Loxitane IM Uses

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What is Loxitane IM?

Loxitane IM is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxitane IM is used to treat agitation related to schizophrenia or bipolar disorder.

Loxitane IM inhalation is given only in a hospital or clinic setting where any breathing problems can be quickly treated.

Loxitane IM inhalation may also be used for purposes not listed in this medication guide.

Loxitane IM indications

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Loxitane IM is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

"Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension." Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior), leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation.

The efficacy of Loxitane IM was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder.

Limitations of Use:

As part of the Loxitane IM REMS Program to mitigate the risk of bronchospasm, Loxitane IM must be administered only in an enrolled healthcare facility.

How should I use Loxitane IM?

Use Loxitane IM powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Loxitane IM powder.

Uses of Loxitane IM in details

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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. Note: As part of the Loxitane IM REMS program to mitigate the risk of bronchospasm, Loxitane IM inhalation must be administered only in an enrolled health care facility.

Loxitane IM description

An antipsychotic agent used in schizophrenia. [PubChem]

Loxitane IM dosage

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Capsules USP 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.

Oral Administration

Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizophrenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizophrenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.

Maintenance Therapy

For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 to 60 mg daily.

How supplied

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Capsules USP are available in the following strengths:

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Succinate 6.8 mg equivalent to 5 mg Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate), black ink, hard shell, opaque, with a white body and cap, printed with Watson 369 on one half and 5 mg on the other, are supplied in bottles of 100.

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Succinate 13.6 mg equivalent to 10 mg Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate), black ink, hard shell, opaque, with a white body and yellow cap, printed with Watson 370 on one half and 10 mg on the other, are supplied in bottles of 100.

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Succinate 34.0 mg equivalent to 25 mg Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate), black ink, hard shell, opaque, with a white body and green cap, printed with Watson 371 on one half and 25 mg on the other, are supplied in bottles of 100.

Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) Succinate 68.1 mg equivalent to 50 mg Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate), black ink, hard shell, opaque, with a white body and blue cap, printed with Watson 372 on one half and 50 mg on the other, are supplied in bottles of 100.

Store at 20°-25°C (68°-77°F). Dispense in a tight, child-resistant container.

Watson Laboratories, Inc. Corona, CA 92880, USA. Revised: March 2008. FDA Rev date: 12/02/02

Loxitane IM interactions

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What other drugs will affect Loxitane IM?

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There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) and lorazepam.

The risk of using Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) in combination with CNS-active drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of Loxitane IM (Loxitane IM succinate) and CNS-active drugs is required.

Loxitane IM side effects

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What are the possible side effects of Loxitane IM?

CNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported.

Extrapyramidal Symptoms - Neuromuscular (extrapyramidal) reactions during the administration of Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) 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 Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) dosage or by administration of antiparkinson drugs in usual dosage.

DystoniaClass effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

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: Tachycardia, hypotension, hypertension, orthostatic hypotension, lightheadedness, and syncope have been reported.

A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) administration.

Hematologic: Rarely, agranulocytosis, thrombocytopenia, leukopenia.

Skin: Dermatitis, edema (puffiness of face), pruritus, rash, alopecia, and seborrhea have been reported with Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate).

Anticholinergic Effects: Dry mouth, nasal congestion, constipation, blurred vision, urinary retention, and paralytic ileus have occurred.

Gastrointestinal: Nausea and vomiting have been reported in some patients. Hepatocellular injury (i.e., SGOT/SGPT elevation) has been reported in association with Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) administration and rarely, jaundice and/or hepatitis questionably related to Loxitane IM (Loxitane IM (Loxitane IM (Loxitane IM succinate) succinate) succinate) treatment.

Other Adverse Reactions: Weight gain, weight loss, dyspnea, ptosis, hyperpyrexia, flushed facies, headache, paresthesia, and polydipsia have been reported in some patients. Rarely, galactorrhea, amenorrhea, gynecomastia, and menstrual irregularity of uncertain etiology have been reported.

Loxitane IM contraindications

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What is the most important information I should know about Loxitane IM?

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Loxitane IM is not for use in psychotic conditions related to dementia. Loxitane IM may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to Loxitane IM, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have restless muscle movements in your eyes, tongue, jaw, or neck.

Loxitane IM may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. You should not take Loxitane IM if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxitane IM can decrease perspiration and you may be more prone to heat stroke.

Active ingredient matches for Loxitane IM:

Loxapine


Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Loxapine Hydrochloride 50 mg / ml

List of Loxitane IM substitutes (brand and generic names):

Loxitane capsule 10 mg/1 (Watson)
Loxitane capsule 25 mg/1 (Watson)
Loxitane capsule 50 mg/1 (Watson)
Concentrate; Oral; Loxapine Hydrochloride 25 mg / ml
LOXONOR tab 10 mg x 10's (Intra Life (Doxis))$ 0.16
LOXONOR tab 25 mg x 10's (Intra Life (Doxis))$ 0.32
LOXPIN 10MG CAPSULE 1 strip / 10 capsules each (Nusearch Organic)$ 0.51
LOXPIN 25MG CAPSULE 1 strip / 10 capsules each (Nusearch Organic)$ 0.88
Loxpin 25mg Capsule (Nusearch Organic)$ 0.09
Normapac 10 mg Capsule (Magnet Labs Pvt Ltd (Mankind Pharmaceuticals Pvt. Ltd))$ 0.05
Normapac 25 mg Capsule (Magnet Labs Pvt Ltd (Mankind Pharmaceuticals Pvt. Ltd))$ 0.11
Tablet; Oral; Loxapine Succinate 10 mg
Tablet; Oral; Loxapine Succinate 25 mg
Tablet; Oral; Loxapine Succinate 5 mg
Tablet; Oral; Loxapine Succinate 50 mg
Nu-loxapine tablet 50 mg (Nu Pharm Inc (Canada))
Nu-loxapine tablet 5 mg (Nu Pharm Inc (Canada))
Nu-loxapine tablet 10 mg (Nu Pharm Inc (Canada))
Nu-loxapine tablet 25 mg (Nu Pharm Inc (Canada))
Solution; Oral; Loxapine Succinate 25 mg / ml
Tablet; Oral; Loxapine Succinate 10 mg
Tablet; Oral; Loxapine Succinate 2.5 mg
Tablet; Oral; Loxapine Succinate 25 mg
Tablet; Oral; Loxapine Succinate 5 mg
Tablet; Oral; Loxapine Succinate 50 mg
PHL-loxapine tablet 2.5 mg (Pharmel Inc (Canada))
PHL-loxapine tablet 5 mg (Pharmel Inc (Canada))
PHL-loxapine solution 25 mg (Pharmel Inc (Canada))
PHL-loxapine tablet 10 mg (Pharmel Inc (Canada))
PHL-loxapine tablet 25 mg (Pharmel Inc (Canada))
PHL-loxapine tablet 50 mg (Pharmel Inc (Canada))
Rosup 25 mg x 100's (Swiss Pharm)
Xylac 60 ml Syrup (MPS Lifesciences Pvt Ltd)$ 0.04
Xylac tablet 2.5 mg (MPS Lifesciences Pvt Ltd)
Xylac tablet 25 mg (MPS Lifesciences Pvt Ltd)
Xylac tablet 50 mg (MPS Lifesciences Pvt Ltd)
Xylac tablet 5 mg (MPS Lifesciences Pvt Ltd)
Xylac solution 25 mg (MPS Lifesciences Pvt Ltd)
Xylac tablet 10 mg (MPS Lifesciences Pvt Ltd)

References

  1. DailyMed. "LOXAPINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "loxapine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "loxapine". http://www.drugbank.ca/drugs/DB00408 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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