Dosing & Uses
Dosage Forms & Strengths
tablet (Parlodel)
- 2.5mg
capsule (Parlodel)
- 5mg
tablet (Cycloset)
- 0.8mg
Hyperprolactinemia-Associated Dysfunctions (Parlodel)
Indicated for treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism; also indicated in patients with prolactin-secreting adenomas
1.25-2.5 mg PO qDay initially; may increase by 2.5 mg/day q2-7Days until optimal therapeutic response achieved
Usual therapeutic dosage ranges from 2.5-15 mg/day
Up to 30 mg/day has been used in some patients with amenorrhea and/or galactorrhea
Parkinson Disease (Parlodel)
Indicated as adjunctive treatment to levodopa for the signs and symptoms of idiopathic/postencephalitic Parkinson disease
1.25 mg PO q12hr initially; may increase dose by 2.5 mg/day q2-4Weeks until optimal therapeutic response achieved
Safety >100 mg/day not established
Acromegaly (Parlodel)
Indicated for acromegaly
1.25-2.5 mg PO qHS for 3 days initially; may increase by 1.25-2.5 mg/day q3-7Days until optimal therapeutic response achieved
Not to exceed 100 mg/day
Type 2 Diabetes Mellitus (Cycloset)
Quick release formulation (Cycloset) is the only bromocriptine product indicated for diabetes mellitus type 2 as adjunct to diet and exercise to improve glycemic control; there is currently no therapeutically equivalent generic version of Cycloset available in the United States
0.8 mg PO qDay initially; may increase by 0.8-mg increments qWeek as tolerated
Usual dosage ranges between 1.5-4.8 mg PO qDay; not to exceed 4.8 mg (6 tablets)/day
Note: Cycloset is not indicated for hyperprolactinemia, Parkinson disease, or acromegaly
see Dosage Modifications (Cycloset) and Administratio (Cycloset)
Neuroleptic Malignant Syndrome (Off-label, Parlodel)
2.5-5 mg PO 2-3 times/day; not to exceed 45 mg/day
[Strawn JR, Keck PE Jr, and Caroff SN, "Neuroleptic Malignant Syndrome," Am J Psychiatry, 2007, 164(6):870-6]
Dosage Modifications
Hepatic impairment: Safety and efficacy has not been established; dosage adjustment may be necessary due to extensive hepatic metabolism; use with caution
Renal impairment: Safety and efficacy has not been established
Cycloset
Concomitant use with CYP3A4 inhibitor
- Strong CYP3A4 inhibitor (eg, azole antimycotics, HIV protease inhibitors): Avoid use; ensure adequate washout of the strong CYP3A4 inhibitor drug before initiating Cycloset treatment
- Moderate CYP3A4 inhibitor (eg, erythromycin): Dose should not exceed 1.6 mg PO qDay
Dosing Considerations
Dosage forms for Cycloset and Parlodel and not interchangeable
Cycloset
Limitations of use
- Not for treatment of type 1 diabetes or diabetic ketoacidosis
- Limited efficacy data in combination with thiazolidinediones
- Efficacy has not been confirmed in combination with insulin
Parlodel
- Patients treated with pituitary irradiation should be withdrawn from Parlodel therapy on a yearly basis to assess both the clinical effects of radiation on the disease process and effects of Parlodel therapy; usual withdrawal period range, 4-8 weeks; recurrence of the signs/symptoms or increases in growth hormone indicate the disease is still active and further courses of Parlodel should be considered
Dosage Forms & Strengths
tablet (Parlodel)
- 2.5mg
capsule (Parlodel)
- 5mg
Hyperprolactinemia (Parlodel)
≤10 years: Safety and efficacy not established
11-15 years: 1.25-2.5 mg PO qDay initially; therapeutic dosage ranges from 2.5-10 mg/day; may need to increase dose for optimal therapeutic response
≥16 years: Safety and efficacy not established
see Administration (Parlodel)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (16)
- almotriptan
bromocriptine, almotriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
- chloramphenicol
chloramphenicol will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- eletriptan
bromocriptine, eletriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
- frovatriptan
bromocriptine, frovatriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
- glyceryl trinitrate pr
bromocriptine decreases effects of glyceryl trinitrate pr by pharmacodynamic antagonism. Contraindicated.
- lopinavir
lopinavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- naratriptan
bromocriptine, naratriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
- nitroglycerin IV
bromocriptine decreases effects of nitroglycerin IV by pharmacodynamic antagonism. Contraindicated.
- nitroglycerin sublingual
bromocriptine decreases effects of nitroglycerin sublingual by pharmacodynamic antagonism. Contraindicated.
- nitroglycerin topical
bromocriptine decreases effects of nitroglycerin topical by pharmacodynamic antagonism. Contraindicated.
- nitroglycerin transdermal
bromocriptine decreases effects of nitroglycerin transdermal by pharmacodynamic antagonism. Contraindicated.
- nitroglycerin translingual
bromocriptine decreases effects of nitroglycerin translingual by pharmacodynamic antagonism. Contraindicated.
- posaconazole
posaconazole will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- sumatriptan
bromocriptine, sumatriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
- sumatriptan intranasal
bromocriptine, sumatriptan intranasal. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Additive vasospasm. Sep. by 24h.
- zolmitriptan
bromocriptine, zolmitriptan. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Vasoconstrictive effects of triptans and bromocriptine may be additive. Drugs should not be used within 24h of one another.
Serious - Use Alternative (54)
- abametapir
abametapir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If concomitant use is warranted, carefully monitor, particularly during treatment initiation and dose adjustment. Discontinue oliceridine if serotonin syndrome is suspected.
- apalutamide
apalutamide will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- aripiprazole
aripiprazole decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- atazanavir
atazanavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cabergoline
cabergoline, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- chlorpromazine
chlorpromazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- clozapine
clozapine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- conivaptan
conivaptan will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- darunavir
darunavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dihydroergotamine
dihydroergotamine, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- dihydroergotamine intranasal
dihydroergotamine intranasal, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- droperidol
droperidol decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- efavirenz
efavirenz increases levels of bromocriptine by decreasing metabolism. Avoid or Use Alternate Drug. Competitive inhibition of CYP3A4 might lead to vasospasm and ischemia.
- ergoloid mesylates
ergoloid mesylates, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- ergotamine
ergotamine, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- fexinidazole
fexinidazole will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- fluphenazine
fluphenazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- haloperidol
haloperidol decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- iloperidone
iloperidone decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- indinavir
indinavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- itraconazole
itraconazole will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- ketoconazole
ketoconazole will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lonafarnib
bromocriptine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.
lonafarnib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling. - loxapine
loxapine decreases effects of bromocriptine by pharmacodynamic antagonism. Contraindicated.
- loxapine inhaled
loxapine inhaled decreases effects of bromocriptine by pharmacodynamic antagonism. Contraindicated.
- methylergonovine
methylergonovine, bromocriptine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. The concomitant use of bromocriptine with ergot alkaloids may potentially lead to ergot toxicity; therefore the combination should be avoided.
- metoclopramide intranasal
bromocriptine, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
metoclopramide intranasal, bromocriptine. dopaminergic effects. Avoid or Use Alternate Drug. Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (eg, parkinsonian symptoms) or decreased therapeutic effects of metoclopramide. - mifepristone
mifepristone will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nefazodone
nefazodone will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nelfinavir
nelfinavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- olanzapine
olanzapine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- paliperidone
paliperidone decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- perphenazine
perphenazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- phenylephrine PO
bromocriptine, phenylephrine PO. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.
- pimozide
pimozide decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- prochlorperazine
prochlorperazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- promethazine
promethazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- quetiapine
quetiapine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- ribociclib
ribociclib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- risperidone
risperidone decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- ritonavir
ritonavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- saquinavir
saquinavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- selinexor
selinexor, bromocriptine. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- thioridazine
thioridazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- thiothixene
thiothixene decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- tipranavir
tipranavir will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- trifluoperazine
trifluoperazine decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
- tucatinib
tucatinib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voriconazole
voriconazole will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voxelotor
voxelotor will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
- ziprasidone
ziprasidone decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.
Monitor Closely (85)
- amifampridine
bromocriptine increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.
- amobarbital
amobarbital will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- apomorphine
apomorphine and bromocriptine both increase dopaminergic effects. Use Caution/Monitor. Combination may enhance efficacy. Monitor for hypotension.
- atazanavir
atazanavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor.
- avapritinib
bromocriptine will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
bromocriptine increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- benazepril
bromocriptine, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.
- bosentan
bosentan will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cabergoline
bromocriptine and cabergoline both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism.
- captopril
bromocriptine, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.
- carbamazepine
carbamazepine will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
cenobamate, bromocriptine. Either increases effects of the other by sedation. Use Caution/Monitor. - clarithromycin
clarithromycin increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- cobicistat
cobicistat will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- crizotinib
crizotinib increases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.
- crofelemer
crofelemer increases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- cyclosporine
bromocriptine increases levels of cyclosporine by unknown mechanism. Use Caution/Monitor.
- dabrafenib
dabrafenib will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- darunavir
darunavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- dexmethylphenidate
bromocriptine, dexmethylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- dextroamphetamine
bromocriptine, dextroamphetamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- dobutamine
bromocriptine, dobutamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- dopamine
bromocriptine and dopamine both increase dopaminergic effects. Use Caution/Monitor.
bromocriptine, dopamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach. - duvelisib
duvelisib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. will increase the level or effect of
- elagolix
elagolix will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.
- encorafenib
encorafenib, bromocriptine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- enzalutamide
enzalutamide will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ephedrine
bromocriptine, ephedrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- epinephrine
bromocriptine, epinephrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- erythromycin base
erythromycin base increases levels of bromocriptine by unknown mechanism. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate increases levels of bromocriptine by unknown mechanism. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate increases levels of bromocriptine by unknown mechanism. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate increases levels of bromocriptine by unknown mechanism. Use Caution/Monitor.
- etravirine
etravirine will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- finerenone
bromocriptine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- flibanserin
bromocriptine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.
- fosamprenavir
fosamprenavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- fosphenytoin
fosphenytoin will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- iloperidone
iloperidone increases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.
- indinavir
indinavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- isoproterenol
bromocriptine, isoproterenol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- istradefylline
istradefylline will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- lanreotide
lanreotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.
- lemborexant
bromocriptine will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.
- letermovir
letermovir increases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- levodopa
bromocriptine and levodopa both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism and may allow for reduced levodopa doses. Dosages should be carefully titrated during concomitant treatment.
- lisdexamfetamine
bromocriptine, lisdexamfetamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- lomitapide
bromocriptine increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.
- lorlatinib
lorlatinib will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lurasidone
lurasidone decreases effects of bromocriptine by pharmacodynamic antagonism. Use Caution/Monitor. Antipsychotics may diminish the therapeutic effect of anti-parkinson's agents.
- methamphetamine
bromocriptine, methamphetamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- methylphenidate
bromocriptine, methylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Potential for additive CNS stimulation.
- metoclopramide
metoclopramide decreases levels of bromocriptine by pharmacodynamic antagonism. Use Caution/Monitor. Avoid combination if possible.
- midazolam intranasal
bromocriptine will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.
midazolam intranasal, bromocriptine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect. - midodrine
bromocriptine, midodrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- mitotane
mitotane decreases levels of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- nafcillin
nafcillin will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nelfinavir
nelfinavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- norepinephrine
bromocriptine, norepinephrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- octreotide
octreotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.
- pasireotide
pasireotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.
- phenobarbital
phenobarbital will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- phentermine
bromocriptine, phentermine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- phenylephrine
bromocriptine, phenylephrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- phenytoin
phenytoin will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- pramipexole
bromocriptine and pramipexole both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism.
- primidone
primidone will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- pseudoephedrine
bromocriptine, pseudoephedrine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.
- rifabutin
rifabutin will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifapentine
rifapentine will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ritonavir
ritonavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- ropinirole
bromocriptine and ropinirole both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism.
- rucaparib
rucaparib will increase the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
saquinavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
- secobarbital
secobarbital will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- solriamfetol
bromocriptine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- stiripentol
stiripentol, bromocriptine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- tacrolimus
bromocriptine increases levels of tacrolimus by decreasing metabolism. Use Caution/Monitor.
- tazemetostat
tazemetostat will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
bromocriptine will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - tecovirimat
tecovirimat will decrease the level or effect of bromocriptine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tinidazole
bromocriptine will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tipranavir
tipranavir increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Increased levels possibly due to CYP3A4 inhibition.
Minor (1)
- ruxolitinib
bromocriptine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Cycloset
-
Monotherapy
- Nausea (32.5 %)
- Rhinitis (13.8%)
- Headache (12.5%)
- Asthenia (12.5%)
- Dizziness (12.5%)
- Constipation (11.3%)
-
Adjunct to sulfonylurea
- Nausea (25.4%)
- Asthenia (18.9%)
- Headache (16.8%)
- Dizziness (11.9%)
- Rhinitis (10.7%)
-
Adjunct to diet or ≤2 antidiabetic medications (eg, metformin, insulin secretagogues, and/or insulin)
- Nausea (32.2%)
- Dizziness (14.8%)
- Fatigue (13.9%)
- Headache (11.4%)
Parlodel
-
Hyperprolactinemic indications
- Nausea (49%)
- Headache (19%)
- Dizziness (17%)
-
Acromegaly
- Nausea (18%)
- Constipation (14%)
1-10%
Cycloset
-
Monotherapy
- Sinusitis (10%)
- Diarrhea (8.8%)
- Amblyopia (7.5%)
- Dyspepsia (7.5%)
- Vomiting (6.3%)
- Infection (6.3%)
- Anorexia (5%)
-
Adjunct to sulfonylurea
- Constipation (9.8%)
- Flu syndrome (9.4%)
- Cold (8.2%)
- Sinusitis (7.4%)
- Somnolence (6.6%)
- Vomiting (5.3%)
- Amblyopia (5.3%)
-
Adjunct to diet or ≤2 antidiabetic medications (eg, metformin, insulin secretagogues, and/or insulin)
- Vomiting (8.1%)
- Diarrhea (8.1%)
- Constipation (5.8%)
Parlodel
-
Hyperprolactinemic indications
- Fatigue (7%)
- Lightheadedness (5%)
- Vomiting (5%)
- Abdominal cramps (4%)
- Nasal congestion (3%)
- Constipation (3%)
- Diarrhea (3%)
- Drowsiness (3%)
-
Acromegaly
- Postural/orthostatic hypotension (6%)
- Anorexia (4%)
- Dry mouth/nasal stuffiness (4%)
- Indigestion/dyspepsia (4%)
- Digital vasospasm (3%)
- Drowsiness/tiredness (3%)
- Vomiting (2%)
- Gastrointestinal bleeding (<2%)
- Dizziness (<2%)
- Exacerbation of Raynaud syndrome (<2%)
- Headache (<2%)
- Syncope (<2%)
-
Postpartum
- Headache (10%)
- Dizziness (8%)
- Nausea (7%)
- Vomiting (3%)
- Fatigue (1%)
<1%
Parlodel
-
Postpartum
- Syncope (0.7%)
- Diarrhea (0.4%)
- Cramps (0.4%)
Frequency Not Defined
Parlodel
-
Parkinson disease
- Most common: Nausea, abnormal involuntary movements, hallucinations, confusion, “on-off’’ phenomenon, dizziness, drowsiness, faintness/fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation, and vertigo
- Less common: Anorexia, anxiety, blepharospasm, dry mouth, dysphagia, edema of the feet and ankles, erythromelalgia, epileptiform seizure, fatigue, headache, lethargy, mottling of skin, nasal stuffiness, nervousness, nightmares, paresthesia, skin rash, urinary frequency, urinary incontinence, urinary retention, and rarely, signs and symptoms of ergotism such as tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud syndrome
Postmarketing Experience
Cycloset
- Hallucinations
- Fibrotic-related complications (eg, retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis, and pericardial effusions)
- Psychotic and psychiatric disorders
- Stroke
- Neuroleptic-like malignant syndrome
- Hypertension, myocardial infarction, seizures
Parlodel
- Psychiatric disorders: Confusion, psychomotor agitation/excitation, hallucinations, psychotic disorders, insomnia, libido increase, hypersexuality
- Nervous system disorders: Headache, drowsiness, dizziness, dyskinesia, somnolence, paraesthesia, excess daytime somnolence, sudden onset of sleep
- Eye disorders: Visual disturbance, vision blurred
- Ear and labyrinth disorders: Tinnitus
- Cardiac disorders: Pericardial effusion, constrictive pericarditis, tachycardia, bradycardia, arrhythmia, cardiac valve fibrosis
- Vascular disorders: Hypotension, orthostatic hypotension (very rarely leading to syncope), reversible pallor of fingers and toes induced by cold (especially in patients with history of Raynaud phenomenon)
- Respiratory, thoracic and mediastinal disorders: Nasal congestion, pleural effusion, pleural fibrosis, pleurisy, pulmonary fibrosis, dyspnea
- Gastrointestinal disorders: Nausea, constipation, vomiting, dry mouth, diarrhoea, abdominal pain, retroperitoneal fibrosis, gastrointestinal ulcer, gastrointestinal hemorrhage
- Skin and subcutaneous tissue disorders: Allergic skin reactions, hair loss
- Musculoskeletal and connective tissue disorders: Leg cramps
- General disorders and administration site conditions: Fatigue, peripheral edema, apathy, anxiety, depression, insomnia, sweating, pain, a syndrome resembling Neuroleptic Malignant Syndrome (NMS) on abrupt withdrawal of Parlodel
Warnings
Contraindications
Parlodel
- Hypersensitivity to bromocriptine, ergot-related drugs, or to any of the excipients in Parlodel
- Uncontrolled hypertension
- Pregnancy in patients treated for hyperprolactinemia (see Pregnancy)
- Postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions
Cycloset
- Hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in Cycloset
- Syncopal migraine
- Women who are nursing (see Lactation)
- Postpartum patients
Cautions
Dosage forms for Cycloset and Parlodel and not interchangeable
Discontinuation of treatment should be undertaken gradually whenever possible, even if patient is to remain on levodopa; a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy
Use with caution in patients with cardiovascular disease, dementia, hepatic impairment, and peptic ulcer disease
Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa; prior to discontinuation of therapy, patients should be informed about potential withdrawal symptoms, and closely monitored during and after discontinuation of treatment; in case of severe withdrawal symptoms, re-administration of a dopamine agonist at lowest effective dose may be considered
Somnolence
- Somnolence, and episodes of sudden sleep onset has been reported, particularly in patients with Parkinson’s disease
- Inform and advise not to drive or operate machines during treatment; dose reduction or termination of therapy may be considered
- 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
- Avoid use in patients with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
- Used with caution in patients with a history of psychosis or cardiovascular disease
- In patients undergoing treatment for macroadenoma-related hyperprolactinemia or who have undergone transsphenoidal surgery, a persistent watery nasal discharge may be sign of CSF rhinorrhea
- Visual field impairment is a known complication of macroprolactinoma; Parlodel therapy may lead to a reduction in hyperprolactinemia and often to a resolution of the visual impairment; monitor visual fields in patients with macroprolactinoma
- Cold-sensitive digital vasospasm has been observed in some acromegalic patients; response is reversible by dose reduction of Parlodel and may be prevented by keeping the fingers warm
- Cases of severe gastrointestinal bleeding from peptic ulcers have been reported; patients with a history of peptic ulcer or gastrointestinal bleeding should be observed carefully during treatment with Parlodel
- Possible tumor expansion while receiving Parlodel therapy has been reported; all patients should be carefully monitored and, if evidence of tumor expansion develops, discontinuation of treatment and alternative procedures considered
- High doses of Parlodel may be associated with confusion and mental disturbances; parkinsonian patients may manifest mild degrees of dementia, caution should be used when treating such patients
- Auditory or visual hallucinations may occur when administered alone or concomitantly with levodopa; hallucinations usually resolve with dosage reduction; occasionally, discontinue therapy
- Postmarketing reports suggest that patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges
- History of MI and a residual atrial, nodal or ventricular arrhythmia, especially with Parkinson disease
- Retroperitoneal fibrosis has been reported in a few patients receiving long-term therapy
- Use of drug for prevention of physiological lactation not recommended
-
Hypertension
- Hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; periodic blood pressure monitoring, during the first weeks of therapy is prudent
- Seizures have also been reported both with and without the prior development of hypertension; stroke have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated
- Use of the drug in patients with uncontrolled hypertension is not recommended (see Contraindications [Parlodel])
- Exercise caution when administering Parlodel therapy concomitantly with other medications known to lower blood pressure
- If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, evaluate patient and therapy should be discontinued
-
Parkinson’s disease
- Hallucinations: occasionally, discontinuation of therapy is required; rarely, after high doses, hallucinations have persisted for several weeks following discontinuation of drug
- Fibrosis: Retroperitoneal fibrosis has been reported in a few patients receiving long-term therapy (2 to 10 years) with drug in doses ranging from 30-140 mg daily
- Safety during long-term use for more than 2 years at the doses required for parkinsonism has not been established
- As with any chronic therapy, periodic evaluation of hepatic, hematopoietic, cardiovascular, and renal function is recommended; symptomatic hypotension can occur and, therefore, caution should be exercised when treating patients receiving antihypertensive drugs
- As with levodopa, caution should be exercised when administering therapy to patients with a history of myocardial infarction who have a residual atrial, nodal, or ventricular arrhythmia
-
Melanoma
- Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- approximately 6-fold higher) of developing melanoma than the general population
- Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear
- Patients and providers are advised to monitor for melanomas frequently and on a regular basis when using drug for any indication
- Ideally, periodic skin examinations should be performed by appropriately qualified individuals (eg, dermatologists)
Cycloset
- Somnolence may occur; inform patients should be made aware of this potential side effect, particularly when initiating therapy; patients experiencing somnolence should refrain from driving or operating heavy machinery
- Fibrotic valve thickening (eg, aortic, mitral, tricuspid), possibly due to excess serotonin activity, usually associated with long-term, chronic use of ergot alkaloids and derivatives reported
- Serious and life-threatening adverse reactions including hypertension, myocardial infarction, seizures, stroke and psychosis reported postmarketing in postpartum women administered treatment for inhibition of lactation
-
Dopamine receptor antagonists
- Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (eg, clozapine, olanzapine, ziprasidone), may reduce the effectiveness of Cycloset and Cycloset may reduce the effectiveness of these agents; concomitant use with dopamine receptor antagonists, including neuroleptic drugs, is not recommended
- Other dopamine receptor agonists are indicated for the treatment of Parkinson’s disease, hyperprolactinemia, restless leg syndrome, acromegaly, and other disorders; effectiveness and safety of Cycloset in patients currently treated with other dopamine receptor agonists is unknown; concomitant use is not recommended
-
Hypotension
- Hypotension, including orthostatic hypotension, can occur, particularly upon Cycloset initiation and with dose escalation
- Assess orthostatic vital signs prior to initiation of Cycloset and periodically thereafter; during early treatment, patients should be advised to make slow postural changes and to avoid situations that could lead to serious injury if syncope was to occur
- Use caution in patients taking anti-hypertensive medication
Pregnancy & Lactation
Pregnancy
Parlodel
- Safety of Parlodel treatment during pregnancy to the mother and fetus has not been established
- If pregnancy occurs during Parlodel administration, careful observation of these patients is mandatory
- Prolactin-secreting adenomas may expand and compression of optic/other cranial nerves may occur, emergency pituitary surgery becoming necessary; in most cases, the compression resolves following delivery
- Reinitiation of Parlodel treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy
- In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed
-
Acromegaly, prolactinoma, or Parkinson disease
- Patients who subsequently become pregnant, determine whether continuing therapy is medically necessary or can discontinues
- If it is continued, discontinue therapy in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated
Cycloset
There are no available data on use in pregnant women with type 2 diabetes; prolonged experience with bromocriptine use in pregnant women for other indications over several decades, based on data from published clinical trials, case reports, and epidemiological studies, have not established a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Only a trace amount of bromocriptine was shown to be transported across placenta in vitro in a published ex vivo human placental perfusion model; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy; should be used during pregnancy only if clearly necessary
-
Animal data
- Studies in which bromocriptine mesylate was administered orally during period of organogenesis, increased prenatal mortality occurred in rats and rabbits at maternally toxic dosages that were more than 24-times human dose of 4.8 mg/day based on body surface area; no adverse developmental outcomes were observed in monkeys administered bromocriptine mesylate orally during various periods of gestation at doses up to 10-times a human dose of 4.8 mg daily
- Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
Lactation
Parlodel: Avoid use during lactation in postpartum women
Cycloset
- Cycloset is contraindicated in women who are nursing
- Serious and life-threatening adverse reactions including hypertension, myocardial infarction, seizures, stroke, and psychosis reported postmarketing in postpartum women who were administered bromocriptine for inhibition of lactation; indication for use of bromocriptine for inhibition of lactation was withdrawn from bromocriptine- containing products
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Parlodel: Semisynthetic ergot alkaloid, dopamine receptor agonist, inhibits prolactin secretion, and lowers blood levels of growth hormone in acromegaly
Cycloset: Mechanism of action is unknown; bromocriptine is believed to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in patients with insulin-resistant
Absorption
Peak plasma concentration (Parlodel): 465 pg/mL (2 doses of 2.5 mg); 628 pg/mL (steady state)
AUC steady state (Parlodel): 2377 pg·hr/mL
Peak plasma time (Cycloset): 53 minutes (fasted); 90-120 minutes (high-fat meal)
Bioavailability (Cycloset): 55-66%
Distribution
Protein bound (Parlodel): 90-96% (to albumin)
Vd (Cycloset): 61L
Metabolism
Parlodel: Primarily hepatic via CYP3A; extensive first-pass biotransformation
Cycloset: Metabolism by; absorbed dose (~93%) undergoes first-pass metabolism and the remaining reaches the systemic circulation
Elimination
Half-life: 4.85 hr (Parlodel); 6 hr (Cycloset)
Excretion: Feces (~82%); urine (2-6%)
Administration
Oral Administration
Parlodel
- Take with food
Cycloset
- Take with food; administer within 2 hours after waking in the morning
- If dose missed, wait until the next morning to take medication
Storage
Cycloset and Parlodel: Store ≤25°C (77°F)
Parlodel: Store in tight, light-resistant container
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Parlodel oral - | 2.5 mg tablet |  | |
| bromocriptine oral - | 2.5 mg tablet |  | |
| bromocriptine oral - | 5 mg capsule |  | |
| bromocriptine oral - | 5 mg capsule |  | |
| bromocriptine oral - | 2.5 mg tablet |  | |
| bromocriptine oral - | 2.5 mg tablet | | |
| bromocriptine oral - | 2.5 mg tablet |  | |
| Cycloset oral - | 0.8 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
bromocriptine oral
BROMOCRIPTINE - ORAL
(BROE-moe-KRIP-teen)
COMMON BRAND NAME(S): Parlodel
USES: Bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson's disease. It can improve your ability to move and can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").Bromocriptine is also used to treat high levels of a certain hormone made by the body (prolactin). High levels of prolactin may cause problems such as unwanted breast milk, missed/stopped periods, difficulty becoming pregnant, decreased sperm production, and decreased sexual ability. Bromocriptine may be used to treat a type of tumor which causes the high levels of prolactin (prolactin-secreting adenomas). It can help to reduce the tumor size. Bromocriptine is not recommended for stopping unwanted breast milk after pregnancy, miscarriage, or abortion because of possible serious side effects (such as high blood pressure, seizure, heart attack, stroke).Bromocriptine is also used to treat high levels of growth hormone (acromegaly).Bromocriptine is an ergot medication that works by acting like a certain natural substance (dopamine) in the brain. It also prevents the release of certain hormones (growth hormone, prolactin). Bromocriptine can lower these hormone levels, but it does not cure the causes of the increased levels.
HOW TO USE: Take this medication by mouth with food as directed by your doctor, usually 1 or 2 times daily. The dosage is based on your medical condition and response to treatment. For the treatment of acromegaly, the dosage is also based on the growth hormone levels. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as fever, muscle stiffness, and confusion. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Nausea, vomiting, dizziness, drowsiness, lightheadedness, tiredness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Some people taking bromocriptine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with bromocriptine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.This medication may increase or decrease your blood pressure. Monitor your blood pressure as directed by your doctor. A decrease in blood pressure usually occurs when you are first starting the medication, when your dose is increased, or when you get up suddenly. This effect can cause dizziness, lightheadedness, and fainting. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Tell your doctor right away if you have any serious side effects, including: back pain, swelling of the legs/ankles/feet, signs of kidney problems (such as change in the amount of urine), persistent runny nose, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, cold or slightly blue fingers/toes, tingling/numbness of hands/feet, mental/mood changes (such as anxiety, confusion, hallucinations, restlessness), unusual strong urges (such as increased gambling, increased sexual urges), slow/fast/irregular heartbeat.Get medical help right away if you have any very serious side effects, including: severe or persistent headache, seizure, trouble speaking, weakness on one side of the body, vision changes (such as decreased/blurred vision), chest/jaw/left arm pain, trouble breathing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking bromocriptine, tell your doctor or pharmacist if you are allergic to it; or to other ergot medications (such as ergotamine, pergolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain genetic enzyme problems (galactose intolerance, lactase deficiency, glucose-galactose malabsorption), high or low blood pressure, liver disease, heart problems (such as coronary artery disease, heart attack, irregular heartbeat), mental/mood disorders (such as psychosis, depression, schizophrenia), stomach/intestinal problems (such as bleeding, ulcer), blood flow problems (such as peripheral vascular disease, Raynaud's disease), recent pregnancy (especially with high blood pressure).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.Bromocriptine can reduce blood flow in the fingers and toes, especially during exposure to cold, increasing the risk of damage (such as frostbite). Keep hands and feet warm during cold weather.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. This medication can cause a dangerous increase in blood pressure during pregnancy. Discuss the risks and benefits with your doctor. This medication should not be used in women who have recently given birth due to risk of serious side effects.Since this medication may restore fertility in women with high prolactin or growth hormone levels, women who do not want to become pregnant should discuss with their doctor the use of non-hormonal birth control methods (such as condoms, diaphragm) while taking this medication. A pregnancy test is recommended at least once every 4 weeks before your period starts again. If you start having your periods regularly, then a pregnancy test is recommended every time you miss your period. If you become pregnant or think you may be pregnant, tell your doctor right away.This drug may affect breast milk production. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antipsychotic drugs (such as chlorpromazine, haloperidol, thioridazine), other ergot medications (such as ergotamine).Other medications can affect the removal of bromocriptine from your body, which may affect how bromocriptine works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as lopinavir, ritonavir), telithromycin, among others.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: mental/mood changes (such as hallucinations, agitation, confusion), severe dizziness, fainting.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood pressure, kidney/liver function, eye exams, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson's disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2020. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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