Zeldox

Zeldox

ziprasidone

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ziprasidone HCl monohydrate
Indications/Uses
Schizophrenia & other psychotic disorders; maintenance of clinical improvement & prevention of relapse. Manic or mixed episodes associated w/ bipolar disorder w/ or w/o psychotic features. Monotherapy for acute treatment of manic or mixed episodes associated w/ bipolar I disorder. Adjunct to lithium or valproate for maintenance treatment of bipolar I disorder.
Dosage/Direction for Use
Adult Initially 40 mg bd. may be adjusted depending on patient status up to max: 80 mg bd. Maintenance of bipolar I Continue w/ same stabilized dose w/in range: 40-80 mg bd.
Administration
Should be taken with food: Swallow whole, do not chew/crush/open.
Contraindications
Hypersensitivity. Known QT-interval prolongation including congenital long QT syndrome; recent MI; uncompensated heart failure; cardiac arrhythmias requiring treatment w/ class IA & III antiarrhythmic drugs.
Special Precautions
Discontinue use if NMS & severe cutaneous ARs occur. Not for dementia-related psychosis. Increased risk of CVA in dementia population. Mild to moderate QT-interval prolongation; VTE; tardive dyskinesia; falls; history of seizures; risk factors for stroke; priapism; hyperprolactinemia; hyperglycemia, DM; history or at risk of sleep apnoea. Concomitant use w/ other CNS drugs, alcohol. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe hepatic impairment. Women of childbearing potential should use effective contraception. Pregnancy. Not to be used during lactation. Childn <18 yr.
Adverse Reactions
Insomnia; somnolence, headache. Mania, agitation, anxiety; dystonia, extrapyramidal disorder, tardive dyskinesia, dyskinesia, hypertonia, akathisia, tremor, dizziness, sedation; visual impairment; tachycardia; vomiting, constipation, nausea, salivary hypersecretion, dry mouth, dyspepsia; rash; muscle rigidity; male sexual dysfunction; asthenia, fatigue; increased/decreased wt.
Drug Interactions
Increased AUC & Cmax w/ ketoconazole. Decreased conc w/ CYP3A4 & P-gp inducers eg, carbamazepine, rifampin, St. John's wort.
MIMS Class
Antipsychotics
ATC Classification
N05AE04 - ziprasidone ; Belongs to the class of indole derivatives antipsychotics.
Presentation/Packing
Form
Zeldox cap 40 mg
Packing/Price
30's
Form
Zeldox cap 60 mg
Packing/Price
30's
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