Parlodel (Bromocriptine Mesylate) - Summary

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).

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.

See all Parlodel indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Parlodel (Bromocriptine)

[Efficacy and safety of ropinirole in the treatment of Parkinson's disease: a multi-center, randomized, double-blind and bromocriptine-controlled trial]. [Article in Chinese] [2013]
Parkinson's disease... CONCLUSIONS: Ropinirole is both effective and safe in the treatment of Chinese

Randomized clinical trial of quick-release bromocriptine among patients with type 2 diabetes on overall safety and cardiovascular outcomes. [2010.07]
CONCLUSIONS: The frequency of SAEs was comparable between the treatment arms. Compared with patients in the placebo arm, fewer patients taking bromocriptine-QR experienced a cardiovascular end point.

Cabergoline versus bromocriptine for symptomatic treatment of premenstrual mastalgia: a randomised, open-label study. [2010.06]
OBJECTIVE: To compare the effectiveness and side effects of cabergoline with bromocriptine for the symptomatic treatment of cyclic mastalgia as a part of the premenstrual syndrome... CONCLUSIONS: Cabergoline is as effective as bromocriptine for the treatment of cyclic mastalgia but has minimal side effects compared to bromocriptine. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

A comparison of bromocriptine & cabergoline on fertility outcome of hyperprolactinemic infertile women undergoing intrauterine insemination. [2010.05]
BACKGROUND & OBJECTIVES: The aim of this study was to compare the effects of bromocriptine versus cabergoline on pregnancy in hyperprolactinaemic infertile women... CONCLUSION: Our results suggest that cabergoline treatment in infertile women with prolactinemia is more effective. It lowers prolactin with better tolerability and much more effective in the achievement of pregnancy.

Evaluation of bromocriptine in the treatment of acute severe peripartum cardiomyopathy: a proof-of-concept pilot study. [2010.04.06]
CONCLUSIONS: In this trial, the addition of bromocriptine to standard heart failure therapy appeared to improve left ventricular ejection fraction and a composite clinical outcome in women with acute severe PPCM, although the number of patients studied was small and the results cannot be considered definitive. Larger-scale multicenter and blinded studies are in progress to test this strategy more robustly.

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Clinical Trials Related to Parlodel (Bromocriptine)

Bromocriptine and Insulin Sensitivity [Recruiting]
In this study the investigators will examine the effect of dopamine (bromocriptine) on insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine whether the timing of bromocriptine administration has influence on insulin sensitivity. To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks bromocriptine. In randomized order, they will use it in the morning or in the evening. The investigators will examine insulin sensitivity by performing a 7-point oral glucose tolerance test. Furthermore, the investigators will examine energy expenditure and subjects will keep track of their eating behaviour in the 3 days before each study visit.

Pharmacokinetic Study of CYCLOSET � 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects [Recruiting]
The objective of this study is to evaluate the relative bioavailability, and the rate and extent of absorption of bromocriptine in male and female children and adolescent Type 2 Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions. It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes children aged 10- to less than 18 years differs appreciably from that in healthy adults. Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children have demonstrated little difference in clearance among children over 10 years of age compared to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may impart differences that could affect the pharmacokinetic properties of bromocriptine-QR. Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18 years who have type 2 diabetes. After describing the profile of bromocriptine-quick release in this patient population, a follow on study will be conducted to evaluate its safety and efficacy in treating children and adolescents who have type 2 diabetes. The pharmacokinetic profile of bromocriptine will be determined following the administration of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study will be a single period, bioavailability study in 30 patients. The study duration will be 3 days.

Effect of Cycloset on Glycemic Control When Added to GLP-1 Analogue Therapy [Recruiting]
Purpose This study will examine the effect of the addition of Cycloset upon glucose metabolism (glycemic control including post prandial glucose metabolism) in individuals with inadequately controlled (HbA1c 7. 5-10. 0) type 2 diabetes (T2DM) who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care. Both a mechanistic rationale and empirical experimental evidence implicate a beneficial interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to plasma glucose (see drug labeling information; www. fda. gov). Thus the combination of Cycloset that is working as a post prandial insulin sensitizier with therapies that increase post prandial insulin would be expected to provide complimentary glucose lowering effects. To date, however, no such studies investigating the interactive effects of a GLP-1 analog and Bromocriptine-QR (Cycloset) have been conducted in humans.

Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4

Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A, Safety/Efficacy Study Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled on GLP-1 Analogue Therapy

Vaginal Bromocriptine for Treatment of Adenomyosis [Active, not recruiting]
Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.

Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg [Completed]
The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed conditions.

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Reports of Suspected Parlodel (Bromocriptine) Side Effects

Maternal Exposure During Pregnancy (9),  Pathological Gambling (7),  Dyspnoea (7),  Impulse-Control Disorder (5),  Epistaxis (5),  Compulsive Shopping (5),  Pulmonary Embolism (4),  Impulsive Behaviour (4),  Somnolence (4),  Cardiomegaly (4), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.

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. )
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.
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.