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Fazaclo

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Fazaclo

PATIENT INFORMATION

Discuss the following issues with patients and caregivers:

  • Agranulocytosis: Prior to initiating treatment, educate patients and caregivers about the significant risk of developing agranulocytosis. Advise them to immediately report the appearance of signs or symptoms consistent with agranulocytosis or infection (e.g., fever; mucus membrane ulcers; skin, pharyngeal, vaginal, urinary, or pulmonary infection; or extreme weakness or lethargy) at any time during FAZACLO therapy [see WARNINGS AND PRECAUTIONS].
    • Inform patients and caregivers that FAZACLO will be made available only through a special program designed to ensure the required blood monitoring in order to reduce the risk of developing agranulocytosis. Inform patients and caregivers the WBC count and ANC will be monitored as follows:
      • Weekly blood tests are required for the first 6 months.
      • If acceptable WBC counts and ANCs (WBC count ≥ 3500/mm³ and ANC ≥ 2000/mm³) have been maintained during the first 6 months of continuous therapy, then WBC counts and ANCs can be monitored every 2 weeks for the next 6 months.
      • Thereafter, if acceptable WBC counts and ANCs have been maintained during the second 6 months of continuous therapy, WBC counts and ANCs can be monitored every 4 weeks.
  • Orthostatic Hypotension, Bradycardia, and Syncope: Inform patients and caregivers about the risk of orthostatic hypotension and syncope, especially during the period of initial dose titration. Instruct them to strictly follow the clinician's instructions for dosage and administration [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
  • Seizures: Inform patients and caregivers about the significant risk of seizure during FAZACLO treatment. Caution them about driving and any other potentially hazardous activity while taking FAZACLO [see WARNINGS AND PRECAUTIONS].
  • Metabolic Changes (hyperglycemia and diabetes mellitus, dyslipidemia, weight gain): Educate patients and caregivers about the risk of metabolic changes and the need for specific monitoring. The risks include hyperglycemia and diabetes mellitus, dyslipidemia, weight gain, and cardiovascular reactions. Educate patients and caregivers about the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus (e.g., polydipsia, polyuria, polyphagia, and weakness). Monitor all patients for these symptoms. Patients who are diagnosed with diabetes or have risk factors for diabetes (obesity, family history of diabetes) should have their fasting blood glucose monitored before beginning treatment and periodically during treatment. Patients who develop symptoms of hyperglycemia should have assessments of fasting glucose. Clinical monitoring of weight is recommended [see WARNINGS AND PRECAUTIONS].
  • Patients with Phenylketonuria: Inform patients and caregivers that FAZACLO contains phenylalanine (a component of aspartame) [see WARNINGS AND PRECAUTIONS].
  • Interference with Cognitive and Motor Performance: Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that FAZACLO does not affect them adversely [see WARNINGS AND PRECAUTIONS].
  • Missed Doses and Re-initiating Treatment: Inform patients and caregivers that if the patient misses taking FAZACLO for more than 2 days, they should not restart their medication at the same dosage but should contact their physician for dosing instructions [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
  • QT Interval Prolongation: Advise patients to consult their clinician immediately if they feel faint, lose consciousness or have signs or symptoms suggestive of arrhythmia. Instruct patients to not take FAZACLO with other drugs that cause QT interval prolongation. Instruct patients to inform their clinicians that they are taking FAZACLO before any new drug [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
  • Concomitant Medication: Advise patients and caregivers to notify the physician if they are taking or plan to take any prescription or over-the-counter drugs or alcohol. [see DRUG INTERACTIONS].
  • Pregnancy: Patients and caregivers should notify the physician if the patient becomes pregnant or intends to become pregnant during therapy. [see Use In Specific Populations].
  • Nursing: Advise patients and caregivers that the patient should not breast feed an infant if they are taking FAZACLO. [see Use in Specific Populations].
  • Administration: Patients should be advised that FAZACLO tablets should remain in the original package until immediately before use [see DOSAGE AND ADMINISTRATION].

Last reviewed on RxList: 8/9/2013
This monograph has been modified to include the generic and brand name in many instances.

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