Zeldox

Zeldox

ziprasidone

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Concise Prescribing Info
Contents
Ziprasidone HCl monohydrate
Indications/Uses
Schizophrenia & other psychotic disorders; maintenance of clinical improvement & prevention of relapse. 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.
Contraindications
Hypersensitivity. 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 neuroleptic malignant syndrome & severe cutaneous adverse reactions occur. Not for dementia-related psychosis. Increased risk of CVA in dementia population. Mild to moderate QT-interval prolongation, venous thromboembolism, tardive dyskinesia, falls, history of seizures, priapism, hyperprolactinemia, hyperglycemia, DM. Concomitant use w/ other CNS drugs & alcohol. 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 & 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; restless leg syndrome, sleep apnea.
Drug Interactions
Increased AUC & Cmax exposure w/ ketoconazole. Decreased conc w/ CYP3A4 & P-gp inducers eg, carbamazepine, rifampin & St. John's wort.
MIMS Class
ATC Classification
N05AE04 - ziprasidone ; Belongs to the class of indole derivatives antipsychotics.
Presentation/Packing
Form
Zeldox cap 60 mg
Packing/Price
30's
Form
Zeldox cap 40 mg
Packing/Price
30's
Form
Zeldox cap 80 mg
Packing/Price
30's
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