Advanced hormone dependent prostatic carcinoma

Active Ingredient: Buserelin

Indication for Buserelin

Population group: men, only adults (18 years old or older)

Buserelin is indicated For the treatment of advanced hormone dependent prostatic carcinoma (stage C or stage D according to the classification of Murphy et al, in Cancer 45, p1889-95, 1980) in which suppression of testosterone is indicated; however, not after bilateral orchiectomy (no further reduction of testosterone level by buserelin to be expected).

Buserelin acts by blockade and subsequent down-regulation of pituitary LHRH receptor synthesis. Gonadotropin release is consequently inhibited. As a result of this inhibition there is reduced stimulation of testosterone secretion and serum testosterone levels fall to castration range. Before inhibition occurs there is a brief stimulatory phase during which testosterone levels may rise.

For this indication, competent medicine agencies globally authorize below treatments:

1.5 mg in 3 divided doses daily

Route of admnistration

Subcutaneous

Defined daily dose

1.5 - 1.5 mg

Dosage regimen

From 0.5 To 0.5 mg 3 time(s) per day every day for 7 day(s)

Detailed description

Initiation of therapy: is most conveniently carried out in hospital; 0.5mg buserelin injection should be injected subcutaneously at 8 hourly intervals for 7 days.

Maintenance therapy: on the 8th day of treatment the patient is changed to intranasal administration of buserelin.

1.2 mg in 6 divided doses daily

Route of admnistration

Nasal

Defined daily dose

1.2 - 1.2 mg

Dosage regimen

From 0.2 To 0.2 mg 6 time(s) per day every day

Detailed description

Initiation of therapy: is most conveniently carried out in hospital; 0.5 ml buserelin injection should be injected subcutaneously at 8 hourly intervals for 7 days.

Maintenance therapy: on the 8th day of treatment the patient is changed to intranasal administration of buserelin. One spray dose is introduced into each nostril 6 times a day according to the following schedule:

  • 1st dose before breakfast
  • 2nd dose after breakfast
  • 3rd and 4th doses before and after midday meal
  • 5th and 6th doses before and after evening meal.

This dosage regimen is to ensure adequate absorption of the material and to distribute the dose throughout the day.

If used correctly, reliable absorption of the active ingredient takes place via nasal mucous membranes. Buserelin nasal spray is absorbed even if the patient has a cold.

If nasal decongestants are being used concurrently, they should be administered at least 30 minutes after buserelin.

9.45 mg once every 3 months

Route of admnistration

Subcutaneous

Defined daily dose

9.45 mg

Dosage regimen

9.45 mg once every 90 day(s)

Active ingredient

Buserelin

Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, LHRH or GNRH). After an initial stimulation of gonadotrophin release, it down-regulates the hypothalanic-pituitary-gonadal axis.

Read more about Buserelin

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