Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Management of patients with prostatic cancer (1) to suppress “flare” with initial LHRH analogue therapy,(2) in long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred, and (3) in the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy.
The maximum daily dose is 300 mg.
For long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred the dosage is 200-300 mg/day.
Dosage for suppression of “flare” with initial LHRH analogue therapy:
Initially 2 tablets of Cyprostat 50 mg twice daily (200 mg) alone for 5-7 days, followed by 2 tablets of Cyprostat 50 mg twice daily (200 mg) for 3–4 weeks together with the LHRH analogue therapy in the dosage recommended by the marketing authorisation holder (see SmPC of LHRH analogue).
For the above two indications the dosage should be divided into 2-3 doses per day and taken with some liquid after meals.
For the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy a 50 mg starting dose, with upward titration if necessary within the range 50-150 mg/day, is recommended. For this indication the dosage should be divided into 1-3 doses per day and taken with some liquid after meals.
Cyprostat is not recommended for use in male children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Cyprostat must not be given before the conclusion of puberty since an unfavourable influence on longitudinal growth and the still unstabilised axes of endocrine function cannot be ruled out.
There are no data suggesting the need for a dosage adjustment in elderly patients.
The use of Cyprostat is contraindicated in patients with liver diseases (see section 4.4 and 4.8).
The use of Cyprostat in patients with renal impairment has not been investigated. There are no data suggesting the need for dosage adjustment in patients with renal impairment (see section 5.2).
For oral administration.
There have been no reports of ill-effects of overdosage, which it is, therefore, generally unnecessary to treat. There are no specific antidotes and if treatment is required it should be symptomatic.
5 years.
None.
Original packs containing 160 tablets (16 blister strips of 10 tablets), 80 tablets (8 blister strips of 10 tablets) or 60 tablets (6 blister strips of 10 tablets).
No special requirements.
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