Fosphenytoin injection is used to control certain types of seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
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.
Pediatric Population
Appropriate studies have not been performed on the relationship of age to the effects of fosphenytoin injection in the pediatric population. Safety and efficacy have not been established.
Geriatric Population
Appropriate studies on the relationship of age to the effects of fosphenytoin injection have not been performed in the geriatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fosphenytoin injection.
Pregnancy
All Trimesters: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Amifampridine
Artemether
Atazanavir
Bepridil
Boceprevir
Cisapride
Cobicistat
Daclatasvir
Dasabuvir
Delamanid
Delavirdine
Dronedarone
Elvitegravir
Isavuconazonium Sulfate
Lurasidone
Maraviroc
Mesoridazine
Ombitasvir
Paritaprevir
Pimozide
Piperaquine
Praziquantel
Ranolazine
Rilpivirine
Ritonavir
Sparfloxacin
Telaprevir
Terfenadine
Thioridazine
Ziprasidone
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.
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.
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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Ethanol
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:
Blood or bone marrow problems (e.g., agranulocytosis, leukopenia, or thrombocytopenia) or
Porphyria (an enzyme problem)—Use with caution. May make these conditions worse.
Heart block (e.g., Adams-Stokes syndrome, AV block, or sinoatrial block) or
Sinus bradycardia (slow heartbeat)—Should not be used in patients with these conditions.
Hypoalbuminemia (low albumin in the blood) or
Kidney disease or
Liver disease—Use with caution. The effects may be increased because of slower removal from the body.
3 Proper Usage
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into one of your muscles or through a needle placed in one of your veins.
Your doctor will only give you a few doses of this medicine until your condition improves. You will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
4 Precautions to Take
It is very important that your doctor check your progress closely while you are receiving this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.
Do not receive this medicine while you are also taking delavirdine (Rescriptor®). Using these medicines together may cause delavirdine to not work as well for you.
This medicine may cause some people to become
dizzy,
lightheaded,
faint,
less alert than they are normally.
Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.
Do not stop using this medicine without first checking with your doctor
Stopping the medicine suddenly may cause your seizures to return or to occur more often.
Stop using this medicine and tell your doctor right away if you develop
swollen, painful, or tender lymph glands in the neck, armpit, or groin;
unusual bleeding or bruising;
yellow eyes or skin.
These may be symptoms of a serious and life-threatening condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.
Tell your doctor right away if your skin feels like it is burning, crawling, or itching, or if you have numbness, prickling, "pins and needles", or tingling feelings after receiving fosphenytoin injection.
This medicine may cause purple glove syndrome.
Tell your doctor right away if you have
skin discoloration,
pain, or swelling at the injection site after receiving this medicine.
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.
Avoid drinking alcohol while you are receiving this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
Blurred vision
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
blistering, burning, crusting, dryness, or flaking of the skin
blood in the urine or stools
bloody nose
bluish color of the fingernails, lips, skin, palms, or nail beds
body aches or pain
bone pain
burning while urinating
change in consciousness
change in personality
change in the ability to see colors, especially blue or yellow
uncontrolled movements, especially of the face, neck, and back
unexplained weight loss
unusual behavior
unusual bleeding or bruising
unusual weak feeling
voice changes
vomiting of blood or material that looks like coffee grounds
weakness or heaviness of the legs
weight gain
wrinkled skin
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
Continuing ringing or buzzing or other unexplained noise in the ears
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