Loxapine Succinate description, usages, side effects, indications, overdosage, supplying and lots more!

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Loxapine Succinate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING
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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis (seeWARNINGS).


LOXAPINE SUCCINATE DESCRIPTION


Loxapine Succinate



CLINICAL PHARMACOLOGY

Pharmacodynamics



Absorption, Distribution, Metabolism, and Excretion


INDICATIONS & USAGE



LOXAPINE SUCCINATE CONTRAINDICATIONS




WARNINGS


BOXED WARNING

Tardive Dyskinesia




ADVERSE REACTIONSInformation for Patients

Neuroleptic Malignant Syndrome (NMS)







PRECAUTIONS

Leukopenia, Neutropenia and Agranulocytosis




General








INFORMATION FOR PATIENTS



DRUG INTERACTIONS




PREGNANCY







NURSING MOTHERS



PEDIATRIC USE



LOXAPINE SUCCINATE ADVERSE REACTIONS

WARNINGS












OVERDOSAGE




DOSAGE & ADMINISTRATION



Oral Administration


Maintenance Therapy


HOW SUPPLIED








PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Loxapine Succinate

Loxapine Succinate

Loxapine Succinate

Loxapine Succinate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-481(NDC:0591-0371)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOXAPINE SUCCINATE LOXAPINE 25 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
BENZYL ALCOHOL
BUTYLPARABEN
edetate calcium disodium
GELATIN
MAGNESIUM STEARATE
METHYLPARABEN
POLACRILIN POTASSIUM
PROPYLPARABEN
SODIUM LAURYL SULFATE
sodium propionate
talc
titanium dioxide
D&C YELLOW NO. 10
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
green 18 mm Watson;371;25;mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-481-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072206 2011-08-15


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