Fospropofol (Intravenous)

Fospropofol is used to help 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.

It is very important for your doctor to monitor your progress while you are using this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep using it.

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

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform 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.

Pediatric

There have not been appropriate studies done on how fospropofol affects children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any geriatric-specific problems that would limit the usefulness of fospropofol in older adults. However, older patients are more likely to have age-related heart disease, which may require a dose adjustment for patients receiving fospropofol.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, 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 knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary 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 increase the 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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

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

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.

In the U.S.

• Lusedra

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.