Buy Parlodel Online

Parlodel (bromocriptine mesylate)

THERAPEUTIC CLASS

Dopamine receptor agonist

DEA CLASS

RX

INDICATIONS

Treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea with or without galactorrhea, infertility, or hypogonadism. Treatment of prolactin-secreting adenomas, acromegaly, and signs and symptoms of idiopathic or postencephalitic Parkinson's disease.

ADULT DOSAGE

Hyperprolactinemia-Associated Dysfunctions

Including Amenorrhea w/ or w/o Galactorrhea, Infertility, or Hypogonadism, in Patients w/ Prolactin-Secreting Adenomas:

Initial: 1/2-1 tab qd
Titrate: May add 1 tab (2.5mg) every 2-7 days, as tolerated until optimal response is achieved
Range: 2.5-15mg/day

In cases where adenectomy is elected, a course of therapy may be used to reduce tumor mass prior to surgery

Acromegaly

Alone or as Adjunctive Therapy w/ Pituitary Irradiation or Surgery:

Initial: 1/2-1 tab qhs w/ food for 3 days
Titrate: May add 1/2-1 tab every 3-7 days, as tolerated until optimal response is achieved; reevaluate monthly and adjust dose based on reductions of growth hormone or clinical response
Range: 20-30mg/day
Max: 100mg/day

Withdraw therapy for 4-8 weeks on a yearly basis if treated w/ pituitary irradiation to assess both the clinical effects of radiation on the disease process and effects of therapy

Parkinson's Disease

Signs/Symptoms of Idiopathic or Postencephalitic Parkinson's Disease:

Initial: 1/2 tab bid w/ meals
Titrate: May increase every 14-28 days by 2.5mg/day
Max: 100mg/day

Maintain levodopa dose during introductory period, if possible

PEDIATRIC DOSAGE

Hyperprolactinemia-Associated Dysfunctions

Including Amenorrhea w/ or w/o Galactorrhea, Infertility, or Hypogonadism, in Patients w/ Prolactin-Secreting Adenomas:

11-15 Years:
Initial: 1/2-1 tab qd
Titrate: May increase as tolerated until optimal response is achieved
Range: 2.5-10mg/day

In cases where adenectomy is elected, a course of therapy may be used to reduce tumor mass prior to surgery

DOSING CONSIDERATIONS

Elderly
Start at lower end of dosing range

Discontinuation
Acromegaly:
After a brief trial w/ therapy, if no significant reduction in growth hormone levels has taken place, carefully assess clinical features of disease; consider dose adjustment or discontinuation if no change has occurred

ADMINISTRATION

Oral route

Take w/ food

HOW SUPPLIED

Cap: 5mg; Tab: 2.5mg* *scored

CONTRAINDICATIONS

Uncontrolled HTN, postpartum period in women with history of coronary artery disease (CAD) and other severe cardiovascular (CV) conditions unless withdrawal is medically contraindicated, pregnancy if treating hyperprolactinemia. Hypertensive disorders of pregnancy (eg, eclampsia, preeclampsia, or pregnancy-induced HTN) if used to treat acromegaly, prolactinoma, or Parkinson's disease, unless withdrawal is medically contraindicated.

WARNINGS/PRECAUTIONS

Perform complete evaluation of the pituitary before treatment. Safety during pregnancy not established; use contraceptive measures, other than oral contraceptives, during treatment. D/C treatment if patient becomes pregnant. Somnolence and episodes of sudden sleep onset may occur, particularly to patients with Parkinson's disease; consider dose reduction or termination of therapy. May impair physical/mental abilities. Symptomatic hypotension may occur. HTN, myocardial infarction (MI), seizures, and stroke reported (rare) in postpartum women; not recommended for prevention of physiological lactation. D/C and evaluate promptly if HTN, severe, progressive or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops. Pleural and pericardial effusions, pleural and pulmonary fibrosis, constrictive pericarditis, and retroperitoneal fibrosis reported, particularly on long-term and high-dose treatment; consider discontinuation of therapy. Caution with history of psychosis or CV disease. Avoid with hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption. Visual field deterioration may develop; consider dose reduction in patients with macroprolactinoma. CSF rhinorrhea reported in patients with prolactin-secreting adenomas. Cold-sensitive digital vasospasm and possible tumor expansion reported in acromegalic patients; d/c therapy and consider alternative procedures if tumor expansion develops. Severe GI bleeding in patients with peptic ulcers reported. Safety during long-term use (>2 yrs) for Parkinson's disease not established. May cause confusion and mental disturbances with high doses; caution with mild degrees of dementia. May cause hallucinations (visual or auditory) with or without concomitant levodopa; dosage reduction or discontinuation of therapy may be required. May cause intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges; consider dose reduction or d/c therapy. Caution with history of MI with residual atrial, nodal, or ventricular arrhythmia. Regularly monitor for melanomas. Symptom complex resembling the neuroleptic malignant syndrome (NMS) reported with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy. Caution with renal/liver impairment and in elderly.

ADVERSE REACTIONS

Confusion, hallucinations, headache, drowsiness, visual disturbance, hypotension, nasal congestion, N/V, dizziness, constipation, anorexia, dry mouth, indigestion/dyspepsia, fatigue, lightheadedness.

DRUG INTERACTIONS

Not recommended with other ergot alkaloids. May potentiate side effects with alcohol. May interact with dopamine antagonists, butyrophenones, and certain other agents. May decrease efficacy with phenothiazines, haloperidol, metoclopramide, and pimozide. Caution with strong CYP3A4 inhibitors (eg, azole antimycotics, HIV protease inhibitors). Increased plasma levels with macrolide antibiotics (eg, erythromycin) and octreotide. Caution in patients recently treated or on concomitant therapy with drugs that can alter BP; concomitant use in puerperium is not recommended.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

Dopamine receptor agonist; activates postsynaptic dopamine receptors and modulates the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor.

PHARMACOKINETICS

Absorption: (Healthy) Cmax =465pg/mL (fasted, 2 x 2.5mg), 628pg/mL (5mg bid); AUC=2377pg•hr/mL; Tmax=2.5 hrs. Distribution: Plasma protein binding (90-96%). Metabolism: Liver (extensive); via CYP3A and hydroxylation. Elimination: Feces (82%), urine (5.6%); T1/2=4.85 hrs.

ASSESSMENT

Assess for previous hypersensitivity to ergot alkaloids, uncontrolled HTN, history of CAD or other severe CV conditions, pituitary tumors, dementia, history of psychosis, unexplained pleuropulmonary disorders, history of peptic ulcer or GI bleeding, hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption, macroadenomas, renal/hepatic disease, pregnancy/nursing status, and possible drug interactions. Perform complete pituitary evaluation.

MONITORING

Monitor for GI bleeding, somnolence, episodes of sudden sleep onset, seizures, stroke, MI, pleural and pericardial effusions, pleural and pulmonary fibrosis, constrictive pericarditis, retroperitoneal fibrosis, cold sensitive digital vasospasm, peptic ulcers, enlargement of a previously undetected or existing prolactin-secreting tumor, symptom complex resembling NMS, confusion and mental disturbances, and other adverse reactions. Monitor prolactin levels. Monitor visual fields in patients with macroprolactinoma; rapidly progressive visual field loss should be evaluated by a neurosurgeon. Periodically evaluate hepatic, hematopoietic, CV, and renal function. Periodic monitoring of BP, particularly during 1st weeks of therapy is prudent. Perform pregnancy test at least every 4 weeks during amenorrhea, and for every missed menstrual period once menses are reinitiated. Periodic skin exam should be performed by qualified individuals (eg, dermatologist).

PATIENT COUNSELING

Inform that dizziness, drowsiness, faintness, fainting, and syncope may occur during treatment. Advise that somnolence and episodes of sudden sleep onset may occur and instruct not to engage in activities requiring rapid and precise responses. Instruct patients with hyperprolactinemic states associated with macroadenoma or those who have had previous transsphenoidal surgery to report any persistent watery nasal discharge. Inform patients with macroadenoma that discontinuation of therapy may be associated with rapid regrowth of tumor and recurrence of their original symptoms. Advise of the possibility that patients may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, and the inability to control these urges while on therapy. Inform that hypotensive reactions may occasionally occur and result in reduced alertness.

STORAGE

<25°C (77°F).

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