GEODON- ziprasidone hydrochloride capsule GEODON- ziprasidone mesylate injection, powder, lyophilized, for solution GEODON- zi

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)

Διαθέσιμο από:

ROERIG

INN (Διεθνής Όνομα):

ZIPRASIDONE HYDROCHLORIDE

Σύνθεση:

ZIPRASIDONE 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]

Περίληψη προϊόντος:

GEODON capsules are differentiated by capsule color/size and are imprinted in black ink with "Pfizer and ZDX [dosage strength]" or with "Pfizer" and a unique number. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied in the following strengths and package configurations: Bottles of 60 20 0049-0052-60 or 0049-0352-60 ZDX 20 Bottles of 60 40 0049-0054-60 or 0049-0354-60 ZDX 40 Bottles of 60 60 0049-0056-60 or 0049-0356-60 ZDX 60 Bottles of 60 80 0049-0058-60 or 0049-0358-60 ZDX 80 or Bottles of 60 20 0049-3960-60 396 Bottles of 60 40 0049-3970-60 397 Bottles of 60 60 0049-3980-60 398 Bottles of 60 80 0049-3990-60 399 GEODON capsules should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4)] . Each mL of ziprasidone mesylate for injection (when reconstituted) affords a colorless to pale pink solution that contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD). Single-dose Vials (carton of 10 vials) 20 mg/mL 0049-3920-83 Single-dose Vials (carton of 10 vials) 20 mg/mL 0049-3920-10 GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°C to 30°C (59°F to 86°F) or up to 7 days refrigerated, 2°C to 8°C (36°F to 46°F).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

GEODON- ZIPRASIDONE HYDROCHLORIDE CAPSULE
GEODON- ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ROERIG
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEODON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEODON.
GEODON (ZIPRASIDONE) CAPSULES, FOR ORAL USE
GEODON (ZIPRASIDONE MESYLATE) FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL:
2001
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE
AT AN INCREASED RISK OF DEATH. GEODON IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
5/2021
INDICATIONS AND USAGE
GEODON is an atypical antipsychotic. In choosing among treatments,
prescribers should be aware of the
capacity of GEODON to prolong the QT interval and may consider the use
of other drugs first (1)
GEODON capsules are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes
associated with bipolar I
disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate in adults. (1)
GEODON for injection is indicated for the:
acute treatment of agitation in schizophrenic patients in adults. (1)
DOSAGE AND ADMINISTRATION
Administer capsules orally with food. Do not open, crush, or chew.
(2.1)
Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be
adjusted up to 80 mg twice daily.
Dose adjustments should occur at intervals of not less than 2 days.
Safety and efficacy has been
demonstrated in doses up to 100 mg twice daily. The lowest effective
dose should be used. (2.2)
Acute treatment of manic/mixed episodes of bipolar I disorder:
Initiate at 40 mg twice daily. Increase to
60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose