Ziprasidone Hydrochloride (Ziprasidone Hydrochloride)

Trade Name : ziprasidone hydrochloride

Sandoz Inc

CAPSULE

Strength 20 mg/1

ZIPRASIDONE HYDROCHLORIDE Atypical Antipsychotic [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ziprasidone Hydrochloride (Ziprasidone Hydrochloride) which is also known as ziprasidone hydrochloride and Manufactured by Sandoz Inc. It is available in strength of 20 mg/1 per ml. Read more

Ziprasidone Hydrochloride (Ziprasidone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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5.1n- 5.2

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone is not approved for the treatment of Dementia-Related Psychosis n
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 ()
Ziprasidone hydrochloride capsules are not approved for elderly patients with dementia- related psychosis ()

Ziprasidone hydrochloride capsules are 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. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidoneu2019s 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 n
Schizophrenia
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone is 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 ()

Give oral doses with food.

Ziprasidone hydrochloride capsules 20 mg, are hard gelatin capsules with opaque yellow cap and opaque blue body, cap imprinted u2018SZ 656u2019 with black ink.
Ziprasidone hydrochloride capsules 40 mg, are hard gelatin capsules with opaque blue cap and opaque blue body, cap imprinted u2018SZ 657u2019 with white ink.
Ziprasidone hydrochloride capsules 60 mg, are hard gelatin capsules with opaque yellow cap and opaque yellow body, cap imprinted u2018SZ 658u2019 with black ink.
Ziprasidone hydrochloride capsules 80 mg, are hard gelatin capsules with opaque yellow cap and opaque blue body, cap imprinted u2018SZ 659u2019 with black ink.

u2022
3

No data

No data

QT Interval Prolongation
Neuroleptic Malignant Syndrome (NMS):
Severe Cutaneous Adverse Reactions
Tardive Dyskinesia:
Metabolic Changes
Hyperglycemia and Diabetes Mellitus (DM):
Dyslipidemia:
Weight Gain:
Rash:
Orthostatic Hypotension:
Leukopenia, Neutropenia, and Agranulocytosis
Seizures:
Potential for Cognitive and Motor impairment:
Suicide:

Commonly observed adverse reactions (incidence u22655% and at least twice the incidence for placebo) were:
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .

Schizophrenia:

Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been evaluated as described below. All interactions studies have been conducted with oral ziprasidone. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated:

4.1n- 7.3

No data

Pregnancy:
Nursing Mothers:
Pediatric Use:

Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which ziprasidone will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of ziprasidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior).

No data

Ziprasidone hydrochloride capsules are available 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 molecular formula of CHClNOS (free base of ziprasidone) represents the following structural formula:
Ziprasidone hydrochloride capsules contain a monohydrochloride, anhydrous salt of ziprasidone. Chemically, ziprasidone hydrochloride anhydrous is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2-indol-2-one, monohydrochloride, anhydrous. The molecular formula is CHClNOS u00b7 HCl and its molecular weight is 449.4. Ziprasidone hydrochloride anhydrous is a light pink to dark pink colored powder.
Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (yellow/blue), 40 mg (blue/blue), 60 mg (yellow/yellow), and 80 mg (yellow/blue) capsules. Ziprasidone hydrochloride capsule, intended for oral administration, contains ziprasidone hydrochloride anhydrous equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone. In addition, each capsule contains the following inactive ingredients: calcium silicate, citric acid, lactose anhydrous, magnesium stearate and pregelatinized starch.
The capsule shell for the 20 mg and 80 mg strengths consists of carboxymethylcellulose, FD&C blue # 2, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink.
The capsule shell for the 40 mg strength consists of FD&C blue # 2, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible white pharmaceutical ink.
The capsule shell for the 60 mg strength consists of carboxymethylcellulose, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule is printed with edible black pharmaceutical ink.
The black ink is comprised of iron oxide black, potassium hydroxide, propylene glycol, shellac and ammonia solution.
The white ink is comprised of povidone, propylene glycol, sodium hydroxide, shellac and titanium dioxide.

No data

Carcinogenesis
Lifetime carcinogenicity studies were conducted with ziprasidone in Long Evans rats and CD-1 mice. Ziprasidone was administered for 24 months in the diet at doses of 2, 6, or 12 mg/kg/day to rats, and 50, 100, or 200 mg/kg/day to mice (0.1 to 0.6 and 1 to 5 times the MRHD of 200 mg/day on a mg/m basis, respectively). In the rat study, there was no evidence of an increased incidence of tumors compared to controls. In male mice, there was no increase in incidence of tumors relative to controls. In female mice, there were dose-related increases in the incidences of pituitary gland adenoma and carcinoma, and mammary gland adenocarcinoma at all doses tested (50 to 200 mg/kg/day or 1 to 5 times the MRHD on a mg/m basis). Proliferative changes in the pituitary and mammary glands of rodents have been observed following chronic administration of other antipsychotic agents and are considered to be prolactin-mediated. Increases in serum prolactin were observed in a 1-month dietary study in female, but not male, mice at 100 and 200 mg/kg/day (or 2.5 and 5 times the MRHD on a mg/m basis). Ziprasidone had no effect on serum prolactin in rats in a 5-week dietary study at the doses that were used in the carcinogenicity study. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown n n
Mutagenesis
Ziprasidone was tested in the Ames bacterial mutation assay, the mammalian cell gene mutation mouse lymphoma assay, the chromosomal aberration assay in human lymphocytes, and the chromosomal aberration assay in mouse bone marrow. There was a reproducible mutagenic response in the Ames assay in one strain of in the absence of metabolic activation. Positive results were obtained in both the mammalian cell gene mutation assay and the chromosomal aberration assay in human lymphocytes.
Impairment of Fertility
Ziprasidone was shown to increase time to copulation in Sprague-Dawley rats in two fertility and early embryonic development studies at doses of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD of 200 mg/day on a mg/m basis). Fertility rate was reduced at 160 mg/kg/day (8 times the MRHD on a mg/m basis). There was no effect on fertility at 40 mg/kg/day (2 times the MRHD on a mg/m basis). The effect on fertility appeared to be in the female since fertility was not impaired when males given 160 mg/kg/day (8 times the MRHD on a mg/m basis) were mated with untreated females. In a 6-month study in male rats given 200 mg/kg/day (10 times the MRHD on a mg/m basis) there were no treatment-related findings observed in the testes.

No data

Ziprasidone hydrochloride capsules are available as follows:
20 mg are hard gelatin capsules with opaque yellow cap and opaque blue body, cap imprinted u2018SZ 656u2019 with black ink.
40 mg are hard gelatin capsules with opaque blue cap and opaque blue body, cap imprinted u2018SZ 657u2019 with white ink.
60 mg are hard gelatin capsules with opaque yellow cap and opaque yellow body, cap imprinted u2018SZ 658u2019 with black ink.
80 mg are hard gelatin capsules with opaque yellow cap and opaque blue body, cap imprinted u2018SZ 659u2019 with black ink.
STORAGE
Ziprasidone hydrochloride capsules should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Administration with Food
Instruct patients to take ziprasidone Capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food n
QTc Prolongation
Advise patients 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 n
Instruct patients 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, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber n
Severe Cutaneous Adverse Reactions
Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndromen
Manufactured in India by Sandoz Private Limited for
Sandoz Inc., Princeton, NJ 08540
PATIENT SUMMARY OF INFORMATION ABOUT
Ziprasidone Hydrochloride Capsules
(zih-PRAZ-ih-dohn)
Information for patients taking ziprasidone hydrochloride capsules or their caregivers
This summary contains important information about ziprasidone hydrochloride capsules. It is not meant to take the place of your doctor's instructions. Read this information carefully before you take ziprasidone hydrochloride capsules. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about ziprasidone hydrochloride capsules.
What are ziprasidone hydrochloride capsules?
Ziprasidone hydrochloride capsules are a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. Ziprasidone hydrochloride capsules can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Ziprasidone hydrochloride capsules can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate.
Who should take ziprasidone hydrochloride capsules?
Only your doctor can know if ziprasidone hydrochloride capsules are right for you. Ziprasidone hydrochloride capsules may be prescribed for you if you have schizophrenia or bipolar disorder.
Symptoms of schizophrenia may include:
Symptoms of manic or mixed episodes of bipolar disorder may include:
If you show a response to ziprasidone hydrochloride capsules, your symptoms may improve. If you continue to take ziprasidone hydrochloride capsules there is less chance of your symptoms returning. Do not stop taking the capsules even when you feel better without first discussing it with your doctor.
It is also important to remember that ziprasidone hydrochloride capsules should be taken with food.
What is the most important safety information I should know about ziprasidone hydrochloride capsules?
Ziprasidone hydrochloride capsules are not approved for the treatment of patients with dementia-related psychosis. Elderly patients with a diagnosis of psychosis related to dementia treated with antipsychotics are at an increased risk of death when compared to patients who are treated with placebo (a sugar pill).
Ziprasidone hydrochloride capsules are an effective drug to treat the symptoms of schizophrenia and the manic or mixed episodes of bipolar disorder. However, one potential side effect is that it may change the way the electrical current in your heart works more than some other drugs. The change is small and it is not known whether this will be harmful, but some other drugs that cause this kind of change have in rare cases caused dangerous heart rhythm abnormalities. Because of this, ziprasidone hydrochloride capsules should be used only after your doctor has considered this risk for ziprasidone hydrochloride capsules against the risks and benefits of other medications available for treating schizophrenia or bipolar manic and mixed episodes.
Your risk of dangerous changes in heart rhythm can be increased if you are taking certain other medicines and if you already have certain abnormal heart conditions. Therefore, it is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines. You must also tell your doctor about any heart problems you have or have had.
Who should NOT take ziprasidone hydrochloride capsules?
Elderly patients with a diagnosis of psychosis related to dementia. Ziprasidone hydrochloride capsules are not approved for the treatment of these patients.
Anything that can increase the chance of a heart rhythm abnormality should be avoided. Therefore, do not take ziprasidone hydrochloride capsules if:
What to tell your doctor before you start ziprasidone hydrochloride capsules
Only your doctor can decide if ziprasidone hydrochloride capsules are right for you. Before you start ziprasidone hydrochloride capsules, be sure to tell your doctor if you:
Your doctor may want you to get additional laboratory tests to see if ziprasidone hydrochloride capsules are an appropriate treatment for you.
Ziprasidone hydrochloride capsules and other medicines
There are some medications that may be unsafe to use when taking ziprasidone hydrochloride capsules, and there are some medicines that can affect how well ziprasidone hydrochloride capsules works. While you are on ziprasidone hydrochloride capsules, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies.
How to take ziprasidone hydrochloride capsules
Possible side effects
Because these problems could mean you're having a heart rhythm abnormality, contact your doctor if you:
Common side effects of ziprasidone hydrochloride capsules include the following and should also be discussed with your doctor if they occur:
If you develop any side effects that concern you, talk with your doctor. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts after such illnesses.
For a list of all side effects that have been reported, ask your doctor or pharmacist for the ziprasidone hydrochloride capsules Professional Package Insert.
What to do for an overdose
In case of an overdose, call your doctor or poison control center right away or go to the nearest emergency room.
Other important safety information
A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including ziprasidone hydrochloride capsules. Signs of NMS include very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. NMS is a rare but serious side effect that could be fatal. Therefore, tell your doctor if you experience any of these signs.
Delayed-onset drug reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.
Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with ziprasidone hydrochloride capsules, and it is not known if ziprasidone hydrochloride capsules are associated with these reactions. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
Dizziness caused by a drop in your blood pressure may occur with ziprasidone hydrochloride capsules, especially when you first start taking this medication or when the dose is increased. If this happens, be careful not to stand up too quickly, and talk to your doctor about the problem.
Before taking ziprasidone hydrochloride capsules, tell your doctor if you are pregnant or plan on becoming pregnant. It is advised that you don't breast feed an infant if you are taking ziprasidone hydrochloride capsules.
Because ziprasidone hydrochloride capsules can cause sleepiness, be careful when operating machinery or driving a motor vehicle.
Since medications of the same drug class as ziprasidone hydrochloride capsules may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity.
It is best to avoid consuming alcoholic beverages while taking ziprasidone hydrochloride capsules. Call your doctor if you take more than the amount of ziprasidone hydrochloride capsules prescribed by your doctor.
Ziprasidone hydrochloride capsules have not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.
Keep ziprasidone hydrochloride capsules and all medicines out of the reach of children.
How to store ziprasidone hydrochloride capsules
Store ziprasidone hydrochloride capsules at room temperature (68u00b0F to 77u00b0F or 20u00b0C to 25u00b0C).
For more information about ziprasidone hydrochloride capsules
This sheet is only a summary. Ziprasidone hydrochloride capsules are a prescription medicine and only your doctor can decide if it is right for you. If you have any questions or want more information about ziprasidone hydrochloride capsules, talk with your doctor or pharmacist.
Maalox is a registered trademark of Novartis.
The brands listed are trademark of their respective owners and are not trademarks of Sandoz Inc.
Manufactured in India by Sandoz Private Limited for
Sandoz Inc., Princeton, NJ 08540
Rev. December 2018

NDC 0781-2164-60
Ziprasidone Hydrochloride Capsules
20 mg*
Rx only

NDC 0781-2166-60
Ziprasidone Hydrochloride Capsules
40 mg*
Rx only

NDC 0781-2167-60
Ziprasidone Hydrochloride Capsules
60 mg*
Rx only

NDC 0781-2168-60
Ziprasidone Hydrochloride Capsules
80 mg*
Rx only

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Ziprasidone Hydrochloride (Ziprasidone Hydrochloride)

Trade Name : ziprasidone hydrochloride

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Ziprasidone Hydrochloride (Ziprasidone Hydrochloride)

Trade Name : ziprasidone hydrochloride

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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