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Loxapine
Overview
What is Loxapine?
Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[
][1,4]oxazepine. It is present as the succinate salt.
Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.1 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, benzyl alcohol NF, butyl paraben NF, edetate calcium disodium USP, gelatin, magnesium stearate, methyl paraben NF, polacrilin potassium, propyl paraben NF, sodium lauryl sulfate NF, sodium propionate NF, talc, and titanium dioxide. Additionally, the 10 mg capsule contains D&C Yellow 10 and FD&C Yellow 6, the 25 mg capsule contains D&C Yellow 10 and FD&C Blue 1, the 50 mg capsule contains FD&C Blue 1.
What does Loxapine look like?
What are the available doses of Loxapine?
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What should I talk to my health care provider before I take Loxapine?
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How should I use Loxapine?
Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Loxapine capsules are administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient’s needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs.
What interacts with Loxapine?
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What are the warnings of Loxapine?
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What are the precautions of Loxapine?
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What are the side effects of Loxapine?
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What should I look out for while using Loxapine?
Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.).
Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.
I
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Loxapine is not approved for the treatment of patients with dementia-related psychosis
What might happen if I take too much Loxapine?
Signs and symptoms of overdosage will depend on the amount ingested and individual patient tolerance. As would be expected from the pharmacologic actions of the drug, the clinical findings may range from mild depression 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 loxapine overdosage has also been reported.
The treatment of overdosage is essentially symptomatic and supportive. Early gastric lavage and extended dialysis might be expected to be beneficial. Centrally-acting emetics may have little effect because of the antiemetic action of loxapine. In addition, emesis should be avoided because of the possibility of aspiration of vomitus. Avoid analeptics, such as pentylenetetrazol, which may cause convulsions. Severe hypotension might be expected to respond to the administration of norepinephrine or phenylephrine.
Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated. Additional measures include oxygen and intravenous fluids.
How should I store and handle Loxapine?
Store BENDEKA (bendamustine hydrochloride) injection in refrigerator, 2°-8°C (36°-46°F). Retain in original carton until time of use to protect from light.Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 Loxapine capsules, USP are available in the following strengths:Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell, opaque, with a white body and cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell, opaque, with a white body and yellow cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell, opaque, with a white body and green cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Loxapine succinate, USP 68.1 mg equivalent to 50 mg loxapine, black ink, hard shell, opaque, with a white body and blue cap, printed with “ ” on one half and “ ” on the other, are supplied in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such manifestations of tranquilization as calming effects and suppression of aggressive behavior.
In normal human volunteers, signs of sedation were seen within 20 to 30 minutes after administration, were most pronounced within one and one-half to three hours, and lasted through 12 hours. Similar timing of primary pharmacologic effects was seen in animals.
Non-Clinical Toxicology
Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.).Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.
I
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Loxapine is not approved for the treatment of patients with dementia-related psychosis
There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam.
The risk of using loxapine in combination with CNS-active drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of loxapine and CNS-active drugs is required.
In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.
Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and 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 loxapine succinate capsules at the first sign of a decline in WBC in the 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 less than 1000/mm ) should discontinue loxapine succinate capsules and have their WBC followed until recovery.
CNS Effects:
Extrapyramidal Symptoms - Neuromuscular (extrapyramidal) reactions during the administration of loxapine have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of loxapine dosage or by administration of antiparkinson drugs in usual dosage.
Dystonia
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Persistent Tardive Dyskinesia - As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movement of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time the syndrome may not develop.
Cardiovascular Effects:
A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to loxapine administration.
Hematologic:
Skin:
Anticholinergic Effects:
Gastrointestinal:
Other Adverse Reactions:
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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