ziprasidone 60 MG Oral Capsule
1 INDICATIONS AND USAGE Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. 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 (5.2) ]. 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 (5.2) ]. Ziprasidone hydrochloride capsules are an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first ( 5.2 ) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. ( 14.1 ) 1.1 Schizophrenia Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatients and in one maintenance trial of stable adult schizophrenic inpatients [see Clinical Studies (14.1) ].
Mylan Institutional Inc.
CAPSULE WHITE Mylan ZE 60
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16 HOW SUPPLIED/STORAGE AND HANDLING Ziprasidone Hydrochloride capsules are available containing ziprasidone hydrochloride monohydrate, USP equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. The 20 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and white opaque body axially printed with MYLAN over ZE 20 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows: NDC 51079-351-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 40 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and blue opaque body axially printed with MYLAN over ZE 40 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows: NDC 51079-352-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 60 mg capsule is a hard-shell gelatin capsule with a white opaque cap and white opaque body axially printed with MYLAN over ZE 60 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows: NDC 51079-353-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 80 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and white opaque body axially printed with MYLAN over ZE 80 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows: NDC 51079-354-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
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