Usual Adult Dose for Hyperprolactinemia

Initial dose: 0.25 mg orally twice a week

• Increase dose in increments of 0.25 mg twice a week no more frequently than every 4 weeks according to patient's prolactin level

• Patients should be maintained on the lowest dose that provides maximal response.
• After maintaining normal serum prolactin levels for 6 months, this drug may be stopped and serum prolactin levels followed to determine whether reinitiating therapy is necessary.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be cautious, generally starting at the lower end of the dosing range.

After maintaining normal serum prolactin levels for 6 months, this drug may be stopped and serum prolactin levels followed to determine whether reinitiating therapy is necessary.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally 2 times a week; may take with or without food

• Since hyperprolactinemia with amenorrhea/galactorrhea and infertility may be associated with pituitary tumors, a complete evaluation of the pituitary should be done prior to initiating treatment.
• Use for postpartum lactation inhibition or suppression is not recommended due to potential risk of hypertension, stroke, and seizures.
• The durability of efficacy beyond 24 months has not been established.

• Perform a cardiovascular evaluation including echocardiogram to assess for valvular disease prior to initiating treatment; routine echocardiographic monitoring should be performed every 6 to 12 months during treatment or more often as clinically indicated.
• Monitor for fibrotic disorders/reactions; consider clinical and diagnostic tests such as erythrocyte sedimentation rate, chest-x-ray, and serum creatinine at baseline and periodically throughout treatment.

• Patients should be instructed to notify their health care provider if they develop shortness of breath, persistent cough, difficulty breathing while lying down, or swelling in extremities.
• Patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.
• Patients should be instructed to report episodes of sudden onset of sleep and new or worsening compulsive behaviors and/or unusual urges.
• Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.