CLOZAPINE (Page 10 of 11)

16.2 Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F) (see USP). Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Discuss the following issues with patients and caregivers:

  • Severe Neutropenia:
    • Instruct patients (and caregivers) beginning treatment with clozapine tablets about the risk of developing severe neutropenia and infection.
    • Instruct patients to immediately report to their physician any symptom or sign of infection (e.g., flu-like illness; fever; lethargy; general weakness or malaise; mucus membrane ulceration; skin, pharyngeal, vaginal, urinary, or pulmonary infection; or extreme weakness or lethargy) occurring at any time during clozapine tablets therapy, to aid in evaluation for neutropenia and to institute prompt and appropriate management. [see Warnings and Precautions ( 5.1), 5.11, 5.14)] .
    • Inform patients and caregivers clozapine tablets are available only through a restricted program called the Clozapine REMS Program designed to ensure the required blood monitoring, in order to reduce the risk of developing severe neutropenia. Advise patients and caregivers of the importance of having blood tested as follows:
      • Weekly blood tests are required for the first 6 months.
      • An ANC is required every 2 weeks for the next 6 months if an acceptable ANC is maintained during the first 6 months of continuous therapy,
      • An ANC is required once every 4 weeks thereafter if an acceptable ANC is maintained during the second 6 months of continuous therapy.
    • Clozapine tablets are available only from certified pharmacies participating in the program. Provide patients (and caregivers) with website information and the telephone number on how to obtain the product ( www.clozapinerems.comor 1-844-267-8678) [see Warnings and Precautions (5.2)].
  • 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 Administraton ( 2.2,2.5) ]. Advise patients to consult their clinician immediately if they feel faint, lose consciousness or have signs or symptoms suggestive of bradycardia or arrhythmia [see Warnings and Precautions ( 5.3)].
  • Seizures: Inform patients and caregivers about the significant risk of seizure during clozapine tablets treatment. Caution them about driving and any other potentially hazardous activity while taking clozapine tablets [see Warnings and Precautions ( 5.5)] .
  • Gastrointestinal Hypomotility with Severe Complications: Educate patients and caregivers on the risks, prevention and treatment of clozapine-induced constipation, including medications to avoid when possible (e.g., drugs with anticholinergic activity). Encourage appropriate hydration, physical activity, and fiber intake and emphasize that prompt attention and treatment to the development of constipation or other gastrointestinal symptoms is critical in preventing severe complications. Advise patients and caregivers to contact their health care provider if they experience symptoms of constipation (e.g., difficulty passing stools, incomplete passage of stool, decreased bowel movement frequency) or other symptoms associated with gastrointestinal hypomotility (e.g., nausea, abdominal distension or pain, vomiting) [see Warnings and Precautions (5.8), Drug Interactions (7.1)] .
  • 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 clozapine tablets with other drugs that cause QT interval prolongation. Instruct patients to inform their clinicians that they are taking clozapine tablets before any new drug [see Warnings and Precautions ( 5.10), Drug Interactions ( 7.1)] .
  • 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 ( 5.11)] .
  • Interference with Cognitive and Motor Performance: Because clozapine tablets may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that clozapine tablets therapy does not affect them adversely [see Warnings and Precautions ( 5.17)] .
  • Missed Doses and Re-initiating Treatment: Inform patients and caregivers that if the patient misses taking clozapine tablets 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 ( 2.5), Warnings and Precautions ( 5.1, 5.3)] .
  • Pregnancy: Patients and caregivers should notify the clinician if the patient becomes pregnant or intends to become pregnant during therapy [see Use in Specific Populations ( 8.1)] .
  • Nursing: Advise patients and caregivers that the patient should not breastfeed an infant if they are taking clozapine tablets [see Use in Specific Populations ( 8.3)] .
  • Concomitant Medication: Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs; there is a potential for significant drug-drug interactions [see Dosage and Administration ( 2.6), Drug Interactions ( 7.1)] .

All trademarks are the property of their respective owners.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Rev. 11/2023

Clozapine Tablets — 25mg

25mg Mohali
(click image for full-size original)

Clozapine Tablets — 50mg

50mg Mohali
(click image for full-size original)

Clozapine Tablets — 100mg

PDP-100mg Mohali
(click image for full-size original)

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.