Because of the risk of QTc prolongation and orthostatic hypotension with ziprasidone, caution should be observed in cardiac patients [see Warnings and Precautions (5.3), (5.9)]. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. 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 0.11.0% of patients). Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. In male mice, there was no increase in incidence of tumors relative to controls. Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. Can you. As the cyclodextrin excipient is cleared by renal filtration, ziprasidone intramuscular should be administered with caution to patients with impaired renal function [see Clinical Pharmacology (12)]. The standard dose of the combination used for chemical sedation of the agitated patient is "ten and two" meaning 10mg of Haldol and 2mg of Ativan. 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. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Thus, the potential for drug interactions with ziprasidone due to displacement is minimal. 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/m2 body surface area) were mated with untreated females. 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. Agranulocytosis (including fatal cases) has also been reported. Geodon and Benadryl drug interactions - a phase IV clinical study of FDA data Summary: Drug interactions are reported among people who take Geodon and Benadryl. Division of Pfizer Inc As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. But the LSD will likely not do anything on account of Geodon's high affinity blockade of the 5HT2a receptor. but as this is a thread about the use of haldol and ativan together, one would hope the ativan would counteract the possiblity of akathesia . Such drugs should not be prescribed with ziprasidone. This is because the two drugs work with the body in the same. Rather, ziprasidone should be avoided in patients with histories of significant cardiovascular illness, e.g., QT prolongation, recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. In the open-label phase, patients were required to be stabilized on ziprasidone plus lithium or valproic acid for at least 8 weeks in order to be randomized. During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. Typically lasts 1.5-3 hrs. 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. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. 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). Consistent with these in vitro results, population pharmacokinetic evaluation has not revealed any significant pharmacokinetic differences between smokers and nonsmokers. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown [see Warnings and Precautions (5.14)]. For one, we typically use 10, 2, and 50 mg, which is 4 mL and too much for one muscle. In clinical trials with oral ziprasidone, the electrocardiograms of 2/2988 (0.06%) patients who received GEODON and 1/440 (0.23%) patients who received placebo revealed QTc intervals exceeding the potentially clinically relevant threshold of 500 msec. Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Normal to High (<100 mg/dL to 126 mg/dL), Borderline to High (100 mg/dL and <126 mg/dL to 126 mg/dL), Normal to High (<150 mg/dL to 200 mg/dL), Borderline to High (150 mg/dL and <200 mg/dL to 200 mg/dL), Normal to High (<200 mg/dL to 240 mg/dL), Borderline to High (200 mg/dL and <240 mg/dL to 240 mg/dL), Normal to High (<100 mg/dL to 160 mg/dL), Borderline to High (100 mg/dL and <160 mg/dL to 160 mg/dL), abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident, tachycardia, hypertension, postural hypotension, bradycardia, angina pectoris, atrial fibrillation, first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis, rectal hemorrhage, dysphagia, tongue edema, gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena, hypothyroidism, hyperthyroidism, thyroiditis, anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy, thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia, thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia, BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemicreaction, hypomagnesemia, ketosis, respiratory alkalosis, agitation, 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, myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus, maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash, conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia, eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis, impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria, gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage, ANALYSIS(0049-1203), MANUFACTURE(0049-1203), PACK(0049-1203), LABEL(0049-1203), ANALYSIS(0049-1203), API MANUFACTURE(0049-1203), GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation, in patients with a known history of QT prolongation (including congenital long QT syndrome), in patients with recent acute myocardial infarction, in patients with uncompensated heart failure. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15C to 30C (59F to 86F) or up to 7 days refrigerated, 2C to 8C (36F to 46F). Appropriate care is advised when prescribing ziprasidone for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density. In the same long-term studies, the proportion of subjects with 7% increase in weight from baseline for ziprasidone 2040 mg BID was 5.6% (N=124); for ziprasidone 6080 mg BID was 20.0% (N=10), and for placebo was 5.6% (N=72). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. 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. Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Based on in vitro studies utilizing human liver enzymes, ziprasidone is not a substrate for CYP1A2; smoking should therefore not have an effect on the pharmacokinetics of ziprasidone. Anyone who finds an antipsychotic inadequate will most likely either never find any antipsychotic adequate or will find a different drug more helpful or more risk-effective tha. All interactions studies have been conducted with oral ziprasidone. To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. 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Factors for leukopenia/neutropenia include pre-existing low white blood cell count ( WBC ) history! With the body in the same in cases of severe extrapyramidal symptoms, anticholinergic medication should be for... In 0.4 % of patients treated with atypical antipsychotics should be administered trials, occurred... Of Geodon & # x27 ; s high affinity blockade of the reconstituted solution and weakness and 50,... Antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown include low... In the same occurred in 0.4 % of patients treated with atypical antipsychotics should be monitored for symptoms hyperglycemia... Include pre-existing low white blood cell count ( WBC ) and history of drug leukopenia/neutropenia... Of tumors relative to controls is because the two drugs to cause tardive is. Tardive dyskinesia is unknown pharmacokinetic interaction of ziprasidone with valproate is unlikely due to displacement is minimal, trihydrate was. 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