Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Adults and Elderly

2.5mg

The usual dose is two Andropatch 2.5 mg Systems applied nightly (approximately 10 pm) and worn for 24 hours, providing approximately 5 mg testosterone per day. The dose can be adjusted up to the equivalent of 7.5 mg nightly or down to 2.5 mg nightly depending on the serum testosterone measured in the morning after application. Measurement of serum testosterone should be repeated taking care to ensure proper system adhesion and correct time of application before the dose is adjusted. Three systems per day may be required for men with a higher body weight >130 kg). Treatment in non-virilised patients may be initiated with one system applied nightly. The dose should be adjusted as appropriate.

The duration of treatment and frequency of testosterone measurements is determined by the physician.

The adhesive side of the Andropatch 2.5 mg System should be applied to a clean, dry area of the skin on the back, abdomen, upper arms, or thighs. Bony prominences, such as the shoulder and hip areas, and areas that may be subjected to prolonged pressure during sleeping or sitting should be avoided. Application to these sites has been associated with burn-like blister reactions (see Section 4.8). Do not apply to broken or damaged skin. Do not apply to the scrotum. The sites of application should be rotated, with an interval of seven days between applications to the same site. The area selected should not be oily, damaged or irritated.

The system should be applied immediately after opening the pouch and removing the protective release liner. The system should be pressed firmly in place, making sure there is good contact with the skin, especially around the edges.

 5mg:

The usual dose is one Andropatch System applied nightly (approximately 10 pm) and worn for 24 hours, providing approximately 5 mg testosterone per day. The dose can be adjusted up to the equivalent of 7.5 mg nightly or down to 2.5 mg patch nightly depending on the serum testosterone measured in the morning after application. Measurement of serum testosterone should be repeated taking care to ensure proper system adhesion and correct time of application before the dose is adjusted. The equivalent of 7.5 mg per day may be required for men with a higher body weight (>130 kg). Treatment in non-virilised patients may be initiated with one 2.5 mg system applied nightly. The dose should be adjusted as appropriate.

The duration of treatment and frequency of testosterone measurements is determined by the physician.

The adhesive side of the Andropatch System should be applied to a clean, dry area of the skin on the back, abdomen, upper arms, or thighs. Bony prominences, such as the shoulder and hip areas, and areas that may be subjected to prolonged pressure during sleeping or sitting should be avoided. Application to these sites has been associated with burn-like blister reactions (see Section 4.8). Do not apply to broken or damaged skin.Do not apply to the scrotum. The sites of application should be rotated, with an interval of seven days between applications to the same site. The area selected should not be oily, damaged or irritated.

The system should be applied immediately after opening the pouch and removing the protective release liner. The system should be pressed firmly in place, making sure there is good contact with the skin, especially around the edges.

Child Dosage

Andropatch is not indicated for use in children as there has been no clinical experience of its use below the age of 15.

Contra Indications

Androgens are contra-indicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, nephrotic syndrome, hypercalcaemia and known hypersensitivity to testosterone.

Andropatch is contra-indicated in men with known hypersensitivity to other constituents of the patch.

Andropatch has not been evaluated in women and must not be used in women. Testosterone may be harmful to the foetus.

Special Precautions

Elderly men treated with androgens may be at an increased risk for the development of prostatic hyperplasia.

Elderly men and others with an increased risk of developing prostatic cancer, should be assessed before starting testosterone replacement therapy because testosterone may promote the growth of subclinical prostate cancer.

As in men without testosterone deficiency, patients on testosterone replacement therapy should be periodically evaluated for prostate cancer.

Care should be taken in patients with skeletal metastases due to the risk of hypercalcaemia/hypercalcuria developing from androgen therapy.

If the patient develops an application site reaction, treatment should be reviewed and discontinued if necessary.

Testosterone may cause a rise in blood pressure and Andropatch should be used with caution in patients with hypertension.

Oedema, with or without congestive heart failure, may result from androgen treatment in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Andropatch should be used with caution in patients with ischaemic heart disease, epilepsy and migraine as these conditions may be aggravated.

Interactions

When given simultaneously with anticoagulants the anticoagulant effect can increase. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may alter blood glucose and, therefore, insulin requirements

Adverse Reactions

In the majority of cases, transient mild to moderate skin reactions have been observed at the site of application at some time during treatment. These include pruritus; irritation with erythema, induration or burning, rash and allergic contact dermatitis. Burn-like lesions characterised by blisters, skin necrosis, and ulceration that healed over several weeks with scarring in some cases have also been observed.

The burn-like lesions occurred sporadically, usually only at one site, (most commonly over bony prominences or areas that may have been subjected to prolonged pressure during sleeping or sitting). Such lesions should be treated as burns.

As seen with other testosterone treatments, prostate abnormalities, prostate cancer, headache, depression and gastrointestinal bleeding were also observed.

Other known undesirable effects associated with testosterone treatments include hirsuitism, male pattern baldness, seborrhoea, acne, excessive frequency and duration of penile erections, nausea, cholestatic jaundice, increased or decreased libido, anxiety, generalised paraesthaesia. Oligospermia may occur at high doses. Prolonged testosterone administration may cause electrolyte disturbances, e.g. retention of sodium, chloride, potassium, calcium, inorganic phosphates and water.

Manufacturer

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