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Drug Details

PARLODEL 1 mg Tablets

• Drug Class Description
  Dopamine agonists.
• Generic Name
  Bromocriptine - growth hormone/ growth disorders
• Presentation
  Tablet: Each tablet is round, white, bevelled edged with a break line on one side, marked with “PARLODEL 1” circumferentially on the reverse.
• Description
  Active substance: Ergotaman-3`, 6`, 18-trione, 2-bromo-12`-hydroxy-2`-(1-methylethyl-5`-(2-methylpropyl)-, (5`alpha)-mono-methanesulphonate. Bromocriptine mesilate Ph. Eur 1.147mg, equivalent to 1mg of bromocriptine base
• Indications
  

  Inhibition of lactation for medical reasons. The inhibition or suppression of puerperal lactation. PARLODEL is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with simple analgesics and breast support.

  Hyperprolactinaemia: The treatment of hyperprolactinaemia in men and women with hypogonadism and/or galactorrhoea. Infertility The treatment of hyperprolactinaemic infertility. PARLODEL has been used successfully in the treatment of a number of infertile women who do not have demonstrable hyperprolactinaemia. Prolactinomas In a number of specialised units, patients who have shown to have prolactin secreting adenomas have been treated successfully with PARLODEL. In particular, PARLODEL can be considered as a first choice of treatment in patients with macro-adenomas and as an alternative to the surgical procedure, transsphenoidal hypophysectomy, in patients with micro-adenomas. Acromegaly 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.

  Parkinson's Disease: 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. Premenstrual symptoms and benign breast disease

• Adult Dosage
  

  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 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.

  Prevention of Lactation

  2.5mg on the day of delivery, followed by 2.5mg 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.

  Suppression of Lactation for Medical Reasons

  2.5mg on first day, increasing after 2 to 3 days to 2.5mg 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.

  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.

  Prolactinomas

  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. Patients have responded to doses of up to 30mg daily.

  Acromegaly

  Introduce PARLODEL gradually, according to the suggested scheme.

  Dosage may then be increased by 2.5mg at 2 to 3 day intervals as follows: - 2.5mg eight-hourly, 2.5mg six-hourly, 5mg six-hourly.

  Parkinson's Disease

  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 40mg daily. 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 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.

• Child Dosage
  

  Administration of PARLODEL is not appropriate for children less than 15 years old.

• Elderly Dosage
  

  There is no clinical evidence that PARLODEL poses a special risk to the elderly.

• Contra Indications
  

  Hypersensitivity to bromocriptine or to any of the excipients of PARLODEL (see Section 2. Qualitative and quantitative composition and 6.1 List of excipients) or other ergot alkaloids.

  Uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post partum 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.

• Special Precautions
  

  PARLODEL is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with severe coronary artery disease, or symptoms and/or a history of serious mental disorders.

  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 inhibition of lactation. In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.

  Patients with severe cardiovascular disorders or psychiatric disorders taking PARLODEL for the indication of macro-adenomas should only take it if the perceived benefits outweigh the potential risks.

  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 specialised 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 macroprolactinoma. 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 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.

  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. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating 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.

  PARLODEL is an ergot derivative. Fibrotic and serosal inflammatory disorders such as pleuritis, pleural and pericardial effusion, pleural and pulmonary fibrosis, constrictive pericarditis, and retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives. The factors predisposing patients to the risk of such disorders are not known, however, Parkinson's disease patients with a history of such disorders should not be treated with PARLODEL, or any other ergot derivative, unless the potential benefit clearly outweighs the risk.

  Attention should be paid to the signs and symptoms of

  pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain

  renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb oedema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis

  cardiac failure as cases of pericardial fibrosis have often manifested as cardiac failure. Constrictive pericarditis should be excluded if such symptoms appear.

  Appropriate investigations such as erythrocyte sedimentation rate, chest X-ray and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder. It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy.

  These disorders can have an insidious onset and patients should be regularly and carefully monitored while taking PARLODEL for manifestations of progressive fibrotic disorders. PARLODEL should be withdrawn if fibrotic or serosal inflammatory changes are diagnosed or suspected.

  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

  Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's disease, including PARLODEL.

• Interactions
  

  Tolerance to PARLODEL may be reduced by alcohol.

  Caution is required in patients who are on concomitant therapy with, or have recently been treated with drugs that can alter blood pressure.

  Although there is no conclusive evidence of an interaction between PARLODEL and other ergot alkaloids, concomitant use of these medications during the puerperium is not recommended.

  The concomitant use of erythromycin and other macrolide antibiotics may increase bromocriptine plasma levels.

  Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme (azole antimycotics, HIV protease inhibitors). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine.

  Dopamine antagonists such as antipsychotics (phenothiazines, butyrophenones and thioxanthenes) may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine. Metoclopramide and domperidone may reduce the prolactin-lowering effect.

• Adverse Drug Reactions
  

  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, <1/10); uncommon (1/1,000, <1/100); rare (1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

  Nervous System Disorders

  Common: Headache, Drowsiness,

  Uncommon: Dizziness, Dyskinesia

  Rare: Somnolence, Paraesthesia

  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

  Uncommon: 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: Pericardial effusion, Constrictive pericarditis, tachycardia, bradycardia, arrhthymia

  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 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.

  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, seizures, stroke or mental disorders have been reported, although the causal relationship is uncertain. In some patients the occurrence of seizures or stroke was preceded by severe headache and/or transient visual disturbances.

  Class effects

  Patients treated with dopamine agonists for treatment with Parkinson's disease, including PARLODEL, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.