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morphine sulfate injection, USP VIAL Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

2.2 Initial Dosage

2.3 Dosage for Intravenous Administration

2.4 Dosage for Epidural Administration

2.5 Dosage for Intrathecal Administration

2.6 Discontinuation of Preservative-Free Morphine Sulfate Injection

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Risks with Neuraxial Administration

5.2 Life-Threatening Respiratory Depression

5.3 Addiction, Abuse, and Misuse

5.4 Neonatal Opioid Withdrawal Syndrome

5.5 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

5.6 Risk of Tolerance and Myoclonic Activity

5.7 Chest Wall Rigidity

5.8 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

5.9 Interaction with Monoamine Oxidase Inhibitors

5.10 Adrenal Insufficiency

5.11 Severe Hypotension

5.12 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

5.13 Risks of Use in Patients with Gastrointestinal Conditions

5.14 Risks of Seizures

5.15 Withdrawal

5.16 Risks of Use in Patients with Urinary System Disorders

5.17 Risks of Use in Ambulatory Patients

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic or Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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