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DRUGS & SUPPLEMENTS
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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).
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.
Plasma cholinesterase activity may be diminished in the presence of genetic abnormalities of plasma cholinesterase (e.g., patients heterozygous or homozygous for the atypical plasma cholinesterase gene), pregnancy, liver or kidney disease, malignant tumors, infections, burns, anemia, decompensated heart disease, peptic ulcer, or myxedema. Plasma cholinesterase activity may also be diminished by chronic administration of oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors and by irreversible inhibitors of plasma cholinesterase (e.g., organophosphate insecticides, echothiophate, and certain antineoplastic drugs).
Mivacron has been used safely in patients heterozygous for the atypical plasma cholinesterase gene. At doses of 0.1 to 0.2 mg/kg Mivacron, the clinically effective duration of action was 8 minutes to 11 minutes longer in patients heterozygous for the atypical gene than in genotypically normal patients.
As with succinylcholine, patients homozygous for the atypical plasma cholinesterase gene (one in 2500 patients) are extremely sensitive to the neuromuscular blocking effect of Mivacron. In three such adult patients, a small dose of 0.03 mg/kg (approximately the ED10-20 in genotypically normal patients) produced complete neuromuscular block for 26 to 128 minutes. Once spontaneous recovery had begun, neuromuscular block in these patients was antagonized with conventional doses of neostigmine. One adult patient, who was homozygous for the atypical plasma cholinesterase gene, received a dose of 0.18 mg/kg Mivacron and exhibited complete neuromuscular block for about 4 hours. Response to post-tetanic stimulation was present after 4 hours, all four responses to train-of-four stimulation were present after 6 hours, and the patient was extubated after 8 hours. Reversal was not attempted in this patient.
The use of Mivacron before succinylcholine to attenuate some of the side effects of succinylcholine has not been studied.
There are no clinical data on the use of Mivacron with other nondepolarizing neuromuscular blocking agents.
Isoflurane and enflurane (administered with nitrous oxide/oxygen to achieve 1.25 MAC) decrease the ED50 of Mivacron by as much as 25% (see CLINICAL PHARMACOLOGY - Pharmacodynamics and Individualization of Dosages ). These agents may also prolong the clinically effective duration of action and decrease the average infusion requirement of Mivacron by as much as 35% to 40%. A greater potentiation of the neuromuscular blocking effects of Mivacron may be expected with higher concentrations of enflurane or isoflurane. Halothane has little or no effect on the ED50, but may prolong the duration of action and decrease the average infusion requirement by as much as 20%.
Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as Mivacron include certain antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistimethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine. The neuromuscular blocking effect of Mivacron may be enhanced by drugs that reduce plasma cholinesterase activity (e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase (see PRECAUTIONS - Reduced Plasma Cholinesterase Activity subsection).
Resistance to the neuromuscular blocking action of nondepolarizing neuromuscular blocking agents has been demonstrated in patients chronically administered phenytoin or carbamazepine. While the effects of chronic phenytoin or carbamazepine therapy on the action of Mivacron are unknown, slightly shorter durations of neuromuscular block may be anticipated and infusion rate requirements may be higher.
Pregnancy Category C
Teratology testing in nonventilated pregnant rats and mice treated subcutaneously with maximum subparalyzing doses of Mivacron revealed no maternal or fetal toxicity or teratogenic effects. There are no adequate and well-controlled studies of Mivacron in pregnant women. Because animal studies are not always predictive of human response, and the doses used were subparalyzing, Mivacron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Overall, hypotension was infrequently reported as an adverse experience in the clinical trials of Mivacron. One of 332 (0.3%) healthy adults who received 0.15 mg/kg Mivacron over 5 to 15 seconds and none of 37 cardiac surgery patients who received 0.15 mg/kg Mivacron over 60 seconds were treated for a decrease in blood pressure in association with the administration of Mivacron. One to two percent of healthy adults given greater than or equal to 0.2 mg/kg Mivacron over 5 to 15 seconds, 2% to 3% of healthy adults given 0.2 mg/kg over 30 seconds, none of 100 healthy adults given 0.25 mg/kg as a divided dose (0.15 mg/kg followed in 30 seconds by 0.1 mg/kg), and 2% to 4% of cardiac surgery patients given greater than or equal to 0.2 mg/kg over 60 seconds were treated for a decrease in blood pressure. None of the 63 children who received the recommended dose of 0.2 mg/kg Mivacron was treated for a decrease in blood pressure in association with the administration of Mivacron.
The following adverse experiences were reported in patients administered Mivacron (all events judged by investigators during the clinical trials to have a possible causal relationship):
Incidence Greater Than 1%
Cardiovascular
Flushing (16%)
Incidence Less Than 1%
Cardiovascular
Hypotension, tachycardia, bradycardia, cardiac arrhythmia, phlebitis
Respiratory
Bronchospasm, wheezing, hypoxemia
Dermatological
Rash, urticaria, erythema, injection site reaction
Nonspecific
Prolonged drug effect
Neurologic
Dizziness
Musculoskeletal
Muscle spasms
Anaphylaxis/Anaphylactoid Reactions: From post-marketing surveillance, Mivacron has been associated with reports of anaphylactic/anaphylactoid reactions which 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 ). In some of these reports, sensitivity to Mivacron was confirmed using skin test procedures.
Other adverse reaction data from clinical practice are insufficient to establish a causal relationship or to support an estimate of their incidence. These adverse events include:
Musculoskeletal
Diminished drug effect, prolonged drug effect
Cardiovascular
Hypotension (rarely severe), flushing
Respiratory
Bronchospasm
Integumentary
Rash
Administration of 0.03 to 0.064 mg/kg neostigmine or 0.5 mg/kg edrophonium at approximately 10% recovery from neuromuscular block (range: 1 to 15) produced 95% recovery of the muscle twitch response and a T4/T1 ratio greater than or equal to 75% in about 10 minutes. The times from 25% recovery of the muscle twitch response to T4/T1 ratio greater than or equal to 75% following these doses of antagonists averaged about 7 to 9 minutes. In comparison, average times for spontaneous recovery from 25% to T4/T1 greater than or equal to 75% were 12 to 13 minutes.
Patients administered antagonists 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.
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 (see OVERDOSAGE ).
The dosage information provided below is intended as a guide only. Doses of Mivacron should be individualized. Factors that may warrant dosage adjustment include but may not be limited to: the presence of significant kidney, liver, or cardiovascular disease, obesity (patients weighing greater than or equal to 30% more than ideal body weight for height), asthma, reduction in plasma cholinesterase activity, and the presence of inhalational anesthetic agents.
When using Mivacron or other neuromuscular blocking agents to facilitate tracheal intubation, it is important to recognize that the most important factors affecting intubation are the depth of general anesthesia and the level of neuromuscular block. Satisfactory intubating conditions can usually be achieved before complete neuromuscular block is attained if there is adequate anesthesia.
The use of a peripheral nerve stimulator will permit the most advantageous use of Mivacron, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery. When using a stimulator to monitor onset of neuromuscular block, clinical studies have shown that all four twitches of the train-of-four response may be present, with little or no fade, at the times recommended for intubation. Therefore, as with other neuromuscular blocking agents, it is important to use other criteria, such as clinical evaluation of the status of relaxation of jaw muscles and vocal cords, in conjunction with peripheral muscle twitch monitoring, to guide the appropriate time of intubation.
The onset of conditions suitable for tracheal intubation occurs earlier after a conventional intubating dose of succinylcholine than after recommended doses of Mivacron.
Doses of 0.15 mg/kg administered over 5 to 15 seconds, 0.2 mg/kg administered over 30 seconds, or 0.25 mg/kg administered in divided doses (0.15 mg/kg followed in 30 seconds by 0.1 mg/kg) are recommended for facilitation of tracheal intubation for most patients.
Dosing Paradigm* | Anesthetic Induction Technique Studied | Time to Generally Good-to- Excellent Intubating Conditions |
0.15 mg/kg, intravenous (over 5 to 15 sec) | Thiopental/opioid/N2O/O2 or propofol/opioid | 2.5 to 3 min after completion of dose |
0.2 mg/kg, intravenous (over 30 sec) | Thiopental/opioid/N2O/O2 or propofol/opioid | 2 to 2.5 min after completion of dose |
0.25 mg/kg, intravenous (0.15 mg/kg followed in 30 sec by 0.1 mg/kg) | Propofol/opioid | 1.5 to 2 min after completion of 0.15 mg/kg dose |
* Dosing instituted after induction of adequate general anesthesia. |
In patients with clinically significant cardiovascular disease and in patients with any history suggesting a greater sensitivity to the release of histamine or other mediators (e.g., asthma), the dose of Mivacron should be 0.15 mg/kg or less, administered over 60 seconds (see PRECAUTIONS ). No data are available on the use of doses of Mivacron above 0.15 mg/kg in patients with clinically significant kidney or liver disease.
Clinically effective neuromuscular block may be expected to last for 15 to 20 minutes (range: 9 to 38 minutes) and spontaneous recovery may be expected to be 95% complete in 25 to 30 minutes (range: 16 to 41 minutes) following 0.15 mg/kg Mivacron administered to patients receiving opioid/nitrous oxide/oxygen anesthesia. The expected duration of clinically effective block and time to 95% spontaneous recovery following 0.2 mg/kg Mivacron are approximately 20 and 30 minutes, respectively, and following 0.25 mg/kg Mivacron are approximately 25 and 35 minutes. Initiation of maintenance dosing during opioid/nitrous oxide/oxygen anesthesia is generally required approximately 15, 20 and 25 minutes following initial doses of 0.15 mg/kg, 0.2 mg/kg, and 0.25 mg/kg Mivacron, respectively. Maintenance doses of 0.1 mg/kg each provide approximately 15 minutes of additional clinically effective block. For shorter or longer durations of action, smaller or larger maintenance doses may be administered.
The neuromuscular blocking action of Mivacron is potentiated by isoflurane or enflurane anesthesia. Recommended initial doses of Mivacron may be used to facilitate tracheal intubation prior to the administration of these agents; however, if Mivacron is first administered after establishment of stable-state isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen to achieve 1.25 MAC), the initial dose of Mivacron may be reduced by as much as 25%. Greater reductions in the dose of Mivacron may be required with higher concentrations of enflurane or isoflurane. With halothane, which has only a minimal potentiating effect on Mivacron, a smaller dosage reduction may be considered.
Continuous Infusion
Continuous infusion of Mivacron may be used to maintain neuromuscular block. Upon early evidence of spontaneous recovery from an initial dose, an initial infusion rate of 9 to 10 mcg/kg/min is recommended. If continuous infusion is initiated simultaneously with the administration of an initial dose, a lower initial infusion rate should be used (e.g., 4 mcg/kg/min). In either case, the initial infusion rate should be adjusted according to the response to peripheral nerve stimulation and to clinical criteria. On average, an infusion rate of 5 to 7 mcg/kg/min (range: 1 to 15 mcg/kg/min) may be expected to maintain neuromuscular block within the range of 89% to 99% for extended periods in adults receiving opioid/nitrous oxide/oxygen anesthesia. In some patients, particularly those with higher infusion requirements (greater than 8 mcg/kg/min) during the first 30 minutes, the infusion rate required to maintain 89% to 99% T1 suppression may decrease gradually (by greater than or equal to 30%) with time over a 4- to 6-hour period of infusion (see CLINICAL PHARMACOLOGY - Pharmacodynamics ). Reduction of the infusion rate by up to 35% to 40% should be considered when Mivacron is administered during stable-state conditions of isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen to achieve 1.25 MAC). Greater reductions in the infusion rate of Mivacron may be required with greater concentrations of enflurane or isoflurane. With halothane, smaller reductions in infusion rate may be required.
Dosage requirements for Mivacron on a mg/kg basis are higher in children than in adults. Onset and recovery of neuromuscular block occur more rapidly in children than in adults.
The recommended dose of Mivacron for facilitating tracheal intubation in children 2 to 12 years of age is 0.2 mg/kg administered over 5 to 15 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.2 mg/kg of Mivacron produces maximum neuromuscular block in an average of 1.9 minutes (range: 1.3 to 3.3 minutes) and clinically effective block for 10 minutes (range: 6 to 15 minutes). Maintenance doses are generally required more frequently in children than in adults. Administration of doses of Mivacron above the recommended range (greater than 0.2 mg/kg) is associated with transient decreases in MAP in some children (see CLINICAL PHARMACOLOGY - Hemodynamics ). Mivacron has not been studied in pediatric patients below the age of 2 years.
Continuous Infusion
Children require higher infusion rates of Mivacron than adults. During opioid/nitrous oxide/oxygen anesthesia, the infusion rate required to maintain 89% to 99% neuromuscular block averages 14 mcg/kg/min (range: 5 to 31 mcg/kg/min). The principles for infusion of Mivacron in adults are also applicable to children.
Drug Delivery Rate (mcg/kg/min) | ||||||||||
4 | 5 | 6 | 7 | 8 | 10 | 14 | 16 | 18 | 20 | |
Patient Weight (kg) | Infusion Delivery Rate (mL/hr) | |||||||||
10 | 1.2 | 1.5 | 1.8 | 2.1 | 2.4 | 3 | 4.2 | 4.8 | 5.4 | 6 |
15 | 1.8 | 2.3 | 2.7 | 3.2 | 3.6 | 4.5 | 6.3 | 7.2 | 8.1 | 9 |
20 | 2.4 | 3 | 3.6 | 4.2 | 4.8 | 6 | 8.4 | 9.6 | 10.8 | 12 |
25 | 3 | 3.8 | 4.5 | 5.3 | 6 | 7.5 | 10.5 | 12 | 13.5 | 15 |
35 | 4.2 | 5.3 | 6.3 | 7.4 | 8.4 | 10.5 | 14.7 | 16.8 | 18.9 | 21 |
50 | 6 | 7.5 | 9 | 10.5 | 12 | 15 | 21 | 24 | 27 | 30 |
60 | 7.2 | 9 | 10.8 | 12.6 | 14.4 | 18 | 25.2 | 28.8 | 32.4 | 36 |
70 | 8.4 | 10.5 | 12.6 | 14.7 | 16.8 | 21 | 29.4 | 33.6 | 37.8 | 42 |
80 | 9.6 | 12 | 14.4 | 16.8 | 19.2 | 24 | 33.6 | 38.4 | 43.2 | 48 |
90 | 10.8 | 13.5 | 16.2 | 18.9 | 21.6 | 27 | 37.8 | 43.2 | 48.6 | 54 |
100 | 12 | 15 | 18 | 21 | 24 | 30 | 42 | 48 | 54 | 60 |
Mivacron Injection may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions).
Studies have shown that Mivacron Injection is compatible with:
Dilution Stability
Mivacron Injection diluted to 0.5 mg mivacurium per mL in 5% Dextrose Injection, USP, 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP, or 5% Dextrose in Lactated Ringer's Injection is physically and chemically stable when stored in PVC (polyvinylchloride) bags at 5° to 25°C (41° to 77°F) for up to 24 hours. Aseptic techniques should be used to prepare the diluted product. Admixtures of Mivacron should be prepared for single patient use only and used within 24 hours of preparation. The unused portion of diluted Mivacron should be discarded after each case.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear and colorless should not be used.
List | Fill | Container | Quantity | NDC# |
4365 | 5 mL | Single-Dose Fliptop Vial | 10 per Carton | NDC 0074-4365-05 |
4365 | 10 mL | Single-Dose Fliptop Vial | 10 per Carton | NDC 0074-4365-10 |
Mivacron is a registered trademark of GlaxoSmithKline, licensed for use by AbbVie Inc.
Sufenta, Alfenta, Sublimaze, Versed, and Inapsine are not trademarks of AbbVie Inc.
©AbbVie Inc. 2014
Manufactured for
AbbVie Inc.
North Chicago, IL 60064, USA
January 2015
10000000126431
NDC 0074–4365–05
10 x 5 mL Vials 10 mg/ 5 mL
Mivacron®
(mivacurium chloride) Injection
10 mg / 5 mL
(2 mg/mL)
Single-dose vials-Discard Unused Portion
For Intravenous Use
Rx only abbvie
Mivacron 10x5mL viials 10mg/5mL
Depending on the reaction of the Mivacron after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mivacron not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Mivacron addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology