Restandol from Schering-Plough

Restandol - Schering-Plough

1. Name of the medicinal product

Restandol TestocapsTM 40 mg capsule.

2. Qualitative and quantitative composition

Each capsule contains Testosterone Undecanoate 40.0 mg which is equivalent to 25.3 mg testosterone.

3. Pharmaceutical form

Capsule:
Soft oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.

4. Therapeutic indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Examples of hypogonadal disorder are:

  • after castration
  • eunuchoidism
  • hypopituitarism
  • endocrine impotence
  • male climacteric symptoms like decreased libido and decreased mental and physical activity
  • certain types of infertility due to disorders of spermatogenesis

Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.

5. Dosage of administration

In general, the dose should be adjusted according to the response of the individual patient.

Adults
The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.

Elderly Patients
It should be noted that smaller and less frequent doses may achieve the same response.

Paediatric population
Safety and efficacy has not been determined in children and adolescents. Pre-pubertal children treated with Restandol Testocaps should be treated with caution.

6. Method of administration

Oral
To ensure absorption, Restandol Testocaps must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.

7. Side effects

All adverse reactions listed by system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data).

System Organ Class Common Not known
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Prostatic cancer1
Blood and lymphatic system disorders Polycythaemia
Metabolism and nutrition disorders Fluid retention
Psychiatric disorders DepressionNervousness

Mood altered

Libido increased

Libido decreased

Vascular disorders Hypertension
Gastrointestinal disorders Nausea
Hepatobiliary disorders Hepatic function abnormal
Skin and subcutaneous tissue disorders Pruritus

Acne

Musculoskeletal and connective tissue disorders Myalgia
Renal and urinary disorders Urinary obstruction
Reproductive system and breast disorders Gynaecomastia

Oligozoospermia

Priapism

Benign prostatic hyperplasia2

Investigations Hematocrit increased

Red blood cell count increased

Haemoglobin increased

Lipids abnormal3

PSA increased

1 Progression of a sub-clinical prostatic cancer
2 Prostatic growth (to normogonadal size)
3 Decrease in serum LDL-C, HDL-C and triglycerides
The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.
With high doses and prolonged treatment electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), hypertension, oligozoospermia, or azospermia, priaprism, changes in lipid metabolism, polycythaemia.
In a few patients diarrhoea and abdominal pain or discomfort have been reported during use of Restandol Testocaps.

8. Shell life

3 years