Ziprasidone Hydrochloride (Page 7 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ziprasidone hydrochloride capsules are differentiated by capsule color/size and are imprinted in black ink. Ziprasidone hydrochloride capsules are supplied for oral administration in :

20 mg- White cap and white body, size “4” hard gelatin capsule imprinted with “W991” in black ink on body, filled with white to pink color powder.

40 mg- Blue cap and white body, size “3” hard gelatin capsule imprinted with “W992” in black ink on body, filled with white to pink color powder.

60 mg- Pink cap and white body, size “2” hard gelatin capsule imprinted with “W993” in black ink on body, filled with white to pink color powder.

80 mg- Blue cap and blue body, size “1” hard gelatin capsule imprinted with “W994” in black ink on body, filled with white to pink color powder.

They are supplied in the following strengths and package configurations:

Ziprasidone Hydrochloride Capsules
Package Configuration Capsule Strength (mg) NDC Code Imprint
Bottles of 30 20 NDC-64679-991-01 991
Bottles of 60 20 NDC-64679-991-02 991
Bottles of 100 20 NDC-64679-991-03 991
Bottles of 500 20 NDC-64679-991-04 991
Carton of 80 (10 cards containing 8 Capsules each) Capsules 20 NDC-64679-991-06 991
Bottles of 30 40 NDC-64679-992-01 992
Bottles of 60 40 NDC-64679-992-02 992
Bottles of 100 40 NDC-64679-992-03 992
Bottles of 500 40 NDC-64679-992-04 992
Carton of 80 (10 cards containing 8 Capsules each) Capsules 40 NDC-64679-992-06 992
Bottles of 30 60 NDC-64679-993-01 993
Bottles of 60 60 NDC-64679-993-02 993
Bottles of 100 60 NDC-64679-993-03 993
Bottles of 500 60 NDC-64679-993-04 993
Carton of 80 (10 cards containing 8 Capsules each) Capsules 60 NDC-64679-993-06 993
Bottles of 30 80 NDC-64679-994-01 994
Bottles of 60 80 NDC-64679-994-02 994
Bottles of 100 80 NDC-64679-994-03 994
Bottles of 500 80 NDC-64679-994-04 994
Carton of 80 (10 cards containing 8 Capsules each) Capsules 80 NDC-64679-994-06 994

Ziprasidone hydrochloride capsules should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA Approved Patient Labeling (17.4).

Please refer to the patient package insert. To assure safe and effective use of ziprasidone hydrochloride capsules, the information and instructions provided in the patient information should be discussed with patients.

17.1 Administration with Food

Patients should be instructed to take ziprasidone hydrochloride capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Drug Interactions (7.8) and Clinical Pharmacology (12.3)].

17.2 QTc Prolongation

Patients should be advised to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see Contraindications (4.1) and Warnings and Precautions (5.2)].

Patients should be instructed to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. In addition, patients should be instructed to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.2) ].

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