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

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Alprazolam

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ALPRAZOLAM DESCRIPTION



Alprazolam








CLINICAL PHARMACOLOGY








INDICATIONS & USAGE




CLINICAL STUDIES


ALPRAZOLAM CONTRAINDICATIONS


WARNINGSPRECAUTIONS-Drug Interactions

WARNINGS

Dependence And Withdrawal Reactions, Including Seizures:
DRUG ABUSE AND DEPENDENCE





Body System/EventNeurologicPsychiatric
DOSAGE AND ADMINISTRATION

Status Epilepticus And Its Treatment:


Interdose Symptoms:
DOSAGE AND ADMINISTRATION

Risk Of Dose Reduction:
DOSAGE AND ADMINISTRATION




Potent CYP 3A Inhibitors:
CONTRAINDICATIONS





Other Drugs Possibly Affecting Alprazolam Metabolism:
PRECAUTIONSPRECAUTIONS-Drug Interactions

PRECAUTIONS

General


DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY



INFORMATION FOR PATIENTS













LABORATORY TESTS



DRUG INTERACTIONS




CONTRAINDICATIONSWARNINGS




WARNINGS

DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects
WARNINGS

Nonteratogenic Effects


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE

CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

ALPRAZOLAM ADVERSE REACTIONS








Treatment-Emergent Symptom IncidenceIncidence ofIntervention Because ofSymptomAlprazolamPlaceboAlprazolam





Treatment-EmergentSymptom Incidence*Central Nervous SystemGastrointestinalCardio-RespiratorySensoryMusculoskeletalCutaneousOther


WARNINGS
DOSAGE AND ADMINISTRATION
Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Therefore, the same precaution must be exercised when using doses of alprazolam greater than 4 mg/day in treating patients with panic disorders as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans.
As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.
Laboratory analyses were performed on all patients participating in the clinical program for alprazolam. The following incidences of abnormalities shown below were observed in patients receiving alprazolam and in patients in the corresponding placebo group. Few of these abnormalities were considered to be of physiological significance.
PlaceboLOWHIGHLOWHIGH*Less Than 1%HEMATOLOGYHematocrit****Hemoglobin****Total WBC Count1.42.31.02.0Neutrophil Count2.33.04.21.7Lymphocyte Count5.57.45.49.5Monocyte Count5.32.86.4*Eosinophil Count3.29.53.37.2Basophil Count****URINALYSISAlbumin--*--*Sugar--*--*RBC/HPF--3.4--5.0WBC/HPF--25.7--25.9BLOOD CHEMISTRYCreatinine2.21.93.51.0Bilirubin*1.6**SGOT*3.21.01.8Alkaline Phosphatase*1.7*1.8When treatment with alprazolam is protracted, periodic blood counts, urinalysis and blood chemistry analyses are advisable.
Minor changes in EEG patterns, usually low-voltage fast activity have been observed in patients during therapy with alprazolam and are of no known significance.
Post Introduction Reports: Various adverse drug reactions have been reported in association with the use of alprazolam since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of alprazolam cannot be readily determined. Reported events include: liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia and galactorrhea.

DRUG ABUSE AND DEPENDENCE



WARNINGS
WARNINGSDOSAGE AND ADMINISTRATION


Controlled Substance Class


OVERDOSAGE




CONTRAINDICATIONSWARNINGSPRECAUTIONS

DOSAGE & ADMINISTRATION



Anxiety Disorders And Transient Symptoms Of Anxiety:





Panic Disorder:


WARNINGSPRECAUTIONSDRUG ABUSE AND DEPENDENCE




ANIMAL PHARMACOLOGY & OR TOXICOLOGY

Animal Studies


CLINICAL STUDIES





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Alprazolam



Alprazolam



Alprazolam

Alprazolam TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-206(NDC:67253-901)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Alprazolam Alprazolam 0.5 mg

Inactive Ingredients

Ingredient Name Strength
DOCUSATE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM BENZOATE
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
yellow 7 mm S901 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-206-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 2011-04-21


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