Ziprasidone Hydrochloride

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Overview

What is Ziprasidone Hydrochloride?

Ziprasidone hydrochloride is available as capsules (ziprasidone hydrochloride) 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-2 -indol-2-one. The empirical formula of C H ClN OS (free base of ziprasidone) represents the following structural formula:

Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2 -indol-2-one, monohydrochloride, monohydrate. The empirical formula is C H ClN OS • HCl • H O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder.

Ziprasidone hydrochloride 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. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride monohydrate, lactose monohydrate, pregelatinized maize starch, and magnesium stearate. The gelatin cap and body contains FD & C blue #1, FD & C red #40, gelatin, titanium dioxide and imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

What does Ziprasidone Hydrochloride look like?

What are the available doses of Ziprasidone Hydrochloride?

Ziprasidone hydrochloride capsules are differentiated by capsule color/size and are imprinted in black ink with "LU" and a unique number. Ziprasidone hydrochloride 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:

What should I talk to my health care provider before I take Ziprasidone Hydrochloride?

How should I use Ziprasidone Hydrochloride?

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 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

Dose Selection

Ziprasidone hydrochloride capsules should be administered at an initial daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment.

Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses above 100 mg twice daily has not been systematically evaluated in clinical trials

Maintenance Treatment

While there is no body of evidence available to answer the question of how long a patient treated with ziprasidone should remain on it, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving ziprasidone hydrochloride. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment.

What interacts with Ziprasidone Hydrochloride?

Sorry No Records found

What are the warnings of Ziprasidone Hydrochloride?

Sorry No Records found

What are the precautions of Ziprasidone Hydrochloride?

Sorry No Records found

What are the side effects of Ziprasidone Hydrochloride?

Sorry No records found

What should I look out for while using Ziprasidone Hydrochloride?

Do not use in patients with a known history of QT prolongation ( )

Do not use in patients with recent acute myocardial infarction ( )

Do not use in patients with uncompensated heart failure ( )

Do not use in combination with other drugs that have demonstrated QT prolongation ( )

Do not use in patients with known hypersensitivity to ziprasidone ( )

What might happen if I take too much Ziprasidone Hydrochloride?

How should I store and handle Ziprasidone Hydrochloride?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] [ ] Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis. Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-331-07 Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-332-07 Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-333-07 Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68180-334-07 Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Maalox is a registered trademark of Novartis.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The mechanism of action of ziprasidone, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D ) and serotonin type 2 (5HT ) antagonism.

Non-Clinical Toxicology

Do not use in patients with a known history of QT prolongation ( )

Do not use in patients with recent acute myocardial infarction ( )

Do not use in patients with uncompensated heart failure ( )

Do not use in combination with other drugs that have demonstrated QT prolongation ( )

Do not use in patients with known hypersensitivity to ziprasidone ( )

Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Metronidazole Injection USP is prescribed for patients on this type of anticoagulant therapy.

The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.

The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole.

Alcoholic beverages should not be consumed during metronidazole therapy because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.

Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone hydrochloride is not approved for the treatment of dementia-related psychosis.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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