(LOKS a peen)
- Loxapine Succinate
- Oxilapine Succinate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol Powder Breath Activated, Inhalation [preservative free]:
Adasuve: 10 mg (1 ea)
Loxitane: 5 mg [DSC], 10 mg [DSC], 25 mg [DSC], 50 mg [DSC]
Generic: 5 mg, 10 mg, 25 mg, 50 mg
Brand Names: U.S.
- Loxitane [DSC]
- First Generation (Typical) Antipsychotic
Loxapine is a dibenzoxazepine antipsychotic which blocks postsynaptic mesolimbic D1 and D2 receptors in the brain, and also possesses serotonin 5-HT2 blocking activity
Oral, IM, inhalation: Rapid and complete
Hepatic to glucuronide conjugates
Urine (as metabolites); feces (as metabolites)
Onset of Action
Oral, IM: Within 30 minutes; Peak effect: 1.5-3 hours
Inhalation: 2 minutes
Duration of Action
Oral, IM: ~12 hours
Biphasic: Oral: Initial: 5 hours; Terminal: 19 hours; Inhalation: 6-8 hours
Use: Labeled Indications
Schizophrenia: IM, Oral: Treatment of schizophrenia.
Agitation associated with schizophrenia or bipolar I disorder: Inhalation: Acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Oral: Hypersensitivity to loxapine or any component of the formulation; severe drug-induced CNS depression; coma
Inhalation: Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm; acute respiratory symptoms or signs (eg, wheezing); current use of medications to treat airways disease, such as asthma or COPD; history of bronchospasm following loxapine treatment; known hypersensitivity to loxapine or amoxapine
Canadian labeling: Additional contraindication (not in US labeling): Oral, IM: Circulatory collapse
Oral: Initial: 10 mg twice daily (up to 50 mg daily may be considered in severely disturbed patients), increase dose until psychotic symptoms are controlled; usual maintenance: 60-100 mg daily in divided doses 2-4 times daily; satisfactory response often observed with doses of 20-60 mg daily (maximum: 250 mg daily). Therapy should be maintained at lowest effective dose.
IM [Canadian product]: 12.5-50 mg every 4-6 hours or longer; individualize dose early in therapy; some patients respond satisfactorily to twice-daily dosing
Acute treatment of agitation associated with schizophrenia or bipolar I disorder: Inhalation: 10 mg once daily; maximum dose 10 mg per 24-hour period
Reduced dosing may be indicated due to risks of adverse events associated with high-dose therapy. Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling. Canadian labeling does not recommend use in severe hepatic disease.
Inhalation: Remove inhaler from foil pouch; indicator light is off. Firmly pull out the plastic tab from the rear of the inhaler. When the green indicator light turns on, the inhaler is ready for use. Administer inhaler within 15 minutes after removing the tab to prevent automatic deactivation of the inhaler. The green indicator light will turn off when deactivated indicating the inhaler is not usable.
Oral solution [Canadian product] should be mixed with orange or grapefruit juice prior to administration.
Inhalation: Must be administered only by a healthcare professional. Instruct patient to exhale fully. Use inhaler on inspiration and instruct patient to hold breath as long as possible, up to 10 seconds. Check that the green light turns off indicating the dose has been delivered. If the light remains on after the patient inhales, the full dose was not delivered. Repeat inhalation up to 2 additional times. If green light still does not turn off, discard inhaler and use a new one. Inhaler may produce a flash of light and clicking sound, and become warm with use; this is normal. Discard after one use.
Oral solution [Canadian product]: Mix prior to administration.
Solution for injection [Canadian product] is administered by IM injection. Do not administer IV
Capsules: Store at 20°C to 25°C (68°F to 77°F).
Inhalation: Store at 15°C to 30°C (59°F to 86°F).
Canadian products (not available in US): Injection solution, oral solution, tablets: Store at 15°C to 30°C (59°F to 86°F).
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Agents to Treat Airway Disease: May enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Amisulpride: Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Avoid combination
Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Monitor therapy
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): May diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Antipsychotic Agents (First Generation [Typical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Avoid concomitant therapy if possible and monitor for decreased effects of both agents when these combinations cannot be avoided. Atypical antipsychotics such as clozapine and quetiapine may be less likely to reduce the effects of anti-Parkinson agents. Consider therapy modification
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
CarBAMazepine: Loxapine may increase serum concentrations of the active metabolite(s) of CarBAMazepine. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Monitor therapy
LORazepam: Loxapine may enhance the adverse/toxic effect of LORazepam. Specifically, prolonged stupor, respiratory depression, and/or hypotension. Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Consider therapy modification
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
MetyroSINE: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
Piribedil [INT]: Antipsychotic Agents may diminish the therapeutic effect of Piribedil [INT]. Piribedil [INT] may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Monitor therapy
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification
Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Avoid combination
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
False-positives for phenylketonuria, amylase, uroporphyrins, urobilinogen
Inhalation: Frequency not always defined.
Cardiovascular: Hypotension (3%), syncope (2%)
Central nervous system: Sedation (12%)
Gastrointestinal: Dysgeusia (14%)
Respiratory: Respiratory distress (includes bronchospasm, chest pain, cough, dyspnea, pharyngeal edema, wheezing; asthma patients: 54%; COPD patients: 19%), throat irritation (3%)
<1% (Limited to important or life-threatening): Extrapyramidal reaction
Oral: Frequency not defined.
Cardiovascular: ECG changes, edema, flushing (facial), hypertension, hypotension, orthostatic hypotension, syncope, tachycardia
Central nervous system: Agitation, confusion, disruption of body temperature regulation, dizziness, drowsiness, extrapyramidal reaction (akathisia, akinesia, dystonia, drug-induced parkinson’s disease, tardive dyskinesia), headache, hyperpyrexia, insomnia, neuroleptic malignant syndrome (NMS), numbness, paresthesia, sedation, seizure, slurred speech, tension, unsteady gait
Dermatologic: Alopecia, dermatitis, pruritus, seborrhea, skin photosensitivity, skin rash
Endocrine & metabolic: Amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia, menstrual disease, polydipsia, weight gain, weight loss
Gastrointestinal: Constipation, nausea, paralytic ileus, vomiting, xerostomia
Genitourinary: Impotence, priapism (rare), urinary retention
Hematologic & oncologic: Agranulocytosis, leukopenia, thrombocytopenia
Hepatic: Hepatitis, increased serum ALT, increased serum AST, jaundice
Neuromuscular & skeletal: Muscle twitching, weakness
Ophthalmic: Blepharoptosis, blurred vision
Respiratory: Dyspnea, nasal congestion
Concerns related to adverse effects:
• Anticholinergic effects: May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, paralytic ileus, urinary retention, BPH, xerostomia, glaucoma, or visual problems. Relative to other antipsychotics, loxapine has a low potency of cholinergic blockade.
• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use; presence of risk factors (eg, preexisting low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1,000/mm3.
• Bronchospasm: [US Boxed Warning]: Loxapine inhalation can cause bronchospasm that has the potential to lead to respiratory distress and arrest. Administer only in an REMS enrolled healthcare facility with immediate access to on-site equipment and personnel trained to manage acute bronchospasm including advanced airway management (intubation and mechanical ventilation). Prior to administering loxapine inhalation, screen patients regarding a current diagnosis or history of asthma, COPD, or other lung diseases associated with bronchospasm, acute respiratory symptoms or signs, current use of medications used to treat airway disease and examine patients for respiratory abnormalities. Loxapine can cause sedation, which can mask the signs of bronchospasm.
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of pneumonia (ie, Alzheimer disease) (Maddalena 2004).
• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia. Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Risk of tardive dyskinesia and potential for irreversibility may be increased in elderly patients (particularly women), prolonged therapy, and higher total cumulative dose; antipsychotics may also mask signs/symptoms of tardive dyskinesia. Consider therapy discontinuation with signs/symptoms of tardive dyskinesia. Increased incidence of EPS has been observed with IM administration compared to oral administration.
• Hyperprolactinemia: Antipsychotic use has been associated with increased prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown (Lehman [APA] 2004; Pollack 1993; Wang 2002).
• Neuroleptic malignant syndrome (NMS): NMS has been associated with use of antipsychotic agents; monitor for hyperpyrexia, mental status changes, fever, muscle rigidity, and/or autonomic instability. Discontinue treatment immediately with onset of NMS; recurrence has been reported in patients rechallenged with antipsychotic therapy.
• Ocular effects: Antipsychotic use has been associated with pigmentary retinopathy, and lenticular and corneal deposits, particularly with prolonged therapy (Oshika 1995).
• Hypotension: May cause hypotension, orthostatic hypotension, and syncope; use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, dehydration, hypovolemia, or concurrent medication use that may predispose to hypotension/bradycardia).
• Temperature regulation: Antipsychotic use has been associated with impaired core body temperature regulation; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects (Kerwin 2004; Kwok 2005; Martinez 2002).
• Cardiovascular disease: Use with caution in patients with cardiovascular disease.
• Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Loxapine is not approved for the treatment of dementia-related psychosis.
• Hepatic impairment: Canadian labeling recommends avoiding use in severe hepatic disease.
• Parkinson disease: Use with caution in patients with Parkinson disease.
• Seizure disorder: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: In older adults, use increases the risk for developing tardive dyskinesia, particularly elderly women.
Dosage forms specific issues:
• Appropriate use: Injection [Canadian product]: Reserve injection for patients unable to tolerate oral administration; convert to oral dosage form with symptom control and ability to tolerate oral administration.
Mental status; vital signs (as clinically indicated); weight, height, BMI, waist circumference (baseline; at every visit for the first 6 months; quarterly with stable antipsychotic dose); 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 and liver function (annually and as clinically indicated); fasting plasma glucose level/HbA1c (baseline, then yearly; in patients with diabetes risk factors or if gaining weight repeat 4 months after starting antipsychotic, then yearly); fasting lipid panel (baseline; repeat every 2 years if LDL level is normal; repeat every 6 months if LDL level is >130 mg/dL); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (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 6 months; high-risk patients every 3 months); visual changes (inquire yearly); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA 2004; Lehman 2004; Marder 2004).
Inhaler: Monitor for signs and symptoms of bronchospasm (vital signs and chest auscultation) at least every 15 minutes for at least 1 hour after administration.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and 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.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience fatigue, insomnia, constipation, dry mouth, bad taste, or pharyngitis. Have patient report immediately to prescriber signs of infection, wheezing, coughing, chest tightness, shortness of breath, abnormal movements, twitching, change in balance, dysphagia, difficulty speaking, tremors, difficulty moving, rigidity, severe dizziness, passing out, tachycardia, severe headache, illogical thinking, vision changes, eye pain, severe eye irritation, seizures, slurred speech, urinary retention, change in amount of urine passed, loss of strength and energy, bruising, bleeding, enlarged breasts, nipple discharge, sexual dysfunction, amenorrhea, agitation, signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, abnormal heartbeat, or sweating a lot), or signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; and puffing cheeks) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.