Monograph: Buprenorphine, Buprenorphine Hydrochloride

Buprenorphine, Buprenorphine Hydrochloride

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Full Title

Buprenorphine, Buprenorphine Hydrochloride

Generic Name

Buprenorphine; Buprenorphine Hydrochloride

Chemical Name

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INV Number

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Classification

CAS Number

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Introduction

Introduction

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Uses

Uses

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Pain

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Parenteral Therapy

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Transdermal Therapy

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Oral Transmucosal Therapy

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Opiate Dependence

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Oral Transmucosal Therapy for Induction and Maintenance Treatment

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Maintenance Treatment with Buprenorphine Extended-release Subcutaneous Injection

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Maintenance Treatment with Buprenorphine Subdermal Implants

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Other Uses

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Dosage and Administration

Dosage and Administration

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Administration

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Risk Evaluation and Mitigation Strategies

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Parenteral Administration

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Conventional Injection for Pain Management

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Extended-release Subcutaneous Injection for Opiate Dependence

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Subdermal Implants for Opiate Dependence

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Sublingual Administration

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Sublingual Preparations for Opiate Dependence

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Buccal Administration

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Buccal Preparations for Pain Management

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Buccal Preparations for Opiate Dependence

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Transdermal Administration

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Transdermal System for Pain Management

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Dosage

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Pain

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Parenteral Dosage

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Transdermal Dosage

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Buccal Dosage

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Opiate Dependence

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Dosage of Lower-bioavailability Oral Transmucosal Formulations for Induction and Maintenance

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Zubsolv® Dosage for Induction and Maintenance

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Bunavail® Dosage for Induction and Maintenance

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Dosage Adjustments When Switching Between Oral Transmucosal Strengths and Preparations

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Table 1. Corresponding Doses and Strengths of Suboxone® Sublingual Tablets and Bunavail® Buccally Dissolving Strips234

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Table 2. Corresponding Dosage Strengths of Suboxone® Sublingual Tablets (or Generic Equivalent) and Zubsolv® Sublingual Tablets235

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Extended-release Subcutaneous Injection Dosage for Maintenance Treatment

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Implant Dosage for Maintenance Treatment

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Discontinuance

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Other Uses

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Restricted Distribution Program for Buprenorphine Treatment of Opiate Dependence

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Prescribers

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Dispensing Pharmacies

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Dosage in Hepatic Impairment

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Cautions

Cautions

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Nervous System Effects

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GI Effects

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Hepatic Effects

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Cardiovascular Effects

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Respiratory Effects

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Sensitivity Reactions

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Ocular Effects

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Dermatologic Effects

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Genitourinary and Endocrine Effects

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Other Adverse Effects

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Opiate Withdrawal

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Precautions and Contraindications

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Addiction, Abuse, and Misuse

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Respiratory and CNS Depression

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Concomitant Use of Benzodiazepines or Other CNS Depressants

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Selection of an Appropriate Formulation

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Accidental Exposure

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QT-Interval Prolongation

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Opiate Withdrawal

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Hepatic Impairment

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Hepatotoxicity

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Hypotension

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Increased Intracranial Pressure or Head Injury

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Seizures

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GI Conditions

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Anesthesia and Analgesia in Patients Receiving Extended-release Injection or Implant Therapy for Opiate Dependence

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Implant Complications

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Extended-release Subcutaneous Injection

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Transdermal Therapy

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Buccal Buprenorphine in Cancer Patients with Mucositis

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Patient Advice

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Contraindications

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Pediatric Precautions

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Geriatric Precautions

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Mutagenicity and Carcinogenicity

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Pregnancy, Fertility, and Lactation

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Pregnancy

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Animal Reproduction Studies

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Clinical Experience

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Fertility

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Lactation

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Drug Interactions

Drug Interactions

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Benzodiazepines and Other CNS Depressants

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Drugs Affecting Hepatic Microsomal Enzymes

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CYP3A4 Inhibitors

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CYP3A4 Inducers

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Antifungals

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Antiretrovirals

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Drugs Metabolized by Hepatic Microsomal Enzymes

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Drugs that Prolong the QT Interval

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Drugs Associated with Serotonin Syndrome

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Drugs Affecting Hepatic Blood Flow

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Anticholinergic Agents

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Diuretics

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Local Anesthetics

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Monoamine Oxidase Inhibitors

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Neuromuscular Blocking Agents

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Opiate Agonists and Partial Agonists

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Chronical Toxicity

Chronic Toxicity

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Acute Toxicity

Acute Toxicity

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Pathogenesis

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Manifestation

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Treatment

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Pharmacology

Pharmacology

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Opiate Agonist and Antagonist Properties

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CNS Effects

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Cardiovascular Effects

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Respiratory Effects

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Endocrine Effects

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GI Effects

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Other Effects

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Pharmacokinetics

Pharmacokinetics

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Absorption

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Buprenorphine Hydrochloride Conventional Injection

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Buprenorphine Transdermal System

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Oral Transmucosal Formulations Used for Analgesia

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Oral Transmucosal Formulations Used for Treatment of Opiate Dependence

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Buprenorphine Extended-release Subcutaneous Injection

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Buprenorphine Hydrochloride Subdermal Implants

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Distribution

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Elimination

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Chemistry and Stability

Chemistry and Stability

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Chemistry

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Stability

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Preparations

Preparations

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Buprenorphine

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Buprenorphine Hydrochloride

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Buprenorphine Hydrochloride Combinations

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REMS

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References

References

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Copyright

AHFS® Drug Information. © Copyright, 1959-2019, Selected Revisions July 22, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Quelle

AHFS Drug Information