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Diprivan
Overview
What is Diprivan?
DIPRIVAN (propofol) injectable emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6‑diisopropylphenol. The structural formula is:
CHO M.W. 178.27
Propofol is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with sodium hydroxide to adjust pH. DIPRIVAN is isotonic and has a pH of 7 to 8.5.
What does Diprivan look like?
What are the available doses of Diprivan?
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What should I talk to my health care provider before I take Diprivan?
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How should I use Diprivan?
DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below.
Table 3. Indications for DIPRIVAN
Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see ).
DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In the Intensive Care Unit (ICU), DIPRIVAN can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
DIPRIVAN is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see .
DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression (see ).
DIPRIVAN is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see ).
Propofol blood concentrations at steady-state are generally proportional to infusion rates, especially in individual patients. Undesirable effects such as cardiorespiratory depression are likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in the infusion rate. An adequate interval (3 minutes to 5 minutes) must be allowed between dose adjustments to allow for and assess the clinical effects.
Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing.
When administering DIPRIVAN by infusion, syringe or volumetric pumps are recommended to provide controlled infusion rates. When infusing DIPRIVAN to patients undergoing magnetic resonance imaging, metered control devices may be utilized if mechanical pumps are impractical.
Changes in vital signs indicating a stress response to surgical stimulation or the emergence from anesthesia may be controlled by the administration of 25 mg (2.5 mL) to
50 mg (5 mL) incremental boluses and/or by increasing the infusion rate of DIPRIVAN.
For minor surgical procedures (e.g., body surface) nitrous oxide (60% to 70%) can be combined with a variable rate DIPRIVAN infusion to provide satisfactory anesthesia. With more stimulating surgical procedures (e.g., intra-abdominal), or if supplementation with nitrous oxide is not provided, administration rate(s) of DIPRIVAN and/or opioids should be increased in order to provide adequate anesthesia.
Infusion rates should always be titrated downward in the absence of clinical signs of light anesthesia until a mild response to surgical stimulation is obtained in order to avoid administration of DIPRIVAN at rates higher than are clinically necessary. Generally, rates of 50 mcg/kg/min to 100 mcg/kg/min in adults should be achieved during maintenance in order to optimize recovery times.
Other drugs that cause CNS depression (e.g., sedatives, anesthetics, and opioids) can increase CNS depression induced by propofol. Morphine premedication (0.15 mg/kg) with nitrous oxide 67% in oxygen has been shown to decrease the necessary propofol injection maintenance infusion rate and therapeutic blood concentrations when compared to non-narcotic (lorazepam) premedication.
What interacts with Diprivan?
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What are the warnings of Diprivan?
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What are the precautions of Diprivan?
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What are the side effects of Diprivan?
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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General
Adverse event information is derived from controlled clinical trials and worldwide marketing experience. In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient.
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Anesthesia and MAC Sedation in Adults
The following estimates of adverse events for DIPRIVAN include data from clinical trials in general anesthesia/MAC sedation (N=2,889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with DIPRIVAN was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.
The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with DIPRIVAN during anesthesia (see below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.
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Anesthesia in Pediatric Patients
Generally the adverse experience profile from reports of 506 DIPRIVAN pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with DIPRIVAN during anesthesia in adults (see Pediatric percentages [Peds %] below). Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.
Array
ICU Sedation in Adults
The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.
Incidence greater than 1% - Probably Causally Related
Events without an * or % had an incidence of 1% to 3%
*Incidence of events 3% to 10%
Incidence less than 1% - Probably Causally Related
Incidence less than 1% - Causal Relationship Unknown
| Anesthesia/MAC Sedation | ICU Sedation | |||
| Cardiovascular: | BradycardiaArrhythmia [Peds: 1.2%]Tachycardia Nodal [Peds: 1.6%]Hypotension* [Peds: 17%](see also )Hypertension [Peds: 8%] | Bradycardia Decreased Cardiac Output Hypotension 26% | ||
| Central Nervous System: | Movement* [Peds: 17%] | |||
| Injection Site: | Burning/Stinging or Pain, 17.6% [Peds:10%] | |||
| Metabolic/Nutritional: | Hyperlipemia* | |||
| Respiratory: | Apnea (see also ) | Respiratory Acidosis During Weaning* | ||
| Skin and Appendages: | Rash [Peds: 5%]Pruritus [Peds: 2%] | |||
| Anesthesia MAC Sedation | ICU Sedation | |||
| Body as a Whole: | Anaphylaxis/Anaphylactoid Reaction | |||
| Perinatal DisorderTachycardiaBigeminyBradycardiaPremature Ventricular ContractionsHemorrhageECG AbnormalArrhythmia AtrialFeverExtremities PainAnticholinergic Syndrome | ||||
| Cardiovascular: | Premature Atrial ContractionsSyncope | |||
| Central Nervous System: | Hypertonia/Dystonia, Paresthesia | Agitation | ||
| Digestive: | HypersalivationNausea | |||
| Hemic/Lymphatic: | Leukocytosis | |||
| Injection Site: | PhlebitisPruritus | |||
| Metabolic: | Hypomagnesemia | |||
| Musculoskeletal: | Myalgia | |||
| Nervous: | DizzinessAgitationChillsSomnolenceDelirium | |||
| Respiratory: | WheezingCoughLaryngospasmHypoxia | Decreased Lung Function | ||
| Skin and Appendages: | Flushing, Pruritus | |||
| Special Senses: | AmblyopiaVision Abnormal | |||
| Urogenital: | Cloudy Urine | Green Urine | ||
| Anesthesia/MAC Sedation | ICU Sedation | |||
| Body as a Whole | Asthenia, Awareness, Chest Pain,Extremities Pain, Fever, IncreasedDrug Effect, Neck Rigidity/Stiffness,Trunk Pain | Fever, Sepsis, Trunk Pain, Whole Body Weakness | ||
| Cardiovascular | Arrhythmia, Atrial Fibrillation,Atrioventricular Heart Block,Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart Block, Hypertension, MyocardialInfarction, Myocardial Ischemia,Premature Ventricular Contractions,ST Segment Depression,Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation | Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, Ventricular Tachycardia | ||
| Central Nervous System: | Abnormal Dreams, Agitation,Amorous Behavior, Anxiety,Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/MyoclonicMovement, Combativeness,Confusion, Delirium, Depression,Dizziness, Emotional Lability,Euphoria, Fatigue, Hallucinations,Headache, Hypotonia, Hysteria,Insomnia, Moaning, Neuropathy,Opisthotonos, Rigidity, Seizures,Somnolence, Tremor, Twitching | Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal | ||
| Digestive: | Cramping, Diarrhea, Dry Mouth,Enlarged Parotid, Nausea, Swallowing,Vomiting | Ileus, Liver Function Abnormal | ||
| Hematologic/Lymphatic: | Coagulation Disorder, Leukocytosis | |||
| Injection Site: | Hives/Itching, Phlebitis,Redness/Discoloration | |||
| Metabolic/Nutritional: | Hyperkalemia, Hyperlipemia | BUN Increased, Creatinine Increased,Dehydration,Hyperglycemia, Metabolic Acidosis, OsmolalityIncreased | ||
| Respiratory: | Bronchospasm, Burning in Throat,Cough, Dyspnea, Hiccough,Hyperventilation, Hypoventilation,Hypoxia, Laryngospasm, Pharyngitis,Sneezing, Tachypnea, Upper AirwayObstruction | Hypoxia | ||
| Skin and Appendages: | Conjunctival Hyperemia, Diaphoresis,Urticaria | Rash | ||
| Special Senses: | Diplopia, Ear Pain, Eye Pain,Nystagmus, Taste Perversion,Tinnitus | |||
| Urogenital: | Oliguria, Urine Retention | Kidney Failure |
What should I look out for while using Diprivan?
DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components.
DIPRIVAN is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.
Use of DIPRIVAN has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.
For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.
For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Use of DIPRIVAN infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes* and/or cardiac failure. The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or prolonged, high-dose infusions of propofol (greater than 5 mg/kg/h for greater than 48h). The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia. In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.
*Coved ST segment elevation (similar to ECG changes of the Brugada syndrome).
Abrupt discontinuation of DIPRIVAN prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Infusions of DIPRIVAN should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level (see ).
DIPRIVAN should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals. The clinical significance of these findings is not known.
There have been reports in which failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits (see ).
There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. DIPRIVAN vial is never to be accessed more than once or used on more than one person.
Pediatric Neurotoxicity
Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than
3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately three years of age in humans (see ).
Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness.
Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.
What might happen if I take too much Diprivan?
If overdosage occurs, DIPRIVAN administration should be discontinued immediately. Overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require repositioning of the patient by raising the patient's legs, increasing the flow rate of intravenous fluids, and administering pressor agents and/or anticholinergic agents.
How should I store and handle Diprivan?
Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).DIPRIVAN (propofol) Injectable Emulsion, USP VialsPropofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. All trademarks are the property of Fresenius Kabi USA, LLC.NOVAPLUS is a registered trademark of Vizient, Inc.DIPRIVAN (propofol) Injectable Emulsion, USP VialsPropofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. All trademarks are the property of Fresenius Kabi USA, LLC.NOVAPLUS is a registered trademark of Vizient, Inc.DIPRIVAN (propofol) Injectable Emulsion, USP VialsPropofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. All trademarks are the property of Fresenius Kabi USA, LLC.NOVAPLUS is a registered trademark of Vizient, Inc.DIPRIVAN (propofol) Injectable Emulsion, USP VialsPropofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. All trademarks are the property of Fresenius Kabi USA, LLC.NOVAPLUS is a registered trademark of Vizient, Inc.DIPRIVAN (propofol) Injectable Emulsion, USP VialsPropofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. All trademarks are the property of Fresenius Kabi USA, LLC.NOVAPLUS is a registered trademark of Vizient, Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
DIPRIVAN is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol induces anesthesia, with minimal excitation, usually within 40 seconds from the start of injection (the time for one arm-brain circulation). As with other rapidly acting intravenous anesthetic agents, the half-time of the blood-brain equilibration is approximately 1 minute to 3 minutes, accounting for the rate of induction of anesthesia. The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA receptors.
Non-Clinical Toxicology
DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components.DIPRIVAN is contraindicated in patients with allergies to eggs, egg products, soybeans or soy products.
Use of DIPRIVAN has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.
For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients.
For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Use of DIPRIVAN infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes* and/or cardiac failure. The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or prolonged, high-dose infusions of propofol (greater than 5 mg/kg/h for greater than 48h). The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia. In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.
*Coved ST segment elevation (similar to ECG changes of the Brugada syndrome).
Abrupt discontinuation of DIPRIVAN prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. Infusions of DIPRIVAN should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level (see ).
DIPRIVAN should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals. The clinical significance of these findings is not known.
There have been reports in which failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits (see ).
There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. DIPRIVAN vial is never to be accessed more than once or used on more than one person.
Pediatric Neurotoxicity
Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than
3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately three years of age in humans (see ).
Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness.
Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.
Drug Interactions
Acidifying Agents
Adrenergic Blockers
Alkalinizing Agents
MAO Inhibitors
Antihistamines
Antihypertensives
Chlorpromazine
Ethosuximide
Haloperidol
Lithium Carbonate
Meperidine
Methenamine Therapy
Norepinephrine
Phenobarbital
Phenytoin
Propoxyphene
Veratrum Alkaloids
Adult and Pediatric Patients
A lower induction dose and a slower maintenance rate of administration should be used in elderly, debilitated, or ASA-PS III or IV patients (see ). Patients should be continuously monitored for early signs of hypotension and/or bradycardia. Apnea requiring ventilatory support often occurs during induction and may persist for more than 60 seconds. DIPRIVAN use requires caution when administered to patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
Very rarely the use of DIPRIVAN may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. This may or may not be preceded by a brief period of wakefulness. Recovery is spontaneous.
When DIPRIVAN is administered to an epileptic patient, there is a risk of seizure during the recovery phase.
Attention should be paid to minimize pain on administration of DIPRIVAN. Transient local pain can be minimized if the larger veins of the forearm or antecubital fossa are used. Pain during intravenous injection may also be reduced by prior injection of IV lidocaine (1 mL of a 1% solution). Pain on injection occurred frequently in pediatric patients (45%) when a small vein of the hand was utilized without lidocaine pretreatment. With lidocaine pretreatment or when antecubital veins were utilized, pain was minimal (incidence less than 10%) and well-tolerated. There have been reports in the literature indicating that the addition of lidocaine to DIPRIVAN in quantities greater than 20 mg lidocaine/200 mg DIPRIVAN results in instability of the emulsion which is associated with increases in globule sizes over time and (in rat studies) a reduction in anesthetic potency. Therefore, it is recommended that lidocaine be administered prior to DIPRIVAN administration or that it be added to DIPRIVAN immediately before administration and in quantities not exceeding 20 mg lidocaine/200 mg DIPRIVAN.
Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (less than 1%). In two clinical studies using dedicated intravenous catheters, no instances of venous sequelae were observed up to 14 days following induction.
Intra-arterial injection in animals did not induce local tissue effects. Accidental intra-arterial injection has been reported in patients, and, other than pain, there were no major sequelae.
Intentional injection into subcutaneous or perivascular tissues of animals caused minimal tissue reaction. During the post-marketing period, there have been rare reports of local pain, swelling, blisters, and/or tissue necrosis following accidental extravasation of DIPRIVAN.
Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with DIPRIVAN administration.
Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following DIPRIVAN administration.
There have been rare reports of pulmonary edema in temporal relationship to the administration of DIPRIVAN, although a causal relationship is unknown.
Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which DIPRIVAN was one of the induction agents used. Due to a variety of confounding factors in these cases, including concomitant medications, a causal relationship to DIPRIVAN is unclear.
DIPRIVAN has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with DIPRIVAN. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. The intravenous administration of anticholinergic agents (e.g., atropine or glycopyrrolate) should be considered to modify potential increases in vagal tone due to concomitant agents (e.g., succinylcholine) or surgical stimuli.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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