Testosterone topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Gel containing testosterone.
Drugs List
Therapeutic Indications
Uses
Testosterone replacement therapy associated with hypogonadism in males
Dosage
Testosterone gel should only be used by men.
Take into account that serum testosterone levels decrease with age.
Adults
16.2mg/g
2.5g of gel (2 pump actuations containing total of 40.5mg testosterone) applied once daily at the same time of day, preferably in the morning.
The dose should be adjusted according to the clinical or laboratory response. Dosage adjustment should be achieved by increments of 1 pump actuation of gel (20.25mg testosterone).
A daily dose of 5g of gel (4 pump actuations containing total of 81mg testosterone) should not be exceeded.
50mg/5g
5g of gel (containing 50mg testosterone) applied once daily at the same time of day, preferably in the morning.
The dose should be adjusted according to the clinical or laboratory response. Some brands advise dosage adjustment by varying the amount of gel applied in 2.5g steps (25mg testosterone).
A daily dose of 10g of gel (100mg testosterone) should not be exceeded.
2% (10mg/0.5g)
3g of gel (containing 60mg testosterone) applied once daily at the same time of day, preferably in the morning.
The dosage should be adjusted according to serum testosterone levels and clinical signs and symptoms of androgen deficiency.
A daily dose of 4g of gel (80mg testosterone) should not be exceeded.
20mg/g
1.15g of gel (1 pump actuation containing total of 23mg testosterone) applied once daily, at the same time of the day, preferably in the morning.
The dose should be adjusted according to the clinical or laboratory response. Dosage adjustment should be achieved by increments of 1 pump actuation of gel (23mg testosterone).
A daily dose of 3.45g of gel (3 pump actuations containing 69mg testosterone) should not be exceeded.
40.5mg/2.5g
2.5g of gel (containing 40.5mg of testosterone) applied once daily at the same time of day, preferably in the morning.
The daily dose should be adjusted depending on the clinical or laboratory response. Dosage adjustment should be achieved by increments of 1.25g of gel (half sachet) steps.
A daily dose of 5g of gel (81mg of testosterone) should not be exceeded.
Additional Dosage Information
The manufacturers of different products suggest monitoring regimes that differ in details. These are outlined below.
All testosterone measurements must be analysed in the same laboratory because of variability in analytical values.
16.2mg/g
Serum testosterone levels must be measured in the morning before application from the third day after starting treatment, as steady state testosterone levels will be reached approximately on the second day of treatment.
If plasma testosterone concentrations are raised above the desired levels the dose may be reduced, or if concentrations are low the dose may be increased, not exceeding 5g of gel (4 pump actuations - 81mg testosterone) per day.
50mg/5g
Serum testosterone levels must be measured in the morning before application from the third day after starting treatment or 7 to 14 days after initiation, depending on the brand used.
If plasma testosterone concentrations are raised above the desired levels the dose may be reduced, or if concentrations are low the dose may be increased, not exceeding 10g of gel (100mg testosterone) per day.
2% (10mg/0.5g)
In order to ensure adequate dosing, serum testosterone levels should be measured 14 days after initiation of treatment and at least 2 hours after application.
Dosage adjustment should be carried out according to the following recommendations:
Serum testosterone concentration between 5 and 15micrograms/litre: No dosage adjustment required.
Serum testosterone concentration below 5micrograms/litre: Increase dose to 4g/day (80mg testosterone).
Serum testosterone concentration above 15micrograms/litre: Reduce dose to 2g/day (40mg testosterone).
Dosage adjustment be carried out with smaller increments of 0.5mg (10mg testosterone) if required.
20mg/g
Serum testosterone levels must be measured 2 to 4 hours after dosing at approximately 14 days and 35 days after starting treatment or after a dose adjustment.
If serum testosterone concentration is below 17.3 nanomole/L, the daily testosterone concentration exceed 36.4 nanomole/L the daily dose may be decreased by 1 pump actuation equivalent to 23mg testosterone.
40.5mg/2.5g
Serum testosterone levels must be measured in the morning before application from the third day after starting treatment, as steady state testosterone levels will be reached approximately on the second day of treatment. If plasma testosterone concentrations are raised above the desired levels the dose may be reduced, or if concentrations are low the dose may be increased, not exceeding 5g of gel (81mg testosterone) per day.
Contraindications
Children under 18 years
Suspected prostate cancer
Breast cancer in males
Prostate cancer
Precautions and Warnings
Obesity
Patients over 65 years
Predisposition to venous thromboembolism
Benign prostatic hyperplasia
Chronic respiratory impairment
Diabetes mellitus
Epileptic disorder
Hypertension
Ischaemic heart disease
Migraine
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Skeletal metastasis
Thrombophilia
Exclude other causes of hypogonadism prior to treatment
Not for the treatment of infertility or impotence
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain propylene glycol
Advise patient to avoid skin contact with pregnant women
Advise patient to wash hands after use
Do not apply to genitalia
Evaluate for prostate cancer before and during treatment
Monitor testosterone levels at baseline and periodically during treatment
Consider alternative therapy if compliance with safety directions doubtful
Monitor antidiabetic drug treatment
Monitor calcium in patients at risk of skeletal metastases
Monitor hepatic function, haematocrit and haemoglobin in long term therapy
Monitor patients with epilepsy while taking this treatment
Monitor patients with migraine during treatment
Monitor serum lipids profile regularly in long term therapy
Regular examination of breasts advised to exclude possibility of cancer
Discontinue treatment and consider diuretic therapy if oedema occurs
Increased risk of sleep apnoea especially in obese/COPD patients
May accelerate progression of benign prostatic hyperplasia
May accelerate progression of sub-clinical prostate cancer
Measurements of plasma testosterone should be carried out in the same lab
Discontinue if signs of excessive androgen exposure persists/re-occurs
Marked skin irritation - interrupt treatment/reduce application frequency
May affect spermatogenesis
Take care not to transfer product to sexual partner or to children
Cases of venous thromboembolism have been reported even under anticoagulant treatment, therefore testosterone treatment requires careful evaluation after the first thrombotic event.
Pregnancy and Lactation
Pregnancy
Not indicated for use in women.
Pregnant women must avoid any contact with the gel including the application sites on the patient. In the event of such contact, the area should be washed with soap and water as soon as possible.
The manufacturer notes that testosterone gel may have a virilising effect on the foetus.
Lactation
Not indicated for use in women.
Counselling
Advise the patient on the correct method of application of the gel and that the hands should be thoroughly washed with soap and water afterwards.
Advise patient not to bathe or shower for at least 1 to 6 hours after application of the gel, depending on brand used.
Advise patients of the safety precautions to be observed to avoid transfer of testosterone to other people by skin contact.
Advise the patient to report any of the following to a physician:
Nervousness, irritability or weight gain
Too frequent/persistent erections
Changes in skin colour
Ankle swelling
Unexplained nausea or vomiting
Breathing disturbances (including those associated with sleep)
Testosterone is an active substance which may produce positive results in doping control tests for athletes.
Side Effects
Abdominal distension
Acne
Aggression
Alopecia
Altered liver function tests
Altered serum lipid profile
Amnesia
Anaemia
Anger
Anxiety
Application site reaction
Asthenia
Changes in hair colour
Changes in libido
Contact dermatitis
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry skin
Dyspnoea
Electrolyte disturbances
Erythema at application site
Flushing
Frequent or persistent erections
Gynaecomastia
Headache
Hirsutism
Hostility
Hyperaesthesia
Hyperglycaemia
Hypertension
Hypertrichosis
Impaired urination
Impatience
Increase in haematocrit
Increase in haemoglobin
Increase in prostate specific antigen (PSA)
Increased libido
Insomnia
Irritability
Irritation at application site
Jaundice
Malaise
Malignant hypertension
Mastodynia
Mood changes
Muscle cramps
Muscle pain
Nausea
Nervousness
Nipple discomfort
Oedema
Oligospermia
Oral pain
Paraesthesia
Peripheral oedema
Phlebitis
Pitting Oedema
Polycythaemia
Prostate abnormalities
Prostatic hyperplasia
Pruritus
Rash
Seborrhoea
Skin lesions
Sleep apnoea
Spermatogenesis suppression
Sweating
Testicular disorders
Testicular pain
Thromboembolic disorders
Urinary obstruction
Urticaria
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2018
Reference Sources
Summary of Product Characteristics: Testavan 20mg/g Transdermal gel. Ferring Pharmaceutical Ltd. Revised February 2018.
Summary of Product Characteristics: Testogel 40.5mg Transdermal gel in sachet. Bensins Healthcare (UK) Ltd. Revised June 2021.
Summary of Product Characteristics: Testogel 50mg, gel in sachet. Laboratoires Besins International. Revised August 2017.
Summary of Product Characteristics: Testogel 16.2mg/g gel. Besins Healthcare. Revised September 2017.
Summary of Product Characteristics: Testim 50mg Transdermal Gel. Endo Ventures Limited. Revised April 2020.
Summary of Product Characteristics: Tostran 2% Gel. Kyowa Kirin Ltd. Revised December 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 February 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.