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APO-LOXAPINE is a brand name for Loxapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-LOXAPINE (loxapine succinate tablets) is indicated in the management of the manifestations of schizophrenia. 1.1 Pediatrics Pediatrics (under 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (over 65…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment APO-LOXAPINE is administered orally, usually in divided doses two to four times a day. Daily dosage should be adjusted to the individual patient's needs, as assessed by the severity of symptomsand previous history of response to antipsychotic drugs.
Initial dosage of 10 mg twice daily isrecommended, although, in severely disturbed patients, initial dosage up to a total of 50 mg daily may be desirable. Based on initial response to the drug, dosage may then be increased fairly rapidly over the first seven to ten days until there is effective control of psychotic symptoms.
The usual therapeutic range is 60 mg to 100 mg daily. However, as with other antipsychotic drugs, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.
For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosage in the range of 20 mg to 60 mg daily. Dosage Adjustments for Special Populations Elderly Given the higher incidence of concomitant illness (renal, hepatic and cardiovascular) and concomitant medication in the elderly, APO-LOXAPINE should be used with caution in this population.
Pediatrics Health Canada has not authorized an indication for patients < 18 years of age (see 1 INDICATIONS). 4 Administration The tablets should be taken with a full glass of water. 5 Missed Dose If a patient misses a dose, advise the patient to take the dose as soon as possible and continue with their regular schedule.
If it is almost time for the next dose, advise the patient to skip the missed dose and continue with the next scheduled dose. Advise patients not to take 2 doses of APO-LOXAPINE at the same time to make up for a missed dose.
1 Adverse Reaction Overview, Tardive Dyskinesia). A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with conventional antipsychotic drugs. Although the prevalence of tardive dyskinesia with conventional antipsychotics appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the beginning of treatment, which patients are likely to develop the syndrome.
Both the risk of developing tardive dyskinesia 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 drug treatment is withdrawn.
Antipsychotic drug treatment itself, however, may suppress (or partially suppress) the signs and symptoms of tardive dyskinesia and thereby may possibly mask the underlying process. The effect that symptom suppression has upon the long-term course of the syndrome is unknown.
Given this consideration, APO-LOXAPINE should be prescribed in a manner that is most likely to minimize the risk of the occurrence of tardive dyskinesia. As with any antipsychotic drug, chronic APO-LOXAPINE use should be reserved for patients who appear to be obtaining Page 11 of 36 substantial benefit from the drug.
In such patients, the smallest dose and the shortest duration of treatment should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on loxapine, drug discontinuation should be considered.
) 2 CONTRAINDICATIONS APO-LOXAPINE is contraindicated in patients with: Known hypersensitivity to loxapine or to any ingredient in the formulation of APO- LOXAPINE, including any non-medicinal ingredient, or component of the container.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate inthe drug-treated patients. , pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
) LOXAPINE is not indicated for the treatment of elderly patients with dementia. 2 Recommended Dose and Dosage Adjustment APO-LOXAPINE is administered orally, usually in divided doses two to four times a day. Daily dosage should be adjusted to the individual patient's needs, as assessed by the severity of symptomsand previous history of response to antipsychotic drugs.
Initial dosage of 10 mg twice daily isrecommended, although, in severely disturbed patients, initial dosage up to a total of 50 mg daily may be desirable. Based on initial response to the drug, dosage may then be increased fairly rapidly over the first seven to ten days until there is effective control of psychotic symptoms.
The usual therapeutic range is 60 mg to 100 mg daily. However, as with other antipsychotic drugs, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.
For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosage in the range of 20 mg to 60 mg daily. Dosage Adjustments for Special Populations Elderly Given the higher incidence of concomitant illness (renal, hepatic and cardiovascular) and concomitant medication in the elderly, APO-LOXAPINE should be used with caution in this population.
APO-LOXAPINE is contraindicated in patients with: Known hypersensitivity to loxapine or to any ingredient in the formulation of APO- LOXAPINE, including any non-medicinal ingredient, or component of the container.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Loxapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
However, some patients may require treatment with APO-LOXAPINE despite thepresence of the syndrome.
Neuroleptic Malignant Syndrome (NMS):
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs including loxapine. 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).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. ) 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: (1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, (2) intensive symptomatic treatment and medical monitoring, and (3) treatment of any concomitant serious medical problems for which specific treatment is 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.
Seizures:
APO-LOXAPINE should be used with extreme caution in patients with a history of convulsive disorders, since it lowers the convulsive threshold. Seizures have been reported in epileptic patients receiving loxapine at antipsychotic dose levels, and may occur even with maintenance ofroutine anticonvulsant drug therapy.
Withdrawal-Emergent Neurological Signs:
Abrupt withdrawal after short-term administration of antipsychotic drugs does not generally pose problems. However, transient dyskinetic signs are experienced by some patients on maintenance therapy after abrupt withdrawal. The signs are very similar to those described under Tardive Dyskinesia, except for duration.
Although it is not known whether gradual withdrawal of antipsychotic drugs will decrease the incidence of withdrawal emergent neurological signs, gradual withdrawal would appear to be advisable.
Parkinson’s Disease and Dementia with Lewy Bodies:
Physicians should weigh the risks versus the benefits when prescribing antipsychotic drugs, including APO-LOXAPINE, to patients with Parkinson’s disease or dementia with Lewy bodies (DLB) since both groups may be at increased risk of neuroleptic malignant syndrome as well as having an increased sensitivity to antipsychotic medications.
Manifestation of this increased sensitivity can include confusion, Page 12 of 36 obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms. Ophthalmologic Although clinical experience has not demonstrated ocular toxicity, 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 with caution in patients with glaucoma particularly with concomitant administration of anticholinergic type of anti- Parkinson medication.
Psychiatric Mental Retardation:
APO-LOXAPINE has not been evaluated for the management of behavioural complications in patients with mental retardation, and therefore cannot be recommended in these patients.
Suicide:
The possibility of suicide or attempted suicide is inherent in psychosis, and thus, close supervision and appropriate clinical management of high-risk patients should accompany drug therapy. […]
Pediatrics Health Canada has not authorized an indication for patients < 18 years of age (see 1 INDICATIONS). 4 Administration The tablets should be taken with a full glass of water. 5 Missed Dose If a patient misses a dose, advise the patient to take the dose as soon as possible and continue with their regular schedule.
If it is almost time for the next dose, advise the patient to skip the missed dose and continue with the next scheduled dose. Advise patients not to take 2 doses of APO-LOXAPINE at the same time to make up for a missed dose. 5 OVERDOSAGE Symptoms: Signs and symptoms of overdosage of APO-LOXAPINE would be expected to range from milddepression of the CNS and cardiovascular systems to profound hypotension, respiratory depression and unconsciousness.
The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind. Renal failure following APO-LOXAPINE overdosage has also been reported.
Treatment:
No specific antidote against APO-LOXAPINE is known. The treatment of overdosage wouldbe essentially symptomatic and supportive. Early gastric lavage would be expected to be beneficial as might be extended dialysis. Additional supportive measures include the administration of oxygen and intravenous fluids.
Centrally acting emetics may have little effect because of the anti-emetic action of APO-LOXAPINE. In addition, emesis should be avoided because of the possibility of aspiration of vomitus. Avoid analeptics, which may cause convulsions.
Severe hypotension might occur following the administration of levarterenol or phenylephrine. EPINEPHRINE SHOULD NOT BE USED SINCE ITS USE IN A PATIENT WITH PARTIAL ADRENERGIC BLOCKADE MAY FURTHER LOWER THE BLOOD PRESSURE. Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
For management of a suspected drug overdose, contact your regional poison control centre. Page 7 of 36 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients* oral Tablet 5 mg Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake.
oral Tablet 10 mg Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake.
oral Tablet 25 mg Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, […]