Ziprasidone capsule

Spl product data elements section

Spl product data elements section

Spl product data elements section

Recent major changes

Boxed Warning
11/2018
Dosage and Administration (2.4)
Removed
11/2018
Warnings and Precautions ( 5.1, 5.2)
11/2018

Warning: increased mortality in elderly patients with dementia-related psychosis

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 [ see Warnings and Precautions ( 5.1)].

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

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 ( 5.1)
  • Ziprasidone is not approved for elderly patients with dementia-related psychosis ( 5.1)

1 indications and usage

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 ziprasidone's 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 [see Warnings and Precautions ( 5.3)]

Schizophrenia

  • Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14.1)].

Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)

  • Ziprasidone is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies ( 14.2)].
  • Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies ( 14.2)].

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 ( 5.3)

Ziprasidone hydrochloride capsules are indicated as an oral formulation for the:

  • Treatment of schizophrenia.
  • Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder
  • Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

2 dosage and administration

Give oral doses with food.

  • Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be adjusted up to 80 mg twice daily. Dose adjustments should occur at intervals of not less than 2 days. Safety and efficacy has been demonstrated in doses up to 100 mg twice daily. The lowest effective dose should be used. ( 2.1)
  • Acute treatment of manic/mixed episodes of bipolar I disorder: Initiate at 40 mg twice daily. Increase to 60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose adjustments should be based on tolerability and efficacy within the range of 40 to 80 mg twice daily. ( 2.2)
  • Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate: Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40-80 mg twice daily. ( 2.2)

3 dosage forms and strengths

Ziprasidone hydrochloride capsules, 20 mg are white to slightly pink granular powder filled in size '4' hard gelatin capsules having a dark blue opaque cap printed with '237' in white ink and a white opaque body.

Ziprasidone hydrochloride capsules, 40 mg are white to slightly pink granular powder filled in size '3' hard gelatin capsules having a dark blue opaque cap printed with '238' in white ink and a dark blue opaque body.

Ziprasidone hydrochloride capsules, 60 mg are white to slightly pink granular powder filled in size '2' hard gelatin capsules having a white opaque cap printed with '239' in black ink and a white opaque body.

Ziprasidone hydrochloride capsules, 80 mg are white to slightly pink granular powder filled in size '1' hard gelatin capsules having a dark blue opaque cap printed with '240' in white ink and a light blue opaque body.

  • Capsules: 20 mg, 40 mg, 60 mg and 80 mg ( 3)

4 contraindications

  • Do not use in patients with a known history of QT prolongation ( 4.1)
  • Do not use in patients with recent acute myocardial infarction ( 4.1)
  • Do not use in patients with uncompensated heart failure ( 4.1)
  • Do not use in combination with other drugs that have demonstrated QT prolongation ( 4.1)
  • Do not use in patients with known hypersensitivity to ziprasidone ( 4.2)

5 warnings and precautions

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). ( 5.2)
  • QT Interval Prolongation: Ziprasidone use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation. ( 5.3)
  • Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring. ( 5.4)
  • Severe Cutaneous Adverse Reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome has been reported with ziprasidone exposure. DRESS and other Severe Cutaneous Adverse Reactions (SCAR) are sometimes fatal. Discontinue ziprasidone if DRESS or SCAR are suspected.( 5.5)
  • Tardive Dyskinesia: May develop acutely or chronically. ( 5.6)
  • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. ( 5.7)
  • Hyperglycemia and Diabetes Mellitus (DM): Monitor all patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with DM risk factors should undergo blood glucose testing before and during treatment. ( 5.7)
  • Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. ( 5.7)
  • Weight Gain: Weight gain has been reported. Monitor weight gain. ( 5.7)
  • Rash: Discontinue in patients who develop a rash without an identified cause. ( 5.8)
  • Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease. ( 5.9)
  • Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue ziprasidone at the first sign of a decline in WBC in the absence of other causative factors. ( 5.11)
  • Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold. ( 5.12)
  • Potential for Cognitive and Motor impairment: Patients should use caution when operating machinery. ( 5.15)
  • Suicide: Closely supervise high-risk patients. ( 5.18)

5.20 laboratory tests

Patients being considered for ziprasidone treatment that are at risk of significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. Low serum potassium and magnesium should be replaced before proceeding with treatment. Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions ( 5.3)].

6 adverse reactions

Commonly observed adverse reactions (incidence 5% and at least twice the incidence for placebo) were :

  • Schizophrenia: Somnolence, respiratory tract infection. ( 6.1)
  • Manic and Mixed Episodes Associated with Bipolar Disorder:
  • Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting. ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1- 877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 drug interactions

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:

  • Ziprasidone should not be used in combination with other drugs that have demonstrated QT prolongation. ( 4.1, 7.3)
  • The absorption of ziprasidone is increased up to two-fold in the presence of food. ( 7.10)
  • The full prescribing information contains additional drug interactions. ( 7).

8 use in specific populations

  • Pregnancy: Ziprasidone should be used during pregnancy only if the potential benefit justifies the potential risk. ( 8.1)
  • Nursing Mothers: Breast feeding is not recommended. ( 8.3)
  • Pediatric Use: Safety and effectiveness for pediatric patients has not been established. ( 8.4)

8.1 pregnancy

Pregnancy Category C

In animal studies ziprasidone demonstrated developmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses. Whenziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the maximum recommended human dose [MRHD] of 200 mg/day on a mg/m 2basis). There was no evidence to suggest that these developmental effects were secondary to maternal toxicity. The developmental no-effect dose was 10 mg/kg/day (equivalent to the MRHD on a mg/m 2basis). In rats, embryofetal toxicity (decreased fetal weights, delayed skeletal ossification) was observed following administration of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD on a mg/m 2basis) during organogenesis or throughout gestation, but there was no evidence of teratogenicity. Doses of 40 and 160 mg/kg/day (2 and 8 times the MRHD on a mg/m 2basis) were associated with maternal toxicity. The developmental no-effect dose was 5 mg/kg/day (0.2 times the MRHD on a mg/m 2basis).

There was an increase in the number of pups born dead and a decrease in postnatal survival through the first 4 days of lactation among the offspring of female rats treated during gestation and lactation with doses of 10 mg/kg/day (0.5 times the MRHD on a mg/m 2basis) or greater. Offspring developmental delays and neurobehavioral functional impairment were observed at doses of 5 mg/kg/day (0.2 times the MRHD on a mg/m 2basis) or greater. A no-effect level was not established for these effects.

There are no adequate and well-controlled studies in pregnant women. Ziprasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects:Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Ziprasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2 labor and delivery

The effect of ziprasidone on labor and delivery in humans is unknown.

8.3 nursing mothers

It is not known whether ziprasidone or its metabolites are excreted in human milk. It is recommended that women receiving ziprasidone should not breastfeed.

8.4 pediatric use

The safety and effectiveness of ziprasidone in pediatric patients have not been established.

8.5 geriatric use

Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Nevertheless, the presence of multiple factors that might increase the pharmacodynamic response to ziprasidone, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period for some elderly patients.

9 drug abuse and dependence

9.3 dependence

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).

10 overdosage

11 description

Ziprasidone 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-2H-indol-2-one. The molecular formula of C 21H 21ClN 4OS (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-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C 21H 21ClN 4OS HCl H 2O and its molecular weight is 467.42.

Ziprasidone hydrochloride monohydrate, USP is white to slightly pink powder; slightly soluble in methanol, methylene chloride, isopropyl alcohol and hot tetrahydrofuran, soluble in formic acid and practically insoluble in water and ethanol.

Each capsule contains ziprasidone hydrochloride monohydrate 20 mg or 40 mg or 60 mg or 80 mg and inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch (botanical source: maize), sodium lauryl sulfate, titanium dioxide, water, FD & C Blue 1 (20 mg, 40 mg and 80 mg) and FD & C Red 40 (20 mg, 40 mg and 80 mg). Additionally capsule shells of 20 mg, 40 mg and 80 mg are imprinted with white pharmaceutical ink and capsule shells of 60 mg are imprinted with black pharmaceutical ink. The compositions of the black and white pharmaceutical ink are: butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, titanium dioxide and ferrosoferric oxide (black pharmaceutical ink).

12 clinical pharmacology

12.1 mechanism of action

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 2) and serotonin type 2 (5HT 2) antagonism. As with other drugs having efficacy in bipolar disorder, the mechanism of action of ziprasidone in bipolar disorder is unknown.

12.2 pharmacodynamics

Ziprasidone exhibited high in vitrobinding affinity for the dopamine D 2and D 3, the serotonin 5HT 2A, 5HT 2C, 5HT 1A, 5HT 1D, and 1-adrenergic receptors (K is of 4.8, 7.2, 0.4, 1.3, 3.4, 2, and 10 nM, respectively), and moderate affinity for the histamine H 1receptor (K i=47 nM). Ziprasidone functioned as an antagonist at the D 2,5HT 2A, and 5HT 1Dreceptors, and as an agonist at the 5HT 1Areceptor. Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC 50>1 M). Antagonism at receptors other than dopamine and 5HT 2with similar receptor affinities may explain some of the other therapeutic and side effects of ziprasidone. Ziprasidone's antagonism of histamine H 1receptors may explain the somnolence observed with this drug. Ziprasidone's antagonism of 1-adrenergic receptors may explain the orthostatic hypotension observed with this drug.

12.3 pharmacokinetics

Oral Pharmacokinetics

Ziprasidone's activity is primarily due to the parent drug. The multiple-dose pharmacokinetics of ziprasidone are dose-proportional within the proposed clinical dose range, and ziprasidone accumulation is predictable with multiple dosing. Elimination of ziprasidone is mainly via hepatic metabolism with a mean terminal half- life of about 7 hours within the proposed clinical dose range. Steady-state concentrations are achieved within one to three days of dosing. The mean apparent systemic clearance is 7.5 mL/min/kg. Ziprasidone is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes.

Absorption

Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. The absolute bioavailability of a 20 mg dose under fed conditions is approximately 60%. The absorption of ziprasidone is increased up to two-fold in the presence of food.

Distribution

Ziprasidone has a mean apparent volume of distribution of 1.5 L/kg. It is greater than 99% bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein. The in vitroplasma protein binding of ziprasidone was not altered by warfarin or propranolol, two highly protein-bound drugs, nor did ziprasidone alter the binding of these drugs in human plasma. Thus, the potential for drug interactions with ziprasidone due to displacement is minimal.

Metabolism and Elimination

Ziprasidone is extensively metabolized after oral administration with only a small amount excreted in the urine (<1%) or feces (<4%) as unchanged drug. Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole (BITP) sulphoxide, BITPsulphone, ziprasidone sulphoxide, and S-methyldihydroziprasidone. Approximately 20% of the dose is excreted in the urine, with approximately 66% being eliminated in the feces. Unchanged ziprasidone represents about 44% of total drug-related material in serum. In vitrostudies using human liver subcellular fractions indicate that S methyldihydroziprasidone is generated in two steps. These studies indicate that the reduction reaction is mediated primarily by chemical reduction by glutathione as well as by enzymatic reduction by aldehyde oxidase and the subsequent methylation is mediated by thiol methyltransferase. In vitrostudies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. CYP1A2 may contribute to a much lesser extent. Based on in vivoabundance of excretory metabolites, less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation and approximately two-thirds via reduction. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase.

13 nonclinical toxicology

14 clinical studies

16 how supplied/storage and handling

Ziprasidone hydrochloride capsules, 20 mg are white to slightly pink granular powder filled in size '4' hard gelatin capsules having a dark blue opaque cap printed with '237' in white ink and a white opaque body and are supplied as:

NDC 70771-1179-6 in bottle of 60 capsules

NDC 70771-1179-5 in bottle of 500 capsules

NDC 70771-1179-8 in cartons of 80 capsules (8 x 10 unit-dose)

Ziprasidone hydrochloride capsules, 40 mg are white to slightly pink granular powder filled in size '3' hard gelatin capsules having a dark blue opaque cap printed with'238' in white ink and a dark blue opaque body and are supplied as:

NDC 70771-1180-6 in bottle of 60 capsules

NDC 70771-1180-5 in bottle of 500 capsules

NDC 70771-1180-8 in cartons of 80 capsules (8 x 10 unit-dose)

Ziprasidone hydrochloride capsules, 60 mg are white to slightly pink granular powder filled in size '2' hard gelatin capsules having a white opaque cap printed with '239' in black ink and a white opaque body and are supplied as:

NDC 70771-1181-6 in bottle of 60 capsules

NDC 70771-1181-5 in bottle of 500 capsules

NDC 70771-1181-8 in cartons of 80 capsules (8 x 10 unit-dose)

Ziprasidone hydrochloride capsules, 80 mg are white to slightly pink granular powder filled in size '1' hard gelatin capsules having a dark blue opaque cap printed with '240' in white ink and a light blue opaque body and are supplied as:

NDC 70771-1182-6 in bottle of 60 capsules

NDC 70771-1182-5 in bottle of 500 capsules

NDC 70771-1182-8 in cartons of 80 capsules (8 x 10 unit-dose)

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

17 patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Administration with Food

Instruct patients to take ziprasidone hydrochloride capsules Capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Drug Interactions ( 7.10) and Clinical Pharmacology ( 12.3)].

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 [see Contraindications ( 4.1) and Warnings and Precautions ( 5.3)].

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 [see Warnings and Precautions ( 5.3)].

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 syndrome [see Warnings and Precautions ( 5.5)].

Spl unclassified

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India

Rev.:01/19

Spl patient package insert

Ziprasidone Hydrochloride (zi-PRAS-i-done HYE-droe-KLOR-ide ) Capsules

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.

Symptoms of schizophrenia may include:

  • hearing voices, seeing things, or sensing things that are not there (hallucinations)
  • beliefs that are not true (delusions)
  • unusual suspiciousness (paranoia)
  • becoming withdrawn from family and friends

Symptoms of manic or mixed episodes of bipolar disorder may include:

  • extremely high or irritable mood
  • increased energy, activity, and restlessness
  • racing thoughts or talking very fast
  • easily distracted
  • little need for sleep

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:

  • You have certain heart diseases, for example, long QT syndrome, a recent heart attack, severe heart failure, or certain irregularities of heart rhythm (discuss the specifics with your doctor)
  • You are currently taking medications that should not be taken in combination with ziprasidone, for example, dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.

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:

  • have had any problem with the way your heart beats or any heart related illness or disease
  • any family history of heart disease, including recent heart attack
  • have had any problem with fainting or dizziness
  • are taking or have recently taken any prescription medicines
  • are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
  • have had any problems with your liver
  • are pregnant, might be pregnant, or plan to get pregnant
  • are breast feeding
  • are allergic to any medicines
  • have ever had an allergic reaction to ziprasidone or any of the other ingredients of Ziprasidone Hydrochloride Capsules. Ask your doctor or pharmacist for a list of these ingredients
  • have low levels of potassium or magnesium in your blood

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

  • Take Ziprasidone Hydrochloride Capsules only as directed by your doctor.
  • Swallow the capsules whole.
  • Take Ziprasidone Hydrochloride Capsules with food.
  • It is best to take Ziprasidone Hydrochloride Capsules at the same time each day.
  • Ziprasidone Hydrochloride Capsules may take a few weeks to work. It is important to be patient.
  • Do not change your dose or stop taking your medicine without your doctor's approval.
  • Remember to keep taking your capsules, even when you feel better.

Possible Side Effects

Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you:

  • Faint or lose consciousness
  • Feel a change in the way that your heart beats (palpitations)

Common side effects of Ziprasidone Hydrochloride Capsules include the following and should also be discussed with your doctor if they occur:

  • Feeling unusually tired or sleepy
  • Nausea or upset stomach
  • Constipation
  • Dizziness
  • Restlessness
  • Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
  • Diarrhea
  • Rash
  • Increased cough / runny nose

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 is 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 immediately 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 between 68F to 77F (20C to 25C).

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, talk with your doctor or pharmacist. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

Brands listed are trademarks of their respective owners.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Spl unclassified

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India

Rev.:01/19

Ingredients and appearance - Product information

Ziprasidone capsule- Ziprasidone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 70771-1179
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ziprasidone hydrochloride ( UNII: 216X081ORU)( Ziprasidone - UNII: 6UKA5VEJ6X ) 20 mgin 1

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Ammonia ( UNII: 5138Q19F1X)
Butyl alcohol ( UNII: 8PJ61P6TS3)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Gelatin ( UNII: 2G86QN327L)
Isopropyl alcohol ( UNII: ND2M416302)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Potassium hydroxide ( UNII: WZH3C48M4T)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Color WHITE (WHITE OPAQUE BODY) Shape CAPSULE (CAPSULE)
Size 14 mm Score 1
Imprint Code 237

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA208988 USA

Labeler - Cadila Healthcare Limited( 918596198)

Establishment

Name ID/FEI Business Operations
Cadila Healthcare Limited 918596198 ANALYSIS( 70771-1179, 70771-1180, 70771-1181, 70771-1182), MANUFACTURE( 70771-1179, 70771-1180, 70771-1181, 70771-1182)

Package label.principal display panel

NDC 70771-1179-6

Ziprasidone capsules, 20 mg

60 Capsules

Rx only

NDC 70771-1180-6

Ziprasidone capsules, 40 mg

60 Capsules

Rx only

NDC 70771-1181-6

Ziprasidone capsules, 60 mg

60 Capsules

Rx only

NDC 70771-1182-6

Ziprasidone capsules, 80 mg

60 Capsules

Rx only