Fresenius Propoven Emulsion For Injection 10Mg Drug Medication Dosage Information
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Fresenius Propoven: Emulsion for injection (10mg)

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What is this Medicine?

PROPOFOL is an anesthetic. It is used to produce relaxation and sleep before or during surgery. It is also used in patients on a ventilator.

In-Depth Information

Fresenius Propoven 1% Emulsion for Injection

NDC: 633230297
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
General Anesthesia Induction, Monitored Anesthesia Care Sedation, General Anesthesia Maintenance, Sedation Induction, Sedation Maintenance

Sometimes used for but not FDA approved for the following conditions:
Status Epilepticus, Migraine, Procedural Sedation, Post-operative Nausea/vomiting (PONV) Prophylaxis, Agitation

Storage Information
Do not expose product to temperatures above 77 degrees F
Do not freeze
Discard unused portion. Do not store for later use.
Fresenius Propoven 1% Emulsion for Injection

Reported Side Effects for Fresenius Propoven 1% Emulsion for Injection

Elated Mood Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Skin Redness Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Emotional Lability Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Dystonic Reaction Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Double Vision Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Diaphoresis Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Confusion Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Chills Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Chest Pain Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Breathing Difficulties Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Weakness Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
<3.0%*
Severity: SEVERE
Onset: EARLY
Anaphylactoid Reactions Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Vomiting Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Fainting Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Convulsions Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Nerve Pain Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Heart Attack Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
High White Blood Cells Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Wheezing Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Weakness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Urine Discoloration Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Blood Clot Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Rapid Breathing Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
ST-T Wave Changes Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Rapid Heart Rate Incidence:
<3.0%*
Severity: MODERATE
Onset: RAPID
Shivering Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Kidney Failure Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Skin Rash Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Abnormal Heart Rhythm Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Irritated Blood Vessels Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Paresthesias Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Vocal Cord Spasm Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Hypoxia Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Shallow, Slow Breathing Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Low Muscle Tone Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Overbreathing Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Excessive Mucle Tone Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Hiccups Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Hallucinations Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Bowel Obstruction Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Low Magnesium Levels Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
<8.0%*
Severity: MODERATE
Onset: EARLY
Extra Saliva Production Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
High Potassium Level Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Heart Failure Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Headache Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Shortness Of Breath Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Drowsiness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Delirium Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Dehydration Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Red Eyes Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Suddenly Stopped Heart Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Heart Block Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Irregular Heart Beat Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Nervousness Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Lazy Eye Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Distressed Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Increased Blood Sugar Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Bundle-branch Block Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Bleeding Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Dry Mouth Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Rapid Heart Rate Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Hives Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Retaining Urine Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Shaking Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Ringing In Ears Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Sneezing Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
High Pressure In Brain Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Inability To Sleep Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Electrolyte Imbalance Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Pain Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Fast Eye Movements Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Eye Pain Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Decreased Urination Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Sore Throat Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Itching Incidence:
<3.0%*
Severity: MILD
Onset: RAPID
Fluid In Lungs Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Slow Heart Beat Incidence:
1.0-3.0%*
Severity: SEVERE
Onset: RAPID
Decreased Breathing Incidence:
1.0-43.0%*
Severity: SEVERE
Onset: DELAYED
Low Blood Pressure Incidence:
3.0-26.0%*
Severity: MODERATE
Onset: RAPID
Rapid Muscle Twitches Incidence:
3.0-17.0%*
Severity: MODERATE
Onset: DELAYED
Injection Site Reaction Incidence:
>10.0%*
Severity: MILD
Onset: RAPID
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Fresenius Propoven 1% Emulsion for Injection

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Alcohol and Fresenius Propoven 1% Emulsion for Injection(Propofol)
Alcohol and CNS Depressants(Propofol)
Avoid alcohol-containing drinks while taking this medicine. Using this drug along with alcohol can lead to serious side effects. You may feel drowsy or more tired when taking these drugs together. Do not drive or operate machinery until you know how this drug affects you, and especially if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, severe weakness, or difficulty breathing, contact your health care provider immediately.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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