Geodon
- Generic Name: ziprasidone
- Brand Name: Geodon
Geodon (Ziprasidone) side effects drug center
Geodon Side Effects Center
What Is Geodon?
Geodon (ziprasidone HCl and ziprasidone mesylate) is an atypical antipsychotic used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Geodon also can be used as maintenance treatment of bipolar disorder when added to lithium or valproate.
What Are Side Effects of Geodon?
Common side effects of Geodon include
- feeling unusually tired or sleepy;
- nausea,
- vomiting,
- upset stomach,
- loss of appetite;
- constipation;
- dizziness,
- drowsiness;
- restlessness;
- anxiety,
- headache,
- depression;
- abnormal muscle movements,
- such as tremor,
- shuffling, and
- uncontrolled involuntary movements,
- muscle pain or twitching;
- diarrhea;
- skin rash;
- weight gain, and
- increased cough or runny or stuffy nose.
Serious side effects of Geodon include
- fainting or
- loss of consciousness or
- heart palpitations.
This is not a complete list of side effects, and others may occur.
Dosage for Geodon
Geodon (ziprasidone HCl) is available as capsules and Geodon (ziprasidone mesylate) is available as an injection for intramuscular use. Geodon Capsules should be administered at an initial daily dose of 20 mg twice daily with food. For intramuscular dosing, the recommended dose of Geodon is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day.
What Drugs, Substances, or Supplements Interact with Geodon?
Geodon may interact with other medicines that make you sleepy (such as cold or allergy medicines, narcotics, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety), diuretics (water pills), blood pressure medicines, heart rhythm medicines, carbamazepine, cisapride, haloperidol, or medicines used to treat Parkinson's Disease.
Tell your doctor all medications and supplements you use.
Geodon During Pregnancy and Breastfeeding
Geodon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women receiving Geodon should not breastfeed. Taking antipsychotic medication such as Geodon during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking Geodon during pregnancy. If you become pregnant while taking Geodon, do not stop taking it without your doctor's advice.
Additional Information
Our Geodon Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Geodon Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Stop using ziprasidone and call your doctor at once if you have:
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
- any skin rash, no matter how mild;
- low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, agitation.
Common side effects may include:
- dizziness, drowsiness, weakness;
- headache;
- nausea, vomiting;
- trouble swallowing;
- weight gain;
- feeling restless or being unable to sit still;
- tremors, involuntary muscle movements;
- vision problems; 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.
Read the entire detailed patient monograph for Geodon (Ziprasidone)
Geodon Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical trials for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure.
Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.
Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Findings Observed In Short-Term, Placebo-Controlled Trials With Oral Ziprasidone
The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.
Commonly Observed Adverse Reactions In Short Term-Placebo-Controlled Trials
The following adverse reactions were the most commonly observed adverse reactions associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo):
Schizophrenia trials (see Table 11)
- Somnolence
- Respiratory Tract Infection
Bipolar trials (see Table 12)
- Somnolence
- Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
- Dizziness which includes the adverse reaction terms dizziness and lightheadedness.
- Akathisia
- Abnormal Vision
- Asthenia
- Vomiting
Schizophrenia
Adverse Reactions Associated With Discontinuation Of Treatment In Short-Term, Placebo-Controlled Trials of Oral Ziprasidone
Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see WARNINGS AND PRECAUTIONS].
Adverse Reactions Occurring At An Incidence Of 2% Or More Among Ziprasidone-Treated Patients In Short-Term, Oral, Placebo- Controlled Trials
Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.
Table 11: Treatment-Emergent Adverse Reaction Incidence In Short-Term Oral Placebo-Controlled Trials - Schizophrenia
| Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | |
| Ziprasidone (N=702) |
Placebo (N=273) |
|
| Body as a Whole | ||
| Asthenia | 5 | 3 |
| Accidental Injury | 4 | 2 |
| Chest Pain | 3 | 2 |
| Cardiovascular | ||
| Tachycardia | 2 | 1 |
| Digestive | ||
| Nausea | 10 | 7 |
| Constipation | 9 | 8 |
| Dyspepsia | 8 | 7 |
| Diarrhea | 5 | 4 |
| Dry Mouth | 4 | 2 |
| Anorexia | 2 | 1 |
| Nervous | ||
| Extrapyramidal Symptoms* | 14 | 8 |
| Somnolence | 14 | 7 |
| Akathisia | 8 | 7 |
| Dizziness† | 8 | 6 |
| Respiratory | ||
| Respiratory Tract Infection | 8 | 3 |
| Rhinitis | 4 | 2 |
| Cough Increased | 3 | 1 |
| Skin and Appendages | ||
| Rash | 4 | 3 |
| Fungal Dermatitis | 2 | 1 |
| Special Senses | ||
| Abnormal Vision | 3 | 2 |
| *Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials.™ †Dizziness includes the adverse reaction terms dizziness and lightheadedness. | ||
Dose Dependency Of Adverse Reactions In Short-Term, Fixed-Dose, Placebo-Controlled Trials
An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision.
Extrapyramidal Symptoms (EPS)
The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.
Dystonia
Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Vital Sign Changes
Ziprasidone is associated with orthostatic hypotension [see WARNINGS AND PRECAUTIONS]
ECG Changes
Ziprasidone is associated with an increase in the QTc interval [see WARNINGS AND PRECAUTIONS]. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients.
Other Adverse Reactions Observed During The Premarketing Evaluation Of Oral Ziprasidone
Following is a list of COSTART terms that reflect treatment-emergent adverse reactions as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses >4 mg/day within the database of 3834 patients. All reported reactions are included except those already listed in Table 11 or elsewhere in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it.
Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:
Frequent - adverse reactions occurring in at least 1/100 patients (≥1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);
Infrequent - adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)
Rare - adverse reactions occurring in fewer than 1/1000 patients (<0.1% of patients).
Body as a Whole
Frequent abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident
Cardiovascular System
Frequent tachycardia, hypertension, postural hypotension
Infrequent bradycardia, angina pectoris, atrial fibrillation
Rare first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis
Digestive System
Frequent anorexia, vomiting
Infrequent rectal hemorrhage, dysphagia, tongue edema
Rare gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena
Endocrine
Rare hypothyroidism, hyperthyroidism, thyroiditis
Hemic and Lymphatic System
Infrequent anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy
Rare thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia
Metabolic and Nutritional Disorders
Infrequent thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia
Rare BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemicreaction, hypomagnesemia, ketosis, respiratory alkalosis
Musculoskeletal System
Frequent myalgia
Infrequent tenosynovitis
Rare myopathy
Nervous System
Frequentagitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy
Infrequent paralysis
Rare myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus
Respiratory System
Frequent dyspnea
Infrequent pneumonia, epistaxis
Rare hemoptysis, laryngismus
Skin and Appendages
Infrequent maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash
Special Senses
Frequent fungal dermatitis
Infrequent conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia
Rare eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis
Urogenital System
Infrequent impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria
Rare gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage
Bipolar Disorder
Acute Treatment Of Manic Or Mixed Episodes
Adverse Reactions Associated With Discontinuation Of Treatment In Short Term, Placebo-Controlled Trials
Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.
Adverse Reactions Occurring At An Incidence Of 2% Or More Among Ziprasidone-Treated Patients In Short-Term, Oral, Placebo- Controlled Trials
Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.
Table 12: Treatment-Emergent Adverse Reactions Incidence In Short-Term Oral Placebo-Controlled Trials - Manic and Mixed Episodes Associated with Bipolar Disorder
| Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | |
| Ziprasidone (N=279) |
Placebo (N=136) |
|
| Body as a Whole | ||
| Headache | 18 | 17 |
| Asthenia | 6 | 2 |
| Accidental Injury | 4 | 1 |
| Cardiovascular | ||
| Hypertension | 3 | 2 |
| Digestive | ||
| Nausea | 10 | 7 |
| Diarrhea | 5 | 4 |
| Dry Mouth | 5 | 4 |
| Vomiting | 5 | 2 |
| Increased Salivation | 4 | 0 |
| Tongue Edema | 3 | 1 |
| Dysphagia | 2 | 0 |
| Musculoskeletal | ||
| Myalgia | 2 | 0 |
| Nervous | ||
| Somnolence | 31 | 12 |
| Extrapyramidal Symptoms* | 31 | 12 |
| Dizziness† | 16 | 7 |
| Akathisia | 10 | 5 |
| Anxiety | 5 | 4 |
| Hypesthesia | 2 | 1 |
| Speech Disorder | 2 | 0 |
| Respiratory | ||
| Pharyngitis | 3 | 1 |
| Dyspnea | 2 | 1 |
| Skin and Appendages | ||
| Fungal Dermatitis | 2 | 1 |
| Special Senses | ||
| Abnormal Vision | 6 | 3 |
| *Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.™ †Dizziness includes the adverse reaction terms dizziness and lightheadedness. | ||
Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.
Intramuscular Ziprasidone
Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone
Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.
In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).
Table 13: Treatment-Emergent Adverse Reaction Incidence In Short-Term Fixed-Dose Intramuscular Trials
| Body System/Adverse Reaction | Percentage of Patients Reporting Reaction | ||
| Ziprasidone 2 mg (N=92) |
Ziprasidone 10 mg (N=63) |
Ziprasidone 20 mg (N=41) |
|
| Body as a Whole | |||
| Headache | 3 | 13 | 5 |
| Injection Site Pain | 9 | 8 | 7 |
| Asthenia | 2 | 0 | 0 |
| Abdominal Pain | 0 | 2 | 0 |
| Flu Syndrome | 1 | 0 | 0 |
| Back Pain | 1 | 0 | 0 |
| Cardiovascular | |||
| Postural Hypotension | 0 | 0 | 5 |
| Hypertension | 2 | 0 | 0 |
| Bradycardia | 0 | 0 | 2 |
| Vasodilation | 1 | 0 | 0 |
| Digestive | |||
| Nausea | 4 | 8 | 12 |
| Rectal Hemorrhage | 0 | 0 | 2 |
| Diarrhea | 3 | 3 | 0 |
| Vomiting | 0 | 3 | 0 |
| Dyspepsia | 1 | 3 | 2 |
| Anorexia | 0 | 2 | 0 |
| Constipation | 0 | 0 | 2 |
| Tooth Disorder | 1 | 0 | 0 |
| Dry Mouth | 1 | 0 | 0 |
| Nervous | |||
| Dizziness | 3 | 3 | 10 |
| Anxiety | 2 | 0 | 0 |
| Insomnia | 3 | 0 | 0 |
| Somnolence | 8 | 8 | 20 |
| Akathisia | 0 | 2 | 0 |
| Agitation | 2 | 2 | 0 |
| Extrapyramidal Syndrome | 2 | 0 | 0 |
| Hypertonia | 1 | 0 | 0 |
| Cogwheel Rigidity | 1 | 0 | 0 |
| Paresthesia | 0 | 2 | 0 |
| Personality Disorder | 0 | 2 | 0 |
| Psychosis | 1 | 0 | 0 |
| Speech Disorder | 0 | 2 | 0 |
| Respiratory | |||
| Rhinitis | 1 | 0 | 0 |
| Skin and Appendages | |||
| Furunculosis | 0 | 2 | 0 |
| Sweating | 0 | 0 | 2 |
| Urogenital | |||
| Dysmenorrhea | 0 | 2 | 0 |
| Priapism | 1 | 0 | 0 |
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of GEODON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following : Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors), [see WARNINGS AND PRECAUTIONS]; Digestive System Disorders: Swollen Tongue; Reproductive System and Breast Disorders: Galactorrhea, priapism; Nervous System Disorders: Facial Droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); Urogenital System Disorders: Enuresis, urinary incontinence; Vascular Disorders: Postural hypotension, syncope.
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:
Metabolic Pathway
Approximately two-thirds of ziprasidone is metabolized via a combination of chemical reduction by glutathione and enzymatic reduction by aldehyde oxidase. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation.
In Vitro Studies
An in vitro enzyme inhibition study utilizing human liver microsomes showed that ziprasidone had little inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, and thus would not likely interfere with the metabolism of drugs primarily metabolized by these enzymes. There is little potential for drug interactions with ziprasidone due to displacement [see CLINICAL PHARMACOLOGY].
Pharmacodynamic Interactions
Ziprasidone should not be used with any drug that prolongs the QT interval [see CONTRAINDICATIONS].
Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs.
Because of its potential for inducing hypotension, ziprasidone may enhance the effects of certain antihypertensive agents.
Ziprasidone may antagonize the effects of levodopa and dopamine agonists.
Pharmacokinetic Interactions
Carbamazepine
Carbamazepine is an inducer of CYP3A4; administration of 200 mg twice daily for 21 days resulted in a decrease of approximately 35% in the AUC of ziprasidone. This effect may be greater when higher doses of carbamazepine are administered.
Ketoconazole
Ketoconazole, a potent inhibitor of CYP3A4, at a dose of 400 mg QD for 5 days, increased the AUC and Cmax of ziprasidone by about 35-40%. Other inhibitors of CYP3A4 would be expected to have similar effects.
Cimetidine
Cimetidine at a dose of 800 mg QD for 2 days did not affect ziprasidone pharmacokinetics.
Antacid
The co-administration of 30 mL of Maalox® with ziprasidone did not affect the pharmacokinetics of ziprasidone.
Lithium
Ziprasidone at a dose of 40 mg twice daily administered concomitantly with lithium at a dose of 450 mg twice daily for 7 days did not affect the steady-state level or renal clearance of lithium. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels.
Oral Contraceptives
In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. Ziprasidone at a dose of 20 mg twice daily did not affect the pharmacokinetics of concomitantly administered oral contraceptives, ethinyl estradiol (0.03 mg) and levonorgestrel (0.15 mg).
Dextromethorphan
Consistent with in vitro results, a study in normal healthy volunteers showed that ziprasidone did not alter the metabolism of dextromethorphan, a CYP2D6 model substrate, to its major metabolite, dextrorphan. There was no statistically significant change in the urinary dextromethorphan/dextrorphan ratio.
Valproate
A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels.
Other Concomitant Drug Therapy
Population pharmacokinetic analysis of schizophrenic patients enrolled in controlled clinical trials has not revealed evidence of any clinically significant pharmacokinetic interactions with benztropine, propranolol, or lorazepam.
Food Interaction
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 [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Geodon (Ziprasidone)
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