Bromocriptinedosage

2 DOSAGE & ADMINISTRATION Before initiating bromocriptine mesylate, evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer bromocriptine mesylate. Take bromocriptine mesylate orally with food Recommended dosage for hyperprolactinemia-associated dysfunction is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the dosage up to 2.5 mg once daily every two to seven days within a recommended dosage of 2.5 mg to 15 mg once daily Recommended dosage for prolactin-secreting adenomas is 1.25 mg to 2.5 mg once daily. Increase the dosage within a recommended dosage of 2.5 mg to 10 mg once daily Recommended dosage for acromegaly is 1.25 to 2.5 mg once at bedtime for 3 days. Increase the dosage 1.25 mg to 2.5 mg once daily every 3 to 7 days up to the maximum recommended dosage is 100 mg/daily. Recommended starting dosage for idiopathic or postencephalitic Parkinson’s disease is 1.25 mg twice daily. Increase the dosage by 1.25 mg twice daily every 14 to 28 days up to the maximum recommended daily dosage of 100 mg/day For dosage modifications for concomitant use of bromocriptine mesylate with moderate CYP3A4 inhibitors, see Full Prescribing Information

2.1 Recommended

Evaluation Before Initiating Bromocriptine Mesylate Before initiating bromocriptine mesylate evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer bromocriptine mesylate.

2.2 Important

Administration Instructions Take bromocriptine mesylate orally with food because a high percentage of patients vomited after they received bromocriptine mesylate under fasting conditions.

2.3 Recommended

Dosage for Hyperprolactinemia-Associated Dysfunction The recommended starting dosage of bromocriptine mesylate in adults with hyperprolactinemia-associated dysfunction is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the bromocriptine mesylate dosage up to 2.5 mg once daily every two to seven days as tolerated until an optimal therapeutic response is achieved within a recommended dosage of 2.5 mg to 15 mg once daily.

2.4 Recommended

Dosage for Prolactin-Secreting Adenomas The recommended starting dosage of bromocriptine mesylate in adult and pediatric patients 11 years of age and older with prolactin-secreting adenomas is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the bromocriptine mesylate dosage as tolerated until an optimal therapeutic response is achieved within a recommended dosage of 2.5 mg to 10 mg once daily. In cases where adenectomy is elected for prolactin-secreting adenomas, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery.

2.5 Recommended

Dosage for Acromegaly The recommended starting dosage of bromocriptine mesylate in adults for acromegaly is 1.25 mg (one-half of a tablet) to 2.5 mg once at bedtime for 3 days. Increase the dosage 1.25 mg to 2.5 mg once daily every 3 to 7 days, as tolerated, until an optimal therapeutic response is achieved. Reevaluate patients monthly and modify the dosage based on growth hormone levels and clinical response. For adults with acromegaly, the usual optimal therapeutic dosage range varies from 20-30 mg once at bedtime in most patients, and the maximum recommended dosage is 100 mg/daily. After a brief trial with bromocriptine mesylate therapy in adults with acromegaly, if there is no significant reduction in growth hormone levels and no changes in the clinical features of acromegaly consider increasing the dosage or discontinuing bromocriptine mesylate. For patients with acromegaly treated with pituitary irradiation, withdraw bromocriptine mesylate (e.g., for four to eight weeks) on a yearly basis to assess the clinical effects of radiation on the disease process as well as the effects of bromocriptine mesylate therapy. Consider restarting bromocriptine mesylate if signs or symptoms of acromegaly or increases in growth hormone occur.

2.6 Recommended

Dosage for Idiopathic Parkinson’s Disease or Postencephalitic Parkinson Parkinsonism The recommended starting dosage of bromocriptine mesylate in adults with idiopathic Parkinson’s disease or postencephalitic parkinsonism is 1.25 mg (one-half of a tablet) twice daily. Increase the dosage by 1.25 mg (one half of a tablet) twice daily every 14 to 28 days based on therapeutic response and tolerability, up to the maximum recommended daily dosage of 100 mg/day. For patients receiving concomitant levodopa, maintain the levodopa dosage during bromocriptine mesylate dosage escalation. If the levodopa dosage is decreased, increase the bromocriptine mesylate dosage in increments of 1.25 mg twice daily.

2.7 Dosage Modification for

Strong and Moderate CYP3A4 Inhibitors Avoid concomitant use of bromocriptine mesylate with strong CYP3A4 inhibitors. Dosage modifications of bromocriptine mesylate for concomitant use with moderate CYP3A4 inhibitors are provided in Table 1. Table 1. Dosage Modifications of Bromocriptine Mesylate for Concomitant Use with Moderate CYP3A4 Inhibitors Starting Dosage Maximum Dosage Hyperprolactinemia-associated dysfunction in adults 1.25 mg once daily (one-half of a tablet) 3.75 mg once daily Prolactin-secreting adenomas in adult and pediatric patients 11 years of age and older 1.25 mg once daily 2.5 mg once daily Acromegaly in adults 1.25 mg once daily 25 mg once daily Idiopathic or postencephalitic parkinsonism in adults 1.25 mg once daily 12.5 mg twice daily