Ziprasidone Hydrochloride

Ziprasidone Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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)]

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)].

History

There is currently no drug history available for this drug.

Other Information

Ziprasidone is available as ziprasidone hydrochloride capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:

chemical-structure

Ziprasidone hydrochloride capsules contain a monohydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride is 5-[2-[4-(1,2-‑benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride is an off white to beige brown powder.

Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (of ziprasidone free base), 40 mg (of ziprasidone free base), 60 mg (of ziprasidone free base), and 80 mg (of ziprasidone free base) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride, colloidal silicon dioxide, crospovidone, sodium starch glycolate, and magnesium stearate. Each capsule shell contains the following inactive ingredients: gelatin and titanium dioxide. The 20 mg, 40 mg and 80 mg capsule shells also contain the following inactive ingredients: D&C Red #28, FD&C Blue #1, FD&C Yellow #6. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, butyl alcohol, potassium hydroxide, propylene glycol and shellac.

Ziprasidone Hydrochloride Manufacturers


  • Proficient Rx Lp
    Ziprasidone Hydrochloride (Ziprasidone Hcl) Capsule [Proficient Rx Lp]
  • Proficient Rx Lp
    Ziprasidone Hydrochloride Capsule [Proficient Rx Lp]
  • American Health Packaging
    Ziprasidone Hydrochloride (Ziprasidone Hcl) Capsule [American Health Packaging]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Golden State Medical Supply, Inc.
    Ziprasidone Hydrochloride (Ziprasidone Hcl) Capsule [Golden State Medical Supply, Inc.]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Major Pharmaceuticals
    Ziprasidone Hydrochloride Capsule [Major Pharmaceuticals]
  • Rebel Distributors Corp
    Ziprasidone Hydrochloride Capsule [Rebel Distributors Corp]
  • Wockhardt Usa Llc.
    Ziprasidone Hydrochloride Capsule [Wockhardt Usa Llc.]
  • Wockhardt Limited
    Ziprasidone Hydrochloride Capsule [Wockhardt Limited]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Unit Dose Services
    Ziprasidone Hydrochloride Capsule [Unit Dose Services]
  • American Health Packaging
    Ziprasidone Hydrochloride Capsule [American Health Packaging]
  • Cardinal Health
    Ziprasidone Hydrochloride Capsule [Cardinal Health]
  • Dr. Reddy’s Laboratories Limited
    Ziprasidone Hydrochloride Capsule [Dr. Reddy’s Laboratories Limited]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Sandoz Inc
    Ziprasidone Hydrochloride Capsule [Sandoz Inc]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Cardinal Health
    Ziprasidone Hydrochloride Capsule [Cardinal Health]
  • Mylan Pharmaceuticals Inc.
    Ziprasidone Hydrochloride Capsule [Mylan Pharmaceuticals Inc.]
  • Bluepoint Laboratories
    Ziprasidone Hydrochloride Capsule [Bluepoint Laboratories]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Ziprasidone Hydrochloride (Ziprasidone Hcl) Capsule [Clinical Solutions Wholesale]
  • Remedyrepack Inc.
    Ziprasidone Hydrochloride Capsule [Remedyrepack Inc. ]
  • Lupin Pharmaceuticals, Inc.
    Ziprasidone Hydrochloride Capsule [Lupin Pharmaceuticals, Inc.]
  • Apotex Corp.
    Ziprasidone Hydrochloride (Ziprasidone Hcl) Capsule [Apotex Corp.]
  • Tya Pharmaceuticals
    Ziprasidone Hydrochloride Capsule [Tya Pharmaceuticals]
  • Tya Pharmaceuticals
    Ziprasidone Hydrochloride Capsule [Tya Pharmaceuticals]
  • Tya Pharmaceuticals
    Ziprasidone Hydrochloride Capsule [Tya Pharmaceuticals]
  • Mylan Institutional Inc.
    Ziprasidone Hydrochloride Capsule [Mylan Institutional Inc.]

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