Fosphenytoin Sodium Solution for...

What is this medicine?

FOSPHENYTOIN (fos FEN i toyn) is used to control seizures in certain types of epilepsy. It can help to prevent seizures occurring during or after surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol abuse problem

• Asian ancestry

• blood disorders or disease

• heart disease, low blood pressure

• kidney disease

• liver disease

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to phenytoin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein or muscle or for infusion into a vein. It is given by a health-care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• delavirdine

This medicine may also interact with the following medications:

• antibiotics known as sulfonamides

• aspirin and aspirin-like medicines

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• carbamazepine

• chloramphenicol

• chlordiazepoxide

• diazepam

• disulfiram

• ethosuximide

• female hormones, including contraceptive or birth control pills

• fluoxetine

• halothane

• heart medicines such as digoxin or digitoxin

• corticosteroid hormones such as prednisone or cortisone

• doxycycline

• furosemide

• isoniazid

• medicines for diabetes

• medicines for mental depression, anxiety or other mood problems

• medicines for stomach problems like cimetidine, famotidine, nizatidine and ranitidine

• medicines to control heart rhythm

• methsuximide

• methylphenidate

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• phenylbutazone

• reserpine

• rifampin, rifabutin or rifapentine

• theophylline

• valproic acid

• vitamin D

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Your doctor or health care professional may schedule regular blood tests, because this medicine needs careful monitoring. Do not stop using this medicine suddenly. This increases the risk of seizures. Because your condition and the use of this medicine carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications and doctor or health care professional.

You may feel dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can make you more dizzy, increase flushing and may cause rapid heartbeats. Avoid alcoholic drinks.

This medicine can cause unusual growth of gum tissues. Visit your dentist regularly. Problems can arise if you need dental work, and in the day to day care of your teeth. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• confusion

• dark yellow or brown urine

• difficulty breathing, wheezing or shortness of breath

• double vision or uncontrollable and rapid eye movement

• fever, sore throat

• headache

• loss of seizure control

• poor control of body movements or difficulty walking

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• unusual bleeding or bruising, pinpoint red spots on skin

• vomiting

• worsening of mood, thoughts or actions of suicide or dying

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• difficulty sleeping

• excessive hair growth on the face or body

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.