Ziprasidone

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature away from light and excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Ziprasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Ziprasidone is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Ziprasidone may also be used for purposes not listed in this medication guide.

Your pharmacist can provide more information about ziprasidone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Ziprasidone is a prescription medication used to treat symptoms of schizophrenia and bipolar disorder. Ziprasidone belongs to a group of drugs called atypical antipsychotics. It is believed to work by lessening the effects of certain chemicals in the brain involved with schizophrenia and bipolar disorder.

This medication comes in a capsule and suspension form and is usually taken twice daily with food.

This medication is available in an injectable form to be given directly into the muscle (IM) by a healthcare professional.

Common side effects of ziprasidone include nausea, constipation, and drowsiness.  Do not drive or operate machinery until you know how this medication affects you.

Ziprasidone may be found in some form under the following brand names:

• Geodon

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if ziprasidone is excreted in human breast milk or if it will harm your nursing baby.

Oral/Injectable:

The following is a list of recommended dosages:

• 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. 
• 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 40–80 mg twice daily. 
• 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. 
• Acute treatment of agitation associated with schizophrenia (intramuscular administration): 10 mg–20 mg up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every 2 hours. Doses of 10 mg may be administered every 2 hours. Doses of 20 mg may be administered every 4 hours 

Your doctor will determine the best dose for you. Take ziprasidone exactly as prescribed. Follow the directions on your prescription label carefully.

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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Ziprasidone is not approved for the treatment of patients with Dementia-Related Psychosis.

Ziprasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Ziprasidone is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Ziprasidone may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, ziprasidone may cause a severe skin reaction that can be fatal if it spreads to other parts of the body. Stop using this medicine and call your doctor right away if you have a new or worsening skin rash with fever, swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough, or trouble breathing.

Also call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• chest pain, fast or pounding heartbeats;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• low white blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, pain when swallowing;

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, agitation; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, drowsiness, unusual tiredness;

• nausea, upset stomach;

• diarrhea, constipation;

• feeling restless;

• tremors;

• rash; or

• runny nose, new or worsening cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ziprasidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ziprasidone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ziprasidone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ziprasidone in the elderly. However, ziprasidone should not be used for behavioral problems in older adults with dementia.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ziprasidone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ziprasidone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Amifampridine
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bepridil
• Bromopride
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Cisapride
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Dronedarone
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Mefloquine
• Mesoridazine
• Methadone
• Metoclopramide
• Metronidazole
• Mizolastine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pimozide
• Pipamperone
• Piperaquine
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Risperidone
• Ritonavir
• Saquinavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sparfloxacin
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Terfenadine
• Tetrabenazine
• Thioridazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Using ziprasidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Almotriptan
• Amineptine
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buspirone
• Butorphanol
• Carbamazepine
• Ceritinib
• Chlorpheniramine
• Cocaine
• Codeine
• Conivaptan
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Duloxetine
• Eletriptan
• Fentanyl
• Fluvoxamine
• Frovatriptan
• Furazolidone
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Idelalisib
• Iproniazid
• Isocarboxazid
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methamphetamine
• Methylene Blue
• Mifepristone
• Milnacipran
• Mirtazapine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Netupitant
• Nialamide
• Nortriptyline
• Opipramol
• Oxycodone
• Oxymorphone
• Pentazocine
• Phenelzine
• Procarbazine
• Rasagiline
• Remifentanil
• Rizatriptan
• Selegiline
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Tianeptine
• Tramadol
• Tranylcypromine
• Tryptophan
• Vilazodone
• Vortioxetine
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of ziprasidone. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (eg, agranulocytosis, leukopenia, neutropenia) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Priapism (painful or prolonged erection of the penis) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Bradycardia (slow heartbeat) or
• Dehydration or
• Heart or blood vessel disease or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of or
• Trouble with swallowing—May cause side effects to become worse.

• Heart attack, recent acute or
• Heart failure, uncompensated or
• Heart rhythm problems (eg, congenital long QT syndrome, QT prolongation)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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)]

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)].

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 68001-136-06    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 68001-137-06    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 68001-138-06 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 68001-139-06    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.

Hypersensitivity to ziprasidone or any component of the formulation; history of (or current) prolonged QT; congenital long QT syndrome; recent myocardial infarction; uncompensated heart failure; concurrent use of other QTc-prolonging agents including arsenic trioxide, chlorpromazine, class Ia antiarrhythmics (eg, disopyramide, quinidine, procainamide), class III antiarrhythmics (eg, amiodarone, dofetilide, ibutilide, sotalol), dolasetron, droperidol, gatifloxacin, halofantrine, levomethadyl, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, probucol, sparfloxacin, tacrolimus, and thioridazine

Bipolar disorder (acute and maintenance as adjuncts to lithium or valproate): Oral: Initial: 40 mg twice daily; may increase to 60 or 80 mg twice daily on second day of treatment; subsequently adjust dose based on response and tolerability. Usual dosage: 40 to 80 mg twice daily.

Schizophrenia: Initial: 20 mg twice daily. Increase dose based on response and tolerability no more frequently than every 2 days; ordinarily patients should be observed for improvement over several weeks before adjusting the dose. Usual dosage: 40 to 100 mg twice daily. Note: Dosages up to 320 mg per day appear safe; however, there is no data suggesting improved efficacy at higher doses (APA 2004).

Acute agitation (schizophrenia): IM: 10 mg every 2 hours or 20 mg every 4 hours (maximum: 40 mg daily). Oral therapy should replace IM administration as soon as possible.

Delusional parasitosis (off-label use): Oral: 20 to 80 mg twice daily (De Berardis 2013; Freudenmann 2008). Additional data may be necessary to further define the role of ziprasidone in this condition.

Major depressive disorder (adjunct to antidepressants) (off-label use): Oral: Initial: 20 mg twice daily; may increase dose by 20 mg twice daily at weekly increments up to 80 mg twice daily based on response and tolerability. Average daily dose was 98 mg/day in the clinical trial (Papakostas 2015).

Discontinuation of therapy: American Psychiatric Association (APA), Canadian Psychiatric Association (CPA), and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines recommend gradually tapering antipsychotics to avoid withdrawal symptoms and minimize the risk of relapse (APA [Lehman 2004]; Cerovecki 2013; CPA [Addington 2005]; WFSBP [Hasan 2012]); risk for withdrawal symptoms may be highest with highly anti-cholinergic or dopaminergic antipsychotics (Cerovecki 2013). When stopping antipsychotic therapy in patients with schizophrenia, the CPA guidelines recommend a gradual taper over 6 to 24 months, and the APA guidelines recommend reducing the dose by 10% each month (APA [Lehman 2004]; CPA [Addington 2005]). Continuing anti-parkinsonism agents for a brief period after discontinuation may prevent withdrawal symptoms (Cerovecki 2013). When switching antipsychotics, 3 strategies have been suggested: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic), overlap and taper (maintaining the dose of the first antipsychotic while gradually increasing the new antipsychotic, then tapering the first antipsychotic), and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). Evidence supporting ideal switch strategies and taper rates is limited, and results are conflicting (Cerovecki 2013; Remington 2005).

No dosage adjustment is recommended; consider initiating at a low end of the dosage range, with slower titration.

Psychosis/agitation associated with dementia (off-label use): Oral: Initial: 20 to 40 mg daily, in 1 to 2 divided doses; increase total daily dose by 20 to 40 mg increments every 2 to 7 days; doses as high as 160 mg daily have been studied (Berkowitz 2003; Cole 2005; Rocha 2006). In patients without a clinically significant response after 4 weeks, taper and withdraw therapy. In patients with an adequate response, attempt to taper and withdraw therapy within 4 months, unless symptoms recurred with a previous taper attempt. Assess symptoms at least monthly during taper and for at least 4 months after withdrawal of therapy (APA [Reus 2016]).

A 2.5 mg/mL oral solution may be made with the injection. Use 8 vials of the 20 mg injectable powder. Add 1.2 mL of distilled water to each vial to make a 20 mg/mL solution. Once dissolved, transfer 7.5 mL to a calibrated bottle and add quantity of vehicle (Ora-Sweet®) sufficient to make 60 mL. Label "shake well" and "refrigerate". Stable for 14 days at room temperature or 42 days refrigerated (preferred).

Frequencies represent oral administration unless otherwise indicated. Note: Although minor QTc prolongation (mean: 10 msec at 160 mg/day) may occur more frequently (incidence not specified), clinically relevant prolongation (>500 msec) was rare (0.06%) and less than placebo (0.23%).

>10%:

Central nervous system: Drowsiness (oral and IM: 8% to 31%; may be dose-related), extrapyramidal reaction (oral: 1% to 31%), headache (oral and IM: 5% to 18%), dizziness (oral and IM: 3% to 16%; includes lightheadedness; may be dose-related)

Gastrointestinal: Nausea (oral and IM: 8% to 12%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (IM: ≤5%, oral: ≥1%; may be dose-related), chest pain (3%), hypertension (oral and IM: 1% to 3%), tachycardia (1% to 2%), bradycardia (oral and IM: ≤2%), facial edema (≥1%), angina pectoris (≤1%), peripheral edema (≤1%)

Central nervous system: Akathisia (oral: 8% to 10%; IM: ≤2%), anxiety (oral: 5%; may be dose-related), hypoesthesia (1% to 2%), agitation (oral: ≥1%, IM: ≤2%), personality disorder (IM: ≤2%), speech disturbance (oral and IM: ≤2%), amnesia (≥1%), ataxia (≥1%), chills (≥1%), confusion (≥1%), delirium (≥1%), dystonia (≥1%; may be dose-related), falling (≥1%), flank pain (≥1%), hostility (≥1%), hypothermia (≥1%), vertigo (≥1%), withdrawal syndrome (≥1%), anorgasmia (≤1%), atrial fibrillation (≤1%), male sexual disorder (≤1%), paralysis (≤1%), insomnia

Dermatologic: Skin rash (1% to 5%; may be dose-related), fungal dermatitis (1% to 2%), diaphoresis (IM: ≤2%), furunculosis (IM: ≤2%), skin photosensitivity (≥1%), alopecia (≤1%), contact dermatitis (≤1%), ecchymoses (≤1%), eczema (≤1%), exfoliative dermatitis (≤1%), maculopapular rash (≤1%), urticaria (≤1%), vesiculobullous dermatitis (≤1%)

Endocrine & metabolic: Weight gain (4% to 16%), albuminuria (≤1%), amenorrhea (≤1%), dehydration (≤1%), glycosuria (≤1%), hypercholesterolemia (≤1%), hyperglycemia (≤1%), hypermenorrhea (≤1%), hypokalemia (≤1%), increased lactate dehydrogenase (≤1%), increased thirst (≤1%)

Gastrointestinal: Constipation (oral: 9%, IM: ≤2%), dyspepsia (oral: 8%, IM: 2% to 3%), vomiting (oral and IM: 1% to 5%), xerostomia (oral: 4% to 5%; may be dose-related), diarrhea (oral and IM: ≤5%), sialorrhea (4%; may be dose-related), abdominal pain (oral and IM: ≤2%), anorexia (oral and IM: ≤2%; may be dose-related), dysmenorrhea (IM: ≤2%), dysphagia (≤2%), buccoglossal syndrome (≥1%)

Genitourinary: Hematuria (≤1%), impotence (≤1%), lactation (female: ≤1%), priapism (IM: ≤1%), urinary retention (≤1%)

Hematologic & oncologic: Rectal hemorrhage (oral and IM: ≤2%), anemia (≤1%), eosinophilia (≤1%), leukocytosis (≤1%), leukopenia (≤1%), lymphadenopathy (≤1%)

Hepatic: Increased serum alkaline phosphatase (≤1%), increased serum transaminases (≤1%)

Hypersensitivity: Tongue edema (≤3%)

Local: Pain at injection site (IM: 7% to 8%)

Neuromuscular & skeletal: Weakness (oral: 5% to 6%; may be dose-related), myalgia (1% to 2%), paresthesia (oral and IM: ≤2%), abnormal gait (≥1%), akinesia (≥1%), choreoathetosis (≥1%), dysarthria (≥1%), dyskinesia (≥1%), hyperkinesia (≥1%), hypokinesia (≥1%), hypotonia (≥1%), neuropathy (≥1%), tremor (≥1%; may be dose-related), twitching (≥1%), cogwheel rigidity (oral: ≥1%), hypertonia (≥1%), increased creatine phosphokinase (≤1%), tenosynovitis (≤1%)

Ophthalmic: Visual disturbance (3% to 6%; may be dose-related), diplopia (≥1%), oculogyric crisis (≥1%), blepharitis (≤1%), cataract (≤1%), conjunctivitis (≤1%), photophobia (≤1%), xerophthalmia (≤1%)

Otic: Tinnitus (≤1%)

Renal: Polyuria (≤1%)

Respiratory: Respiratory tract infection (8%), rhinitis (oral: 4%), cough (3%), pharyngitis (3%), dyspnea (1% to 2%), flu-like symptoms (oral: ≥1%), epistaxis (≤1%), pneumonia (≤1%)

Miscellaneous: Accidental injury (4%), fever (≥1%), motor vehicle accident (≥1%)

<1% (Limited to important or life-threatening): Agranulocytosis, basophilia, bundle branch block, cardiomegaly, cerebral infarction, cerebrovascular accident, cholestatic jaundice, decreased glucose tolerance, deep vein thrombophlebitis, diabetic coma, DRESS syndrome, ejaculatory disorder, facial droop, fecal impaction, female sexual disorder, first degree atrioventricular block, galactorrhea, gingival hemorrhage, granulocytopenia, gynecomastia, hematemesis, hemophthalmos, hemoptysis, hepatitis, hepatomegaly, hyperchloremia, hyperkalemia, hyperreflexia, hypersensitivity reaction (including allergic dermatitis, orofacial edema), hyperthyroidism, hyperuricemia, hypocalcemia, hypochloremia, hypocholesterolemia, hypochromic anemia, hypoglycemia, hypomagnesemia, hypomania, hyponatremia, hypoproteinemia, hypothyroidism, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased monocytes, increased serum creatinine, increased serum prolactin, jaundice, keratitis, keratoconjunctivitis, ketosis, laryngismus, liver steatosis, lymphedema, lymphocytosis, mania, melena, myocarditis, myoclonus, myopathy, neuroleptic malignant syndrome, neutropenia, nocturia, nystagmus, oliguria, opisthotonos, oral leukoplakia, oral paresthesia, phlebitis, polycythemia, prolonged Q-T interval on ECG, pulmonary embolism, respiratory alkalosis, seizure, serotonin syndrome (with or without serotonergic medications), sleep apnea syndrome (obstructive) (Health Canada 2016, Shirani 2011), Stevens-Johnson syndrome, syncope, tardive dyskinesia, thrombocythemia, thrombocytopenia, thrombophlebitis, thyroiditis, torsades de pointes, torticollis, trismus, urinary incontinence, vaginal hemorrhage, visual field defect

Mental status; vital signs (as clinically indicated); blood pressure (baseline; repeat 3 months after antipsychotic initiation, then yearly); ECG (as clinically indicated); weight, height, BMI, waist circumference (baseline; repeat at 4, 8, and 12 weeks after initiating or changing therapy, then quarterly; consider switching to a different antipsychotic for a weight gain ≥5% of initial weight); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with pre-existing low WBC or history of drug-induced leukopenia/neutropenia); electrolytes (annually and as clinically indicated; perform baseline potassium and magnesium measurements in patients at risk for electrolyte disturbances and periodically monitor if diuretics are initiated during ziprasidone treatment); liver function (annually and as clinically indicated); personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease (baseline; repeat annually); fasting plasma glucose level/HbA1c (baseline; repeat 3 months after starting antipsychotic, then yearly); fasting lipid panel (baseline; repeat 3 months after initiation of antipsychotic; if LDL level is normal repeat at 2-5 year intervals or more frequently if clinical indicated); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (at each visit for the first 12 weeks after the antipsychotic is initiated or until the dose is stable, then yearly); abnormal involuntary movements or parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 12 months; high-risk patients every 6 months); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA, 2004; Lehman, 2004; Marder, 2004).

Adverse events were observed in animal reproduction studies. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization. Ziprasidone may cause hyperprolactinemia, which may decrease reproductive function in both males and females.

The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG, 2008).

Healthcare providers are encouraged to enroll women 18-45 years of age exposed to ziprasidone during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388 or http://www.womensmentalhealth.org/pregnancyregistry).

Oral: No adjustment recommended
IM: Use cautiously as the cyclodextrin excipient is cleared by renal filtration; IM formulation has not been systematically studied in patients with renal impairment.