Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3508 Limassol, Cyprus
In the treatment of idiopathic Parkinson’s disease. Bromocriptine has been used both alone and in combination with levodopa in the management of previously untreated patients and those disabled by “on/off” phenomena. Bromocriptine has been used with occasional benefit in patients who do not respond or are unable to tolerate levodopa and those whose response to levodopa is declining.
In a number of specialised units, patients who have been shown to have prolactin secreting adenomas have been treated successfully with bromocriptine. In particular bromocriptine can be considered as a first choice of treatment in patients with macroadenomas and as an alternative to the surgical procedure transsphenoidal hypophysectomy in patients with microadenomas.
Bromocriptine has been used in a number of specialized units, as an adjunct to surgery and/or radiotherapy to reduce circulating growth hormone in the management of acromegalic patients.
For the treatment of hyperprolactinaemia in patients with hypogonadism and/or galactorrhoea.
In the treatment of female infertility associated with normal basal gonadotrophin levels and hyperprolactinaemia (Absolute or relative).
Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother).
Brameston is not recommended for the routine suppression of lactation or the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
There is insufficient evidence of efficacy of bromocriptine in the treatment of premenstrual symptoms and benign breast disease. The use of bromocriptine in patients with these conditions is therefore not recommended.
Brameston should always be taken during a meal.
A number of disparate conditions are amenable to treatment with Brameston, and for this reason, the recommended dosage regimens are variable. In most indications, irrespective of the final dosage the optimum response with the minimum of side-effects is best achieved by gradual introduction of Brameston. The following scheme is suggested:
Initially half a tablet (1.25 mg) at bedtime, increasing after 2 to 3 days to 2 mg to 2.5 mg at bedtime. Dosage may then be increased by half to one tablet at 2 to 3 day intervals, until a dosage of 2.5 mg twice daily is achieved. Further dosage increments, if necessary, should be added in a similar manner.
2.5 mg on the first day of delivery followed by 2.5 mg twice daily for 14 days. Gradual introduction of Brameston is not necessary in this indication.
Suppression of lactation:
2.5 mg on the first first day, increasing after 2 to 3 days to 2.5 mg twice daily for 14 days. Gradual introduction of Brameston is not necessary in this indication.
Introduce Brameston according to the suggested scheme.
Most of the patients with hyperprolactinaemia respond to 7.5 mg daily in divided doses, but doses of up to 30 mg daily have been used. In infertile patients without demonstrably elevated serum prolactin levels the usual dosage is 2.5 mg twice daily.
Introduce Brameston gradually, according to the suggested scheme. Dosage may then be increased by 2.5 mg daily at 2 to 3 day interval as follows: 2.5 mg eight-hourly, 2.5 mg six-hourly, 5 mg six-hourly. The final dose is usually 20–60 mg daily.
Brameston should be introduced gradually.
Week 1: 1 to 1.25 mg at bedtime.
Week 2: 2 to 2.50 mg at bedtime
Week 3: 2.5 mg twice daily
Week 4: 2.5 mg three times daily.
Thereafter take three times a day increasing by 2.5 mg every 3 to 14 days depending on the patient’s response. Continue until the optimum dose is reached. This will usually be between 10 and 40 mg daily. In patients already receiving levodopa the dosage of this drug may be gradually decreased, while the dosage of Brameston is increased until the optimum balance is determined.
Introduce Brameston gradually according to the suggested scheme. Dosage may then be increased by 2.5 mg daily at 2 to 3 day intervals as follows: 2.5 mg every eight-hourly, 2.5 mg every six-hourly, 5 mg every six-hourly. Patients have responded to up to 30 mg daily.
Brameston should not be used in children less than 15 years of age.
There is no clinical evidence that bromocriptine poses a special risk to elderly.
Oral.
All patients who have taken an overdose of bromocriptine alone have survived; the maximum single dose so far ingested is 325 mg. The observed symptoms were nausea, dizziness, hypotension, postural hypotension, tachycardia, drowsiness, somnolence, lethargy, confusion and hallucinations.
There have been isolated reports of children who accidentally ingested bromocriptine. Vomiting, somnolence and fever were reported as adverse events. Patients recovered either spontaneously within a few hours or after appropriate management.
In the case of overdose, administration of activated charcoal is recommended and in the case of very recent oral intake, gastric lavage may be considered.
The management of acute intoxication is symptomatic. Metoclopramide may be indicated for the treatment of emesis or hallucinations.
3 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack-sizes of 30 and 1000 tablets.
PP containers with PE closure. Pack-size of 1000 tablets.
Not all pack-sizes may be marketed.
No special requirements.
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