FDA label 20dd8b0d-ae77-4f0f-a030-bdd5afc1d945

THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY-TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.

WARNINGS ARDUAN ® (PIPECURONIUM BROMIDE) FOR INJECTION SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH THE DRUG'S ACTIONS AND THE POSSIBLE COMPLICATIONS OF ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS FACILITIES FOR INTUBATION, ARTIFICIAL RESPIRATION, OXYGEN THERAPY, AND AN ANTAGONIST ARE WITHIN IMMEDIATE REACH. IT IS RECOMMENDED THAT CLINICIANS ADMINISTERING LONG-ACTING NEUROMUSCULAR BLOCKING AGENTS SUCH AS ARDUAN ® EMPLOY A PERIPHERAL NERVE STIMULATOR TO MONITOR DRUG RESPONSE, NEED FOR ADDITIONAL RELAXANT, AND ADEQUACY OF SPONTANEOUS RECOVERY OR ANTAGONISM. Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including ARDUAN ® , have been reported. These reactions have, in some cases, been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported. In patients with myasthenia gravis or myasthenic (Eaton-Lambert) syndrome, small doses of non-depolarizing neuromuscular blocking agents may have profound effects. Shorter acting muscle relaxants than ARDUAN ® may be more suitable for these patients.

ADVERSE REACTIONS The most frequent side effect of non-depolarizing blocking agents, as a class, is an extension of drug's pharmacological action beyond the time period needed for surgery and anesthesia (see CLINICAL PHARMACOLOGY ). Clinical signs may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency or apnea. This may be due to the drug's effect or inadequate antagonism. The following listings are based upon U.S. clinical studies involving nearly 600 patients, utilizing a variety of premedications, varying lengths of surgical procedures and various anesthetic agents. Adverse experiences in greater than 1% of cases and judged by the investigator to have a possible casual relationship: Clinically significant hypotension (2.5% of cases). Clinically significant bradycardia (1.4 % of cases). Adverse experiences in less than 1% of cases and judged by the investigator to have a possible causal relationship: Cardiovascular: hypertension, myocardial ischemia, cerebrovascular accident, thrombosis, atrial fibrillation, ventricular extrasystole. Metabolic and Nutritional: increased creatinine, hypoglycemia, hyperkalemia. Musculoskeletal: muscle atrophy, difficult intubation. Nervous: hypesthesia, CNS depression. Respiratory: dyspnea, respiratory depression, laryngismus, atelectasis. Skin and Appendages: rash, urticaria. Urogenital system: anuria. There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) with the use of neuromuscular blocking agents of which ARDUAN ® is a member. These reactions, in some cases, have been life-threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see WARNINGS and PRECAUTIONS ).

<table width="90%"> <col width="30%" align="left" valign="top"/> <col width="70%" align="left" valign="top"/> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Cardiovascular:</td> <td styleCode="Rrule">hypertension, myocardial ischemia, cerebrovascular accident, thrombosis, atrial fibrillation, ventricular extrasystole.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Metabolic and Nutritional:</td> <td styleCode="Rrule">increased creatinine, hypoglycemia, hyperkalemia.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Musculoskeletal:</td> <td styleCode="Rrule">muscle atrophy, difficult intubation.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Nervous:</td> <td styleCode="Rrule">hypesthesia, CNS depression.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Respiratory:</td> <td styleCode="Rrule">dyspnea, respiratory depression, laryngismus, atelectasis.</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Skin and Appendages:</td> <td styleCode="Rrule">rash, urticaria.</td> </tr> <tr> <td styleCode="Lrule Rrule">Urogenital system:</td> <td styleCode="Rrule">anuria.</td> </tr> </tbody> </table>