PARLODEL SUMMARY
Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate).
Parlodel is indicated for the following:
Hyperprolactinemia -Associated Dysfunctions
Parlodel® (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin -secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.
Acromegaly
Parlodel therapy is indicated in the treatment of acromegaly. Parlodel therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels.
Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with Parlodel offers potential benefit before the effects of irradiation are manifested.
Parkinson's Disease
Parlodel SnapTabs® or capsules are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), Parlodel therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure’’ on levodopa therapy. Parlodel therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off’’ phenomenon). Continued efficacy of Parlodel therapy during treatment of more than 2 years has not been established.
Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with Parlodel. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Parlodel-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Parlodel (Bromocriptine)
Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects. [2009.03]
AIMS: To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease... CONCLUSIONS: These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.
Clinical efficacy of novel unidirectional buccoadhesive vs. vaginoadhesive bromocriptine mesylate discs for treating pathologic hyperprolactinemia. [2008.11]
OBJECTIVE: To test the clinical effectiveness of new bioadhesive unidirectional buccal and vaginal bromocriptine methylate discs in hyperprolactinemic patients... Buccoadhesive discs have the advantages of being gender nonspecific (i.e., could be used by men), avoiding manipulating the vagina, which could be inconvenient to some patients, such as virgins; not being dependent on cyclic estrogen (E) levels; and could be easily used during menstruation.
A randomized, crossover comparison of herbal medicine and bromocriptine against risperidone-induced hyperprolactinemia in patients with schizophrenia. [2008.06]
Hyperprolactinemia is a common adverse effect that occurs as a result of antipsychotic therapies, which often results in discontinuation. Empirical evidence has shown that some herbal medicines have suppressive effects on prolactin (PRL) hyperactivities... These results suggest that the herbal therapy can yield additional benefits while having comparable efficacy in treating antipsychotic-induced hyperprolactinemia in individuals with schizophrenia.
The effects of bromocriptine on attention deficits after traumatic brain injury: a placebo-controlled pilot study. [2008.02]
OBJECTIVE: To evaluate the effects of bromocriptine on a variety of aspects of attention, ranging from laboratory-based impairment measures to caregiver ratings and work productivity, in individuals after traumatic brain injury... CONCLUSIONS: Bromocriptine in a dose of 5 mg, given twice a day to individuals with attentional complaints after TBI, does not seem to enhance attentional skills, and it may be associated with an excess of adverse events. It is not clear whether intermittent dosing or lower doses might confer benefit.
Role of bromocriptine and pyridoxine in premenstrual tension syndrome. [2007.10]
Premenstrual syndrome (PMS) is a universal problem of women of reproductive age group... It is concluded that both the drugs are effective for treatment of premenstrual syndrome but, pyridoxine showed significantly higher response rate and lesser incidence of side effects than bromocriptine.
Clinical Trials Related to Parlodel (Bromocriptine)
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy [Not yet recruiting]
A randomized, controlled clinical trial to evaluate the efficacy and safety of bromocriptine
for improvement of left ventricular function of women with Peripartum cardiomyopathy (PPCM).
A Multi center trial in Germany.
Comparing Prism Adaptation Therapy and Bromocriptine Medication for Spatial Neglect: Theoretical and Practical Outcomes [Recruiting]
The purpose of this research study is to examine the effects of prism adaptation or
bromocriptine treatment on two visual-spatial recovery components. After a stroke, an
"internal GPS", locating where objects or people lie in a particular area of space, may be
impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming
movements. The research team wishes to discover whether using prism goggles, or taking a
medication (bromocriptine) affects visual-spatial where or aiming errors selectively after
stroke.
This research represents one of the first attempts to apply what we know about the brain
from neuroscience research, to modern clinical rehabilitation practices.
Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine [Not yet recruiting]
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the
dopamine receptors in the pituitary. Schizophrenic patients suffering from a
neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug
effects and diagnoses will be confirmed by measuring hormones.
The Therapeutic Effect of Bromocriptin in Patients With Primary Aldosteronism [Recruiting]
we propose that bromocriptine may be an alternative treatment of primary aldosteronism, both
APA and BAH.
MOTION, Safinamide in Early IPD, as Add-on to Dopamine Agonist [Recruiting]
Parkinson's disease is a major neurodegenerative disorder in which there is a progressive
loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of
dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a
precursor of DA that crosses the blood brain barrier, and also to the use of selective
inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi
national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p. o. q. a.m.)
versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects
with early idiopathic Parkinson's Disease.
The principal efficacy measure, i. e., change in mean value of UPDRS - Section III total
score from baseline to endpoint, was chosen based on regulatory guidance and prior use in
other trials in similar populations.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Parlodel has an overall score of 8.50. The effectiveness score is 8 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
| | Parlodel review by 39 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | High level of Prolactin |
| Dosage & duration: | | 1 mg/day taken daily for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | It was effective for the regulation of the prolactin levels and the menstrual periods. The regulation of the ovulation helped achieved pregnancy within a few months. |
| Side effects: | | The only side effect was mild nausea, that could be prevented by eating before taking the medicine in the morning or taking it at bedtime. |
| Comments: | | The use of parlodel to regulate ovulation and prolactin levels for about two years with regular blood tests to check levels of prolactin. After 2 years and a stable level of prolactin, the medicine dose was reduced to half and then completely stopped without increasing the levels of prolactin. |
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| | Parlodel review by 33 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Psoriatic Arthritis |
| Dosage & duration: | | 2.5mg taken daily for the period of 1 year |
| Other conditions: | | midly elevated Prolactin |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | IT decreased mildly elevated Prolactin immediately from 25 units to 10 units. (mg/l ?)
It also increased my sex drive, but this stopped after a while.
It also moderately decreased Psoriatic Arthritis pains and also symptoms in nails and joints, but needed to be taken very regular for this.. Forgetting to take it twice a week already made it work less effective.
(Cabergoline was more effective, had less side effects- but potentially has side effects on heart valve, so one needs to be very careful with it. )
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| Side effects: | | Some dyspepsia. This was all the side effects I noticed. I did not like these side effects though and therefore discontinued when the psoriatic arthritis seemed to be under control. When I discontinued Parlodel, I took Cabergoline( with a much longer half life in the body) in a very low dosage to make sure that my Prolactin levels only gradually moved back.
I know once I took Parlodel and stopped and then took a Prolactin test 48h later and the levels were higher then without taking any meds.
So best is to decrease dosage slowly and not suddenly. I think this is the case with any ergot derivative.
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| Comments: | | Taken for 6 months. Once daily, but half a tablet of 2.5 mg was taken after a while to reduce side effects. I found the best way to get a stable prolactin levels and best improvement was to take half a tablet once in morning and once in evening.
I was diagnosed with Psoriatic Arthritis, symptoms were mild, but psorisis was clearly visible on nails. I considered if there was a link between my elevated Prolactin and the psorisis. Found this on the internet and asked doc to prescribe parlodel. |
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Page last updated: 2009-10-20
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