WARNING - FDA records indicate that this drug has been recalled.
Product Description: | 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02 |
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Status: | Ongoing |
City: | Deerfield |
State: | IL |
Country: | US |
Voluntary/Mandated: | Voluntary: Firm Initiated |
Initial Firm Notification: | Letter |
Distribution Pattern: | US, Puerto Rico, and Bermuda |
Classification: | Class I |
Product Quantity: | 402,284 bags |
Reason For Recall: | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) |
Recall Initiation Date: | 20150324 |
Report Date: | 20150715 |
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Uses
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
PROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:
Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.
The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.
PROTONIX (pantoprazole sodium) is supplied as a for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg).
Each PROTONIX (pantoprazole sodium) Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.
PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension, 40 mg, contains the active ingredient pantoprazole sodium sesquihydrate in the form of enteric‑coated granules in unit dose packets. Each unit dose packet contains enteric-coated granules containing 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole) with the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.
Sources
Protonix Delayed-release Manufacturers
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Stat Rx Usa Llc
Protonix Delayed-release | Stat Rx Usa Llc
2.1 Recommended Dosing SchedulePROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for PROTONIX Indication
Dose
Frequency
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg
Once daily for up to 8 weeks
≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily** 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions
Formulation
Route
Instructions*
* Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed. Delayed-Release Tablets
Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension
Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension
Nasogastric tube See instructions below PROTONIX Delayed-Release TabletsPROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed‑Release Tablets.
PROTONIX For Delayed-Release Oral SuspensionPROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.
Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.
PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce Open packet. Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES. Take within 10 minutes of preparation. Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary. PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice Open packet. Empty granules into a small cup or teaspoon containing one teaspoon of apple juice. Stir for 5 seconds (granules will not dissolve) and swallow immediately. To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately. PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube AdministrationFor patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed‑Release Oral Suspension can be given as follows:
Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger. Connect the catheter tip of the syringe to a 16 French (or larger) tube. Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing. Empty the contents of the packet into the barrel of the syringe. Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe. -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Protonix Delayed-release | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
2.1 Recommended Dosing SchedulePROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for PROTONIX Indication
Dose
Frequency
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg
Once daily for up to 8 weeks
≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily** 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions
Formulation
Route
Instructions*
* Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed. Delayed-Release Tablets
Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension
Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension
Nasogastric tube See instructions below PROTONIX Delayed-Release TabletsPROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed‑Release Tablets.
PROTONIX For Delayed-Release Oral SuspensionPROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.
Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.
PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce Open packet. Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES. Take within 10 minutes of preparation. Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary. PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice Open packet. Empty granules into a small cup or teaspoon containing one teaspoon of apple juice. Stir for 5 seconds (granules will not dissolve) and swallow immediately. To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately. PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube AdministrationFor patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed‑Release Oral Suspension can be given as follows:
Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger. Connect the catheter tip of the syringe to a 16 French (or larger) tube. Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing. Empty the contents of the packet into the barrel of the syringe. Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe. -
Physicians Total Care, Inc.
Protonix Delayed-release | Physicians Total Care, Inc.
2.1 Recommended Dosing SchedulePROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for PROTONIX Indication
Dose
Frequency
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg
Once daily for up to 8 weeks
≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily** 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions
Formulation
Route
Instructions*
* Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed. Delayed-Release Tablets
Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension
Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension
Nasogastric tube See instructions below PROTONIX Delayed-Release TabletsPROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed‑Release Tablets.
PROTONIX For Delayed-Release Oral SuspensionPROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.
Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.
PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce Open packet. Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES. Take within 10 minutes of preparation. Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary. PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice Open packet. Empty granules into a small cup or teaspoon containing one teaspoon of apple juice. Stir for 5 seconds (granules will not dissolve) and swallow immediately. To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately. PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube AdministrationFor patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed‑Release Oral Suspension can be given as follows:
Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger. Connect the catheter tip of the syringe to a 16 French (or larger) tube. Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing. Empty the contents of the packet into the barrel of the syringe. Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe. -
Cardinal Health
Protonix Delayed-release | Baxter Healthcare Corporation
As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
Do not administer unless solution is clear and seal is intact.
All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.
The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
-
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
Protonix Delayed-release | Abbvie Inc.
MIVACRON SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.
The dosage information provided below is intended as a guide only. Doses of MIVACRON should be individualized (see CLINICAL PHARMACOLOGY - Individualization of Dosages). 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.
AdultsInitial Doses
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 (see Table 7).
Table 7. Recommended Initial Dosing Regimens for Adults 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.The purpose of slowed or divided dosing of MIVACRON at doses above 0.15 mg/kg is to minimize the transient decreases in blood pressure observed in some patients given these doses over 5 to 15 seconds (see CLINICAL PHARMACOLOGY, PRECAUTIONS, and ADVERSE REACTIONS). The quality of intubation conditions does not significantly differ for the times and doses of MIVACRON recommended in Table 7, but the onset of suitable intubation conditions may be reached earlier with higher doses. The choice of a particular dose and regimen should be based on individual circumstances and patient requirements (see CLINICAL PHARMACOLOGY - Individualization of Dosages).
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 (see Table 1). 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.
ChildrenInitial Doses
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 (see CLINICAL PHARMACOLOGY).
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 (see above).
Infusion Rate TablesFor adults and children the amount of infusion solution required per hour depends upon the clinical requirements of the patient, the concentration of MIVACRON in the infusion solution, and the patient's weight. The contribution of the infusion solution to the fluid requirements of the patient must be considered. Table 8 provides guidelines for delivery in mL/hr (equivalent to microdrops/min when 60 microdrops = 1 mL) of MIVACRON Injection (2 mg/mL).
Table 8. Infusion Rates for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia Using MIVACRON Injection (2 mg/mL) 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 Compatibility and AdmixturesY-site Administration
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:
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 in 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 Versed® (midazolam hydrochloride) Injection, diluted as directed Inapsine® (droperidol) Injection, diluted as directedCompatibility studies with other parenteral products have not been conducted.
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.
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