PIRODAL Tablet Ref.[28112] Active ingredients: Bromocriptine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: CODAL-SYNTO Ltd, 33 Theklas Lysioti Street, 3030, Limassol, Cyprus

4.1. Therapeutic indications

  • 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).
  • Bromocriptine is not recommended for the routine suppression of lactation or for 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.
  • Treatment of hyperprolactinaemia in males and females with hypogonadism and/or galactorrhoea.
  • Treatment of infertile females with or without demonstrable hyperprolactinaemia.
  • Treatment of patients with prolactin secreting adenomas, treatment of macroadenomas and as an alternative to surgical intervention in patients with microadenomas.
  • Acromegaly: Pirodal has been used in a number of specialised units, as an adjunct to surgery and/or radiotherapy to reduce circulating growth hormone in the management of acromegalic patients.
  • Parkinson’s Disease: In the treatment of idiopathic Parkinson’s Disease, Pirodal has been used both alone and in combination with Levodopa in the management of previously untreated patients and those disabled by ‘on-off’ phenomena. Pirodal has been used with occasional benefit in patients who do not respond to or are unable to tolerate Levodopa and those whose response to Levodopa is declining.
  • Premenstrual symptoms and benign breast disease (see section 4.4).

4.2. Posology and method of administration

Posology

Due to the variety of conditions, the recommended dosage regimes are variable. Irrespective of the final dosage, gradual introduction of bromocriptine to achieve the optimum response with minimal side effects is recommended. Initial dose should be given at bedtime, with dosage increments of 1.25 mg to 2.5 mg at two to three day intervals, and divided doses, until 2.5 mg twice a day is reached. Subsequent dosage increments, if needed, should be done in the same way.

The maximum daily dose is restricted to 30mg/day.

Adults

Prevention of lactation

2.5 mg on day of delivery, followed by 2.5 mg twice a day for fourteen days. Gradual introduction is unnecessary for this indication.

Suppression of lactation

2.5 mg on first day, increased after two or three days to 2.5 mg twice a day for fourteen days. Gradual introduction is unnecessary for this indication.

Hypogonadism / galactorrhoea / infertility

Introduce bromocriptine gradually as recommended initially. The majority of patients with hyperprolactinaemia respond to 7.5 mg daily in divided doses, but 30 mg daily has been used. Infertile patients without elevated serum prolactin usually respond to 2.5 mg twice a day.

Prolactinomas

Introduce bromocriptine gradually as recommended initially. Dosage may then be increased by 2.5 mg daily at two to three day intervals: 2.5 mg every eight hours, 2.5 mg every six hours, 5 mg every six hours. Up to 30 mg daily has been used.

Acromegaly

Standard gradual introduction, followed by dosage increments of 2.5 mg daily every two to three days to reach: 2.5 mg every eight hours, 2.5 mg every six hours, 5 mg every six hours.

Parkinson’s disease

Introduce as in the table:

Week 1 1-1.25 mg at bed time.
Week 2 2-2.5 mg at bed time.
Week 3 2.5 mg two times a day.
Week 4 2.5 mg three times a day.
Thereafter Three times a day, increasing by 2.5 mg every three to
fourteen days, depending upon response. Continue until
optimum dose achieved, usually between 10 mg and 30 mg
daily. Patients concomitantly on levodopa can have the
dosage reduced as bromocriptine is increased until
optimum balance is achieved.

Paediatric population

Not appropriate for children under seven years of age.

Elderly

No special dosage recommendations.

Renal impairment

Dosage adjustment should not be necessary.

Hepatic impairment

As bromocriptine is extensively metabolised in the liver, dosage reduction must be anticipated in hepatic impairment. Caution is advised.

Method of administration

Pirodal tablets are for oral administration. They should be taken with a meal.

4.9. Overdose

Overdosage with Pirodal is likely to result in vomiting and other symptoms which could be due to over stimulation of dopaminergic receptors and might include nausea, dizziness, hypotension, postural hypotension, tachycardia, drowsiness, somnolence, lethargy, confusion and hallucinations. General supportive measures should be undertaken to remove any unabsorbed material and maintain blood pressure if necessary.

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.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

Polyvinylchloride and aluminium combination blisters. Blisters and leaflet in an outer carton.

Pirodal 2.5 mg tablets are available in packs of 30, 100 or 500 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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