Zeldox Capsules (Hard Gelatin)
Ziprasidone
80mg
PFIZER GmbH
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 389.00 AED |
Available as:
Indications
Zeldox Capsules (Hard Gelatin) is used for:
Schizophrenia, Bipolar Disorder, Mania
Adult Dose
Oral
Schizophrenia
Adult: As ziprasidone HCl: Initially, 20 mg bid, increase if necessary at intervals of not <2 days up to 80 mg bid. Maintenance: 20 mg bid.
Acute mixed or manic episodes in bipolar disorder
Adult: As ziprasidone HCl: Initially, 40 mg bid, increased to 60 mg or 80 mg bid on the 2nd day. Adjust subsequent doses according to patient's response and tolerance level. Maintenance treatment of bipolar I disorder (adjunctive therapy to either lithium or valproate): Continue at the same dosage on which the patient was initially stabilised w/in 40-80 mg bid.
Elderly: Lower initial dose and slower titration.
Hepatic impairment: Use caution
Child Dose
Renal Dose
Renal impairment: Dose adjustment not necessary with PO administration;
Administration
Should be taken with food.
Contra Indications
Concomitant use of oral and IM ziprasidone. Recent acute MI, decompensated heart failure, cardiac arrhythmias, conditions that may increase QT interval eg, QT-interval prolongation or history of QT prolongation; prolactin dependent tumours. Lactation. Not for treatment of behavioural disorders in elderly with dementia.
Precautions
Patient w/ history of seizures or conditions that lower the seizure threshold, CV or cerebrovascular disease, conditions which predispose to hypotension. Renal impairment. Elderly w/ dementia-related psychosis. Pregnancy and lactation. Patient Counselling This drug may cause somnolence, impairment of judgment, thinking or motor skills, if affected, do not drive, operate machinery or perform hazardous tasks. Avoid alcohol. Monitoring Parameters Monitor serum electrolytes if on concurrent diuretic therapy. Monitor ECG in patients who show symptoms of torsades de pointes (e.g. syncope, dizziness, palpitations); wt gain. Closely monitor worsening of glucose control in patients w/ pre-existing DM. Frequently monitor CBC during 1st few mth of therapy in patients w/ pre-existing low leucocyte count or history of drug-induced leucopenia or neutropenia.
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy-Lactation
Pregnancy category: C
Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for EPS or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization
Lactation: Unknown if excreted in breast milk; not recommended
Interactions
Antagonistic effect with levodopa and dopamine antagonists. Additive hypotensive effect with antihypertensives. Additive sedative effects with other CNS agents, alcohol.
Potentially Fatal: Increased risk of torsades de pointes with drugs that prolong QT interval e.g. dofetilide, quinidine, sotalol, and other Class Ia and III antiarrhythmics, moxifloxacin, pimozide, sparfloxacin, thioridazine.
Adverse Effects
Side effects of Ziprasidone :
>10%
Somnolence (11-15%), Headache (11%), Nausea (4-12%), Extrapyramidal symptoms (2-31%), Dizziness (3-16%)
1-10%
Respiratory disorders (1-8%), Constipation (2-9%), Dyspepsia (1-8%), Rash (4-5%), Tachycardia (2%), Hypoesthesia (2%), Priapism (1%), Orthostatic hypotension (5%), Xerostomia (1-5%), Anorexia (2%), Myalgia (2%), Rhinitis (1-4%), Cough (3%)
<1%
Syncope, Seizures
Frequency Not Defined
Prolongation of QT interval, Neuroleptic malignant syndrome (NMS), Hyperprolactinemia, Drug reaction with eosinophilia and systemic syntoms
Potentially Fatal: Blood dyscrasias, neuroleptic malignant syndrome.
Mechanism of Action
Ziprasidone, an atypical antipsychotic, produces antischizophrenic effect through a combination of dopamine D2 and serotonin 5H2 receptor antagonism.
Note
Zeldox 80mg Capsules (Hard Gelatin) manufactured by PFIZER GmbH. Its generic name is Ziprasidone. Zeldox is availble in United Arab Emirates.
Farmaco UAE drug index information on Zeldox Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.