Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
The treatment of hyperprolactinaemia in men and women with hypogonadism and/or galactorrhoea.
Amenorrhoea and oligomenorrhoea, with or without galactorrhoea.
Drug-induced hyperprolactinaemic disorders.
Polycystic ovary syndrome.
Some infertile women with oligomenorrhoea or amenorrhoea and galactorrhoea may be unduly sensitive to prolactin. PARLODEL has been used successfully in the treatment of a number of infertile women with galactorrhoea who do not have demonstrable hyperprolactinaemia.
To reduce tumour size, particularly in those at risk of optic nerve compression.
PARLODEL 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.
In the treatment of idiopathic Parkinson’s Disease, PARLODEL has been used both alone and in combination with Levodopa in the management of previously untreated patients and those disabled by ‘on-off’ phenomena. PARLODEL 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.
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. The following scheme is suggested: Initially, 1mg to 1.25mg at bed time, increasing after 2 to 3 days to 2mg to 2.5mg at bed time. Dosage may then be increased by 1mg to 2.5mg at 2 to 3 day intervals, until a dosage of 2.5mg twice daily is achieved. Further dosage increments, if necessary, should be added in a similar manner.
Introduce PARLODEL gradually according to the suggested scheme. Most patients with hyperprolactinaemia have responded to 7.5mg daily, in divided doses, but doses of up to 30mg daily have been used. In infertile patients without demonstrably elevated serum prolactin levels, the usual dose is 2,5mg twice daily.
Introduce PARLODEL gradually according to the suggested scheme. Dosage may then be increased by 2.5mg daily at 2 to 3 day intervals as follows: 2.5mg eight-hourly, 2.5mg six hourly, 5mg six-hourly. Daily doses should not exceed 30 mg.
Introduce PARLODEL gradually, according to the suggested scheme. Dosage may then be increased by 2.5mg daily at 2 to 3 day intervals as follows 2.5mg eight-hourly, 2.5mg six-hourly, 5mg six-hourly, 5mg six-hourly.
Introduce PARLODEL gradually, as follows: Week 1: 1mg to 1.25mg at bed time. Week 2: 2mg to 2.5mg at bed time. Week 3: 2.5mg twice daily. Week 4: 2.5mg three times daily. Thereafter take three times a day increasing by 2.5mg 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 daily of PARLODEL is increased until the optimum balance is determined.
Prescribing of PARLODEL in children and adolescents (aged 7-17) should be limited to Paediatric Endocrinologists.
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.
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.
There is no clinical evidence that PARLODEL poses a special risk to the elderly.
In patients with impaired hepatic function, the speed of elimination may be retarded and plasma levels may increase, requiring dose adjustment.
Overdosage with PARLODEL 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.
There have been isolated reports of children who accidentally ingested PARLODEL. Vomiting, somnolence and fever were reported as adverse events. Patients recovered either spontaneously within a few hours or after symptomatic treatment.
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.
Opaque white PV/PVDC blister strip: 24 months.
Amber glass bottle: 36 months.
Amber glass bottle: Store below 30°C. Store in the original package in order to protect from light.
Opaque white PV/PVDC blister strip: Store below 25°C. Store in the original package in order to protect from light.
Opaque white PV/PVDC blister strip containing 30 PARLODEL 5mg capsules.
Amber glass bottle with a tamper resistant closure containing 100 PARLODEL 5mg capsules.
Not all pack sizes will be marketed.
No special requirements.
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