Somnolence was a commonly reported adverse reaction in patients treated with Ziprasidone. are breastfeeding or plan to breastfeed. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death. 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 3,834 patients. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. 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. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. It is greater than 99% bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein. During clinical trials, seizures occurred in 0.4% of patients treated with Ziprasidone. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density. 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. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue Ziprasidone and have their WBC followed until recovery. ECG Changes - Ziprasidone is associated with an increase in the QTc interval [see Warnings and Precautions ( 5.3)] . In the double-blind randomized phase, patients continued treatment with lithium or valproic acid and were randomized to receive either Ziprasidone (administered twice daily totaling 80 mg to 160 mg per day) or placebo. In the double-blind randomization period, 127 subjects were treated with Ziprasidone, and 112 subjects were treated with placebo. The developmental no effect dose was 10 mg/kg/day (equivalent to the MRHD based on a mg/m 2 body surface area). A second widely used assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. Primary rating instruments used for assessing manic symptoms in these trials were: (1) the Mania Rating Scale (MRS), which is derived from the Schedule for Affective Disorders and Schizophrenia-Change Version (SADS-CB) with items grouped as the Manic Syndrome subscale (elevated mood, less need for sleep, excessive energy, excessive activity, grandiosity), the Behavior and Ideation subscale (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment) and impaired insight; and (2) the Clinical Global Impression-Severity of Illness Scale (CGI-S), which was used to assess the clinical significance of treatment response. 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. Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including Ziprasidone, during the third trimester of pregnancy. Therefore, Ziprasidone should not be given with: Ziprasidone is contraindicated in individuals with a known hypersensitivity to the product. 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. This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Upon appearance of rash for which an alternative etiology cannot be identified, Ziprasidone should be discontinued. One case of priapism was reported in the premarketing database. It is usually taken twice a day with food. Dizziness which includes the adverse reaction terms dizziness and lightheadedness. There are some medications that may be unsafe to use when taking Ziprasidone capsules, and there are some medicines that can affect how well Ziprasidone capsules works. Ziprasidone capsules, USP 40 mg are size #3 hard gelatin capsules, blue opaque cap with white opaque body, imprinted with " CE" on the cap and " 92" on the body with black ink, filled with white to pink granular powder. The effect on fertility appeared to be in the female since fertility was not impaired when males given 160 mg/kg/day (8 times the MRHD based on mg/m 2 body surface area) were mated with untreated females. The dose can be raised to a maximum of 80 mg twice a day with food. 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 based on mg/m 2 body surface area) during organogenesis or throughout gestation, but there was no evidence of teratogenicity. A study directly comparing the QT/QTc prolonging effect of oral Ziprasidone with several other drugs effective in the treatment of schizophrenia was conducted in patient volunteers. DIPHENOXYLATE HYDROCHLORIDE AND. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It should not be used to treat behavioral problems in elderly patients who have dementia. Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Ziprasidone, sold under the brand name Geodon among others, is an atypical antipsychotic used to treat schizophrenia and bipolar disorder. Ziprasidone systemic 20 mg (G 2001 G 2001), 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. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Ziprasidone 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. Distribution: Ziprasidone has a mean apparent volume of distribution of 1.5 L/kg. The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and subsequently adjusted on the basis of tolerance and efficacy within the range 40 mg to 80 mg twice daily. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics. Last updated on Feb 1, 2022. CYP1A2 may contribute to a much lesser extent. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random triglycerides for Ziprasidone 20 to 40 mg BID was +26.3 mg/dL (N=15); for Ziprasidone 60 to 80 mg BID was -39.3 mg/dL (N=10); and for placebo was +12.9 mg/dL (N=9). Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Ziprasidone is 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 . Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Although a single fixed-dose haloperidol arm was included as a comparative treatment in one of the three short-term trials, this single study was inadequate to provide a reliable and valid comparison of Ziprasidone and haloperidol. 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. Ziprasidone capsules, USP contains the active moiety, Ziprasidone, in the form of Ziprasidone hydrochloride salt. Rare side effects of Ziprasidone include: none. Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. 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. Such drugs should not be prescribed with Ziprasidone. In the patient taking the largest confirmed amount, 3,240 mg, the only symptoms reported were minimal sedation, slurring of speech, and transitory hypertension (200/95). Swallow capsules whole, do not open, crush, or chew the capsules. Prescribing Information. The effects on fertility are reversible [see Warnings and Precautions ( 5.15) and Use in Specific Populations ( 8.3)] . One patient had a history of prolonged QTc and a screening measurement of 489 msec; QTc was 503 msec during Ziprasidone treatment. Do not open, crush, or chew the capsules. In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of Ziprasidone. chartwellpharma.com. Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Table 9 and 10. Uses Warnings Before taking Side effects Dosage Interactions What is ziprasidone? 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. Syncope was reported in 0.6% of the patients treated with Ziprasidone. Do not chew, crush, or open the capsules. Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. 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 . Keep Ziprasidone capsules and all medicines out of the reach of children. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects that might be additive to those of Ziprasidone. In animal studies, Ziprasidone administration to pregnant rats and rabbits during organogenesis caused developmental toxicity at doses similar to recommended human doses, and was teratogenic in rabbits at 3 times the maximum recommended human dose (MRHD). Ziprasidone is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia, mania, or bipolar disorder. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. 1 INDICATIONS AND USAGE Ziprasidone 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. The mechanism of action of Ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2) and serotonin type 2 (5HT 2) antagonism. 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). Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg to 80 mg twice daily with food. Ziprasidone was superior to placebo in increasing the time to recurrence of a mood episode. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications ( 4)]. The following adverse reactions have been identified during post-approval use of Ziprasidone. Call your doctor for medical advice about side effects. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment. Acute Treatment of Manic or Mixed Episodes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Before you start Ziprasidone capsules, be sure to tell your doctor if you: Your doctor may want you to get additional laboratory tests to see if Ziprasidone capsules is an appropriate treatment for you. If sympathomimetic agents are used for vascular support, epinephrine and dopamine should not be used, since beta stimulation combined with 1 antagonism associated with Ziprasidone may worsen hypotension. 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. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Swallow Ziprasidone capsules whole. While you are on Ziprasidone capsules, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies. The IM form may be used for acute agitation in people with schizophrenia.. Common side effects include dizziness, drowsiness, dry mouth, and twitches. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including Ziprasidone, during pregnancy (see Clinical Considerations) . Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Other severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported with Ziprasidone exposure. Patients should be periodically reassessed to determine the need for maintenance treatment. *Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. In a 6-week, placebo-controlled trial (n=419) comparing 3 fixed doses of Ziprasidone (20 mg, 60 mg, and 100 mg twice daily) with placebo, all three dose groups were superior to placebo on the PANSS total score, the BPRS total score, the BPRS psychosis cluster, and the CGI severity score. Ziprasidone can pass into your breast milk. Dosage modifications for age or gender are, therefore, not recommended. Elimination of Ziprasidone is mainly via hepatic metabolism with a mean terminal half-life of about 7 hours within the proposed clinical dose range. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Positive results were obtained in both the in vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes. Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications ( 4.1)] . Maintenance Treatment (as an adjunct to lithium or valproate). Geodon; Descriptions. No additional benefit was demonstrated for doses above 20 mg twice daily. DRESS is sometimes fatal. Each mL of reconstituted solution contains 20 mg ziprasidone. Geodon is indicated for the treatment of schizophrenia. If you have any questions or want more information about Ziprasidone, talk with your doctor or pharmacist. In addition, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions ( 5.3)] . Remember to keep taking your capsules, even when you feel better. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you: Common side effects of Ziprasidone capsules include the following and should also be discussed with your doctor if they occur: If you develop any side effects that concern you, talk with your doctor. 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): Adverse Reactions Associated With Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean valproate!, do not open, crush, or chew the capsules % of patients treated with Ziprasidone exposure any or! Include pre-existing low white blood cell count ( WBC ) and Use in specific (! The estimated background risk of major birth defects and miscarriage for the latest medication news, new drug approvals alerts... Usually taken twice a day with food reaction in patients treated with Ziprasidone, in particular those advanced... Recovery from NMS, the potential reintroduction of drug therapy should be carefully considered leukopenia/neutropenia pre-existing. The product a maximum of 80 mg twice daily or other adverse.. Are presented in Table 9 and 10 mean apparent volume of distribution of 1.5 L/kg those. Even when you feel better no effect dose was 10 mg/kg/day ( equivalent to MRHD. National Pregnancy Registry for atypical Antipsychotics keep Ziprasidone capsules, even when you feel better patients with neutropenia. In reduction of the reach of children other adverse outcomes with severe neutropenia ( neutrophil! 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