Parlodel Special Precautions

General: If women with conditions not associated with hyperprolactinemia are treated with Parlodel, the drug should be given in the lowest effective dose necessary to relieve the symptoms; this is in order to avoid the possibility of suppressing plasma prolactin below normal levels, with a consequent impairment of luteal function.
Gastrointestinal: A few cases of gastrointestinal bleeding and gastric ulcer have been reported. If this occurs, Parlodel should be withdrawn. Patients with a history or evidence of peptic ulceration should be closely monitored when receiving the treatment.
Fibrotic conditions: 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. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g. back pain, edema 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 Parlodel medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.
Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Parlodel. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Use in postpartum women: In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychic disorders have been reported in postpartum women treated with Parlodel for the inhibition of lactation. In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances. Although the causal relationship of these events to the drug is uncertain, periodic monitoring of blood pressure is advisable in postpartum women receiving Parlodel for the inhibition of lactation, as well as in patients treated for any other condition. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of CNS toxicity develop, the administration of Parlodel should be discontinued and the patient should be evaluated promptly.
Particular caution is required in patients who have recently been treated or are on concomitant therapy with drugs that can alter blood pressure, e.g. vasoconstrictors such as sympathomimetics or ergot alkaloids including ergometrine or methylergometrine and their concomitant use in the puerperium is not recommended.
Use in prolactin-secreting adenoma patients: 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 field 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 macroprolactinoma. Effective treatment with Parlodel leads to a reduction in hyperprolactinemia and often to a 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 macroprolactinoma 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.
Driving and using machines: Since, especially during the first 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.
Parlodel 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 not to drive or operate machines during treatment with bromocriptine. Patients who have experienced somnolence and/or an episode of sudden sleep onset must not drive or operate machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Use in Children: Pediatric patients (aged 7 to 17 years): The safety and effectiveness of bromocriptine in pediatric patients has only been established for the Prolactinomas and Acromegaly indications, in patients aged 7 or above. Only isolated data are available for bromocriptine use in pediatric patients under the age of 7 years. However, other reported clinical experiences, including post-marketing reporting of adverse events, have not identified differences in tolerability between adults and adolescents or children. Even though no variation in adverse reaction profile in pediatric patients taking Parlodel has been observed, greater sensitivity in some younger individuals cannot be ruled out, and it is recommended that dose titration in pediatric patients should be cautious.
Use in the Elderly: Geriatric patients (aged 65 years or above): Clinical studies for Parlodel did not include sufficient numbers of subjects aged 65 and above to determine whether the elderly respond differently from younger subjects. However, other reported clinical experiences, including post-marketing reporting of adverse events, have identified no differences in response or tolerability between elderly and younger patients.
Even though no variation in efficacy or adverse reaction profile in elderly patients taking Parlodel has been observed, greater sensitivity in some elderly individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, starting at the lower end of the dose range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy in this population.