9/12/2023 0 Comments White rectangle pill g 3722![]() ![]() The use of benzodiazepines, including alprazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.Follow patients for signs and symptoms of respiratory depression and sedation. Limit dosages and durations to the minimum required. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ABUSE, MISUSE, AND ADDICTION and DEPENDENCE AND WITHDRAWAL REACTIONS ( 2.2, 5.3)įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ABUSE, MISUSE, AND ADDICTION and DEPENDENCE AND WITHDRAWAL REACTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1ĝosage in Generalized Anxiety Disorder 2.2ĝosage in Panic Disorder 2.3ĝiscontinuation or Dosage Reduction of Alprazolam 2.4ĝosage Recommendations in Geriatric Patients 2.5ĝosage Recommendations in Patients with Hepatic Impairment 2.6 Dosage Modifications for Drug Interactions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Risks from Concomitant Use with Opioids 5.2Ěbuse, Misuse, and Addiction 5.3ĝependence and Withdrawal Reactions 5.4Ğffects on Driving and Operating Machinery 5.5 Neonatal Sedation and Withdrawal Syndrome 5.6 Interaction with Drugs that Inhibit Metabolism via Cytochrome P450 3A 5.7 Patients with Depression 5.8 Mania 5.9 Risk in Patients with Impaired Respiratory Function 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1ĝrugs Having Clinically Important Interactions with Alprazolam 7.2ĝrug/Laboratory Test Interactions 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE 10.1Ĝlinical Experience 10.2 Management of Overdose 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Generalized Anxiety Disorder 14.2 Panic Disorder 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage. Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening.Before prescribing alprazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. ![]() Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ABUSE, MISUSE, AND ADDICTION and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning.
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