. Store in the original container.

    Testosterone implant
    Do not store above 25°C.
    Store in the original package.

    Testosterone gel (Testim)
    Do not store above 25°C.

    Testosterone gel (Testogel)
    This medicinal product does not require any special storage conditions

    Testosterone gel (Tostran)
    Do not store above 25°C.
    Do not refrigerate

TESTOSTERONE USES

What is it used for?

  • Testosterone is used to replace naturally occurring testosterone in men with low levels and help the reproductive system to function normally. It is also used to treat certain other conditions in women.
  • It is a steroid hormone, sometimes known as male sex hormone or androgen.
  • It is used to treat a variety of conditions involving the male and female reproductive system. Testosterone is a natural male hormone, which is produced mainly by the testes in males and by the ovaries in females. Testosterone is used to increase the level of testosterone (testosterone replacement therapy) in men with low levels of natural testosterone (hypogonadism). A lack of testosterone can cause impotence, low sexual desire (libido), tiredness, depression, a reduction in male sexual characteristics such as body hair and deep voice, problems with sperm production and weak bones (osteoporosis). The low levels of testosterone may be due to a variety of reasons such as castration (removal of testes) or hormonal problems in the testes or pituitary gland. It is also used in women to treat breast cancer (only after the menopause), in female to male sex changes, and to treat post-menopausal symptoms as hormone replacement therapy).
  • In general this drug is used to replace testosterone (testosterone replacement therapy) in men with low natural levels of testosterone and to improve male sexual characteristics including sexual functioning and sexual desire.
  • Benefits of being on this drug can include improvements in sexual functioning and sexual desire.
  • Listed below are the typical uses of testosterone. The uses depend on the formulation used.

Males uses:

  • Testosterone replacement therapy due to low natural testosterone arising from castration or lack of testes, or disease of the pituitary gland or testes (hypogonadism)
  • Improve sexual desire, physical and mental activity
  • Impotence (due to lack of testosterone)
  • Improved sperm production
  • Weak bones (osteoporosis)
  • Delayed puberty due to undescended testicles.

Female uses:

  • Breastcancer in post-menopausal women
  • Hypoactive sexual desire disorder (HSDD) in women with no ovaries or womb following surgery (hysterectomy)
  • Post menopausal symptoms such as decreased sexual desire (libido) and lack of energy (given with oestrogen replacement therapy)
  • Female to male sex change.

On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.

  • None known

HOW TO USE/TAKE

How often do I take it? >

Testosterone is available in a variety of forms: as oral capsules, skin patches, ampoules for injection, as an implant and as gels. It is available as testosterone and as testosterone esters (such as testosterone undecanoate, testosterone propionate) which release testosterone into the body.

  • Testosterone undecanoate capsules (Restandol Testocaps)
    Take this medication by mouth, usually twice daily with food. It is best to take half of the daily dose in the morning and the other half in the evening. Swallow the capsules whole without chewing.
  • Testosterone 300 µg patches (Intrinsa) - female use only
    Take this medication by applying the patch to the skin of your lower abdomen, usually twice weekly and keep it on for about 3 to 4 days before replacing it with a fresh patch. Directions for using the patches are given in the Patient Information Leaflet. The patches must be used with oestrogen therapy.
  • Testosterone by IM injection (Nebido)
    This medication will be given to you as an injection into a muscle by a doctor or nurse, usually every 10 to 14 weeks.
  • Testosterone by IM injection (Sustanon)
    This medication will be given to you as an injection into a muscle by a doctor or nurse, usually one injection every 3 weeks.
  • Testosterone enanthate ampoules for IM injection
    This medication will be given to you as an injection into a muscle by a doctor or nurse, usually every 2 to 3 weeks. The frequency of dosing depends on the condition for which you are being treated.
  • Testosterone implant
    This medication will be given to you as subcutaneous implant (beneath the skin) by a doctor using a local anaesthetic. The effect of the implant lasts for about 4 to 5 months.
  • Testosterone gels (Tostran, Testogel, Testim)
    Take this medication by applying the gel to your skin of your lower abdomen, inner thighs or shoulders and upper arms, usually once daily. Directions for using the gel are given in the Patient Information Leaflet.
  • Use this medication regularly in order to get the most benefit from it.
  • It may take up to a few months before the full benefit of this drug takes effect.
  • Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • Testosterone is not known to affect driving or operating machinery.
  • Testosterone patches: You may shower and bathe with the patch on, but avoid rubbing it too much.
  • Testosterone gels: Take care to avoid transferring your gel to anyone else during personal contact by covering the application site with loose clothing, or by showering or bathing prior to contact. It is particularly important to avoid transfer to women and children. Avoid sexual intercourse for a long period of time after applying the gel to prevent transfer to your partner.
  • Consult your doctor or pharmacist for more details.

When can I stop?

  • It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.
  • Testosterone 300 µg patches (Intrinsa): If you have not noticed an improvement within 3 to 6 months, you should see your doctor.

TESTOSTERONE SIDE EFFECTS

Testosterone capsules (Restandol Testocaps)

  • Prostate problems including enlarged prostate and prostate cancer
  • Headache
  • Dizziness
  • Diarrhoea
  • Nausea
  • Depression
  • Increased body hair
  • Loss of head hair - male pattern baldness
  • Oily skin
  • Acne
  • Frequent and prolonged erections of the penis
  • Yellowing of skin and whites of the eyes (due to cholestatic jaundice)
  • Changes in sexual desire (libido)
  • Anxiety
  • Tingling feeling
  • Abnormal blood tests - changes in electrolytes e.g. sodium, chloride, potassium, calcium, inorganic phosphates
  • Testosterone 300 µg patches (Intrinsa) common side effects:

    • Difficulty sleeping
    • Migraine
    • Abdominal pain
    • Weight gain
    • Breast pain
    • Application skin reactions including itching, rash and redness
    • Increased facial hair (chin, lips), generally mild
    • Acne
    • Voice deepening or hoarseness
    • Loss of head hair (alopecia)

    Testosterone given by IM injection (Nebido) common side effects include:

    • Acne
    • Injection site pain
    • Large increases in red blood cell count
    • Weight gain
    • Hot flush
    • Prostate problems including enlarged prostate and prostate cancer

    Testosterone given by IM injection (Sustanon) common side effects include:

    • Worsening of the early stages of prostate cancer
    • Acne
    • Prolonged and painful erection
    • High blood pressure
    • Increases in sexual desire (libido)
    • Hoarse voice
    • Changes in sperm formation
    • Swollen ankles (due to fluid retention)
    • Large increases in the red blood cell count
    • Changes in liver enzymes

    Similar side effects are seen with testosterone enanthate and testosterone propionate (Virormone) given by IM injection. Women treated with these medications for breast cancer may develop acne, increased facial hair, head hair loss and a deep voice.

    Common side effects seen with the use of testosterone gels (Tostran, Testim and Testogel) include:

    • Application site reactions including itching, rash and redness
    • High blood pressure
    • Headache
    • Acne
    • Increases in the blood of prostatic specific antigen (PSA) produced by the prostate gland
    • Large increases red blood cell count
    • Swelling of hands and feet
    • Loss of head hair
    • Increased body hair growth
    • Breast enlargement
    • Flushing

    When testosterone is given to boys, it may lead to early sexual development and delayed bone growth.

    If any of these persist or you consider them severe then inform your doctor or pharmacist. Application skin reactions including itching, irritation, burning, rash and redness or blisters - stop taking if the reaction is severe.

    Tell your doctor immediately if you develop any of the following symptoms:

    • Breathing abnormalities including any during sleep
    • Prolonged and painful erections of your penis
    • Swelling of your ankles
    • Changes in skin colour
    • Feeling irritable or nervous
    • Gain weight
    • Nausea or vomiting
    • A change in the frequency with which you need to urinate or the appearance of the urine
    • Yellowing of your skin and whites of your eyes
    • Women: Hair loss, enlargement of the clitoris, an increase in the amount of facial hair or your voice deepening or becoming hoarse with use of testosterone 300 µg patches (Intrinsa).

    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.

    A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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.

    The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

    TESTOSTERONE PRECAUTIONS

    Before taking testosterone, tell your doctor or pharmacist if you are allergic to it; or to other androgens; or if you have any other allergies.

    This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:

    • Hypersensitivity (allergy) to testosterone or to any of the ingredients in the medication
    • Peanut allergy (IM injection- Sustanon only)
    • Male breast cancer
    • Known or suspected prostate cancer
    • For some formulations if you have:

      • Or have had liver tumours
      • High blood or urine calcium levels (hypercalcaemia or hypercalciuria)
      • Kidney damage (nephrotic syndrome)
      • Enlarged prostate gland

      Before using this medication tell your doctor or pharmacist your medical history, especially any of the following

      • Bone cancer
      • Lung cancer
      • High blood pressure, heart problems and heart blood flow problems (ischaemic heart disease)
      • Kidney or liver problems
      • Difficulties in urinating
      • Epilepsy (fits)
      • Migraine
      • Diabetes
      • Long standing lung diseases such as chronic bronchitis or emphysema or are overweight
      • Interrupted breathing during sleep known as sleep apnoea
      • Any skin problems (if testosterone is applied to the skin)

      Before having surgery, tell your doctor or dentist that you are taking this medication.

      Does alcohol intake affect this drug?

      • Alcohol is not known to affect testosterone.

      The elderly: testosterone should be used with caution in elderly men as they are at a higher risk of developing prostate problems and swelling due to fluid retention (oedema). Testosterone 300 µg patches (Intrinsa) are only to be used in surgically menopausal women up to the age of 60.

      Pregnancy and breastfeeding - please ensure you read the detailed information below

      PREGNANCY

      Testosterone is not safe to take if you are, or are planning to become, pregnant.

      BREAST FEEDING

      Testosterone is not safe to take if you are breastfeeding.

    TESTOSTERONE INTERACTIONS

    Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

    This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: None known

    Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

    • Medications to prevent blood clotting such as warfarin
    • Insulin and other medications to treat diabetes
    • Adrenocorticothrophic hormone (ACTH) or corticosteroid therapy used to treat inflammation and allergies (e.g. asthma)
    • Rifampicin (used to treat tuberculosis, TB)
    • Medications used to treat epilepsy (fits) such as carbamazepine, phenobarbital, phenytoin and primidone
    • Women taking Intrinsa: conjugated equine estrogens (used as hormone replacement therapy and in some oral contraceptives)

    Testosterone may interfere with some laboratory tests such as those for glucose tolerance and thyroid function.

    This information does not contain all possible interactions. Therefore, before using testosterone, tell your doctor or pharmacist of all the products you use.

    TESTOSTERONE OVERDOSE

    • Testosterone undecanoate capsules (Restandol Testocaps)
      If you have taken several capsules at once, there is no need for great concern, however you should tell your doctor. The castor oil in the capsule may cause diarrhoea.
    • Testosterone 300 µg patches (Intrinsa)
      If you have applied more than one patch at a time
      Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with the medication. Overdosing is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
    • Testosterone given by IM injection
      Overdose with testosterone can cause irritability, nervousness, weight gain and long-lasting or frequent erections. Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.
    • Testosterone implant
      Overdose can cause prolonged and painful periods and deepening voice in women. See your doctor to remove the implant.
    • Testosterone gels
      If you have applied too much gel, contact a doctor, hospital or pharmacist. Overdose with testosterone gel can cause irritability, nervousness, weight gain and prolonged or frequent erections. If you get these symptoms with normal use, it may indicate that you need your dose adjusting.
    If you think you, or someone you care for, might have accidentally taken more than the recommended dose of testosterone or intentional overdose is suspected, contact your local hospital, GP or if in England call NHS 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

    MISSED DOSE

    Testosterone undecanoate capsules (Restandol Testocaps)

    • If you miss the morning dose and it is more than 2 hours after breakfast, wait until lunch-time and then take the dose. If you miss the evening dose, and it's more than 2 hours after dinner, do not take the missed dose. Take the next morning dose as normal.

    Testosterone 300 µg patches (Intrinsa)

    • Change your patch as soon as you remember, and then continue with your regular schedule of patch change days, even if this means discarding a patch after you have worn it for less than 3 to 4 days. Returning to your regular schedule will help you remember when to change your patch.

    Testosterone gels

    • If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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