What is a common adverse reaction to sedative

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Diprivan Side Effects Center

What Is Diprivan?

Diprivan (propofol) Injectable Emulsion is a sedative-hypnotic agent used to help you relax before and during general anesthesia for surgery or other medical procedure. It is also used in critically ill patients who require a breathing tube connected to a ventilator. Diprivan is available in generic form.

What Are Side Effects of Diprivan?

Common side effects of Diprivan include:

  • nausea,
  • cough,
  • burning or stinging around the IV needle,
  • itching or skin rash,
  • numbness or tingly feeling,
  • confusion,
  • agitation,
  • anxiety,
  • muscle pain, or
  • discolored urine.

Tell your doctor if you have serious side effect of Diprivan including:

  • injection site reactions (pain, swelling, blisters, or skin changes),
  • seizures (convulsions),
  • weak or shallow breathing, or
  • fast or slow heart rate.

Dosage for Diprivan?

Diprivan is administered under a physician's supervision. Dose depends on the condition being treated and the patient's weight.

What Drugs, Substances, or Supplements Interact with Diprivan?

Diprivan may interact with chloral hydrate, droperidol, barbiturates, diazepam or similar medicines, or narcotics. Tell your doctor all medications you use.

Diprivan During Pregnancy and Breastfeeding

Diprivan is not expected to be harmful to a fetus. Tell your doctor if you are pregnant before you are treated with this drug. This medication can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Diprivan (propofol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is a common adverse reaction to sedative

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Diprivan Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

  • a light-headed feeling (like you might pass out) even after feeling awake;
  • weak or shallow breathing; or
  • severe pain or discomfort where the injection is given.

Common side effects may include:

  • mild itching or rash;
  • fast or slow heart rate; or
  • slight burning or stinging around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is a common adverse reaction to sedative

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Diprivan Professional Information

SIDE EFFECTS

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.

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.

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.

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.

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

Anesthesia/MAC Sedation ICU Sedation
Cardiovascular: Bradycardia Bradycardia
Arrhythmia [Peds: 1.2%]
Tachycardia Nodal [Peds: 1.6%]
Hypotension* [Peds: 17%](see also CLINICAL PHARMACOLOGY) Decreased Cardiac Output
Hypertension [Peds: 8%] 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 CLINICAL PHARMACOLOGY) Respiratory Acidosis During Weaning*
Skin and Appendages: Rash [Peds: 5%] Pruritus [Peds: 2%]
Events without an * or % had an incidence of 1% to 3%
*Incidence of events 3% to 10%

Incidence less than 1% - Probably Causally Related

Anesthesia MAC Sedation ICU Sedation
Body as a Whole: Anaphylaxis/Anaphylactoid Reaction
Perinatal Disorder Tachycardia Bigeminy Bradycardia Premature Ventricular Contractions Hemorrhage ECG Abnormal Arrhythmia Atrial Fever Extremities Pain Anticholinergic Syndrome
Cardiovascular: Premature Atrial Contractions Syncope
Central Nervous System: Hypertonia/Dystonia, Paresthesia Agitation
Digestive: Hypersalivation Nausea
Hemic/Lymphatic: Leukocytosis
Injection Site: Phlebitis Pruritus
Metabolic: Hypomagnesemia
Musculoskeletal: Myalgia
Nervous: Dizziness Agitation Chills Somnolence Delirium
Respiratory: Wheezing Cough Laryngospasm Hypoxia Decreased Lung Function
Skin and Appendages: Flushing, Pruritus
Special Senses: Amblyopia Vision Abnormal
Urogenital: Cloudy Urine Green Urine

Incidence less than 1% - Causal Relationship Unknown

Anesthesia/MAC Sedation ICU Sedation
Body as a Whole: Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug 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, Myocardial Infarction, 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/Myoclonic Movement, 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, Osmolality Increased
Respiratory: Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction 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

Drug Abuse And Dependence

There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of DIPRIVAN by health care professionals have also been reported, which have resulted in fatalities and other injuries. Inventories of DIPRIVAN should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

DRUG INTERACTIONS

The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with narcotics (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These agents may increase the anesthetic or sedative effects of DIPRIVAN and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output.

During maintenance of anesthesia or sedation, the rate of DIPRIVAN administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids). The concurrent administration of potent inhalational agents (e.g., isoflurane, enflurane, and halothane) during maintenance with DIPRIVAN has not been extensively evaluated. These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of DIPRIVAN.

The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression.

DIPRIVAN does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants).

No significant adverse interactions with commonly used premedications or drugs used during anesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents, and local anesthetic agents) have been observed in adults. In pediatric patients, administration of fentanyl concomitantly with DIPRIVAN may result in serious bradycardia.

Read the entire FDA prescribing information for Diprivan (Propofol)

© Diprivan Patient Information is supplied by Cerner Multum, Inc. and Diprivan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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What is the most common complication of sedation?

When compared with local anesthesia alone, the two most significant negative variables introduced by moderate sedation, as well as deep sedation and general anesthesia, are the added risks for either respiratory depression, ie, hypoventilation, or airway obstruction in the deeply sedated or unconscious patient.

What is the side effect of sedative?

Long-term sedative use can lead to the following side effects: frequently forgetting or losing your memory (amnesia) symptoms of depression, such as fatigue, feelings of hopelessness, or suicidal thoughts. mental health conditions, such as anxiety.

What is the most worrisome side effect of sedation administration?

The greatest threat to the safety of a sedated patient is airway compromise and/or respiratory arrest.

What are some adverse effects of sedatives and hypnotics?

Side effects of sedative/hypnotics may include the following:.
Somnolence (drowsiness).
Headache..
Asthenia (weakness).
Neuromuscular and skeletal weakness..
Ataxia (impaired coordination, balance and speech).
Dizziness..
Lethargy..
Lightheadedness..

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