"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
NUROMAX (doxacurium chloride) , like other long-acting neuromuscular blocking agents, displays variability in the duration of its effect. The potential for a prolonged clinical duration of neuromuscular block must be considered when NUROMAX (doxacurium chloride) is selected for administration. The dosage information provided below is intended as a guide only. Doses should be individualized (see CLINICAL PHARMACOLOGY -Individualization of Dosages). Factors that may warrant dosage adjustment include: advancing age, the presence of kidney or liver disease, or obesity (patients weighing ≥ 30% more than ideal body weight for height). The use of a peripheral nerve stimulator will permit the most advantageous use of NUROMAX (doxacurium chloride) , minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
When administered as a component of a thiopental/narcotic induction-intubation paradigm as well as for production of long-duration neuromuscular block during surgery, 0.05 mg/kg (2 × ED95) NUROMAX (doxacurium chloride) produces good-to-excellent conditions for tracheal intubation in 5 minutes in approximately 90% of patients. Lower doses of NUROMAX (doxacurium chloride) may result in a longer time for development of satisfactory intubation conditions. Clinically effective neuromuscular block may be expected to last approximately 100 minutes on average (range: 39 to 232) following 0.05 mg/kg NUROMAX (doxacurium chloride) administered to patients receiving balanced anesthesia.
An initial NUROMAX (doxacurium chloride) dose of 0.08 mg/kg (3 × ED95) should be reserved for instances in which a need for very prolonged neuromuscular block is anticipated. In approximately 90% of patients, good-toexcellent intubation conditions may be expected in 4 minutes after this dose; however, clinically effective block may be expected to persist for as long as 160 minutes or more (range: 110 to 338) (see CLINICAL PHARMACOLOGY).
If NUROMAX (doxacurium chloride) is administered during steady-state isoflurane, enflurane, or halothane anesthesia, reduction of the dose of NUROMAX (doxacurium chloride) by one third should be considered.
When succinylcholine is administered to facilitate tracheal intubation in patients receiving balanced anesthesia, an initial dose of 0.025 mg/kg (ED95) NUROMAX (doxacurium chloride) provides about 60 minutes (range: 9 to 145) of clinically effective neuromuscular block for surgery. For a longer duration of action, a larger initial dose may be administered.
Maintenance dosing will generally be required about 60 minutes after an initial dose of 0.025 mg/kg NUROMAX (doxacurium chloride) or 100 minutes after an initial dose of 0.05 mg/kg NUROMAX (doxacurium chloride) during balanced anesthesia. Repeated maintenance doses administered at 25% T1 recovery may be expected to be required at relatively regular intervals in each patient. The interval may vary considerably between patients. Maintenance doses of 0.005 and 0.01 mg/kg NUROMAX (doxacurium chloride) each provide an average 30 minutes (range: 9 to 57) and 45 minutes (range: 14 to 108), respectively, of additional clinically effective neuromuscular block. For shorter or longer desired durations, smaller or larger maintenance doses may be administered.
When administered during halothane anesthesia, an initial dose of 0.03 mg/kg (ED95) produces maximum neuromuscular block in about 7 minutes (range: 5 to 11) and clinically effective block for an average of 30 minutes (range: 12 to 54). Under halothane anesthesia, 0.05 mg/kg produces maximum block in about 4 minutes (range: 2 to 10) and clinically effective block for 45 minutes (range: 30 to 80). Maintenance doses are generally required more frequently in children than in adults. Because of the potentiating effect of halothane seen in adults, a higher dose of NUROMAX (doxacurium chloride) may be required in children receiving balanced anesthesia than in children receiving halothane anesthesia to achieve a comparable onset and duration of neuromuscular block. NUROMAX (doxacurium chloride) has not been studied in pediatric patients below the age of 2 years.
NUROMAX (doxacurium chloride) Injection may not be compatible with alkaline solutions with a pH greater than 8.5 (e.g., barbiturate solutions).
NUROMAX (doxacurium chloride) is compatible with:
- 5% Dextrose Injection, USP
- 0.9% Sodium Chloride Injection, USP
- 5% Dextrose and 0.9% Sodium Chloride Injection, USP
- Lactated Ringer's Injection, USP
- 5% Dextrose and Lactated Ringer's Injection
- Sufenta® (sufentanil citrate) Injection, diluted as directed
- Alfenta® (alfentanil hydrochloride) Injection, diluted as directed
- Sublimaze® (fentanyl citrate) Injection, diluted as directed
NUROMAX (doxacurium chloride) diluted up to 1:10 in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP has been shown to be physically and chemically stable when stored in polypropylene syringes at 5° to 25°C (41° to 77°F), for up to 24 hours. Since dilution diminishes the preservative effectiveness of benzyl alcohol, aseptic techniques should be used to prepare the diluted product. Immediate use of the diluted product is preferred, and any unused portion of diluted NUROMAX (doxacurium chloride) should be discarded after 8 hours.
NUROMAX (doxacurium chloride) Injection, 1 mg doxacurium in each mL.
5-mL Multiple-dose vials containing 0.9% w/v benzyl alcohol as a preservative (see WARNINGS). Tray of 10 (List No. 4437).
Store NUROMAX (doxacurium chloride) Injection at room temperature of 15° to 25°C (59° to 77°F). DO NOT FREEZE.
Manufactured for Abbott Laboratories, North Chicago, IL 60064, USA. Revised 09/2010
Last reviewed on RxList: 1/4/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Nuromax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.