ZELDOX Capsule (2020)
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Περιεχόμενα
Name of the medicinal product
ZELDOX Ziprasidone capsules.
Summary product information
Route of Administration Dosage Form/Strength All Nonmedicinal Ingredients Oral Capsules 20, 40, 60, and 80 mg Lactose monohydrate, magnesium stearate, pregelatinized starch, and gelatin capsules.
Indications and clinical use
Schizophrenia ZELDOX (ziprasidone hydrochloride) is indicated for the treatment of schizophrenia and related psychotic disorders. The prescriber should consider the finding of ziprasidones greater capacity ...
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, ziprasidone is contraindicated ...
Warnings and precautions
QT Prolongation (see also CONTRAINDICATIONS) ZELDOX (ziprasidone hydrochloride) is associated with moderate QT/QTC interval prolongation, as described in the subsections below. Recommendations regarding ...
Adverse reactions
Adverse Drug Reaction Overview The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An ...
Drug interactions
Overview Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs ...
Dosage and administration
Dosing Considerations The absorption of ziprasidone is increased up to two-fold in the presence of a meal. ZELDOX (ziprasidone hydrochloride) should be administered with a meal. See also: WARNINGS and ...
Overdosage
Symptoms In premarketing trials, accidental or intentional overdosage of ziprasidone was documented in 10 patients. All of these patients survived without sequelae. In the patient taking the largest confirmed ...
Action and clinical pharmacology
ZELDOX (ziprasidone hydrochloride) is an atypical antipsychotic agent for oral administration. Mechanism of Action The mechanism of action of ziprasidone, as with other drugs having efficacy in schizophrenia, ...
Storage and stability
Store at controlled room temperature between 15-30°C.
Dosage forms, composition and packaging
Opaque hard gelatin capsules contain ziprasidone hydrochloride, monohydrate equivalent to 20, 40, 60 and 80 mg of ziprasidone. The non-medicinal ingredients include: lactose monohydrate, pregelatinized ...
Pharmaceutical information
Drug Substance Proper name: Ziprasidone hydrochloride, monohydrate (U.S.A.N.) Ziprasidone (I.N.N.) Chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2Hindol-2-one, ...
Detailed pharmacology
ANIMAL Pharmacodynamics Ziprasidone exhibits potent effects in preclinical assays predictive of antipsychotic activity. While the compound was found to be a dopamine antagonist in vitro and in vivo, its ...
Clinical trials
Schizophrenia Trials The efficacy of oral ZELDOX (ziprasidone hydrochloride) in the treatment of schizophrenia was established in 4 short-term (4- to 6-week) and 1 long-term (52-week) placebo-controlled ...
Toxicology
Acute Toxicity Mice and rats Description of findings CP-88,059-1 has a low order of acute toxicity in mice and rats when given either orally or intraperitoneally. No definitive target organs of toxicity ...
References
1. Addington D.; Pantelis, C.; Dineen, M., et al, Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, ...
Serious warnings and precautions box
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. Analyses of 13 placebo-controlled ...
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