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PARLODEL is a brand name for Bromocriptine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Inhibition of lactation for medical reasons 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). Parlodel is not recommended for the routine suppression of lactation or for the relief of…
Verbatim from this product's MHRA label. Tap a section to expand.
PARLODEL should always be taken with food. A number of disparate conditions are amenable to treatment with PARLODEL and for this reason, the recommended dosage regimens are variable. In most indications, irrespective of the final dose, the optimum response with the minimum of side effects is best achieved by gradual introduction of PARLODEL.
5mg at bed time. 5mg twice daily is achieved. Further dosage increments, if necessary, should be added in a similar manner. 5mg twice daily for 14 days. Treatment should be instituted within a few hours of parturition once vital signs have been stabilised.
Gradual introduction of PARLODEL is not necessary in this indication. 5mg twice daily for 14 days. Gradual introduction of PARLODEL is not necessary in this indication. Hypogonadism/Galactorrhea syndromes/Infertility Introduce PARLODEL gradually according to the suggested scheme.
5mg daily, in divided doses, but doses of up to 30mg daily have been used. 5mg twice daily. Prolactinomas Introduce PARLODEL gradually according to the suggested scheme. 5mg six hourly, 5mg six hourly. Daily doses should not exceed 30 mg.
Acromegaly Introduce PARLODEL gradually, according to the suggested scheme. 5mg six-hourly, 5mg six-hourly. 25mg at bed time. 5mg at bed time. 5mg twice daily. 5mg three times daily. 5mg every 3 to 14 days, depending on the patient’s response.
Continue until the optimum dose is reached. This will usually be between 10mg and 30mg daily. Daily doses should not exceed 30 mg. In patients already receiving Levodopa the dosage of this drug may gradually be decreased, while the dosage of PARLODEL is increased until the optimum balance is determined.
Use in Children and adolescents (aged 7-17) Prescribing of PARLODEL in children and adolescents (aged 7-17) should be limited to Paediatric Endocrinologists.
Prolactinomas:
Paediatric population 7 years and older: 1 mg 2 or 3 times daily, gradually increasing to several tablets daily as required to keep plasma prolactin adequately suppressed. Maximum daily dose recommended in children aged 7 to 12 years is 5 mg.
Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Gigantism (acromegaly):
The occurrence of side-effects can be minimised by gradual introduction of the dose or a dose reduction followed by a more gradual titration. If necessary, initial nausea and/or vomiting may be reduced by taking PARLODEL during a meal and by the intake of a peripheral dopamine antagonist, such as domperidone, for a few days, at least one hour prior to the administration of PARLODEL.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) including isolated reports.
Nervous System Disorders Common:
Headache, drowsiness Uncommon: Dizziness, dyskinesia Rare: Somnolence, paresthesia Very Rare: Excess daytime somnolence and sudden sleep onset Psychiatric Disorders Uncommon: Confusion, psychomotor agitation, hallucinations Rare: Psychotic disorders, insomnia Gastrointestinal Disorders Common: Nausea, constipation Uncommon: Vomiting, dry mouth Rare: Diarrhoea, abdominal pain, retroperitoneal fibrosis, gastrointestinal ulcer, gastrointestinal haemorrhage Vascular Disorders Uncommon: Hypotension including orthostatic hypotension (which may in very rare instances lead to collapse) Very Rare: Reversible pallor of fingers and toes induced by cold (especially in patients who have a history of Raynaud’s phenomenon) Cardiac Disorders Rare: Tachycardia, bradycardia, arrhthymia Very rare: Cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).
Respiratory, thoracic and mediastinal disorders Common:
Nasal congestion Rare: Pleural effusion, pleural and pulmonary fibrosis, pleuritis, dyspneoa Musculoskeletal and connective tissue disorders Uncommon: Leg cramps Skin and subcutaneous tissue disorders Uncommon: Allergic skin reactions, hair loss General disorders and administration site conditions Uncommon: Fatigue Rare: Peripheral oedema Very Rarely: A syndrome resembling Neuroleptic Malignant Syndrome has been reported on withdrawal of PARLODEL.
). 2 Posology and method of administration PARLODEL should always be taken with food. A number of disparate conditions are amenable to treatment with PARLODEL and for this reason, the recommended dosage regimens are variable. In most indications, irrespective of the final dose, the optimum response with the minimum of side effects is best achieved by gradual introduction of PARLODEL.
5mg at bed time. 5mg twice daily is achieved. Further dosage increments, if necessary, should be added in a similar manner. 5mg twice daily for 14 days. Treatment should be instituted within a few hours of parturition once vital signs have been stabilised.
Gradual introduction of PARLODEL is not necessary in this indication. 5mg twice daily for 14 days. Gradual introduction of PARLODEL is not necessary in this indication. Hypogonadism/Galactorrhea syndromes/Infertility Introduce PARLODEL gradually according to the suggested scheme.
5mg daily, in divided doses, but doses of up to 30mg daily have been used. 5mg twice daily. Prolactinomas Introduce PARLODEL gradually according to the suggested scheme. 5mg six hourly, 5mg six hourly. Daily doses should not exceed 30 mg.
Acromegaly Introduce PARLODEL gradually, according to the suggested scheme. 5mg six-hourly, 5mg six-hourly. 25mg at bed time. 5mg at bed time. 5mg twice daily. 5mg three times daily. 5mg every 3 to 14 days, depending on the patient’s response.
Continue until the optimum dose is reached. This will usually be between 10mg and 30mg daily. Daily doses should not exceed 30 mg. In patients already receiving Levodopa the dosage of this drug may gradually be decreased, while the dosage of PARLODEL is increased until the optimum balance is determined.
Use in Children and adolescents (aged 7-17) Prescribing of PARLODEL in children and adolescents (aged 7-17) should be limited to Paediatric Endocrinologists.
Hypersensitivity to bromocriptine or to any of the excipients of Parlodel (see Section 2. 1 List of excipients) or other ergot alkaloids. Parlodel is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension postpartum and in the puerperium.
Parlodel is contraindicated for use in the suppression of lactation or other non- life threatening indications in patients with a history of coronary artery disease, or other severe cardiovascular conditions, or symptoms / history of severe psychiatric disorders.
Patients with these underlying conditions taking Parlodel for the indication of macro-adenomas should only take it if the perceived benefits outweigh the potential risks (see Section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paediatric population 7 years and older: The starting dose should be titrated in response to Growth Hormone levels. Maximum daily dose recommended in children ages 7 to 12 years is 10 mg. Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Use in Elderly There is no clinical evidence that PARLODEL poses a special risk to the elderly. Use in Patients with Hepatic Impairment In patients with impaired hepatic function, the speed of elimination may be retarded and plasma levels may increase, requiring dose adjustment.
Eye Disorders Rare:
Visual disturbances, vision blurred Ear and Labyrinth Disorders Rare: Tinnitus Post-partum women In extremely rare cases (in postpartum women treated with PARLODEL for the prevention of lactation) serious adverse events including hypertension, myocardial infarction, convulsion, stroke or mental disorders have been reported, although the causal relationship is uncertain.
4 Special warnings and precautions for use). Impulse control disorders Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including PARLODEL.
4 ‘Special warnings and precautions for use’). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance f the medicinal product.
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Prolactinomas:
Paediatric population 7 years and older: 1 mg 2 or 3 times daily, gradually increasing to several tablets daily as required to keep plasma prolactin adequately suppressed. Maximum daily dose recommended in children aged 7 to 12 years is 5 mg.
Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Gigantism (acromegaly):
Paediatric population 7 years and older: The starting dose should be titrated in response to Growth Hormone levels. Maximum daily dose recommended in children ages 7 to 12 years is 10 mg. Maximum daily dose recommended in adolescent patients (13-17 years) is 20 mg.
Use in Elderly There is no clinical evidence that PARLODEL poses a special risk to the elderly. Use in Patients with Hepatic Impairment In patients with impaired hepatic function, the speed of elimination may be retarded and plasma levels may increase, requiring dose adjustment.
3 Contraindications Hypersensitivity to bromocriptine or to any of the excipients of Parlodel (see Section 2. 1 List of excipients) or other ergot alkaloids. Parlodel is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension postpartum and in the puerperium.
Parlodel is contraindicated for use in the suppression of lactation or other non- life threatening indications in patients with a history of coronary artery disease, or other severe cardiovascular conditions, or symptoms / history of severe psychiatric disorders.
4 Special Warnings and Precautions).
For long-term treatment:
Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography. 3 Contraindications). Other There is insufficient evidence of efficacy of Parlodel in the treatment of premenstrual symptoms and benign breast disease.
The use of Parlodel in patients with these conditions is therefore not recommended. In rare cases, serious adverse events, including hypertension, myocardial infarction, seizures, stroke or psychiatric disorders have been reported in postpartum women treated with Parlodel for the inhibition of lactation.
8; Undesirable effects). 3 Contraindications). Blood pressure should be carefully monitored, especially during the first days of therapy. Particular caution is required in patients who are on concomitant therapy with, or have […]