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cisatracurium besylate Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

2.2 Recommended Cisatracurium Besylate Injection Dose for Performing Tracheal Intubation

2.3 Recommended Maintenance Bolus Cisatracurium Besylate Injection Doses in Adult Surgical Procedures

2.4 Dosage in Burn Patients

2.5 Dosage for Continuous Infusion

2.6 Rate Tables for Continuous Infusion

2.7 Preparation of Cisatracurium Besylate Injection

2.8 Drug Compatibility

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Residual Paralysis

5.2 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative in 10 mL Multiple-Dose Vials

5.3 Risk of Seizure

5.4 Hypersensitivity Reactions Including Anaphylaxis

5.5 Risk of Death Due to Medication Errors

5.6 Risks Due to Inadequate Anesthesia

5.7 Risk for Infection

5.8 Potentiation of Neuromuscular Blockade

5.9 Resistance to Neuromuscular Blockade with Certain Drugs

5.10 Malignant Hyperthermia (MH)

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Clinically Significant Drug Interactions

7.2 Drugs Without Clinically Significant Drug Interactions With Cisatracurium Besylate Injection

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Patients with Renal Impairment

8.7 Patients with Hepatic Impairment

8.8 Burn Patients

8.9 Patients with Hemiparesis or Paraparesis

8.10 Patients with Neuromuscular Disease

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

14 CLINICAL STUDIES

14.1 Skeletal Muscle Relaxation for Intubation of Adult Patients

14.2 Skeletal Muscle Relaxation for Intubation of Pediatric Patients

14.3 Skeletal Muscle Relaxation in ICU Patients

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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