Mivacron (Page 5 of 10)

Burns

While patients with burns are known to develop resistance to nondepolarizing neuromuscular blocking agents, they may also have reduced plasma cholinesterase activity. Consequently, in these patients, a test dose of not more than 0.015 to 0.02 mg/kg MIVACRON is recommended, followed by additional appropriate dosing guided by the use of a neuromuscular block monitor (see PRECAUTIONS — General).

Cardiovascular Disease

In patients with clinically significant cardiovascular disease, the initial dose of MIVACRON should be 0.15 mg/kg or less, administered over 60 seconds (see CLINICAL PHARMACOLOGY — Hemodynamics subsection and PRECAUTIONS — General).

Obesity

Obese patients (patients weighing greater than or equal to 30% more than their ideal body weight) dosed on the basis of actual body weight, thereby receiving a larger dose than if dosed on the basis of ideal body weight, had a greater probability of experiencing a decrease of greater than or equal to 30% in MAP (see CLINICAL PHARMACOLOGY — Hemodynamics subsection and PRECAUTIONS — General). Therefore, in obese patients, the initial dose should be determined using the patient’s ideal body weight (IBW), according to the following formulae:

Men: IBW in kg = (106 + [6 x inches in height above 5 feet])/2.2
Women: IBW in kg = (100 + [5 x inches in height above 5 feet])/2.2

Allergy and Sensitivity

In patients with any history suggestive of a greater sensitivity to the release of histamine or related mediators (e.g., asthma), the initial dose of MIVACRON should be 0.15 mg/kg or less, administered over 60 seconds (see PRECAUTIONS — General).

INDICATIONS AND USAGE

MIVACRON is a short-acting neuromuscular blocking agent indicated for inpatients and outpatients, as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

CONTRAINDICATIONS

MIVACRON is contraindicated in patients with known hypersensitivity to the product and its components.

WARNINGS

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including MIVACRON, 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 this class of drugs.

Risk of Death Due to Medication Errors

Administration of MIVACRON results in paralysis, which may lead to respiratory arrest and death; this progression may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.

Administration

MIVACRON 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 personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy), and an antagonist of MIVACRON are immediately available. It is recommended that a peripheral nerve stimulator be used to measure neuromuscular function during the administration of MIVACRON in order to monitor drug effect, determine the need for additional drug, and confirm recovery from neuromuscular block.

MIVACRON has no known effect on consciousness, pain threshold, or cerebration. To avoid distress to the patient, neuromuscular block should not be induced before unconsciousness.

MIVACRON is metabolized by plasma cholinesterase and should be used with great caution, if at all, in patients known to be or suspected of being homozygous for the atypical plasma cholinesterase gene.

MIVACRON Injection is acidic (pH 3.5 to 5) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions).

PRECAUTIONS

General

Although MIVACRON (a mixture of three stereoisomers) is not a potent histamine releaser, the possibility of substantial histamine release must be considered. Release of histamine is related to the dose and speed of injection.

Caution should be exercised in administering MIVACRON to patients with clinically significant cardiovascular disease and patients with any history suggesting a greater sensitivity to the release of histamine or related mediators (e.g., asthma). In such patients, the initial dose of MIVACRON should be 0.15 mg/kg or less, administered over 60 seconds; assurance of adequate hydration and careful monitoring of hemodynamic status are important (see CLINICAL PHARMACOLOGY — Hemodynamics and Individualization of Dosages).

Obese patients may be more likely to experience clinically significant transient decreases in MAP than non-obese patients when the dose of MIVACRON is based on actual rather than ideal body weight. Therefore, in obese patients, the initial dose should be determined using the patient’s ideal body weight (see CLINICAL PHARMACOLOGY — Hemodynamics and Individualization of Dosages).

Recommended doses of MIVACRON have no clinically significant effects on heart rate; therefore, MIVACRON will not counteract the bradycardia produced by many anesthetic agents or by vagal stimulation.

Neuromuscular blocking agents may have a profound effect in patients with neuromuscular diseases (e.g., myasthenia gravis and the myasthenic syndrome). In these and other conditions in which prolonged neuromuscular block is a possibility (e.g., carcinomatosis), the use of a peripheral nerve stimulator and a dose of not more than 0.015 to 0.02 mg/kg MIVACRON is recommended to assess the level of neuromuscular block and to monitor dosage requirements (see CLINICAL PHARMACOLOGY — Individualization of Dosages).

MIVACRON has not been studied in patients with burns. Resistance to nondepolarizing neuromuscular blocking agents may develop in patients with burns, depending upon the time elapsed since the injury and the size of the burn. Patients with burns may have reduced plasma cholinesterase activity which may offset this resistance (see CLINICAL PHARMACOLOGY — Individualization of Dosages).

Acid-base and/or serum electrolyte abnormalities may potentiate or antagonize the action of neuromuscular blocking agents. The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of toxemia of pregnancy (see CLINICAL PHARMACOLOGY — Individualization of Dosages).

No data are available to support the use of MIVACRON by intramuscular injection.

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