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Parlodel Generic Name & Formulations
Legal Class
Rx
General Description
Bromocriptine (as mesylate) 2.5mg; scored tabs.
Pharmacological Class
Dopamine agonist (ergot deriv).
See Also
How Supplied
Tabs, caps—30, 100
Manufacturer
Generic Availability
YES
Parlodel Indications
Indications
Parkinsonism. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.
Parlodel Dosage and Administration
Adult
Take with food. Initially 1.25mg twice daily. May increase every 14–28 days by 2.5mg/day; max 100mg/day. Maintain levodopa dose at first.
Children
Not established.
Parlodel Contraindications
Contraindications
Uncontrolled hypertension. Ergot alkaloid sensitivity. Pregnancy (in patients being treated for hyperprolactinemia). Hypertension of pregnancy. Postpartum women with a history of coronary artery disease and other severe CV conditions.
Parlodel Boxed Warnings
Not Applicable
Parlodel Warnings/Precautions
Warnings/Precautions
Evaluate pituitary first. Discontinue if hypertension, severe headache, or CNS toxicity occurs. Evaluate unexplained pleuropulmonary disorders; consider discontinuing if occurs. Risk of retroperitoneal fibrosis (esp. on long-term, high-dose therapy); discontinue if suspected or confirmed. Impulse control/compulsive behaviors (eg, gambling, uncontrolled spending, sexual or other urges) during therapy; consider reducing dose or discontinuing if develop. Psychosis. Dementia. Cardiovascular disease (eg, MI, arrhythmias). Galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption: not recommended. Macroprolactinoma: monitor visual fields. Peptic ulcer. GI bleed. Monitor for tumor expansion; discontinue and consider alternatives if occurs. Risk of neuroleptic malignant-like syndrome with rapid dose reduction, withdrawal, or changes in therapy. Evaluate hematopoietic, cardiovascular (monitor BP), hepatic and renal function periodically. Perform periodic skin exams. Avoid abrupt cessation. Advise to use barrier contraception until ovulation normalizes. Pregnancy (Cat.B); discontinue if occurs in patients with hyperprolactinemia; assess risk vs benefit in other indications (see full labeling). Nursing mothers: not recommended.
Parlodel Pharmacokinetics
See Literature
Parlodel Interactions
Interactions
See Contraindications. Adverse reactions potentiated by alcohol. Potentiated by macrolide antibiotics (eg, erythromycin), octreotide, other strong CYP3A4 inhibitors (eg, azole antimycotics, HIV protease inhibitors). Concomitant ergot alkaloids: not recommended. Caution with dopamine antagonists, butyrophenones, drugs that affect BP. Antagonized by phenothiazines, haloperidol, metoclopramide, pimozide.
Parlodel Adverse Reactions
Adverse Reactions
GI upset, headache, dizziness, fatigue, lightheadedness, drowsiness, hypotension; rare: hypertension, seizures, stroke, MI. Acromegaly: also digital vasospasm, GI bleed. Parkinsonism: also involuntary movements, hallucinations, confusion, on-off phenomenon, visual disturbance, ataxia, insomnia.
Parlodel Clinical Trials
See Literature
Parlodel Note
Not Applicable
Parlodel Patient Counseling
See Literature
Parlodel Generic Name & Formulations
Legal Class
Rx
General Description
Bromocriptine (as mesylate) 2.5mg; scored tabs.
Pharmacological Class
Dopamine agonist (ergot deriv).
See Also
How Supplied
Tabs, caps—30, 100
Manufacturer
Generic Availability
YES
Parlodel Indications
Indications
Hyperprolactinemia-associated amenorrhea (with or without) galactorrhea, infertility, hypogonadism. Prolactin-secreting adenomas. Acromegaly.
Parlodel Dosage and Administration
Adult
Take with food. Hyperprolactinemia: initially 1.25–2.5mg/day, may increase every 2–7 days by 2.5mg/day; range 2.5–15mg/day. Acromegaly: 1.25–2.5mg at bedtime for 3 days then increase by 1.25–2.5mg/day every 3–7 days; range 20–30mg/day; max 100mg/day.
Children
<11yrs: not established. 11–15yrs: initially 1.25mg–2.5mg daily; range 2.5–10mg/day.
Parlodel Contraindications
Contraindications
Uncontrolled hypertension. Ergot alkaloid sensitivity. Pregnancy (in patients being treated for hyperprolactinemia). Hypertension of pregnancy. Postpartum women with a history of coronary artery disease and other severe CV conditions.
Parlodel Boxed Warnings
Not Applicable
Parlodel Warnings/Precautions
Warnings/Precautions
Evaluate pituitary first. Discontinue if hypertension, severe headache, or CNS toxicity occurs. Evaluate unexplained pleuropulmonary disorders; consider discontinuing if occurs. Risk of retroperitoneal fibrosis (esp. on long-term, high-dose therapy); discontinue if suspected or confirmed. Impulse control/compulsive behaviors (eg, gambling, uncontrolled spending, sexual or other urges) during therapy; consider reducing dose or discontinuing if develop. Psychosis. Dementia. Cardiovascular disease (eg, MI, arrhythmias). Galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption: not recommended. Macroprolactinoma: monitor visual fields. Peptic ulcer. GI bleed. Monitor for tumor expansion; discontinue and consider alternatives if occurs. Risk of neuroleptic malignant-like syndrome with rapid dose reduction, withdrawal, or changes in therapy. Evaluate hematopoietic, cardiovascular (monitor BP), hepatic and renal function periodically. Perform periodic skin exams. Avoid abrupt cessation. Advise to use barrier contraception until ovulation normalizes. Pregnancy (Cat.B); discontinue if occurs in patients with hyperprolactinemia; assess risk vs benefit in other indications (see full labeling). Nursing mothers: not recommended.
Parlodel Pharmacokinetics
See Literature
Parlodel Interactions
Interactions
See Contraindications. Adverse reactions potentiated by alcohol. Potentiated by macrolide antibiotics (eg, erythromycin), octreotide, other strong CYP3A4 inhibitors (eg, azole antimycotics, HIV protease inhibitors). Concomitant ergot alkaloids: not recommended. Caution with dopamine antagonists, butyrophenones, drugs that affect BP. Antagonized by phenothiazines, haloperidol, metoclopramide, pimozide.
Parlodel Adverse Reactions
Adverse Reactions
GI upset, headache, dizziness, fatigue, lightheadedness, drowsiness, hypotension; rare: hypertension, seizures, stroke, MI. Acromegaly: also digital vasospasm, GI bleed. Parkinsonism: also involuntary movements, hallucinations, confusion, on-off phenomenon, visual disturbance, ataxia, insomnia.
Parlodel Clinical Trials
See Literature
Parlodel Note
Not Applicable
Parlodel Patient Counseling
See Literature
