PARLODEL

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. 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) 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). 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 recently been treated with drugs that can alter blood pressure.

Concomitant use of bromocriptine with vasoconstrictors such as sympathomimetics or ergot alkaloids including ergometrine or methylergometrine during the puerperium is not recommended. If hypertension, unremitting headache, or any signs of CNS toxicity develop, treatment should be discontinued immediately.

Hyperprolactinaemia may be idiopathic, drug-induced, or due to hypothalamic or pituitary disease. The possibility that hyperprolactinaemic patients may have a pituitary tumour should be recognised and complete investigation at specialized units to identify such patients is advisable.

PARLODEL will effectively lower prolactin levels in patients with pituitary tumours but does not obviate the necessity for radiotherapy or surgical intervention where appropriate in acromegaly. Since patients with macro-adenomas of the pituitary might have accompanying hypopituitarism due to compression or destruction of pituitary tissue, one should make a complete evaluation of pituitary functions and institute appropriate substitution therapy prior to administration of PARLODEL.

In patients with secondary adrenal insufficiency, substitution with corticosteroids is essential. The evolution of tumour size in patients with pituitary macro-adenomas should be carefully monitored and if evidence of tumour expansion develops, surgical procedures must be considered.

If in adenoma patients, pregnancy occurs after the administration of PARLODEL, careful observation is mandatory. Prolactin-secreting adenomas may expand during pregnancy. In these patients, treatment with PARLODEL often results in tumour shrinkage and rapid improvement of the visual fields defects.

In severe cases, compression of the optic or other cranial nerves may necessitate emergency pituitary surgery. Visual field impairment is a known complication of macro-prolactinoma. Effective treatment with Parlodel leads to a reduction in hyperprolactinaemia and often to resolution of the visual impairment.

In some patients, however, a secondary deterioration of visual fields may subsequently develop despite normalised prolactin levels and tumour shrinkage, which may result from traction on the optic chiasm which is pulled down into the now partially empty sella.

In these cases the visual field defect may improve on reduction of bromocriptine dosage while there is some elevation of prolactin and some tumour re-expansion. Monitoring of visual fields in patients with macro- prolactinoma is therefore recommended for an early recognition of secondary field loss due to chiasmal herniation and adaptation of drug dosage.

In some patients with prolactin-secreting adenomas treated with Parlodel cerebrospinal fluid rhinorrhea has been observed. The data available suggest that this may result from shrinkage of invasive tumours. Bromocriptine has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease.

Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with bromocriptine.

7 Effects on ability to drive and use machines). Furthermore, a reduction of dosage or termination of therapy may be considered. When women of child-bearing age are treated with PARLODEL for conditions not associated with hyperprolactinaemia the lowest effective dose should be used.

This is in order to avoid suppression of prolactin to below normal levels, with consequent impairment of luteal function. Gynaecological assessment, preferably including cervical and endometrial cytology, is recommended for women receiving PARLODEL for extensive periods.

Six monthly assessment is suggested for post-menopausal women and annual assessment for women with regular menstruation. A few cases of gastrointestinal bleeding and gastric ulcer have been reported. If this occurs, PARLODEL should be withdrawn.

Patients with a history of evidence of peptic ulceration should be closely monitored when receiving the treatment. Since, especially during the first few days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, particular care should be exercised when driving a vehicle or operating machinery.

Among patients on Parlodel, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported. Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of Parlodel therapy should be contemplated.

In a few patients on Parlodel, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. g. back pain, oedema of the lower limbs, impaired kidney function) should be watched in this category of patients.

Parlodel medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected. Attention should be paid to the signs and symptoms of
pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain
cardiac failure as cases of pericardial […]

). 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. 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) 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). O t h e r 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, convulsion, stroke or psychiatric disorders have been reported in postpartum women treated with PARLODEL for 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 recently been treated with drugs that can alter blood pressure.

Concomitant use of bromocriptine with vasoconstrictors such as sympathomimetics or ergot alkaloids including ergometrine or methylergometrine during the puerperium is not recommended. If hypertension, unremitting headache, or any signs of CNS toxicity develop, treatment should be discontinued immediately.

Hyperprolactinaemia may be idiopathic, drug-induced, or due to hypothalamic or pituitary […]

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