Redormin is used to relieve pain during and after surgery or other medical procedures. It is also used with other medicines (e.g., isoflurane, propofol, midazolam, thiopental, Diprivan®) just before or during an operation to help the anesthetic work better.
Redormin belongs to the group of medicines known as narcotic analgesics (pain medicines). It works by acting on the central nervous system (CNS) or brain to relieve pain.
Redormin is to be administered only by or under the immediate supervision of your doctor.
Redormin is available only with your doctor's prescription.
Redormin indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Intravenous
Analgesia during induction of anaesthesia
Adult: To be used in conjunction an hypnotic agent (e.g. propofol, thiopentone, isoflurane): Infuse at 0.5-1 mcg/kg/minute. If the patient is to be intubated <8 minutes after the start of the infusion, an additional initial IV bolus of 1 mcg/kg may be given over 30-60 seconds.
Reconstitution: Add 1 ml of diluent per mg of Redormin and shake well. The reconstituted solution should be further diluted to 20, 25, 50 or 250 mcg/ml before admin. Suitable diluents include sterile water for inj, 5% dextrose, 5% dextrose and 0.9% sodium chloride, 0.9% sodium chloride, 0.45% sodium chloride.
Incompatibility: Other than co-administration with propofol into a running IV catheter, compatibility with other therapeutic agents has not been evaluated. Do not mix with blood products, lactated Ringer's inj with or without 5% glucose.
Intravenous
Analgesia during maintenance of anaesthesia in ventilated patients
Adult: Usual infusion doses range: 0.05-2 mcg/kg/minute depending on the anaesthetic drug used and titrated according to patient response. In response to light anaesthesia or intense surgical stress, supplemental IV boluses of 0.5-1 mcg/kg may be admin every 2-5 minutes. In spontaneous respiration, infuse at 0.04 mcg/kg/minute, then titrated according to response. Usual range of 0.025- 0.1 mcg/kg/minute. Bolus doses not recommended during spontaneous ventilation.
Child: Neonates: IV infusion 0.4-1.0 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV inj of 1 mcg/kg dose may be given. 1-12 yr: initially 0.1-1 mcg/kg by IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion 0.05-1.3 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion. 12-18 yr: 0.1-1 mcg/kg IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion of 0.05-2 mcg/kg/minute depending on anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion.
Reconstitution: Add 1 ml of diluent per mg of Redormin and shake well. The reconstituted solution should be further diluted to 20, 25, 50 or 250 mcg/ml before admin. Suitable diluents include sterile water for inj, 5% dextrose, 5% dextrose and 0.9% sodium chloride, 0.9% sodium chloride, 0.45% sodium chloride.
Incompatibility: Other than co-administration with propofol into a running IV catheter, compatibility with other therapeutic agents has not been evaluated. Do not mix with blood products, lactated Ringer's inj with or without 5% glucose.
Intravenous
Continuation of analgesia into immediate postoperative period
Adult: Usual range: 100-200 nanograms/kg per minute, given via IV infusion. Infusion rates >0.2 mcg/kg/minute may be associated with respiratory depression. Not recommended to give supplemental bolus doses during the postoperative period.
Reconstitution: Add 1 ml of diluent per mg of Redormin and shake well. The reconstituted solution should be further diluted to 20, 25, 50 or 250 mcg/ml before admin. Suitable diluents include sterile water for inj, 5% dextrose, 5% dextrose and 0.9% sodium chloride, 0.9% sodium chloride, 0.45% sodium chloride.
Incompatibility: Other than co-administration with propofol into a running IV catheter, compatibility with other therapeutic agents has not been evaluated. Do not mix with blood products, lactated Ringer's inj with or without 5% glucose.
Intravenous
Analgesia and sedation in ventilated patients under intensive care
Adult: Initially, IV infusion 0.1-0.15 mcg/kg/minute, titrated in increments of 0.025 mcg/kg/minute according to response, allowing at least 5 minutes between dose adjustments. Add additional sedative drugs if desired response not obtained after an infusion rate of 0.2 mcg/kg/minute reached. If patient undergoing stimulating or painful procedures (e.g. endotracheal suctioning, wound dressing), maintain an infusion rate of at least 0.1 mcg/kg/minute 5 minutes before procedure, adjust rate every 2-5 minutes according to response, max: 0.75 mcg/kg/min; bolus doses not recommended. For extubation and discontinuation of Redormin, titrate infusion rate downwards in stages to 0.1 mcg/kg/minute up to 1 hr before extubation. After extubation, infusion rate to be further reduced in 25% decrements in at least 10 minute intervals until infusion is discontinued. Do not increase infusion rate during weaning from ventilator.
Reconstitution: Add 1 ml of diluent per mg of Redormin and shake well. The reconstituted solution should be further diluted to 20, 25, 50 or 250 mcg/ml before admin. Suitable diluents include sterile water for inj, 5% dextrose, 5% dextrose and 0.9% sodium chloride, 0.9% sodium chloride, 0.45% sodium chloride.
Incompatibility: Other than co-administration with propofol into a running IV catheter, compatibility with other therapeutic agents has not been evaluated. Do not mix with blood products, lactated Ringer's inj with or without 5% glucose.
Intravenous
Analgesia in cardiac anaesthesia
Adult: Induction of anaesthesia: By continuous infusion at a rate of 1 mcg/kg/minute, endotracheal intubation to start at least 5 minutes after start of infusion. Maintenance of anaesthesia (in conjunction with hypnotic agent): After intubation, titrate infusion upwards or downwards by 25-50% every 2-5 minutes, depending on patient response. Supplemental IV bolus of 0.5-1 mcg/kg, admin over at least 30 seconds, may be given every 2-5 minutes as needed. Max bolus dose in high risk cardiac patients (e.g. undergoing valve surgery) and hypothermic cardiopulmonary bypass: 0.5 mcg/kg. Infusion of Redormin to be maintained at final intra-operative rate post-operatively, titrated according to patient's needs. Prior to discontinuation of Redormin, alternative analgesic and sedative agents to be admin and allowed to reach therapeutic effects. Reduce infusion rate by 25% decrements at least every 10 minutes until infusion is discontinued.
Reconstitution: Add 1 ml of diluent per mg of Redormin and shake well. The reconstituted solution should be further diluted to 20, 25, 50 or 250 mcg/ml before admin. Suitable diluents include sterile water for inj, 5% dextrose, 5% dextrose and 0.9% sodium chloride, 0.9% sodium chloride, 0.45% sodium chloride.
Incompatibility: Other than co-administration with propofol into a running IV catheter, compatibility with other therapeutic agents has not been evaluated. Do not mix with blood products, lactated Ringer's inj with or without 5% glucose.
Special Populations: For obese patients, the dosage should be based on ideal body wt.
How should I use Redormin?
Use Redormin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Redormin is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions you may have about Redormin.
If you miss a dose of Redormin, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Redormin.
Uses of Redormin in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Anesthesia: Analgesic for use during the induction and maintenance of general anesthesia; continued analgesia into the immediate postoperative period in adults; analgesic component of monitored anesthesia in adults
Off Label Uses
Pain in mechanically ventilated patients (management)
Based on the Society of Critical Care Medicine guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit, Redormin is an effective and recommended agent for management of pain in critically ill patients.
Redormin description
A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Redormin has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of anxiety disorders, and also for the short-term management of insomnia but has largely been superseded by the benzodiazepines. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) Redormin is a controlled substance in the U.S.
Redormin dosage
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Redormin (Redormin) is for IV use only. Continuous infusions of Redormin (Redormin) should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion.
During General Anesthesia: Redormin (Redormin) is not recommended as the sole agent in general anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Redormin (Redormin) is synergistic with other anesthetics; therefore, clinicians may need to reduce doses of thiopental, propofol, isoflurane, and midazolam by up to 75% with the coadministration of Redormin (Redormin). The administration of Redormin (Redormin) must be individualized based on the patient's response.
Table 10 summarizes the recommended doses in adult patients, predominately ASA physical status I, II, or III.
Table 10: Dosing Guidelines in Adults - General Anesthesia and Continuing as an Analgesic into the Postoperative Care Unit or Intensive Care Setting*
Phase
Continuous IV
Infusion of Redormin (Redormin)
(mcg/kg/min)
Infusion Dose
Range of Redormin (Redormin)
(mcg/kg/min)
Supplemental IV
Bolus Dose of
Redormin (Redormin) (mcg/kg)
Induction of Anesthesia (through intubation)
0.5 - 1*
Maintenance of anesthesia with:
Nitrous oxide (66%)
0.4
0.1 - 2
1
Isoflurane (0.4 to 1.5 MAC)
0.25
0.05 - 2
1
Propofol (100 to 200 mcg/kg/min)
0.25
0.05 - 2
1
Continuation as an analgesic into the immediate postoperativeperiod
0.1
0.025 - 0.2
not recommended
*An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
Table 11 summarizes the recommended doses in pediatric patients, predominantly ASA physical status I, II, or III. In pediatric patients, Redormin was administered with nitrous oxide or nitrous oxide in combination with halothane, sevoflurane, or isoflurane.
Table 11: Dosing Guidelines in Pediatric Patients - Maintenance of Anesthesia
Phase
Continuous IV
Infusion of Redormin (Redormin)
(mcg/kg/min)
Infusion Dose
Range of Redormin (Redormin)
(mcg/kg/min)
Supplemental IV
Bolus Dose of
Redormin (Redormin) (mcg/kg)
*Maintenance of anesthesia in patients aged 1 to 12 years old with:
Halothane (0.3 to 1.5 MAC)
0.25
0.05 - 1.3
1
Sevoflurane (0.3 to 1.5 MAC)
0.25
0.05 - 1.3
1
Isoflurane (0.4 to 1.5 MAC)
0.25
0.05 - 1.3
1
Maintenance of anesthesia for patients from birth to 2 months of age with:
Nitrous oxide (70%)**
0.4
0.4 - 1.0
1***
*An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
**The initial maintenance infusion regimen of Redormin (Redormin) evaluated in full term pediatric patients from birth to 2 months of age undergoing pyloromyotomy was 0.4 mcg/kg/min, the approved adult regimen for use with NO. The clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. Therefore, while a starting infusion of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated. The use of atropine may blunt the potential for bradycardia that can occur upon administration of Redormin..
*** Boluses of 1 mcg/kg were studied in ASA 1 and 2, full-term patients weighing at least 2500 gm, undergoing pyloromyotomy who received pretreatment with atropine. Some neonates, particularly those receiving supplementation with potent inhalation agents or neuraxial anesthesia, those with significant co-morbidities or undergoing significant fluid shifts, or those who have not been pretreated with atropine, may require smaller bolus doses to avoid hypotension and/or bradycardia.
During Induction of Anesthesia: Redormin (Redormin) should be administered at an infusion rate of 0.5 to 1 mcg/kg/min with a hypnotic or volatile agent for the induction of anesthesia. If endotracheal intubation is to occur less than 8 minutes after the start of the infusion of Redormin (Redormin), then an initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
During Maintenance of Anesthesia: After endotracheal intubation, the infusion rate of Redormin (Redormin) should be decreased in accordance with the dosing guidelines in Tables 10 (adults) and 11 (pediatric patients). Due to the fast onset and short duration of action of Redormin (Redormin), the rate of administration during anesthesia can be titrated upward in 25% to 100% increments in adult patients or up to 50% increments in pediatric patients, or downward in 25% to 50% decrements every 2 to 5 minutes to attain the desired level of μ-opioid effect. In response to light anesthesia or transient episodes of intense surgical stress, supplem ental bolus doses of 1 mcg/kg may be administered every 2 to 5 minutes. At infusion rates > 1 mcg/kg/min, increases in the concomitant anesthetic agents should be considered to increase the depth of anesthesia. See CLINICAL PHARMACOLOGY: Special Populations: Pediatric Patients, and DOSAGE AND ADMINISTRATION, Table 11 for additional information.
Continuation as an Analgesic into the Immediate Postoperative Period Under the Direct Supervision of an Anesthesia Practitioner: Infusions of Redormin (Redormin) may be continued into the immediate postoperative period for select patients for whom later transition to longer acting analgesics may be desired. The use of bolus injections of Redormin (Redormin) to treat pain during the postoperative period is not recommended. When used as an IV analgesic in the immediate postoperative period, Redormin (Redormin) should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min. The infusion rate may be adjusted every 5 minutes in 0.025-mcg/kg/min increments to balance the patient's Infusion rates greater than 0.2 mcg/kg/min are associated with respiratory depression (respiratory rate less than 8 breaths/min).
Guidelines for Discontinuation: Upon discontinuation of Redormin (Redormin), the IV tubing should be cleared to prevent the inadvertent administration of Redormin (Redormin) at a later time.
Due to the rapid offset of action of Redormin (Redormin), no residual analgesic activity will be present within 5 to 10 minutes after discontinuation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, alternative analgesics should be administered prior to discontinuation of Redormin (Redormin). The choice of analgesic should be appropriate for the patient's surgical procedure and the level of follow-up care
Analgesic Component of Monitored Anesthesia Care: It is strongly recommended that supplemental oxygen be supplied to the patient whenever Redormin (Redormin) is administered.
Table 12 summarizes the recommended doses for monitored anesthesia care in adult patients, predominately ASA physical status I, II, or III. Redormin (Redormin) has not been studied for use in children in monitored anesthesia care.
Table 12: Dosing Guidelines in Adults - Monitored Anesthesia Care
Method
Timing
Redormin Alone
Redormin + 2 mg Midazolam
Single IV Dose
Given 90 seconds before local anesthetic
1 mcg/kg over 30 to 60 seconds
0.5 mcg/kg over 30 to 60 seconds
Continuous IV Infusion
Beginning 5 minutes before local anesthetic
0.1 mcg/kg/min
0.05 mcg/kg/min
After local anesthetic
0.05 mcg/kg/min (Range: 0.025 -0.2 mcg/kg/min)
0.025 mcg/kg/min (Range: 0.025 -0.2 mcg/kg/min)
Single Dose: A single IV dose of 0.5 to 1 mcg/kg over 30 to 60 seconds of Redormin (Redormin) may be given 90 seconds before the placement of the local or regional anesthetic block.
Continuous Infusion: When used alone as an IV analgesic component of monitored anesthesia care, Redormin (Redormin) should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min beginning 5 minutes before placement of the local or regional anesthetic block. Because of the risk for hypoventilation, the infusion rate of Redormin (Redormin) should be decreased to 0.05 mcg/kg/min following placement of the block. Thereafter, rate adjustments of 0.025 mcg/kg/min at 5-minute intervals may be used to balance the patient's level of analgesia and respiratory rate. Rates greater than 0.2 mcg/kg/min are generally associated with respiratory depression (respiratory rates less than 8 breaths/min). Bolus doses of Redormin (Redormin) administered simultaneously with a continuous infusion of Redormin (Redormin) to spontaneously breathing patients are not recommended.
Individualization of Dosage
Use in Geriatric Patients: The starting doses of Redormin (Redormin) should be decreased by 50% in elderly patients ( > 65 years). Redormin (Redormin) should then be cautiously titrated to effect.
Use in Pediatric Patients: See Table 11 for dosing recommendations for use of Redormin (Redormin) in pediatric patients from birth to 12 years of age for maintenance of anesthesia. See CLINICAL PHARMACOLOGY: Special Populations: Pediatric Patients, and DOSAGE AND ADMINISTRATION, Table 11 and During Maintenance of Anesthesia for additional information.
Redormin (Redormin) has not been studied in pediatric patients for use in the immediate postoperative period or for use as a component of monitored anesthesia care.
Use in Coronary Artery Bypass Surgery: Table 13 summarizes the recommended doses for induction, maintenance, and continuation as an analgesic into the ICU in adult patients, predominantly ASA physical status III or IV. To avoid hypotension during the induction phase, it is important to consider the concomitant medication regimens described in the Clinical Trials: Coronary Artery Bypass Surgery subsection.
Table 13: Dosing Recommendations* - Coronary Artery Bypass Surgery
Phase
Continuous IV
Infusion of Redormin (Redormin)
(mcg/kg/min)
Infusion Dose
Range of Redormin (Redormin)
(mcg/kg/min)
Supplemental
IV Bolus Dose of
Redormin (Redormin) (mcg/kg)
Induction of Anesthesia (through intubation)
1
Maintenance of Anesthesia
1
0.125 - 4
0.5 - 1
Continuation as an analgesic into ICU
1
0.05 - 1
* See Clinical Trials: Coronary Artery Bypass Surgery subsection for concomitant medication regimens.
Use in Obese Patients: The starting doses of Redormin (Redormin) should be based on ideal body weight (IBW) in obese patients (greater than 30% over their IBW).
Preanesthetic Medication: The need for premedication and the choice of anesthetic agents must be individualized. In clinical studies, patients who received Redormin (Redormin) frequently received a benzodiazepine premedication.
Preparation for Administration: To reconstitute solution, add 1 mL of diluent per mg of Redormin. Shake well to dissolve. When reconstituted as directed, the solution contains approximately 1 mg of Redormin activity per 1 mL. Redormin (Redormin) should be diluted to a recommended final concentration of 20, 25, 50, or 250 mcg/mL prior to administration. Redormin (Redormin) should not be administered without dilution.
Table 14: Reconstitution and Dilution of Redormin (Redormin) analgesic into ICU
Final Concentration
Amount of Redormin in Each Vial
Final Volume After Reconstitution and Dilution
20 mcg/mL
1 mg
50 mL
2 mg
100 mL
5 mg
250 mL
25 mcg/mL
1 mg
40 mL
2 mg
80 mL
5 mg
200 mL
50 mcg/mL
1 mg
20 mL
2 mg
40 mL
5 mg
100 mL
250 mcg/mL
5 mg
20 mL
Continuous IV infusions of Redormin (Redormin) should be administered only by an infusion device. Infusion rates of Redormin (Redormin) can be individualized for each patient using Table 15:
Table 15: IV Infusion Rates of Redormin (Redormin) (mL/kg/h)
Drug Delivery Rate (mcg/kg/min)
Infusion Delivery Rate (mL/kg/h)
20 mcg/mL
25 mcg/mL
50 mcg/mL
250 mcg/mL
0.0125
0.038
0.03
0.015
not recommended
0.025
0.075
0.06
0.03
not recommended
0.05
0.15
0.12
0.06
0.012
0.075
0.23
0.18
0.09
0.018
0.1
0.3
0.24
0.12
0.024
0.15
0.45
0.36
0.18
0.036
0.2
0.6
0.48
0.24
0.048
0.25
0.75
0.6
0.3
0.06
0.5
1.5
1.2
0.6
0.12
0.75
2.25
1.8
0.9
0.18
1.0
3.0
2.4
1.2
0.24
1.25
3.75
3.0
1.5
0.3
1.5
4.5
3.6
1.8
0.36
1.75
5.25
4.2
2.1
0.42
2.0
6.0
4.8
2.4
0.48
When Redormin (Redormin) is used as an analgesic component of monitored analgesia care, a final concentration of 25 mcg/mL is recommended. When Redormin (Redormin) is used for pediatric patients 1 year of age and older, a final concentration of 20 or 25 mcg/mL is recommended. Table 16 is a guideline for milliliter-per-hour delivery for a solution of 20 mcg/mL with an infusion device.
Table 16: IV Infusion Rates of Redormin (Redormin) (mL/h) for a 20-mcg/mL Solution
Infusion Rate
(mcg/kg/min)
Patient Weight (kg)
5
10
20
30
40
50
60
0.0125
0.188
0.375
0.75
1.125
1.5
1.875
2.25
0.025
0.375
0.75
1.5
2.25
3.0
3.75
4.5
0.05
0.75
1.5
3.0
4.5
6.0
7.5
9.0
0.075
1.125
2.25
4.5
6.75
9.0
11.25
13.5
0.1
1.5
3.0
6.0
9.0
12.0
15.0
18.0
0.15
2.25
4.5
9.0
13.5
18.0
22.5
27.0
0.2
3.0
6.0
12.0
18.0
24.0
30.0
36.0
0.25
3.75
7.5
15.0
22.5
30.0
37.5
45.0
0.3
4.5
9.0
18.0
27.0
36.0
45.0
54.0
0.35
5.25
10.5
21.0
31.5
42.0
52.5
63.0
0.4
6.0
12.0
24.0
36.0
48.0
60.0
72.0
Table 17 is a guideline for milliliter-per-hour delivery for a solution of 25 mcg/mL with an infusion device.
Table 17: IV Infusion Rates of Redormin (Redormin) (mL/h) for a 25-mcg/mL Solution
Infusion Rate
(mcg/kg/min)
PatientWeight (kg)
10
20
30
40
50
60
70
80
90
100
0.0125
0.3
0.6
0.9
1.2
1.5
1.8
2.1
2.4
2.7
3.0
0.025
0.6
1.2
1.8
2.4
3.0
3.6
4.2
4.8
5.4
6.0
0.05
1.2
2.4
3.6
4.8
6.0
7.2
8.4
9.6
10.8
12.0
0.075
1.8
3.6
5.4
7.2
9.0
10.8
12.6
14.4
16.2
18.0
0.1
2.4
4.8
7.2
9.6
12.0
14.4
16.8
19.2
21.6
24.0
0.15
3.6
7.2
10.8
14.4
18.0
21.6
25.2
28.8
32.4
36.0
0.2
4.8
9.6
14.4
19.2
24.0
28.8
33.6
38.4
43.2
48.0
Table 18 is a guideline for milliliter-per-hour delivery for a solution of 50 mcg/mL with an infusion device.
Table 18: IV Infusion Rates of Redormin (Redormin) (mL/h) for a 50-mcg/mL Solution
Infusion Rate
(mcg/kg/min)
PatientWeight (kg)
30
40
50
60
70
80
90
100
0.025
2.1
2.4
2.7
3.0
0.05
2.4
3.0
3.6
4.2
4.8
5.4
6.0
0.075
2.7
3.6
4.5
5.4
6.3
7.2
8.1
9.0
0.1
3.6
4.8
6.0
7.2
8.4
9.6
10.8
12.0
0.15
5.4
7.2
9.0
10.8
12.6
14.4
16.2
18.0
0.2
7.2
9.6
12.0
14.4
16.8
19.2
21.6
24.0
0.25
9.0
12.0
15.0
18.0
21.0
24.0
27.0
30.0
0.5
18.0
24.0
30.0
36.0
42.0
48.0
54.0
60.0
0.75
27.0
36.0
45.0
54.0
63.0
72.0
81.0
90.0
1.0
36.0
48.0
60.0
72.0
84.0
96.0
108.0
120.0
1.25
45.0
60.0
75.0
90.0
105.0
120.0
135.0
150.0
1.5
54.0
72.0
90.0
108.0
126.0
144.0
162.0
180.0
1.75
63.0
84.0
105.0
126.0
147.0
168.0
189.0
210.0
2.0
72.0
96.0
120.0
144.0
168.0
192.0
216.0
240.0
Table 19 is a guideline for milliliter-per-hour delivery for a solution of 250 mcg/mL with an infusion device.
Table 19: IV Infusion Rates of Redormin (Redormin) (mL/h) for a 250-mcg/mL Solution
Infusion Rate
(mcg/kg/min)
PatientWeight (kg)
30
40
50
60
70
80
90
100
0.1
0.72
0.96
1.20
1.44
1.68
1.92
2.16
2.40
0.15
1.08
1.44
1.80
2.16
2.52
2.88
3.24
3.60
0.2
1.44
1.92
2.40
2.88
3.36
3.84
4.32
4.80
0.25
1.80
2.40
3.00
3.60
4.20
4.80
5.40
6.00
0.5
3.60
4.80
6.00
7.20
8.40
9.60
10.80
12.00
0.75
5.40
7.20
9.00
10.80
12.60
14.40
16.20
18.00
1.0
7.20
9.60
12.00
14.40
16.80
19.20
21.60
24.00
1.25
9.00
12.00
15.00
18.00
21.00
24.00
27.00
30.00
1.5
10.80
14.40
18.00
21.60
25.20
28.80
32.40
36.00
1.75
12.60
16.80
21.00
25.20
29.40
33.60
37.80
42.00
2.0
14.40
19.20
24.00
28.80
33.60
38.40
43.20
48.00
Compatibility And Stability
Reconstitution and Dilution Prior to Administration: Redormin (Redormin) is stable for 24 hours at room temperature after reconstitution and further dilution to concentrations of 20 to 250 mcg/mL with the IV fluids listed below.
Sterile Water for Injection, USP
5% Dextrose Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
Lactated Ringer's and 5% Dextrose Injection, USP
Redormin (Redormin) is stable for 4 hours at room temperature after reconstitution and further dilution to concentrations of 20 to 250 mcg/mL with Lactated Ringer's Injection, USP.
Redormin (Redormin) has been shown to be compatible with these IV fluids when coadministered into a running IV administration set.
Compatibility With Other Therapeutic Agents: Redormin (Redormin) has been shown to be compatible with DIPRIVAN® (propofol) Injection when coadministered into a running IV administration set. The compatibility of Redormin (Redormin) with other therapeutic agents has not been evaluated.
Incompatibilities: Nonspecific esterases in blood products may lead to the hydrolysis of Redormin to its carboxylic acid metabolite. Therefore, administration of Redormin (Redormin) into the same IV tubing with blood is not recommended.
Note:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product should be a clear, colorless liquid after reconstitution and free of visible particulate matter.
Redormin (Redormin) does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions.
How supplied
Redormin (Redormin) should be stored at 2° to 25°C (36° to 77°F). Redormin (Redormin) for IV use is supplied as follows:
List
Container
Concentration
Quantity
4498
3 mL Vial
1 mg lyophilized powder
Box of 10
4504
5 mL Vial
2 mg lyophilized powder
Box of 10
4507
10 mL Vial
5 mg lyophilized powder
Box of 10
Redormin (Redormin) is a registered trademark of Abbott Laboratories., DIPRIVAN® is a registered trademark of Zeneca Pharmaceuticals. Revised: August, 2006, Manufactured by: Hospira, Inc., Lake Forest, IL 60045 USA. For: Abbott Laboratories, North Chicago, IL 60064 USA. FDA revision date: 3/8/2004
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Alizapride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Alvimopan: Opioid Agonists may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Consider therapy modification
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification
Amphetamines: May enhance the analgesic effect of Opioid Agonists. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Beta-Blockers: Opioids (Anilidopiperidine) may enhance the bradycardic effect of Beta-Blockers. Opioids (Anilidopiperidine) may enhance the hypotensive effect of Beta-Blockers. Monitor therapy
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Bromopride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Avoid combination
Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination
Calcium Channel Blockers (Nondihydropyridine): Opioids (Anilidopiperidine) may enhance the bradycardic effect of Calcium Channel Blockers (Nondihydropyridine). Opioids (Anilidopiperidine) may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Monitor therapy
Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification
Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
CNS Depressants: May enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification
Desmopressin: Opioid Agonists may enhance the adverse/toxic effect of Desmopressin. Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Diuretics: Opioid Agonists may enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy
Eluxadoline: Opioid Agonists may enhance the constipating effect of Eluxadoline. Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
Gastrointestinal Agents (Prokinetic): Opioid Agonists may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification
Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy
Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Redormin. Specifically, the risk for opioid toxicity (eg, respiratory depression) may be increased. Redormin may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This could result in serotonin syndrome. Management: The use of Redormin is not recommended for patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation. Consider therapy modification
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nalmefene: May diminish the therapeutic effect of Opioid Agonists. Management: Avoid the concomitant use of nalmefene and opioid agonists. Discontinue nalmefene 1 week prior to any anticipated use of opioid agonistss. If combined, larger doses of opioid agonists will likely be required. Consider therapy modification
Naltrexone: May diminish the therapeutic effect of Opioid Agonists. Management: Seek therapeutic alternatives to opioids. See full drug interaction monograph for detailed recommendations. Consider therapy modification
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification
Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification
Opioids (Mixed Agonist / Antagonist): May diminish the analgesic effect of Opioid Agonists. Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Avoid combination
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Pegvisomant: Opioid Agonists may diminish the therapeutic effect of Pegvisomant. Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy
Ramosetron: Opioid Agonists may enhance the constipating effect of Ramosetron. Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Serotonergic Agents (High Risk): Opioid Agonists may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification
Succinylcholine: May enhance the bradycardic effect of Opioid Agonists. Monitor therapy
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
Redormin (Redormin) produces adverse events that are characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipate within minutes of discontinuing or decreasing the infusion rate of Redormin. See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS on the management of these events.
Adverse event information is derived from controlled clinical trials that were conducted in a variety of surgical procedures of varying duration, using a variety of premedications and other anesthetics, and in patient populations with diverse characteristics including underlying disease.
Adults: Approximately 2770 adult patients were exposed to Redormin (Redormin) in controlled clinical trials. The frequencies of adverse events during general anesthesia with the recommended doses of Redormin (Redormin) are given in Table 3. Each patient was counted once for each type of adverse event.
Table 3: Adverse Events Reported in 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of Redormin (Redormin)
Adverse Event
Induction/Maintenance
Postoperative Analgesia
After Discontinuation
Redormin
(n = 921)
Alfentanil/ Fentanyl
(n = 466)
Redormin
(n = 281)
Morphine
(n = 98)
Redormin
(n = 929)
Alfentanil/ Fentanyl
(n = 466)
Nausea
8 ( < 1%)
0
61 (22%)
15 (15%)
339 (36%)
202 (43%)
Hypotension
178 (19%)
30 (6%)
0
0
16 (2%)
9 (2%)
Vomiting
4 ( < 1%)
1 ( < 1%)
22 (8%)
5 (5%)
150 (16%)
91 (20%)
Muscle rigidity
98
(11%)‡ 37
(8%) 7
(2%) 0
2 ( < 1%)
1 ( < 1%)
Bradycardia
62 (7%)
24 (5%)
3 (1%)
3 (3%)
11 (1%)
6 (1%)
Shivering
3 ( < 1%)
0
15 (5%)
9 (9%)
49 (5%)
10 (2%)
Fever
1 ( < 1%)
0
2 ( < 1%)
0
44 (5%)
9 (2%)
Dizziness
0
0
1 ( < 1%)
0
27 (3%)
9 (2%)
Visual disturbance
0
0
0
0
24 (3%)
14 (3%)
Headache
0
0
1 ( < 1%)
1 (1%)
21 (2%)
8 (2%)
Respiratory depression
1 ( < 1%)
0
19 (7%)
4 (4%)
17 (2%)
20 (4%)
Apnea
0
1 ( < 1%)
9 (3%)
2 (2%)
2 ( < 1%)
1 ( < 1%)
Pruritus
2 ( < 1%)
0
7 (2%)
1 (1%)
22 (2%)
7 (2%)
Tachycardia
6 ( < 1%)
7 (2%)
0
0
10 (1%)
8 (2%)
Postoperative pain
0
0
7 (2%)
0
4 ( < 1%)
5 (1%)
Hypertension
10 (1%)
7 (2%)
5 (2%)
3 (3%)
12 (1%)
8 (2%)
Agitation
2 ( < 1%)
0
3 (1%)
1 (1%)
6 ( < 1%)
1 ( < 1%)
Hypoxia
0
0
1 ( < 1%)
0
10 (1%)
7 (2%)
*Does not include adverse events from cardiac studies or the neonatal study. See Tables 6, 7, and 8 for cardiac information.
† See Table 10 for recommended doses. Not all doses of Redormin (Redormin) were equipotent to the comparator opioid. Administration of Redormin (Redormin) in excess of the recommended dose (i.e., doses > 1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%).
‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is < 1% when Redormin is administered concurrently or after a hypnotic induction agent.
In the elderly population ( > 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower.
Table 4: Incidence (%) of Most Common Adverse Events by Gender in General Anesthesia Studies* at the Recommended Doses† of Redormin (Redormin)
Adverse Event n
Induction/Maintenance
Postoperative Analgesia
After Discontinuation
Redormin
Alfentanil/ Fentanyl
Redormin
Morphine
Redormin
Alfentanil/ Fentanyl
Male 326
Female 595
Male 183
Female 283
Male 85
Female 196
Male 36
Female 62
Male 332
Female 597
Male 183
Female 283
Nausea
2%
< 1%
0
0
12%
26%
8%
19%
22%
45%
30%
52%
Hypotension
29%
14%
7%
6%
0
0
0
0
2%
2%
2%
2%
Vomiting
< 1%
< 1%
0
< 1%
4%
10%
0
8%
5%
22%
8%
27%
Muscle rigidity
17%
7%
14%
4%
6%
1%
0
0
< 1%
< 1%
0
< 1%
*Does not include adverse events from cardiac studies or the neonatal study.
† See Table 10 for recommended doses. Not all doses of Redormin (Redormin) were equipotent to the comparator opioid.
The frequencies of adverse events from the clinical studies at the recommended doses of Redormin (Redormin) in monitored anesthesia care are given in Table 5.
Table 5: Adverse Events Reported in 1% of Adult Patients in Monitored Anesthesia Care Studies at the Recommended Doses* of Redormin (Redormin)
Adverse Event
Redormin
(n = 159)
Redormin + 2 mg Midazolam† Propofol
(n = 103)
(0.5 mg/kg then 50 mcg/kg/min)
(n = 63)
Nausea
70 (44%)
19 (18%)
20 (32%)
Vomiting
35 (22%)
5 (5%)
13 (21%)
Pruritus
28 (18%)
16 (16%)
0
Headache
28 (18%)
12 (12%)
6 (10%)
Sweating
10 (6%)
0
1 (2%)
Shivering
8 (5%)
1 ( < 1%)
1 (2%)
Dizziness
8 (5%)
5 (5%)
1 (2%)
Hypotension
7 (4%)
0
6 (10%)
Bradycardia
6 (4%)
0
7 (11%)
Respiratory depression
4 (3%)
1 ( < 1%)*
0
Muscle rigidity
4 (3%)
0
1 (2%)
Chills
2 (1%)
0
2 (3%)
Flushing
2 (1%)
0
0
Warm sensation
2 (1%)
0
0
Pain at study IV site
2 (1%)
0
11 (17%)
* See Table 12 for recommended doses. Administration of Redormin (Redormin) in excess of the recommended infusion rate (i.e., starting doses > 0.1 mcg/kg/min) resulted in a higher incidence of some adverse events: nausea (60%), apnea (8%), and muscle rigidity (5%).
With higher midazolam doses, higher incidences of respiratory depression and apnea were observed.
Other Adverse Events in Adult Patients: The frequencies of less commonly reported adverse clinical events from all controlled general anesthesia and monitored anesthesia care studies are presented below.
Event frequencies are calculated as the number of patients who were administered Redormin (Redormin) and reported an event divided by the total number of patients exposed to Redormin (Redormin) in all controlled studies including cardiac dose-ranging and neurosurgery studies (n = 1883 general anesthesia, n = 609 monitored anesthesia care).
Hematologic and Lymphatic: anemia, lymphopenia, leukocytosis, thrombocytopenia.
The frequencies of adverse events from the clinical studies at the recommended doses of Redormin (Redormin) in cardiac surgery are given in Tables 6, 7, and 8. These tables represent adverse events collected during discrete phases of cardiac surgery. Any event should be viewed as temporally associated with drug administration and the phase indicated should not be perceived as the only time the event might occur.
Table 6: Adverse Events Reported in 1% of Patients in the Induction/Intubation and Maintenance Phases of Cardiac Surgery Studies at the Recommended Doses* of Redormin (Redormin)
Adverse Event
Induction/Intubation
Maintenance
Redormin
(n = 227)
Fentanyl
(n = 176)
Sufentanil
(n = 41)
Redormin
(n = 227)
Fentanyl
(n = 176)
Sufentanil
(n = 41)
Hypotension
18 (8%)
6 (3%)
7 (17%)
26 (11%)
6 (3%)
1 (2%)
Bradycardia
9 (4%)
5 (3%)
0
3 (1%)
1 ( < 1%)
1 (2%)
Hypertension
3 (1%)
2 (1%)
2 (5%)
8 (4%)
6 (3%)
1 (2%)
Constipation
9 (4%)
1 ( < 1%)
3 (7%)
0
0
1 (2%)
Muscle rigidity
2 ( < 1%)
2 (1%)
0
5 (2%)
8 (5%)
0
Premature ventricular beats
1 ( < 1%)
0
0
3 (1%)
1 ( < 1%)
0
Myocardial ischemia
0
0
0
7 (3%)
8 (5%)
1 (2%)
Atrial fibrillation
0
0
0
7 (3%)
3 (2%)
1 (2%)
Decreased cardiac output
0
0
0
5 (2%)
1 ( < 1%)
1 (2%)
Tachycardia
0
1 ( < 1%)
0
4 (2%)
2 (1%)
0
Coagulation disorder
0
0
0
4 (2%)
0
1 (2%)
Arrhythmia
0
0
0
3 (1%)
0
0
Ventricular fibrillation
0
0
0
3 (1%)
1 ( < 1%)
1 (2%)
Postoperative complication
0
0
0
3 (1%)
0
0
Third degree heart block
0
0
0
2 ( < 1%)
0
1 (2%)
Hemorrhage
0
0
0
2 ( < 1%)
0
1 (2%)
Perioperative complication
0
0
0
2 ( < 1%)
1 ( < 1%)
1 (2%)
Involuntary movement(s)
0
0
0
2 ( < 1%)
3 (2%)
0
Thrombocytopenia
0
0
1 (2%)
0
0
0
Oliguria
0
0
0
0
3 (2%)
0
Anemia
0
0
0
2 ( < 1%)
2 (1%)
0
*See Table 13 for recommended doses.
Table 7: Adverse Events Reported in 1% of Patients in the ICU Phase of Cardiac Surgery Studies at the Recommended Doses* of Redormin (Redormin)
Adverse Event
Redormin
n = 227
Fentanyl
n = 176
Sufentanil
n = 41
Hypertension
14 (6%)
8 (5%)
2 (5%)
Hypotension
12 (5%)
3 (2%)
1 (2%)
Tachycardia
9 (4%)
5 (3%)
0
Shivering
8 (4%)
3 (2%)
1 (2%)
Nausea
8 (4%)
3 (2%)
0
Hemorrhage
4 (2%)
1 ( < 1%)
1 (2%)
Postoperative complication
4 (2%)
5 (3%)
2 (5%)
Agitation
4 (2%)
1 ( < 1%)
1 (2%)
Ache
4 (2%)
0
0
Decreased cardiac output
3 (1%)
0
0
Arrhythmia
3 (1%)
0
0
Muscle rigidity
2 ( < 1%)
1 ( < 1%)
2 (5%)
Bradycardia
2 ( < 1%)
2 (1%)
0
Vomiting
1 ( < 1%)
2 (1%)
0
Premature ventricular beats
1 ( < 1%)
2 (1%)
0
Anemia
0
3 (2%)
0
Somnolence
0
0
1 (2%)
Fever
0
2 (1%)
0
*See Table 13 for recommended doses.
Table 8: Adverse Events Reported in 1% of Patients in the Post-Study Drug Phase of Cardiac Surgery Studies at the Recommended Doses* of Redormin (Redormin)
Adverse Event
Redormin
n = 227
Fentanyl
n = 176
Sufentanil
n = 41
Nausea
90 (40%)
63 (36%)
16 (39%)
Vomiting
33 (15%)
26 (15%)
3 (7%)
Fever
30 (13%)
15 (9%)
0
Atrial fibrillation
27 (12%)
33 (19%)
4 (10%)
Constipation
20 (9%)
35 (20%)
3 (7%)
Pleural effusion
11 (5%)
2 (1%)
2 (5%)
Hypotension
8 (4%)
8 (5%)
1 (2%)
Tachycardia
9 (4%)
15 (9%)
0
Postoperative complication
10 (4%)
6 (3%)
2 (5%)
Oliguria
7 (3%)
7 (4%)
1 (2%)
Confusion
7 (3%)
10 (6%)
5 (12%)
Ache
6 (3%)
2 (1%)
0
Anxiety
6 (3%)
6 (3%)
0
Headache
6 (3%)
2 (1%)
0
Perioperative complication
5 (2%)
7 (4%)
1 (2%)
Anemia
5 (2%)
5 (3%)
1 (2%)
Agitation
5 (2%)
3 (2%)
1 (2%)
Diarrhea
5 (2%)
1 ( < 1%)
1 (2%)
Edema
4 (2%)
6 (3%)
0
Dizziness
4 (2%)
3 (2%)
1 (2%)
Postoperative infection
5 (2%)
7 (4%)
0
Hypoxia
4 (2%)
5 (3%)
0
Apnea
4 (2%)
1 ( < 1%)
1 (2%)
Hypertension
3 (1%)
3 (2%)
0
Shivering
3 (1%)
1 ( < 1%)
0
Heartburn
3 (1%)
3 (2%)
0
Atrial flutter
3 (1%)
1 ( < 1%)
0
Arrhythmia
3 (1%)
5 (3%)
0
Hallucinations
3 (1%)
3 (2%)
0
Pneumonia
3 (1%)
3 (2%)
1 (2%)
Pharyngitis
3 (1%)
1 ( < 1%)
1 (2%)
Decreased mental acuity
3 (1%)
1 ( < 1%)
0
Dyspnea
3 (1%)
1 ( < 1%)
0
Cough
3 (1%)
0
0
Decreased cardiac output
1 ( < 1%)
0
3 (7%)
Renal insufficiency
1 ( < 1%)
5 (3%)
0
Bradycardia
1 ( < 1%)
1 ( < 1%)
1 (2%)
Urine retention
2 ( < 1%)
3 (2%)
0
Cerebral infarction
2 ( < 1%)
2 (1%)
1 (2%)
Premature ventricular beats
2 ( < 1%)
3 (2%)
0
Cerebral ischemia
1 ( < 1%)
1 ( < 1%)
1 (2%)
Paresthesia
2 ( < 1%)
2 (1%)
0
Seizure
2 ( < 1%)
1 ( < 1%)
1 (2%)
Sleep disorder
1 ( < 1%)
1 ( < 1%)
1 (2%)
Bronchospasm
1 ( < 1%)
6 (3%)
0
Atelectasis
2 ( < 1%)
3 (2%)
0
Respiratory depression
2 ( < 1%)
3 (2%)
0
Pulmonary edema
1 ( < 1%)
2 (1%)
0
Respiratory distress
2 ( < 1%)
0
1 (2%)
Hyperkalemia
2 ( < 1%)
3 (2%)
0
Electrolyte disorder
0
3 (2%)
0
Chest congestion
0
3 (2%)
0
Hemoptysis
0
2 (1%)
0
Facial ptosis
0
2 (1%)
0
Hemorrhage
0
2 (1%)
0
Hematuria
0
1 ( < 1%)
1 (2%)
Visual disturbance(s)
0
1 ( < 1%)
1 (2%)
Hypokalemia
0
2 (1%)
0
Exacerbation of renal failure
0
0
1 (2%)
Blood in stool
0
0
1 (2%)
First degree heart block
0
0
1 (2%)
Pericarditis
0
0
1 (2%)
*See Table 13 for recommended doses.
Pediatrics: Redormin (Redormin) has been studied in 342 pediatric patients in controlled clinical trials for maintenance of general anesthesia. In the pediatric population (birth to 12 years), the most commonly reported events were nausea, vomiting, and shivering.
The frequencies of adverse events during general anesthesia with the recommended doses of Redormin (Redormin) are given in Table 9. Each patient was counted once for each type of adverse event. There were no adverse events 1% for any treatment group during the maintenance period in the pediatric patient general anesthesia studies.
Table 9: Adverse Events Reported in 1% of Pediatric Patients Receiving Redormin (Redormin) in General Anesthesia Studies at the Recommended Doses* of Redormin (Redormin)
Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Redormin in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Redormin.
Cardiovascular: Asystole.
Non-Site Specific: Anaphylactic/anaphylactoid responses, which in some cases have been severe (e.g., shock).
Drug Abuse And Dependence
Redormin (Redormin) is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused.
You should not receive this medication if you are allergic to Redormin.
Before you receive Redormin, tell your doctor about all of your medical conditions. You may need a dose adjustment or special tests to safely receive this medication.
Tell your doctor if you are pregnant or breast-feeding before you are treated with Redormin.
Your breathing and other vital signs will be constantly monitored while you are being treated with Redormin.
Redormin can cause side effects that may impair your thinking or reactions. You should not plan on driving or doing anything that requires you to be awake and alert right after you are treated with this medication.
Follow your doctor's instructions about any other restrictions on food, beverages, or activity after you are treated with Redormin.
The results of a survey conducted on ndrugs.com for Redormin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Redormin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
11 consumers reported age
Users
%
16-29
7
63.6%
30-45
2
18.2%
> 60
1
9.1%
46-60
1
9.1%
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