Consumer medicine information

TESTOGEL

Testosterone

BRAND INFORMATION

Brand name

Testogel sachet

Active ingredient

Testosterone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using TESTOGEL.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Testogel. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Testogel against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT TESTOGEL IS USED FOR

Testogel is used to replace the body’s natural hormone testosterone when not enough is made by the body.

Testosterone is a natural hormone, known as an androgen, which controls normal sexual development and function in men.

Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as facial and body hair growth, deep voice, sexual drive, muscle mass and body fat distribution.

Testogel is a testosterone-containing gel that is applied by the patient daily to the skin. The testosterone passes from the gel through the skin and into the bloodstream at a steady rate.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

BEFORE YOU USE TESTOGEL

When you must not use it

Do not use Testogel if you have an allergy to:

  • testosterone, the active ingredient in Testogel
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not use Testogel if you have or are suspected to have:

  • prostate cancer
  • male breast cancer.

Testogel must not be used by children under the age of 18 years.

The safety of Testogel in children under 18 years of age has not been established.

Testogel must not be used by women.

Do not use this medicine after the expiry date printed on the pack and sachet.

The expiry date is printed on the carton and on each sachet after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not use this medicine if the packaging is torn or shows signs of tampering.

If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have, or have had, any of the following medical conditions:

  • high blood calcium levels associated with tumours (hypercalcaemia)
  • high levels of calcium in the urine (hypercalciuria)
  • high blood pressure or heart disease
  • a tendency to retain fluid (signs may include swollen feet or ankles)
  • liver or kidney disease
  • epilepsy
  • migraines
  • diabetes
  • sleep apnoea (abnormal pauses in breathing during sleep)
  • polycythaemia (a blood disorder where too many red blood cells are being produced).

Testogel may quicken the growth of existing prostatic tumours and benign prostatic hyperplasia (enlargement of the prostate gland). It may also increase the risk of breast cancer in males.

Before treatment, your doctor should conduct tests to check that you do not have existing prostate or breast cancer.

If you use Testogel over long periods of time, you may develop an abnormal increase in the number of red blood cells in the blood (polycythaemia). Your doctor may organise regular blood counts to monitor this.

If you have not told your doctor about any of the above, tell them before you start using Testogel.

Athletes should note that the active substance, testosterone, may produce a positive reaction in anti-doping tests.

Misuse of androgens to enhance your physical ability in sport carries serious health risks and is discouraged. Use of androgens for reasons other than what your doctor prescribed carries a serious health risk and is strongly discouraged.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Testogel may interfere with each other. These include:

  • oral anticoagulants, medicines used to thin blood and to treat or prevent blood clots
  • corticosteroids or adrenocorticotropic hormone (ACTH), hormones used to control inflammation
  • oxyphenbutazone, a medicine used to treat pain and inflammation
  • insulin, a medicine used to control blood sugar levels
  • bupropion, a medicine used to aid in smoking cessation
  • cyclosporin, a medicine used to suppress the immune system
  • some herbal products.

These medicines may be affected by Testogel or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

HOW TO USE TESTOGEL

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How much to use

The usual starting dose is one 5 g sachet of gel per day. Your doctor or pharmacist will tell you exactly how much to use. You should not use more than 10 g of gel per day.

How to use it

Do not apply Testogel to the testes, scrotum or penis.

The high alcohol content may cause local irritation.

Follow these steps when applying Testogel:

  1. Open the sachet(s).
  2. Spread a thin layer of Testogel onto clean, dry, healthy skin over the upper arms, shoulders or stomach.
  3. Allow the gel to dry for at least 3-5 minutes before dressing.
  4. Wash your hands thoroughly with soap and water after applying the gel.
  5. Cover the application area with clothing once the gel has dried.
  6. Do not shower for at least six (6) hours after applying Testogel.

When to use it

Apply Testogel once per day at approximately the same time each day, preferably in the morning.

Using it at the same time each day helps maintain a steady level of testosterone in the blood. It will also help you remember when to apply it.

How long to use it

Testogel helps control the symptoms of your condition, but does not cure it. Therefore you must use Testogel every day.

When you have finished a pack, start the next pack on the following day. Never leave a break between packs.

Continue using Testogel for as long as your doctor tells you to.

If you forget to use it

If you forget to apply a dose, apply it as soon as you remember.

If you do not remember to apply the dose until the next dose is due, then just apply one dose.

Do not apply a double dose to make up for a forgotten individual dose.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much Testogel. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

WHILE YOU ARE USING TESTOGEL

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Testogel.

Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.

Keep all of your doctor’s appointments.

Your doctor may monitor your blood pressure, examine your prostate and conduct other tests (including blood tests) from time to time, particularly if you are elderly. This is to make sure the medicine is working and to check for unwanted side effects.

The use of Testogel may affect the results of certain laboratory tests.

If you are about to have any tests, tell your doctor that you are using this medicine.

Things you must not do

Do not use Testogel to treat any other complaints unless your doctor tells you to.

Do not give Testogel to anyone else, even if their symptoms seem similar to yours.

Do not stop using Testogel, or change the dosage, without checking first with your doctor.

If you stop using it suddenly, your condition may worsen or you may have unwanted side effects.

Things to be careful of

Testosterone may be transferred to another person during close and relatively prolonged skin contact with the gel application area.

If contact occurs a number of times or for long periods of time this could cause the other person to show signs of increased testosterone such as more hair on the face and body and a deepened voice. In women, this may also cause changes in the menstrual cycle.

Unwanted transfer of testosterone to another person can be avoided by wearing clothes which cover the application area and/or by showering before contact.

You need to ensure that your partner is not put at risk of receiving testosterone by accident.

You should leave a gap of 6 hours between applying Testogel and having intimate physical contact. You should also wear clothing such as a T-shirt to cover the gel application area and/or have a shower or bath beforehand.

You should also follow these precautions before coming into close contact with women and children.

If a woman or child does come into contact with Testogel, thoroughly wash the area of skin exposed to the gel with soap and water.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Testogel.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell you doctor if you notice any of the following and they worry you:

  • skin reactions such as irritation, redness, dry or stinging skin and/or hives
  • headaches
  • prostatic disorders such as difficulty or pain while urinating, frequent urination
  • painful, tender or enlarged breasts
  • dizziness
  • feeling of “pins and needles” or tingling sensation
  • memory loss
  • heightened senses
  • mood changes
  • high blood pressure
  • diarrhoea
  • hair loss.

These are the common side effects of Testogel.

Tell your doctor immediately, or go to Accident and Emergency department at your nearest hospital if you notice any of the following:

  • yellowing of the skin and eyes, also called jaundice.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Your doctor may need to monitor your blood pressure and conduct blood tests, as Testogel can increase your blood pressure and affect your liver function. You may not experience any specific symptoms.

Side effects associated with high doses or long term treatment include:

  • increased tendency to retain fluid (signs may include swollen feet or ankles)
  • decreased sperm count, which may affect fertility
  • unwanted, frequent or prolonged and painful erections. erections
  • severe stomach pain or tenderness, which do not disappear within a short time.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some patients.

AFTER USING TESTOGEL

Storage

Keep Testogel in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Testogel is a clear, colourless gel presented in 5 g sachets.

Packs contain 10 or 30 sachets.

Ingredients

Active ingredient per sachet:

Testogel - 50 mg testosterone in 5 g gel

Inactive ingredients:

  • carbomer 980
  • isopropyl myristate
  • ethanol
  • sodium hydroxide
  • purified water.

Supplier

Made in Belgium for:

Besins Healthcare Australia Pty Ltd
Level 23 Governor Macquarie Tower
1 Farrer Place Sydney NSW 2000

Australian Registration Numbers

Testogel - AUST R 96131

Date of Preparation

January 2014

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

BRAND INFORMATION

Brand name

Testogel sachet

Active ingredient

Testosterone

Schedule

S4

 

Name of the medicine

Testosterone.

Excipients.

Isopropyl myristate, ethanol, carbomer 980, sodium hydroxide and purified water.

Description

Chemical name: 17β-hydroxyandrost-4-en-3-one. Molecular formula: C19H28O2. MW: 288.4. CAS: 58-22-0. Testosterone is a white, crystalline powder, odourless or almost odourless, produced semisynthetically from plant origin. It is practically insoluble in water, freely soluble in ethanol (96%); slightly soluble in ethyl oleate.

Pharmacology

Pharmacodynamic properties.

Testogel is an androgen replacement therapy containing the male hormone testosterone.
Endogenous androgens, principally testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), are responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.
Testosterone does not produce testicular development; it reduces the pituitary secretion of gonadotropins.
The effects of testosterone in some target organs arise after peripheral conversion of testosterone to oestradiol, which binds to oestrogen receptors in the target cell nucleus, e.g. the pituitary, fat, brain, bone and testicular Leydig cells.

Pharmacokinetics.

Approximately 10% of the testosterone dose applied on the skin surface from Testogel is absorbed into the systemic circulation. The surface area of skin contact does not greatly affect the level of testosterone absorption.
Following percutaneous absorption, testosterone diffuses into the systemic circulation at relatively constant concentrations during the 24 hour cycle.
Serum testosterone concentrations increase from the first hour after an application, reaching steady state from the end of day two. Daily changes in testosterone concentrations are then of similar amplitude to those observed during the circadian rhythm of endogenous testosterone. The percutaneous route avoids blood peaks or the first-pass effect of oral androgen therapy.
Administration of 5 g of Testogel produces an average testosterone concentration increase in hypogonadic men of approximately 8.7 nanomol/L in plasma.
When treatment is stopped, testosterone concentrations start decreasing approximately 24 hours after the last dose. Concentrations return to baseline approximately 72 to 96 hours after the final dose.
The major active metabolites of testosterone are DHT and oestradiol.
Testosterone is excreted, mostly in urine, and in faeces as conjugated testosterone metabolites.

Clinical Trials

The pivotal study was a phase III, randomised, positive controlled, parallel group study of Testogel and a commercially available nonscrotal transdermal testosterone patch. Hypogonadal men (n = 227) were assigned to receive 5 g Testogel (50 mg testosterone) per day, 10 g Testogel (100 mg testosterone) per day or 5 mg testosterone patch (2 x 2.5 mg) per day for 90 days. The primary efficacy analysis was designed to demonstrate the comparability of Testogel with the testosterone patch on the basis of Cmin and Cavg serum testosterone levels being within the eugonadal range. Other efficacy variables that were examined included testosterone concentrations at day 90, dihydrotestosterone, oestradiol, luteinising hormone, follicle stimulating hormone and steroid hormone binding globulin trough concentrations, sexual questionnaire, muscle strength, body composition and bone markers. Testogel was demonstrated to be noninferior to the testosterone patch for the outcomes investigated.
Table 1 demonstrates the Cavg serum testosterone levels (nanogram/dL) achieved from baseline up to 90 days of treatment in hypogonadal men (number of patients in parentheses).

Indications

Testogel is indicated for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Contraindications

Testogel is contraindicated: in cases of known or suspected prostatic cancer or breast carcinoma;
in cases of known hypersensitivity to testosterone or to any other constituent of the gel.
Testogel must not be used in women or children.

Precautions

Testogel should be used only if hypogonadism (hypergonadotrophic and hypogonadotrophic) has been demonstrated and if other aetiologies responsible for the symptoms have been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction, etc.) and confirmed by biochemical tests (two separate blood testosterone measurements). Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels fall with increasing age.
Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory.
Testogel is not a treatment for male sterility or impotence.
Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude the risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients, and at risk patients (those with clinical or familial factors).
Androgens may accelerate the progression of subclinical prostatic cancer and benign prostatic hyperplasia.
Testogel should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentrations is recommended in these patients.
In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment with Testogel may cause severe complications characterised by oedema with or without congestive cardiac failure. In this case, treatment must be stopped immediately. In addition, diuretic therapy may be required.
Testogel should be used with caution in patients with ischaemic heart disease.
Testosterone may cause a rise in blood pressure and Testogel should be used with caution in patients with hypertension.
Testogel should be used with caution in patients with epilepsy and migraine as these conditions may be aggravated.
There are published reports of increased risk of sleep apnoea in hypogonadal subjects treated with testosterone esters, especially in those with risk factors such as obesity and chronic respiratory disease.
Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.
Certain clinical signs (irritability, nervousness, weight gain, prolonged or frequent erections) may indicate excessive androgen exposure requiring dosage adjustment.
If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.
The attention of athletes is drawn to the fact that this proprietary medicinal product contains an active substance (testosterone) which may produce a positive reaction in antidoping tests.
Testogel must not be used in women, due to possible virilising effects.
Beside laboratory tests of the testosterone concentrations in patients on long-term androgen therapy, the following laboratory parameters should be checked periodically: haemoglobin, haematocrit (to detect polycythaemia), liver function tests and determination of lipids profile.

Carcinogenicity and mutagenicity.

Sex hormones are known to promote the growth of certain hormone dependent tissues and tumours. Subcutaneous implantation of testosterone produced cervical uterine tumours in female mice, which metastasised in some cases. Metastasising prostatic adenocarcinomas occurred in male rats after chemical induction and subcutaneous implantation of testosterone. Testosterone promotes hepatocarcinogenesis in mice and rats.
Hepatocellular carcinoma has been reported in patients receiving long-term therapy with androgens. Chronic androgen deficiency is a protective factor for prostatic disease and hypogonadal men receiving androgen replacement therapy require surveillance for prostatic disease similar to that recommended for eugonadal men of comparable age.
The genotoxic potential of testosterone has not been fully investigated, although limited data available to date suggest that it is not genotoxic.

Potential testosterone transfer.

If no precaution is taken, testosterone gel can be transferred to other persons by close skin to skin contact, resulting in increased testosterone serum levels and possibly adverse effects (e.g. growth of facial and/or body hair, deepening of the voice, irregularities of the menstrual cycle) in case of repeat contact (inadvertent androgenisation).
The doctor should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see below). Testogel should not be prescribed in patients with a major risk of noncompliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).
This transfer is avoided by wearing clothes covering the application area or showering prior to contact.
As a result, the following precautions are recommended.

For the patient.

Wash hands with soap and water after applying the gel; cover the application area with clothing once the gel has dried; shower before any situation in which this type of contact is foreseen.

For people not being treated with Testogel.

In the event of contact with an application area which has not been washed or is not covered with clothing, wash the area of skin onto which testosterone may have been transferred as soon as possible, using soap and water; report the development of signs of excessive androgen exposure such as acne or hair modification.
According to in vitro absorption studies on testosterone conducted with Testogel, it seems preferable for patients to observe at least six hours between gel application and bathing or showering. Occasional baths or showers taken between one and six hours after application of the gel should not significantly influence the treatment outcome.
To facilitate partner safety the patient should be advised, for example, to observe a long interval between Testogel application and sexual intercourse, to wear a T-shirt covering the application site during contact period or to shower before sexual intercourse. In the case of a pregnant partner, the patient must reinforce his attention to the precautions for use.
Furthermore, it is recommended to wear a T-shirt, covering the application site, during contact period with children, in order to avoid a contamination risk to the child's skin.

Use in pregnancy.

(Category D)
Testogel must not be used in pregnant women under any circumstance. No clinical study has been conducted with this treatment in women, but testosterone is known to have potential adverse virilising effects on the fetus.
Pregnant women must avoid any contact with Testogel application sites (see Precautions). In the event of contact, wash with soap and water as soon as possible.

Use in lactation.

Testogel should not be used in breastfeeding women. Care should be taken by breastfeeding women to avoid contact with Testogel application sites. In the event of contact, wash with soap and water as soon as possible.

Effects on ability to drive and use machines.

Testogel has no influence on the ability to drive and use machines.

Interactions

Oral anticoagulants.

Changes in anticoagulant activity (the increased effect of the oral anticoagulant by modification of coagulation factor hepatic synthesis and competitive inhibition of plasma protein binding).
Increased monitoring of the prothrombin time, and INR determinations are recommended. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped.
Concomitant administration of testosterone and ACTH or corticosteroids may increase the risk of developing oedema. As a result, these medicinal products should be administered cautiously, particularly in patients suffering from cardiac, renal or hepatic disease.
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose levels, and therefore, insulin requirements.
Concurrent administration of testosterone and buproprion may result in a lowered seizure threshold.
Concurrent administration with cyclosporin may result in increased cyclosporin toxicity and elevated cyclosporin blood levels.
Theoretically, in general, any substance which affects liver function should not be taken with testosterone, although this may not be as problematic with transdermal preparations such as Testogel. Examples of herbal products include Angelica dahurica, chapparal, comfrey, eucalyptus, germander tea, Jin Bu Huan, kava, pennyroyal oil, skullcap and valerian.

Effects on laboratory tests.

Androgens may decrease levels of thyroxine binding globulin, resulting in decreased T4 serum concentrations and in increased resin uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged and there is no clinical evidence of thyroid insufficiency.

Adverse Effects

The most frequently observed adverse drug reactions at the recommended dosage of 5 g of gel per day were skin reactions (10%): reaction at the application site, erythema, acne and dry skin.
Adverse drug reactions reported in 1 to < 10% of patients treated with Testogel in the controlled clinical trials are listed as follows.

Blood and lymphatic system disorders.

Changes in laboratory tests (polycythaemia, increased lipids).

General disorders and administration site conditions.

Headache.

Renal and urinary disorders.

Prostatic disorders.

Reproductive system and breast disorders.

Gynaecomastia, mastodynia.

Nervous system disorders.

Dizziness, paraesthesia, amnesia, hyperaesthesia.

Psychiatric disorders.

Mood disorders.

Vascular disorders.

Hypertension.

Gastrointestinal disorders.

Diarrhoea.

Skin and subcutaneous disorders.

Alopecia, urticaria.
Gynaecomastia, which may be persistent, is a common finding in patients treated for hypogonadism.
The other known adverse effects of oral or injectable treatments containing testosterone are prostatic changes and progression of subclinical prostatic cancer, urinary obstruction, pruritus, arterial vasodilatation, nausea, cholestatic jaundice, changes in liver function tests, increased libido, depression, nervousness, myalgia and, during high dose prolonged treatment, electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), oligospermia and priapism (frequent or prolonged erections).
Other rare known adverse effects associated with excessive dosages of testosterone include hepatic neoplasms.
Because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin.
The pivotal clinical trial of Testogel versus a transdermal testosterone patch showed that some individuals would achieve suboptimal bioavailability.

Dosage and Administration

Adult men.

The recommended dose is 5 g of gel (i.e. 50 mg of testosterone which equates to four pump actuations, two 25 mg sachets or one 50 mg sachet) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of dosage should be achieved by 2.5 g of gel steps.
Lower doses may be required in renal or hepatic impairment.
The application should be administered by the patient himself, onto clean, dry, healthy skin over either shoulder or either arm or abdomen.
If using the gel sachets, after opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin.
If using the metered dose pump pack, it is necessary to prime the pump pack only before initial use. To do so, with the pump pack in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. Each pump actuation delivers 12.5 mg of testosterone in 1.25 g of gel and to obtain the equivalent of 50 mg of testosterone, 4 pump actuations are needed. Please refer below to dosing information.

Dosing information for Testogel 1% from the metered dose pump.

Amount of testosterone: number of pump actuations.

50 mg: 4 (once daily);
75 mg: 6 (once daily);
100 mg: 8 (once daily).
After extracting the gel, the gel has to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least three to five minutes before dressing. Wash hands with soap and water after applications.
Do not apply to the genital areas as the high alcohol content may cause local irritation.
Steady-state plasma testosterone concentrations are reached by the end of the 2nd day of treatment with Testogel. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day.

Paediatric use.

Testogel is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.

Overdosage

Only one case of acute testosterone overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with a high plasma testosterone concentration of 114 nanogram/mL (395 nanomol/L). It would be most unlikely that such plasma testosterone concentrations could be achieved using the transdermal route.

Presentation

Sachet.

Gel, 1% (25 mg/2.5 g*, 50 mg/5 g) (clear, colourless, hydroalcoholic): 1's*, 2's*, 7's*, 10's*, 14's*, 28's*, 30's, 50's*, 60's*, 90's*, 100's* (multilayer sachet (PET/Al/LDPE) in box, AUST R 96131).

Metered dose pump pack.

Gel, 1% (880 mg/88 g) (clear, colourless, hydroalcoholic): 1's*, 2's (polypropylene (PP) bottle and multilayer pouch (PET/Al/LDPE) delivering 60 actuations, AUST R 227563. Each individual pump actuation delivers 12.5 mg of testosterone in 1.25 g of gel).
*Not currently marketed in Australia.

Storage

Each sachet should not be opened until immediately prior to application of the gel.
Store below 25°C.

Poison Schedule

S4.