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PMS-ZIPRASIDONE is a brand name for Ziprasidone, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Schizophrenia pms-ZIPRASIDONE (ziprasidone hydrochloride) is indicated for the treatment of schizophrenia and related psychotic disorders. The prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to other antipsychotic drugs (see
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 04/2023 7 WARNINGS AND PRECAUTIONS 04/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................
4 1 INDICATIONS ........................................................................................................... 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................ 5 2 CONTRAINDICATIONS ..............................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS ................................................................. 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................
4 Administration........................................................................................................ 5 Missed Dose ...........................................................................................................
8 5 OVERDOSAGE .......................................................................................................... 8
). 4% of patients treated with ziprasidone. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. , Alzheimer’s dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.
Serotonin toxicity / Serotonin syndrome:
Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition in patients taking multiple serotonergic agents or who have had considerable exposure to a single serotonin-augmenting drug. 5 Post-Market Adverse Reactions).
g. g. anxiety, agitation, hypomania). In accordance with the Hunter Criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • spontaneous clonus • inducible clonus or ocular clonus with agitation or diaphoresis • tremor and hyperreflexia • hypertonia and body temperature >38°C and ocular clonus or inducible clonus.
If concomitant treatment with pms-ZIPRASIDONE and serotonergic agents is clinically warranted, careful observation of the patient is advised. If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered.
Psychiatric • Suicide:
The possibility of a suicide attempt is inherent in psychotic illness; thus, close supervision and appropriate clinical management of high-risk patients should accompany drug therapy. Prescriptions for pms-ZIPRASIDONE should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
3 Pharmacokinetics, Renal Insufficiency).
Reproductive Health:
04/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................
4 1 INDICATIONS ........................................................................................................... 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................ 5 2 CONTRAINDICATIONS ..............................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS ................................................................. 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................
4 Administration........................................................................................................ 5 Missed Dose ...........................................................................................................
8 5 OVERDOSAGE .......................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 9 7 WARNINGS AND PRECAUTIONS .............................................................................
, 7 WARNINGS AND PRECAUTIONS). The efficacy of ziprasidone was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see 14 CLINICAL TRIALS). Ziprasidone hydrochloride has been shown to be effective in maintaining clinical improvement during long- term therapy (1-year).
The health professional who elects to use pms-ZIPRASIDONE for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. • Bipolar Disorder pms-ZIPRASIDONE (ziprasidone hydrochloride) is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder.
The prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to other antipsychotic drugs (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS). The efficacy of ziprasidone in acute mania was established in 2 placebo-controlled, double- blind, 3-week studies which compared ziprasidone with placebo and 1 double-blind, 12- week (3-week placebo-controlled, active comparator acute phase and 9-week active comparator phase) study which compared ziprasidone to haloperidol and placebo, in patients meeting DSM-IV criteria for Bipolar I Disorder (see 14 CLINICAL TRIALS).
The effectiveness of ziprasidone hydrochloride for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, health professionals who elect to use ziprasidone for extended periods should periodically re- evaluate the long- term risks and benefits of the drug for the individual patient.
1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ziprasidone hydrochloride in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ziprasidone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Female and Male Potential There are no adequate and well-controlled studies in women and men exposed to ziprasidone.
Skin • Severe Cutaneous Adverse Reactions:
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) are potentially life threatening adverse drug reactions that have been reported with atypical antipsychotic exposure.
SCARs commonly present as a combination pms-ZIPRASIDONE (Ziprasidone Capsules) Page 21 of 61 of the following symptoms: malaise, mucosal ulceration, extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy and possible eosinophilia.
5 Post-Market Adverse Reactions). Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with ziprasidone exposure. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis.
5 Post Market Adverse Reactions). Severe cutaneous adverse reactions are sometimes fatal. Discontinue ziprasidone if severe cutaneous adverse reactions occur. • Rash: In pre-marketing trials with ziprasidone, about 5% of patients developed rash (173/3834) and/or urticaria (12/3834), with discontinuation in about one-sixth of these cases.
The occurrence of rash was related to dose of ziprasidone, although the finding might also be explained by the longer exposure time in the higher dose patients. , elevated white blood cells (WBC). Most patients improved promptly with adjunctive treatment with antihistamines or steroids and/or upon discontinuation of ziprasidone, and all patients experiencing these events were reported to recover completely.
Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential receiving ziprasidone should therefore be counselled on the need to use an effective method of contraception during treatment with pms-ZIPRASIDONE.
Patients should be advised to notify their health professional if they become pregnant or intend to become pregnant. pms-ZIPRASIDONE should not be used during pregnancy unless the expected benefits to the mother markedly outweigh the potential risks to the fetus.
Teratogenic effects:
In animal studies, ziprasidone demonstrated developmental toxicity, including possible pms-ZIPRASIDONE (Ziprasidone Capsules) Page 22 of 61 teratogenic effects at doses similar to human therapeutic doses. When ziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis).
There was no evidence to suggest that these developmental effects were secondary to maternal toxicity. The developmental no-effect dose was 10 mg/kg/day […]
1 Special Populations .............................................................................................. 1 Pregnant Women .............................................................................................................
2 Breast-feeding .................................................................................................................. 3 Pediatrics ..........................................................................................................................
4 Geriatrics .......................................................................................................................... 23 8 ADVERSE REACTIONS .............................................................................................
1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions............................................................................ 1 Clinical Trial Adverse Reactions – Pediatrics ........................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions ........................................................................... 38 9 DRUG INTERACTIONS .............................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions.........................................................................................
5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions .......................................................................
41 10 CLINICAL PHARMACOLOGY .................................................................................... 1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ..............................................................................................
3 Pharmacokinetics Overview ................................................................................. 42 11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 44 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................
44 PART II: SCIENTIFIC INFORMATION .................................................................................... 45 13 PHARMACEUTICAL INFORMATION ......................................................................... 45 14 CLINICAL TRIALS .....................................................................................................
1 Trial Design and Study Demographics Schizophrenia Trials ................................ 2 Study Results ........................................................................................................ 3 Comparative Bioavailability Study .......................................................................
49 15 MICROBIOLOGY ..................................................................................................... 49 16 NON-CLINICAL TOXICOLOGY ..................................................................................
49 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................. 52 PATIENT MEDICATION INFORMATION ............................................................................... 53 pms-ZIPRASIDONE (Ziprasidone Capsules) Page 4 of 61 PART I: HEALTH PROFESSIONAL […]
3 Pediatrics). 2 Geriatrics pms-ZIPRASIDONE is not indicated for use in elderly patients with dementia (see