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ZELDOX 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 ZELDOX (ziprasidone) 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.
). 2 CONTRAINDICATIONS QT Prolongation: Because of ziprasidone’s dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ZELDOX is contraindicated in patients with: • known history of QT prolongation (including congenital long QT syndrome); • recent acute myocardial infarction; or • uncompensated heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmias, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in their respective Product Monograph as a contraindication or a warning (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Hypersensitivity: ZELDOX is contraindicated in patients who are hypersensitive to ziprasidone or to any ingredient in the formulation or component of the container. For a complete listing see
). 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.
ZELDOX (ziprasidone capsules) – Product Monograph Page 18 of 56 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 ZELDOX 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 ZELDOX 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:
). The efficacy of ziprasidone was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see 14 CLINICAL TRIALS). ZELDOX has been shown to be effective in maintaining clinical improvement during long- term therapy (1-year).
The health professional who elects to use ZELDOX for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Bipolar Disorder ZELDOX 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 ZELDOX 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 ZELDOX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics). 3 Pharmacokinetics, Special Populations and Conditions). The greater frequency of decreased hepatic, renal, or cardiac function, characteristic of the elderly, as well as concomitant disease and use of other drugs may impact the ZELDOX (ziprasidone capsules) – Product Monograph Page 5 of 56 pharmacokinetics of ZELDOX in this population.
, 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). ZELDOX has been shown to be effective in maintaining clinical improvement during long- term therapy (1-year).
The health professional who elects to use ZELDOX for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Bipolar Disorder ZELDOX 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 ZELDOX 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 ZELDOX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics). 2 Geriatrics ZELDOX is not indicated for use in elderly patients with dementia (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 ZELDOX (ziprasidone capsules) – Product Monograph Page 19 of 56 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 ZELDOX.
Patients should be advised to notify their health professional if they become pregnant or intend to become pregnant. ZELDOX 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 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 ZELDOX (ziprasidone capsules) – Product Monograph Page 20 of 56 no evidence to suggest that these developmental effects were secondary to maternal toxicity. The developmental no-effect dose was 10 mg/kg/day (equivalent to […]
3 Pharmacokinetics, Special Populations and Conditions, and 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS QT Prolongation: Because of ziprasidone’s dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ZELDOX is contraindicated in patients with: • known history of QT prolongation (including congenital long QT syndrome); • recent acute myocardial infarction; or • uncompensated heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmias, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in their respective Product Monograph as a contraindication or a warning (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Hypersensitivity: ZELDOX is contraindicated in patients who are hypersensitive to ziprasidone or to any ingredient in the formulation or component of the container. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
ZELDOX (ziprasidone capsules) – Product Monograph Page 6 of 56 3 SERIOUS WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate in the drug-treated patients. 4 Geriatrics, Use in Geriatric Patients with Dementia). 1 Dosing Considerations Dosage adjustments are generally not required on the basis of age, gender, race, or renal impairment.
The absorption of ziprasidone is increased up to two-fold in the presence of a meal. Concomitant treatment with other drugs that have been consistently observed to prolong the QT/QTc interval should be avoided. See also: 7 WARNINGS and PRECAUTIONS, Recommendations Regarding Risk Factors for QT Prolongation.
3 Pediatrics) Adults: • Schizophrenia Initial Treatment: ZELDOX may be administered at an initial daily dose of 40 mg BID with a meal. However, individual patients may benefit from an initial dose of 20 mg BID. Daily dosage may subsequently be adjusted on the basis of clinical status up to 80 mg BID.
Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, since steady-state is achieved within 1 to 3 days. Efficacy in schizophrenia was studied in a dose range of 20 to 100 mg BID in short-term, placebo-controlled clinical trials.
There were trends toward dose response within the range of 20 to 80 mg BID, but results […]