Alprazolam
FULL PRESCRIBING INFORMATION: CONTENTS*
- ALPRAZOLAM DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- ALPRAZOLAM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- ALPRAZOLAM ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- CLINICAL STUDIES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
ALPRAZOLAM DESCRIPTION
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
GeneralDOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY
INFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
CONTRAINDICATIONSWARNINGS
WARNINGS
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsWARNINGS
Nonteratogenic Effects
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATIONALPRAZOLAM 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 StudiesCLINICAL STUDIES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
AlprazolamAlprazolam TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
