Parlodel Capsules

— THERAPEUTIC CATEGORIES —
  • Parkinsonism
  • Pituitary disorders

Parlodel Capsules Generic Name & Formulations

General Description

Bromocriptine (as mesylate) 5mg.

Pharmacological Class

Dopamine agonist (ergot deriv).

See Also

How Supplied

Tabs, caps—30, 100

Generic Availability

YES

Parlodel Capsules Indications

Indications

Parkinsonism. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.

Parlodel Capsules 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 Capsules 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 Capsules Boxed Warnings

Not Applicable

Parlodel Capsules 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 Capsules Pharmacokinetics

See Literature

Parlodel Capsules 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 Capsules 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 Capsules Clinical Trials

See Literature

Parlodel Capsules Note

Not Applicable

Parlodel Capsules Patient Counseling

See Literature

Parlodel Capsules Generic Name & Formulations

General Description

Bromocriptine (as mesylate) 5mg.

Pharmacological Class

Dopamine agonist (ergot deriv).

See Also

How Supplied

Tabs, caps—30, 100

Generic Availability

YES

Parlodel Capsules Indications

Indications

Hyperprolactinemia-associated amenorrhea (with or without) galactorrhea, infertility, hypogonadism. Prolactin-secreting adenomas. Acromegaly.

Parlodel Capsules 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 Capsules 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 Capsules Boxed Warnings

Not Applicable

Parlodel Capsules 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 Capsules Pharmacokinetics

See Literature

Parlodel Capsules 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 Capsules 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 Capsules Clinical Trials

See Literature

Parlodel Capsules Note

Not Applicable

Parlodel Capsules Patient Counseling

See Literature