Drug Information

Drug Interaction:

CNS drugs, antihypertensives, Levodopa, antagonists , Carbamazepine, ketoconazole Correct hypokalemia, hypomagnesameia in diuretics

Indication:

Schizophrenia

LIST OF DRUGS DURING 2004

Sr.No- 238

Name of the Drug- Ziprasidone powder for Injection

(after reconstitution 20mg/ml )

Pharmacological Classification- Anti-psychosis

Date of Approval- 03-09-2004

Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Ziprosidone Hcl Schizophrenia 18-03-2002

2.Ziprasidone Powder Anti-Psychotic 03-09-2004

for Injection

(After reconstitution

20mg/ml)

Adverse Reaction:

Somonolence , extrapyrimadal syndrome, Respiratory disorder GI uspset, rash, distonia, Tachycardia, myalgia, postural hypotension, QTc prolongation and risk of sudden death Headache, weight gain, hyperglycemia, Increased risk of death in elderly patients with dementia- related psychosis Prisapism, serotonin syndrome Mania, hypomania, Orofacial edema, urticaria Swollen tongue, facial droop, Enuresis, urinary incontinence Leukopenia, neutropenia Agranulocytosis Discontinue therapy if neutrophil < 1000/mm2

Contra-Indications:

History of QT prolongation Congenital long QT syndrome, recent acute MI uncompensated heart failure, concomittant drugs that cause QT prolongation, including dofetilide , solatol, quinidine, other class Ia and class III antiarrhytmics , mesoridazime. thioridazine, chlorpromazine, pimozide, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic troxide, pobucol, levomethadyl, dolasetron, tracolimus

Special precautions

Hepatic impairment Discontinue if QTc > 500 msec persists Neuroleptic malignant syndrome, or unexplained rash occurs Consider discontinuing if tardive dyskinesia occurs. Conditions that increase risk of torse de pointes ( eg. dizziness, palpitations, syncope )

Cardio- or cerebrovascular disease Risk of hypotension or seizures History of breast cancer Dysphagia, expose to extreme heat, re-evalute periodically Labour and delivery pregnancy and lactation, prescribe lowest possible dose Hyperglycaemia, ketoacidosis, hyperomolar coma or death Diabetic should be monitored regularly for worsening of glucose control Test fasting blood sugar in potentially diabetes with family history Elderly patients with dementia

Dosages/ Overdosage Etc:

Schizophrenia

Dosage-

Administer initial of 20mg twice daily with food In some patients daily dosage subsequently may be adjusted on the basis of individual clinical status up to 80mg twice daily Dosage adjustments should generally occur at intervals of 2 days or more as steady state is acheived within 1 to 3 days

Observe patients for improvement for several weeks before upward adjustments

Pharmacology/ Pharmacokinetics:

GROUP - CENTRAL NERVOUS SYSTEM AGENTS ANTIPSYCHOTIC AGENTS CHEMICAL CLASS - Benzisoxazole Derivatives

Interaction with Food:

To be taken with food

Pregnancy and lactation:

Observe extreme caution if required to be administered during pregnancy and lactation

Ziprasidone - Antipsychotic Agents - Benzisoxazole derivative- (Sep 2004)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation