Loxapine

Loxapine is a prescription medication used for the treatment of Schizophrenia.

• Loxapine is available under the following different brand names: Loxitane

Adult  dosage

Capsule

• 5mg
• 10mg
• 25mg
• 50mg

Schizophrenia

Adult dosage

• Initial: 10-25 mg orally every 12 hours
• Maintenance: 60-100 mg/day divided every 6-12 hours; not to exceed 250 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Loxitane include:

• dizziness,
• problems with balance or walking,
• swelling in the face,
• itching,
• rash,
• tremors,
• muscle twitching,
• stiffness,
• numbness,
• weakness,
• blurred vision,
• feeling restless or agitated,
• nausea,
• vomiting,
• constipation,
• dry mouth,
• stuffy nose, and
• sleep problems (insomnia).

Serious side effects of the Loxitane include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fast or uneven heart rate,
• lightheadedness,
• confusion,
• slurred speech,
• seizure,
• sudden weakness,
• ill-feeling,
• fever,
• chills,
• sore throat,
• cough,
• cold or flu symptoms,
• little or no urination,
• severe constipation,
• very stiff (rigid) muscle,
• high fever,
• sweating,
• confusion, and
• tremors

Rare side effects of the Loxitane include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Loxitane has severe interactions with the following drug:
  • amisulpride
• Loxitane has serious interactions with at least 22 other drugs.
• Loxitane has moderate interactions with at least 258 other drugs.
• Loxitane has minor interactions with the following drugs:
  • brimonidine
  • chasteberry
  • ethanol
  • eucalyptus
  • sage
  • smoking

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity; severe CNS depression; severe liver or cardiac disease, bone marrow suppression; narrow-angle glaucoma
• CNS depression (including coma), neuroleptic malignant syndrome (NMS), poorly controlled seizure disorder

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Loxitane?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Loxitane?”

Cautions

• Use with extreme caution in patients with a history of convulsive disorders since it lowers the convulsive threshold; seizures have been reported in patients receiving drugs at antipsychotic dose levels and may occur in epileptic patients even with the maintenance of routine anticonvulsant drug therapy
• The drug has an antiemetic effect in animals; since this effect may also occur in man, therapy may mask signs of overdosage of toxic drugs and may obscure conditions such as intestinal obstruction and brain tumor
• Use with caution in patients with cardiovascular disease; increased pulse rates are reported in the majority of patients receiving antipsychotic doses; transient hypotension has been reported
• Watch for hypotension if administering IM; in the presence of severe hypotension requiring vasopressor therapy, the preferred drugs may be norepinephrine or angiotensin; usual doses of epinephrine may be ineffective because of inhibition of its vasopressor effect by the drug
• The possibility of ocular toxicity from therapy cannot be excluded; careful observation should be made for pigmentary retinopathy and lenticular pigmentation since these have been observed in some patients receiving certain other antipsychotic drugs for prolonged periods
• Because of possible anticholinergic action, the drug should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medication
• Experience to date indicates the possibility of a slightly higher incidence of extrapyramidal effects following intramuscular administration than normally anticipated with oral formulations; the increase may be attributable to higher plasma levels following intramuscular injection
• Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration; tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer
• Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients; an increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs; neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association
• In patients taking benzodiazepines, loxapine should be preceded by stopping benzodiazepine therapy for 2 weeks to avoid drug interactions capable of respiratory depression
• May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
• FDA warning regarding off-label use for dementia in elderly
• Can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest (see BBW)
• Tardive dyskinesia
  • Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs
  • Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome
  • Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown; both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase
  • However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses; there is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn
  • Antipsychotic treatment itself, however, may suppress (or partially suppress) signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process
  • The effect that symptomatic suppression has on the long-term course of the syndrome is unknown; given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia
  • Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, is known to respond to antipsychotic drugs, and for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate
  • In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought; the need for continued treatment should be reassessed periodically
  • If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered; however, some patients may require treatment despite the presence of the syndrome
• Neuroleptic malignant syndrome
  • A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic drugs
  • Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias); the diagnostic evaluation of patients with this syndrome is complicated
  • In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (eg, pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS); other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology
  • The management of NMS should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems for which specific treatments are available
  • There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS; if a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered
  • The patient should be carefully monitored since recurrences of NMS have been reported; the drug, like other antipsychotics, may impair mental and/or physical abilities, especially during the first few days of therapy; therefore, ambulatory patients should be warned about activities requiring alertness (eg, operating vehicles or machinery) and about the concomitant use of alcohol and other CNS depressants
  • The drug has not been evaluated for the management of behavioral complications in patients with mental retardation, and therefore, it cannot be recommended
• Leukopenia, neutropenia, agranulocytosis
  • Leukopenia/neutropenia and agranulocytosis reported temporally related to antipsychotic agents
  • Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and a history of drug-induced leukopenia/neutropenia
  • Patients with a preexisting low WBC or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue therapy at the first sign of a decline in WBC in absence of other causative factors
  • 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
  • Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue therapy and have their WBC followed until recovery
• REMS to mitigate bronchospasm
  • Available only through a restricted program under a REMS called the ADASUVE REMS
  • Healthcare facilities that dispense and administer therapy must be enrolled and comply with REMS requirements; certified healthcare facilities must be able to provide immediate access on-site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services
  • Facilities must have a short-acting bronchodilator (e.g., albuterol), including nebulizers and inhalation solutions, for immediate treatment of bronchospasm
  • Wholesalers and distributors must distribute only to enrolled healthcare facilities

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
• These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization
• Lactation
  • Avoid in breastfeeding