Pronunciation:

fos-proe-POE-fol

Brand Names:

• Lusedra

Uses of This Medicine:

Fospropofol is used to make a person relax or sleep (be unconscious) before and during surgery or procedures. This medicine is a strong sedative.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fospropofol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fospropofol in the elderly. However, elderly patients are more likely to have age-related heart disease, which may require an adjustment in the dose for patients receiving fospropofol.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Barbital
• Benzhydrocodone
• Bromazepam
• Bupivacaine
• Bupivacaine Liposome
• Buprenorphine
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Daridorexant
• Dexmedetomidine
• Diazepam
• Dichloralphenazone
• Dihydrocodeine
• Doxylamine
• Esketamine
• Estazolam
• Eszopiclone
• Fentanyl
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lidocaine
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Mephobarbital
• Meprobamate
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxazepam
• Oxycodone
• Oxymorphone
• Paraldehyde
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Ramelteon
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Tapentadol
• Temazepam
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Zaleplon
• Zolpidem
• Zopiclone
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Succinylcholine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Heart disease or
• Hypotension (low blood pressure) or
• Hypoxemia (low oxygen in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or surgery clinic. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel dizzy or lightheaded when getting up suddenly from a lying or sitting position, so get up slowly.

This medicine may cause your skin to itch and a side effect called paresthesias. This may cause burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings on your skin. Check with your doctor if you have these symptoms after receiving the injection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Less common

Bluish lips or skin

blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

sweating

unusual tiredness or weakness

Rare

Difficult or troubled breathing

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

shortness of breath

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Itching skin

Less common

Headache

nausea

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.