Fospropofol (Intravenous route)
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:
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.
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.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Propoxyphene Napsylate
- Sodium Oxybate
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:
- More common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Less common
- Bluish lips or skin
- blurred vision
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- unusual tiredness or weakness
- Difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- shortness of breath
- More common
- Itching skin
- Less common
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:
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:
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.
Last Updated: 11/4/2014