Loxapine 5 mg/1
Loxapine · CAPSULE · REMEDYREPACK INC.
Loxapine is a capsule containing loxapine at 5 mg/1, taken oral. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- Loxapine
- Generic Name
- Loxapine
- NDC Code (Product)
70518-0346- Manufacturer
- REMEDYREPACK INC.
- Strength
- 5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA072204
- Marketing Start
- 03/21/2017
Recall History
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Watson Laboratories Inc
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Aidapak Services, LLC
Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014.
Watson Laboratories Inc
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Watson Laboratories Inc
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Mylan Pharmaceuticals Inc.
CGMP Deviations
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Mylan Pharmaceuticals Inc.
CGMP Deviations
Watson Laboratories Inc
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Watson Laboratories Inc
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Loxapine Capsules, USP 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Loxapine 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.
Warnings
WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis 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 ( see BOXED WARNING ). 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 period…
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Drug Interactions 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.
Adverse Reactions
ADVERSE REACTIONS 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 loxapine 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 (see WARNINGS ). 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…
Frequently Asked Questions
What is Loxapine used for?
Loxapine contains Loxapine. It is a capsule taken oral. Consult your doctor for specific uses.
Is Loxapine a controlled substance?
Loxapine is not classified as a controlled substance by the DEA.
What is the generic name for Loxapine?
The generic name for Loxapine is Loxapine. There are no other listed brand versions of Loxapine.
What is the NDC code for Loxapine 5 mg/1?
The NDC (National Drug Code) for Loxapine 5 mg/1 is 70518-0346, listed by REMEDYREPACK INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)