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This drug should be administered only by adequately trained individuals familiar with its actions, characteristics, and hazards.
Nuromax (doxacurium chloride) is a long-acting, nondepolarizing skeletal muscle relaxant for intravenous administration. Doxacurium chloride is [1α,2β(1'S*,2'R*)] - 2,2' - [(1,4 - dioxo - 1,4 - butanediyl)bis(oxy - 3,1 - propanediyl)]bis[1,2,3,4 - tetrahydro - 6,7,8 - trimethoxy - 2 - methyl-1-[(3,4,5-trimethoxyphenyl)methyl]isoquinolinium] dichloride (meso form). The molecular formula is C56H78CI2N2O16 and the molecular weight is 1106.14. The compound does not partition into the 1-octanol phase of a distilled water/ 1-octanol system, i.e., the n-octanol:water partition coefficient is 0.
Doxacurium chloride is a mixture of three trans, trans stereoisomers, a dl pair [(1R,1'R,2S,2'S) and (1S,1'S,2R,2'R)] and a meso form (1R,1'S,2S,2'R). The meso form is illustrated below:
Nuromax Injection is a sterile, nonpyrogenic aqueous solution (pH 3.9 to 5.0) containing doxacurium chloride equivalent to 1 mg/mL doxacurium in Water for Injection. Hydrochloric acid may have been added to adjust pH. Nuromax Injection contains 0.9% w/v benzyl alcohol.
Nuromax binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in a block of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine.
Nuromax is approximately 2.5 to 3 times more potent than pancuronium and 10 to 12 times more potent than metocurine. Nuromax in doses of 1.5 to 2 × ED95 has a clinical duration of action (range and variability) similar to that of equipotent doses of pancuronium and metocurine (historic data and limited comparison). The average ED95 (dose required to produce 95% suppression of the adductor pollicis muscle twitch response to ulnar nerve stimulation) of Nuromax is 0.025 mg/kg (range: 0.020 to 0.033) in adults receiving balanced anesthesia.
The onset and clinically effective duration (time from injection to 25% recovery) of Nuromax administered alone or after succinylcholine during stable balanced anesthesia are shown in Table 1.
| Initial Dose of Nuromax (mg/kg) | |||
* Values shown are means (range). † Nuromax administered after 10% to 100% recovery from an intubating dose of succinylcholine. | |||
| 0.025† (n = 34) | 0.05 (n = 27) | 0.08 (n = 9) | |
| Time to Maximum Block (min) | 9.3 (5.4-16) | 5.2 (2.5-13) | 3.5 (2.4-5) |
| Clinical Duration (min) (Time to 25% Recovery) | 55 (9-145) | 100 (39-232) | 160 (110-338) |
Initial doses of 0.05 mg/kg (2 × ED95) and 0.08 mg/kg (3 × ED95) Nuromax administered during the induction of thiopental-narcotic anesthesia produced good-to-excellent conditions for tracheal intubation in 5 minutes (13 of 15 cases studied) and 4 minutes (eight of nine cases studied) (which are before maximum block), respectively.
As with other long-acting agents, the clinical duration of neuromuscular block associated with Nuromax shows considerable interpatient variability. An analysis of 390 cases in US clinical trials utilizing a variety of premedications, varying lengths of surgery, and various anesthetic agents, indicates that approximately two thirds of the patients had clinical durations within 30 minutes of the duration predicted by dose (based on mg/kg actual body weight). Patients ≥ 60 years old are approximately twice as likely to experience prolonged clinical duration (30 minutes longer than predicted) than patients < 60 years old; thus, care should be used in older patients when prolonged recovery is undesirable (see PRECAUTIONS -Geriatric Use and CLINICAL PHARMACOLOGY - Individualization of Dosages subsection). In addition, obese patients (patients weighing ≥ 30% more than ideal body weight for height) were almost twice as likely to experience prolonged clinical duration than non-obese patients; therefore, dosing should be based on ideal body weight (IBW) for obese patients (see CLINICAL PHARMACOLOGY - Individualization of Dosages subsection).
The mean time for spontaneous T1 recovery from 25% to 50% of control following initial doses of Nuromax is approximately 26 minutes (range: 7 to 104, n = 253) during balanced anesthesia. The mean time for spontaneous T1 recovery from 25% to 75% is 54 minutes (range: 14 to 184, n = 184).
Most patients receiving Nuromax in clinical trials required pharmacologic reversal prior to full spontaneous recovery from neuromuscular block (see OVERDOSAGE - Antagonism of Neuromuscular Block); therefore, relatively few data are available on the time from injection to 95% spontaneous recovery of the twitch response. As with other long-acting neuromuscular blocking agents, Nuromax may be associated with prolonged times to full spontaneous recovery. Following an initial dose of 0.025 mg/kg Nuromax, some patients may require as long as 4 hours to exhibit full spontaneous recovery.
Cumulative neuromuscular blocking effects are not associated with repeated administration of maintenance doses of Nuromax at 25% T1 recovery. As with initial doses, however, the duration of action following maintenance doses of Nuromax may vary considerably among patients.
The Nuromax ED95 for children 2 to 12 years of age receiving halothane anesthesia is approximately 0.03 mg/kg. Children require higher doses of Nuromax on a mg/kg basis than adults to achieve comparable levels of block. The onset time and duration of block are shorter in children than adults. During halothane anesthesia, doses of 0.03 mg/kg and 0.05 mg/kg Nuromax produce maximum block in approximately 7 and 4 minutes, respectively. The duration of clinically effective block is approximately 30 minutes after an initial dose of 0.03 mg/kg and approximately 45 minutes after 0.05 mg/kg. Nuromax has not been studied in pediatric patients below the age of 2 years.
The neuromuscular block produced by Nuromax may be antagonized by anticholinesterase agents. As with other nondepolarizing neuromuscular blocking agents, the more profound the neuromuscular block at reversal, the longer the time and the greater the dose of anticholinesterase required for recovery of neuromuscular function.
Administration of doses of Nuromax up to and including 0.08 mg/kg (~3 × ED95) over 5 to 15 seconds to healthy adult patients during stable-state balanced anesthesia and to patients with serious cardiovascular disease undergoing coronary artery bypass grafting, cardiac valvular repair, or vascular repair produced no dose-related effects on mean arterial blood pressure (MAP) or heart rate (HR).
No dose-related changes in MAP and HR were observed following administration of up to 0.05 mg/kg Nuromax over 5 to 15 seconds in 2- to 12-year-old children receiving halothane anesthesia.
Doses of 0.03 to 0.08 mg/kg (1.2 to 3 × ED95) were not associated with dose-dependent changes in mean plasma histamine concentration. Clinical experience with more than 1000 patients indicates that adverse experiences typically associated with histamine release (e.g., bronchospasm, hypotension, tachycardia, cutaneous flushing, urticaria, etc.) are very rare following the administration of Nuromax (see ADVERSE REACTIONS).
Pharmacokinetic and pharmacodynamic results from a study of 24 healthy young adult patients and eight healthy elderly patients are summarized in Table 2. The pharmacokinetics are linear over the dosage range tested (i.e., plasma concentrations are approximately proportional to dose).
| Healthy Young Adult Patients (22 to 49 yrs) | Healthy Elderly Patients (67 to 72 yrs) | |||
* Values shown are means (range). † Time from injection to 25% recovery of the control twitch height. | ||||
| Parameter | 0.025 mg/kg (n = 8) | 0.05 mg/kg (n = 8) | 0.08 mg/kg (n = 8) | 0.025 mg/kg (n = 8) |
| t½ elimination (min) | 86 (25-171) | 123 (61-163) | 98 (47-163) | 96 (50-114) |
| Volume of Distribution at Steady State (L/kg) | 0.15 (0.10-0.21) | 0.24 (0.13-0.30) | 0.22 (0.16-0.33) | 0.22 (0.14-0.40) |
| Plasma Clearance (mL/min per kg) | 2.22 (1.02-3.95) | 2.62 (1.21-5.70) | 2.53 (1.88-3.38) | 2.47 (1.58-3.60) |
| Maximum Block (%) | 97 (88-100) | 100 (100-100) | 100 (100-100) | 96 (90-100) |
| Clinically Effective Duration of Block† (min) | 68 (35-90) | 91 (47-132) | 177 (74-268) | 97 (36-179) |
This study showed that the pharmacokinetics of Nuromax were similar in healthy young adult and elderly patients. Some healthy elderly patients tended to be more sensitive to the neuromuscular blocking effects of Nuromax than healthy young adult patients receiving the same dose. The time to maximum block was longer in elderly patients than in young adult patients (11.2 minutes versus 7.7 minutes at 0.025 mg/kg Nuromax). In addition, the clinically effective duration of block was more variable and tended to be longer in healthy elderly patients than in healthy young adult patients receiving the same dose. In contrast, a second study evaluated the pharmacokinetics and pharmacodynamics of doxacurium and showed that the plasma clearance was lower (1.75 ± 0.16 vs. 2.54 ± 0.24, respectively) and the half-life was longer (120 ± 10 vs. 75.9 ± 4.4 minutes, respectively) in 9 elderly patients (70 to 83 years of age) than in 9 younger patients (19 to 39 years of age) receiving a single intravenous dose of Nuromax 0.03 mg/kg. In addition, the time to maximum block was slower (12.9 versus 8.9 minutes, respectively) and the time to 25% T1 recovery was longer (113.4 ± 17.0 vs. 48.1 ± 5.2 minutes, respectively) in elderly patients than in younger patients. Overall, these studies showed that there may be differences in the pharmacokinetics of doxacurium in individual elderly patients and that the onset is slower and the duration of action is likely to be more variable and may be longer in elderly patients.
Table 3 summarizes the pharmacokinetic and pharmacodynamic results from a study of nine healthy young adult patients, eight patients with end-stage kidney disease undergoing kidney transplantation, and seven patients with end-stage liver disease undergoing liver transplantation. The results suggest that a longer t½ can be expected in patients with end-stage kidney disease; in addition, these patients may be more sensitive to the neuromuscular blocking effects of Nuromax. The time to maximum block was slightly longer and the clinically effective duration of block was prolonged in patients with end-stage kidney disease.
| Healthy Young Adult Patients | Kidney Transplant Patients | Liver Transplant Patients | |
* Values shown are means (range). | |||
| Parameter | 0.015 mg/kg (n = 9) | 0.015 mg/kg (n = 8) | 0.015 mg/kg (n = 7) |
| t½ elimination (min) | 99 (48-193) | 221 (84-592) | 115 (69-148) |
| Volume of Distribution at Steady State (L/kg) | 0.22 (0.11-0.43) | 0.27 (0.17-0.55) | 0.29 (0.17-0.35) |
| Plasma Clearance (mL/min per kg) | 2.66 (1.35-6.66) | 1.23 (0.48-2.40) | 2.30 (1.96-3.05) |
| Maximum Block (%) | 86 (59-100) | 98 (95-100) | 70 (0-100) |
| Clinically Effective Duration of Block (min) | 36 (19-80) | 80 (29-133) | 52 (20-91) |
No data are available from patients with liver disease not requiring transplantation. There are no significant alterations in the pharmacokinetics of Nuromax in liver transplant patients. Sensitivity to the neuromuscular blocking effects of Nuromax was highly variable in patients undergoing liver transplantation. Three of seven patients developed ≤ 50% block, indicating that a reduced sensitivity to Nuromax may occur in such patients. In those patients who developed > 50% neuromuscular block, the time to maximum block and the clinically effective duration tended to be longer than in healthy young adult patients (see CLINICAL PHARMACOLOGY - Individualization of Dosages subsection).
Consecutively administered maintenance doses of 0.005 mg/kg Nuromax, each given at 25% T1 recovery following the preceding dose, do not result in a progressive increase in the plasma concentration of doxacurium or a progressive increase in the depth or duration of block produced by each dose.
Nuromax is not metabolized in vitro in fresh human plasma. Plasma protein binding of Nuromax is approximately 30% in human plasma.
In vivo data from humans suggest that Nuromax is not metabolized and that the major elimination pathway is excretion of unchanged drug in urine and bile. In studies of healthy adult patients, 24% to 38% of an administered dose was recovered as parent drug in urine over 6 to 12 hours after dosing. High bile concentrations of Nuromax (relative to plasma) have been found 35 to 90 minutes after administration. The overall extent of biliary excretion is unknown. The data derived from analysis of human urine and bile are consistent with data from in vivo studies in the rat, cat, and dog, which indicate that all of an administered dose of Nuromax is recovered as parent drug in the urine and bile of these species.
In elderly patients or patients who have impaired renal function, the potential for a prolongation of block may be reduced by decreasing the initial dose of Nuromax and by titrating the dose to achieve the desired depth of block. In obese patients (patients weighing ≥ 30% more than ideal body weight for height), the dose of Nuromax should be determined using the patient's ideal body weight (IBW), according to the following formulae:
Men: IBW in kg = [106 + (6 × inches in height above 5 feet)]/2.2
Women: IBW in kg = [100 + (5 × inches in height above 5 feet)]/2.2
Dosage requirements for patients with severe liver disease are variable; some patients may require a higher than normal initial dose of Nuromax to achieve clinically effective block. Once adequate block is established, the clinical duration of block may be prolonged in such patients relative to patients with normal liver function.
As with pancuronium, metocurine, and vecuronium, resistance to Nuromax, manifested by a reduced intensity and/or shortened duration of block, must be considered when Nuromax is selected for use in patients receiving phenytoin or carbamazepine (see PRECAUTIONS - Drug Interactions).
As with other nondepolarizing neuromuscular blocking agents, a reduction in dosage of Nuromax must be considered in cachectic or debilitated patients; in patients with neuromuscular diseases, severe electrolyte abnormalities, or carcinomatosis; and in other patients in whom potentiation of neuromuscular block or difficulty with reversal is anticipated. Increased doses of Nuromax may be required in burn patients (see PRECAUTIONS).
Nuromax is a long-acting neuromuscular blocking agent, indicated to provide skeletal muscle relaxation as an adjunct to general anesthesia, for endotracheal intubation or to facilitate mechanical ventilation.
Nuromax is contraindicated in patients known to have hypersensitivity to it. Use of Nuromax from multiple-dose vials containing benzyl alcohol as a preservative is contraindicated in patients with a known hypersensitivity to benzyl alcohol.
Nuromax 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 Nuromax EMPLOY A PERIPHERAL NERVE STIMULATOR TO MONITOR DRUG RESPONSE, NEED FOR ADDITIONAL RELAXANTS, AND ADEQUACY OF SPONTANEOUS RECOVERY OR ANTAGONISM.
Nuromax HAS NO KNOWN EFFECT ON CONSCIOUSNESS, PAIN THRESHOLD, OR CEREBRATION. TO AVOID DISTRESS TO THE PATIENT, NEUROMUSCULAR BLOCK SHOULD NOT BE INDUCED BEFORE UNCONSCIOUSNESS.
Nuromax Injection is acidic (pH 3.9 to 5.0) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions).
Nuromax Injection contains benzyl alcohol. In newborn infants, benzyl alcohol has been associated with an increased incidence of neurological and other complications which are sometimes fatal (see PRECAUTIONS - Pediatric Use).
Nuromax has no clinically significant effects on heart rate; therefore, Nuromax 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 small test dose of Nuromax are recommended to assess the level of neuromuscular block and to monitor dosage requirements. Shorter acting muscle relaxants than Nuromax may be more suitable for these patients.
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. Nuromax has not been studied in patients with burns.
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.
Nuromax has not been studied in patients with asthma.
No data are available to support the use of Nuromax by intramuscular injection.
Nuromax has been studied in patients with end-stage kidney (n = 8) or liver (n = 7) disease undergoing transplantation procedures (see CLINICAL PHARMACOLOGY). The possibility of prolonged neuromuscular block in patients undergoing renal transplantation and the possibility of a variable onset and duration of neuromuscular block in patients undergoing liver transplantation must be considered when Nuromax is used in such patients.
Administration of Nuromax on the basis of actual body weight is associated with a prolonged duration of action in obese patients (patients weighing ≥ 30% more than ideal body weight for height) (see CLINICAL PHARMACOLOGY). Therefore, the dose of Nuromax should be based upon ideal body weight in obese patients (see CLINICAL PHARMACOLOGY - Individualization of Dosages).
In a study of MH-susceptible pigs, Nuromax did not trigger MH. Nuromax has not been studied in MH-susceptible patients. Since MH can develop in the absence of established triggering agents, the clinician should be prepared to recognize and treat MH in any patient scheduled for general anesthesia.
Information on the use of Nuromax in the ICU is limited. In a double-blind, randomized study, 17 patients received Nuromax by intermittent bolus injection for a mean of 2.7 ± 0.5 days (range: 0.8 to 6.8 days) to facilitate mechanical ventilation. No evidence of tachyphylaxis, accumulation, or prolonged recovery was observed. The adverse experiences in patients receiving Nuromax were consistent in type, severity, and frequency to those expected in a critically ill patient population. Since many ICU patients have hepatic and/or renal failure, a prolonged duration of block should be anticipated in these patients after administration of Nuromax.
WHENEVER THE USE OF Nuromax OR ANY NEUROMUSCULAR BLOCKING AGENT IS CONTEMPLATED IN THE ICU, IT IS RECOMMENDED THAT NEUROMUSCULAR TRANSMISSION BE MONITORED CONTINUOUSLY DURING ADMINISTRATION WITH THE HELP OF A NERVE STIMULATOR. ADDITIONAL DOSES OF Nuromax OR ANY OTHER NEUROMUSCULAR BLOCKING AGENT SHOULD NOT BE GIVEN BEFORE THERE IS A DEFINITE RESPONSE TO T1, OR TO THE FIRST TWITCH. IF NO RESPONSE IS ELICITED, BOLUS ADMINISTRATION SHOULD BE DELAYED UNTIL A RESPONSE RETURNS.
Prior administration of succinylcholine has no clinically important effect on the neuromuscular blocking action of Nuromax.
The use of Nuromax before succinylcholine to attenuate some of the side effects of succinylcholine has not been studied.
There are no clinical data on concomitant use of Nuromax and other nondepolarizing neuromuscular blocking agents.
Isoflurane, enflurane, and halothane decrease the ED50 of Nuromax by 30% to 45%. These agents may also prolong the clinically effective duration of action by up to 25%.
Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Nuromax include certain antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistimethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine.
As with some other nondepolarizing neuromuscular blocking agents, the time of onset of neuromuscular block induced by Nuromax is lengthened and the duration of block is shortened in patients receiving phenytoin or carbamazepine.
Carcinogenesis and fertility studies have not been performed. Nuromax was evaluated in a battery of four short-term mutagenicity tests. It was nonmutagenic in the Ames Salmonella assay, in the mouse lymphoma assay, and in the human lymphocyte assay. In the in vivo rat bone marrow cytogenetic assay, statistically significant increases in the incidence of structural abnormalities, relative to vehicle controls, were observed in male rats dosed with 0.1 mg/kg (0.625 mg/m2) Nuromax and sacrificed at 6 hours, but not at 24 or 48 hours, and in female rats dosed with 0.2 mg/kg (1.25 mg/m2) Nuromax and sacrificed at 24 hours, but not at 6 or 48 hours. There was no increase in structural abnormalities in either male or female rats given 0.3 mg/kg (1.875 mg/m2) Nuromax and sacrificed at 6, 24, or 48 hours. Thus, the incidence of abnormalities in the in vivo rat bone marrow cytogenetic assay was not dose-dependent and, therefore, the likelihood that the observed abnormalities were treatment-related or clinically significant is low.
Teratology testing in nonventilated, pregnant rats and mice treated subcutaneously with maximum subparalyzing doses of Nuromax revealed no maternal or fetal toxicity or teratogenic effects. There are no adequate and well-controlled studies of Nuromax in pregnant women. Because animal studies are not always predictive of human response and the doses used were subparalyzing, Nuromax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The use of Nuromax during labor, vaginal delivery, or cesarean section has not been studied. It is not known whether Nuromax administered to the mother has immediate or delayed effects on the fetus. The duration of action of Nuromax exceeds the usual duration of operative obstetrics (cesarean section). Therefore, Nuromax is not recommended for use in patients undergoing C-section.
It is not known whether Nuromax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised following administration of Nuromax to a nursing woman.
Nuromax has not been studied in pediatric patients below the age of 2 years. See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION for clinical experience and recommendations for use in children 2 to 12 years of age.
Of the total number of subjects in the clinical studies of Nuromax, 134 were 60 years of age and over while 37 were 70 years of age and over. The geriatric population included a subset of patients with significant cardiovascular disease. The clearance of doxacurium may be reduced and the half-life may be prolonged in elderly patients. In addition, the onset of maximum block is slower and the duration of neuromuscular block produced by Nuromax is more variable and, in some cases, longer than in young adult patients (see CLINICAL PHARMACOLOGY - Pharmacodynamics and Individualization of Dosages).
This drug is known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
The most frequent adverse effect of nondepolarizing blocking agents as a class consists of an extension of the pharmacological action beyond the time needed for surgery and anesthesia. This effect may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency and apnea which require manual or mechanical ventilation until recovery is judged to be clinically adequate (see OVERDOSAGE). Inadequate reversal of neuromuscular block from Nuromax is possible, as with all nondepolarizing agents. Prolonged neuromuscular block and inadequate reversal may lead to postoperative complications.
Adverse experiences were uncommon among the 1034 surgical patients and volunteers who received Nuromax and other drugs in US clinical studies in the course of a wide variety of procedures conducted during balanced or inhalational anesthesia. The following adverse experiences were reported in patients administered Nuromax (all events judged by investigators during the clinical trials to have a possible causal relationship):
None
| Cardiovascular:* | Hypotension,† flushing,† ventricular fibrillation, myocardial infarction |
* Reports of ventricular fibrillation (n = 1) and myocardial infarction (n = 1) were limited to ASA Class 3-4 patients undergoing cardiac surgery (n = 142). † 0.3% incidence. All other reactions unmarked were ≤ 0.1%. | |
| Respiratory: | Bronchospasm, wheezing |
| Dermatological: | Urticaria, injection site reaction |
| Special Senses: | Diplopia |
| Nonspecific: | Difficult neuromuscular block reversal, prolonged drug effect, fever |
Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent (e.g., neostigmine, edrophonium) in conjunction with an appropriate anticholinergic agent (see Antagonism of Neuromuscular Block below).
ANTAGONISTS (SUCH AS NEOSTIGMINE) SHOULD NOT BE ADMINISTERED PRIOR TO THE DEMONSTRATION OF SOME SPONTANEOUS RECOVERY FROM NEUROMUSCULAR BLOCK. THE USE OF A NERVE STIMULATOR TO DOCUMENT RECOVERY AND ANTAGONISM OF NEUROMUSCULAR BLOCK IS RECOMMENDED. T4/T1 SHOULD BE > ZERO BEFORE ANTAGONISM IS ATTEMPTED.
In an analysis of patients in whom antagonism of neuromuscular block was evaluated following administration of single doses of neostigmine averaging 0.06 mg/kg (range: 0.05 to 0.075) administered at approximately 25% T1 spontaneous recovery during balanced anesthesia, 71% of patients exhibited T4/T1≥ 0.7 before monitoring was discontinued. For these patients, the mean time to T4/T1≥ 0.7 was 19 minutes (range: 7 to 55). As with other long-acting nondepolarizing neuromuscular blocking agents, the time for recovery of neuromuscular function following administration of neostigmine is dependent upon the level of residual neuromuscular block at the time of attempted reversal; longer recovery times than those cited above may be anticipated when neostigmine is administered at more profound levels of block (i.e., at < 25% T1 recovery).
Patients should be evaluated for adequate clinical evidence of antagonism, e.g., 5-second head lift, and grip strength. Ventilation must be supported until no longer required. As with other neuromuscular blocking agents, physicians should be alert to the possibility that the action of the drugs used to antagonize neuromuscular block may wear off before the effects of Nuromax on the neuromuscular junction have declined sufficiently.
Antagonism may be delayed in the presence of debilitation, carcinomatosis, and the concomitant use of certain broad-spectrum antibiotics or anesthetic agents and other drugs which enhance neuromuscular block or separately cause respiratory depression (see PRECAUTIONS - Drug Interactions). Under such circumstances the management is the same as that of prolonged neuromuscular block.
In clinical trials, a dose of 1 mg/kg edrophonium was not as effective as a dose of 0.06 mg/kg neostigmine in antagonizing moderate to deep levels of neuromuscular block (i.e., < 60% T1 recovery). Therefore, the use of 1 mg/kg edrophonium is not recommended for reversal from moderate to deep levels of block. The use of pyridostigmine has not been studied.
Nuromax SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.
Nuromax, 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 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, 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 produces good-to-excellent conditions for tracheal intubation in 5 minutes in approximately 90% of patients. Lower doses of Nuromax 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 administered to patients receiving balanced anesthesia.
An initial Nuromax 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-to-excellent 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 is administered during steady-state isoflurane, enflurane, or halothane anesthesia, reduction of the dose of Nuromax 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 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 or 100 minutes after an initial dose of 0.05 mg/kg Nuromax 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 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 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 has not been studied in pediatric patients below the age of 2 years.
Nuromax Injection may not be compatible with alkaline solutions with a pH greater than 8.5 (e.g., barbiturate solutions).
Nuromax is compatible with:
Nuromax 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 should be discarded after 8 hours.
Nuromax 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 Injection at room temperature of 15° to 25°C (59° to 77°F). DO NOT FREEZE.
US Patent No. 4,701,460
Nuromax is a registered trademark of GlaxoSmithKline, licensed for use by Abbott Laboratories.
Manufactured for Abbott Laboratories, North Chicago, IL 60064, USA
©Abbott 2003
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Sertra Basics may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertra Basics in the following countries:
International Drug Name Search
Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)
Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs
Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.
Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.
Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.
You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.
Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.
a perforated bowel;
a bowel obstruction or severe constipation; or
colitis or toxic megacolon.
If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.
Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:
nausea or vomiting;
trouble swallowing; or
a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.
Older adults may be more likely to have serious side effects from this medicine.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.
Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.
The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.
Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.
Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.
An overdose of this medication is not expected to produce life-threatening symptoms.
Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.
severe stomach pain or bloating;
no bowel movement within 2 hours after use; or
gagging, choking, or vomiting.
If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.
Less serious side effects may include:
mild stomach cramps, gas, or bloating;
rectal pain or irritation;
nausea; or
passing gas.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with polyethylene glycol electrolyte solution. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: NuLYTELY side effects (in more detail)
Niprina may be available in the countries listed below.
Nitrendipine is reported as an ingredient of Niprina in the following countries:
International Drug Name Search
Generic Name: iron polysaccharide (I ern paw lee SACK ah ride)
Brand Names: Ezfe, Ferrex-150, Ferus Pic-150, Niferex, Niferex Elixir, Nu-Iron 150, Poly Iron, Polysaccharide Iron
Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.
Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.
Iron polysaccharide may also be used for purposes other than those listed in this medication guide.
Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.
hemochromatosis,
hemosiderosis, or
hemolytic anemia.
Iron polysaccharide may be dangerous if you have any of the conditions listed above.
If you do not have an iron deficiency, talk to your doctor about the use of iron polysaccharide. Generally, iron polysaccharide should not be taken chronically by individuals with a normal iron balance.
Take iron polysaccharide exactly as directed by your doctor, or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Mix the liquid forms of iron polysaccharide with water, juice, or another beverage as directed and drink the mixture through a straw to prevent staining of the teeth.
Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.
Take the missed dose as soon as you remember. However, if it is almost time to take the next dose, skip the dose you missed and take the next regularly scheduled dose as directed. Do not take a double dose.
Symptoms of a iron polysaccharide overdose include decreased energy; nausea; vomiting; abdominal pain; tarry stools; a weak, rapid pulse; fever; coma; seizures; and death.
Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.
Other less serious side effects are more likely to occur. Continue taking iron polysaccharide and talk to your doctor or pharmacist if you experience
stomach upset,
nausea or vomiting,
constipation,
diarrhea,
black or darker than normal appearing stools, or
temporary staining of the teeth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
a tetracycline antibiotic such as tetracycline (Achromycin, Sumycin), minocycline (Minocin, Dynacin), doxycycline (Vibramycin, Monodox), demeclocycline (Declomycin), oxytetracycline (Terramycin), or troleandomycin (TAO);
a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), enoxacin (Penetrex) ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), sparfloxacin (Zagam), or trovafloxacin (Trovan);
levodopa (Larodopa, Dopar, Sinemet);
levothyroxine (Synthroid, Levoxyl, others);
methyldopa (Aldomet); or
penicillamine (Cuprimine).
Iron polysaccharide may decrease the absorption of the drugs listed above.
Do not take antacids within 2 hours of a dose of iron polysaccharide. Antacids may decrease the absorption of iron polysaccharide.
Drugs other than those listed here may also interact with iron polysaccharide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines while taking iron polysaccharide.
See also: Niferex side effects (in more detail)
Treating high blood pressure and/or improving survival rates in patients who have left ventricular systolic dysfunction and congestive heart failure following a heart attack. It is sometimes used with other medicines. It may also be used for other conditions as determined by your doctor.
Inspra is a mineralocorticoid receptor blocker. It works by blocking aldosterone. This widens blood vessels and reduces fluid and sodium retention, lowering blood pressure to help prevent strokes, heart attacks, and kidney problems.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Inspra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Inspra. Tell your health care provider if you are taking any other medicines, especially any of the following:
Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the effects of Inspra when used to treat high blood pressure may be decreased
Imidazoles (eg, ketoconazole, itraconazole), ketolide or macrolide antibiotics (eg, clarithromycin, troleandomycin), nefazodone, protease inhibitors (eg, ritonavir , nelfinavir), or verapamil because the side effects of Inspra may be increased
Amiloride, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin-receptor blockers (eg, valsartan), potassium supplements, spironolactone, or triamterene because the risk of abnormal heartbeat due to high blood potassium levels may be increased
Lithium because it may increase lithium blood levels
This may not be a complete list of all interactions that may occur. Ask your health care provider if Inspra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Inspra as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Inspra.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cough; diarrhea; dizziness; flu-like symptoms (fever, chills, muscle ache, tiredness); headache; stomach pain.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal discharge; chest pain; enlarged or swollen breasts; irregular heartbeat; severe muscle weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Inspra side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include irregular heartbeat; severe dizziness; severe muscle weakness.
Store Inspra at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Inspra out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Inspra. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Sotalol Biogaran may be available in the countries listed below.
Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Sotalol Biogaran in the following countries:
International Drug Name Search
Generic Name: efalizumab (EF a LIZ oo mab)
Brand Names: Raptiva
Efalizumab is a man-made form of a protein similar to human antibodies. Efalizumab is made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Efalizumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.
Efalizumab may also be used for other purposes not listed in this medication guide.
Before using efalizumab, tell your doctor about all other medications you are using, especially other psoriasis medications or phototherapy, or drugs that weaken your immune system such as cancer medicine, steroids, and medicines to prevent rejection of a transplanted organ.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using efalizumab, tell your doctor if you have:
any active or chronic infection;
arthritis; or
a weak immune system (caused by disease or by using certain medicines).
You should be current on all immunizations before you start using efalizumab.
Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether efalizumab had any effect on the baby.
Treatment with efalizumab may increase your risk of developing certain types of cancer. Talk with your doctor about your individual risk.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Efalizumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Efalizumab is usually given once per week. Try to use the medicine on the same day each week.
Use a different place on your stomach, thigh, buttocks, or upper arm each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row.
Efalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.
Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
A day or two after using your first dose of efalizumab, you may have nausea, vomiting, muscle pain, and/or a headache. Call your doctor if these effects become severe.
Efalizumab can lower blood cells that help your body fight infections, making it easier for you to bleed from an injury or get sick from being around others who are ill.
Call your doctor if your symptoms do not improve, or if they get worse while using efalizumab. Your psoriasis may get worse after you stop using efalizumab for any reason. Your doctor may want to keep checking to make sure your psoriasis does not get worse. Do not miss any follow-up visits.
Call your doctor for instructions if you miss a dose of efalizumab.
Overdose may cause severe vomiting.
Avoid being near people who have colds, the flu, or other contagious illnesses.
signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, or mouth sores;
signs of a skin infection, such as redness, tenderness, and swelling;
pale or yellowed skin, dark colored urine, confusion or weakness;
change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
cough with yellow or green mucus, stabbing chest pain or tightness, wheezing, trouble breathing;
neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);
numbness or tingly feeling in your feet and spreading upward, muscle weakness in your face; or
problems with vision, speech, swallowing, or bladder and bowel functions.
Less serious side effects may include:
headache, muscle pain, and nausea or vomiting (especially after the first dose);
back pain;
joint pain, stiffness, or swelling; or
swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Psoriasis:
Genentech and the FDA notified healthcare professionals of the voluntary, phased withdrawal of efalizumab from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, efalizumab will no longer be available in the United States. Prescribers are being asked not to initiate efalizumab treatment for any new patients. Prescribers should immediately begin discussing with patients currently using efalizumab how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis. The following dosage information applies to when the drug was available in the U.S.
Initial Dose: 0.7 mg/kg subcutaneously once.
Maintenance Dose: 1 mg/kg subcutaneously weekly.
A maximum single dosage has been imposed at 200 mg as recommended by the manufacturer.
The safety and efficacy of efalizumab therapy beyond one year have not been established.
Tell your doctor about all other medications you are using, especially:
other psoriasis medications or phototherapy;
drugs that weaken your immune system (such as cancer medicine or steroids);
cyclosporine (Neoral, Sandimmune, Gengraf);
sirolimus (Rapamune), tacrolimus (Prograf);
basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
mycophenolate mofetil (CellCept); or
azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).
This list is not complete and there may be other drugs that can interact with efalizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: efalizumab side effects (in more detail)
Generic Name: orphenadrine, aspirin, and caffeine (Oral route)
or-FEN-a-dreen SIT-rate, AS-pir-in, KAF-een
In the U.S.
Available Dosage Forms:
Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
Pharmacologic Class: Orphenadrine
Chemical Class: Salicylate, Aspirin
Orphenadrine and aspirin combination is used to help relax certain muscles in your body and relieve the pain and discomfort caused by strains, sprains, or other injury to your muscles. However, this medicine does not take the place of rest, exercise, or other treatment that your doctor may recommend for your medical problem.
Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects. Actions in the CNS may also be responsible for some of its side effects. Orphenadrine also has other actions (antimuscarinic) that may be responsible for some of its side effects.
This combination medicine also contains caffeine.
In the U.S., this combination medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
There is no specific information about the use of orphenadrine in children.
Elderly people are especially sensitive to the effects of aspirin. This may increase the chance of side effects during treatment.
There is no specific information about the use of orphenadrine in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain orphenadrine, aspirin, and caffeine. It may not be specific to Norgesic. Please read with care.
Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.
Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.
Do not take more of this medicine than your doctor ordered to lessen the chance of side effects or overdose.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If you will be taking this medicine for a long time (for example, more than a few weeks), your doctor should check your progress at regular visits.
Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain orphenadrine or aspirin or other salicylates be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your health care professional.
Too much use of acetaminophen or certain other medicines together with the aspirin in this combination medicine may increase the chance of unwanted effects. The risk depends on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or any of the following medicines together with this combination medicine for more than a few days, unless your doctor has directed you to do so and is following your progress:
For diabetic patients:
Do not take this medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.
The orphenadrine in this combination medicine may add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.
This medicine may cause some people to have blurred vision or to become drowsy, dizzy, lightheaded, faint, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Dryness of the mouth may occur while you are taking this medicine. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
If you think that you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Get emergency help immediately if any of the following symptoms of overdose occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Norgesic side effects (in more detail)
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