Bromocriptine

Registered South African indications:

• Lactation inhibition
• Hyperprolactinaemia
• Prolactinomas
• Acromegaly
• Parkinsonism

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Breastfeeding
• Uncontrolled hypertension
• Hypertensive disorders of pregnancy
• Postpartum hypertension
• Suppression of lactation/treatment or macroadenomas in patients with: Coronary artery disease; Severe cardiovascular conditions; Current or history of severe psychiatric disorders
• Cardiac valvulopathy

Cautions

• Pregnancy
• Renal impairment
• Hepatic impairment
• Elderly
• Children (<7 years)
• Post-partum women
• Hypertension
• Secondary adrenal insufficiency
• History of peptic ulceration
• Impulse control disorders
• Pleuropulmonary disorders
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Inhibition of  postpartum lactation

• Oral (tab): 2.5mg, taken within the first 8hrs of delivery, then 12hrly; Treatment duration: 14 days; Treatment may be continued for a further week (if milk secretion observed after discontinuation of treatment): 2.5mg, dly

Inhibition of lactation

• Oral (tab): 2.5mg, dly for 2-3 days; Thereafter, 2.5mg, 12hrly; Treatment duration: 14 days; Treatment may be continued for a further week (if milk secretion observed after discontinuation of treatment): 2.5mg, dly

Female infertility associated with hyperprolactinaemia and menstrual cycle disorders

• Oral (tab): Initial: 1.25mg, dly at night for 3 days;
  Thereafter, 2.5mg, dly at night for 3 days; Maintenance: 2.5mg, 12hrly; Increase to 2.5mg, 8hrly, if needed; Titrate by 2.5mg at intervals of 2-3 days; Therapeutic range: 2.5-15mg/day 

Hyperprolactinaemia

• Oral (tab): Initial: 1.25mg, 8-12hrly; Titrate gradually; Max: 15mg/24hrs  

Acromegaly

• Oral (tab): Initial: 1.25mg, 8-12hrly; Titrate gradually increasing to 10-20mg, dly over 3-7 days; Used as an adjunct therapy

Parkinson's disease

• Oral (tab): Week 1: 1.25mg, dly at night; Titrate by 1.25mg at intervals of 1 week; Administer in 2-3 divided doses; Therapeutic response may be reached between weeks 6-8; Further titrate by 2.5mg at intervals of 1 week if needed; Maximum daily dose is 100mg/24hrs 

Must be administered with food

Paed. forms avail. in SA and covered in this monograph: tab

Prolactinoma

Younger than 7 years

• Not established for use  

Between 7-17 years

• Oral (tab): Initial: 1.25mg, 8-12hrly; Titrate gradually;
  Maintenance: 5-7.5mg/day in divided doses; Max: 15mg/24hrs 

Older than 17 years

• See adult dosage

Careful evaluation by a paediatric endocrinologist/neurosurgeon is essential

Acromegaly

Younger than 7 years

• Not established for use

Between 7-17 years

• Oral (tab): Titrate to growth hormone levels; Max: 10mg/24hrs

Older than 17 years

• See adult dosage

Careful evaluation by a paediatric endocrinologist/neurosurgeon is essential

Administer with food

Pregnancy 

• Caution; no evidence of risk in studies
• If pregnancy occurs it is generally advisable to withdraw bromocriptine after the first missed menstrual period
• Rapid expansion of pituitary tumours sometimes occurs during pregnancy and this may also occur in patients who have been able to conceive as a result of bromocriptine therapy. As a precautionary measure, patients should be monitored to detect signs of pituitary enlargement so that bromocriptine may be reintroduced if necessary. Based on the outcome of more than 2,000 pregnancies, the use of bromocriptine to restore fertility has not been associated with an increased risk of abortion, premature delivery, multiple pregnancy or malformation in infants. Because this accumulated evidence suggests a lack of teratogenic or embryopathic effects in humans, maintenance of bromocriptine treatment during pregnancy may be considered where there is a large tumour or evidence of expansion

Breastfeeding 

• Contraindicated
• Since bromocriptine inhibits lactation, it should not be administered to mothers who elect to breastfeed as breastfeeding is not possible during therapy
• Bromocriptine should not be used postpartum, or in puerperium in women with high blood pressure, coronary artery disease, or symptoms (or history) of serious mental disorder

Fertility

• Fertility may be restored by treatment with bromocriptine. Women of childbearing age who do not wish to conceive should, therefore, be advised to practice a reliable method of contraception

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
  Reduce maintenance dose by 50%; Reduce maximum daily dose (when the dosage is > 10mg) by 50%
  *See additional prescribing notes for adjustments per indication
• Severe: Avoid use

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Dyskinesia
• Somnolence 
• Paresthesia
• Confusion
• Psychomotor agitation
• Hallucinations
• Psychotic disorders 
• Impulse control disorders
• Insomnia
• Fatigue

Cardiovascular Disorders

• Hypotension
• Reversible pallor of fingers and toes induced by cold
• Tachycardia
• Bradycardia
• Arrhythmia
• Cardiac valvulopathy
• Pericarditis 
• Pericardial effusion
• Peripheral oedema

Respiratory Disorders

• Nasal congestion
• Pleural effusion
• Pleural and pulmonary fibrosis
• Pleuritis
• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Dry mouth
• Diarrhoea
• Abdominal pain
• Retroperitoneal fibrosis
• Gastrointestinal ulcer
• Gastrointestinal haemorrhage

Musculoskeletal Disorders

• Leg cramps

Sensory Disorders

• Tinnitus
• Visual disturbances
• Vision blurred

• Alcohol
• Antihypertensives
• Ergot alkaloids
• Macrolide antibiotics
• CYP3A4 inhibitors
• CYP3A4 substrates
• Dopamine antagonists
• Sympathomimetics

• Blood pressure
• Pituitary function
• Erythrocyte sedimentation rate
• Chest x-ray
• Renal function
• Hepatic function
• Psychiatric examination
• Pregnancy test

Specific cases may require 

• Visual field 
• Cervical cytology
• Endometrial cytology
• Echocardiography

Hepatic Impairment

Adjustments as per indication:

• Inhibition of lactation:
  Dosage should not exceed 1.25mg dly
• Female infertility associated with hyperprolactinaemia and menstrual cycle disorders:
  Initial and maintenance dose: 1.25mg; Dosage should not exceed 10mg dly (when necessary; for short period)
• Parkinson's disease:
  Initial and maintenance dose: 1.25mg dly; Maximum daily dose of 10mg dly (when necessary; for short period)
  Consider alternative (non-ergot) dopamine receptors agonist like Apomorphine or Rotigotine
• Hyperprolactinaemia:
  Dosage should not exceed 1.25mg dly 

Bromocriptine inhibits prolactin secretion and stimulates dopamine receptors. As a specific inhibitor of prolactin secretion, bromocriptine can be used to prevent or suppress physiological lactation as well as to treat prolactin-induced pathological states. In amenorrhoea and/or anovulation (with or without galactorrhoea), bromocriptine can be used to restore menstrual cycles and ovulation.

Tablet 2.5mg

• Aspen bromocriptine (Pharmacare)