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Details for: CEREBYX

Company: ERFA CANADA 2012 INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02230988CEREBYXFOSPHENYTOIN SODIUM75 MG / MLLIQUIDINTRAMUSCULAR
02230988CEREBYXFOSPHENYTOIN SODIUM75 MG / MLLIQUIDINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

CEREBYX is used in situations when other means of phenytoin administration are unavailable, inappropriate or deemed less advantageous. It can also be used for the control of generalized convulsive status epilepticus or for the prevention and treatment of seizures occurring during neurosurgery.

What it does

CEREBYX is converted by the body into phenytoin, which is an anticonvulsant medication. This family of medications stops seizure activity in the brain.

When it should not be used
  • are allergic to the active ingredient fosphenytoin sodium, phenobarbital, or any of the other ingredients.
  • have a serious heart condition (such as; sinus bradycardia, sino-atrial block, second and third degree AV block and Adams-Stokes syndrome).
  • are taking delavirdine, a drug used to treat HIV.
What the medicinal ingredient is

75 mg/mL of fosphenytoin sodium as heptahydrate, equivalent to 50 mg/mL phenytoin sodium after administration.

What the non-medicinal ingredients are

Water for Injection and tromethamine buffer (12 mg/mL) adjusted to pH 8.6 to 9.0 with either hydrochloric acid or sodium hydroxide.

What dosage form it comes in

Liquid: 50 mg/mL

Warnings and precautions

Serious Warnings and Precautions

Cardiovascular Risk

  • You will receive CEREBYX through injection into the vein or muscle. If your healthcare professional injects this medication into the vein too fast, your blood pressure may drop quickly, and you may experience irregular heartbeat. This can be serious. Therefore, your healthcare professional should observe you closely while you are receiving CEREBYX and after.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CEREBYX. Talk about any health conditions or problems you may have, including if you:

  • Have ever had a rash or unusual reaction while taking fosphenytoin sodium or any other antiepileptic drug
  • Have kidney or liver problems. Your healthcare professional may need to adjust the dose
  • Drink alcohol. Drinking alcohol with CEREBYX may make you less alert and may make feelings of anger, confusion or sadness worse
  • Suffer from seizures that spread to the whole brain
  • Are pregnant or planning to become pregnant You must only take CEREBYX during pregnancy if your healthcare professional tells you to
    • If you become pregnant while taking CEREBYX, talk to your healthcare professional about registering with the North American Antiepileptic Drug (NAAED) Pregnancy RegistryThe purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy You can enroll in this registry by calling 1-888-233-2334 Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/
    • Are nursing or plan to nurse your baby Nursing while you are taking CEREBYX is not recommended
  • Are taking birth control
    • CEREBYX may make hormonal birth control such as “the pill” less effective
    • Use other forms of safe and effective birth control when taking CEREBYX
    • You need to use other forms of birth control until the end of your menstrual cycle after stopping treatment
  • Have low blood pressure
  • Have heart problems
  • Are diabetic
  • Are of Asian or African descent. You may be at a higher risk of developing serious skin reactions
  • Have a blood disorder (such as; porphyria)
  • Have a family history of hypersensitivity to CEREBRYX, phenytoin or other hydantoins
  • Are being treated with irradiation and corticosteroids
  • Have low bone density.

Other warnings you should know about:

  • Ask your healthcare professional about signs and symptoms of life threatening skin reactions such as Stevens Johnson Syndrome (SJS; a skin reaction with rash and blisters) and Toxic Epidermal Necrolysis (TEN; a skin rash often with blisters, lesions and lifting skin) that have been reported during CEREBRYX treatment. Closely monitor for skin reactions. Most often, SJS or TEN happen in the first weeks of treatment. If symptoms or signs of SJS or TEN are present, CEREBYX treatment should be stopped. The best results in managing SJS and TEN come from early detection and stopping the drug treatment right away (see table of Serious Side Effects and What to do About Them, below).
  • Anti-epileptic drugs, including CEREBRYX, should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus.

DURING treatment with CEREBRYX, tell your healthcare professional if you develop:

  • Thoughts of suicide or self harm
  • Abnormal vision (blurry or double vision)

Driving and using machines:

Before doing tasks that require special attention, wait until you know how you respond to CEREBYX. Being dizzy or drowsy can occur. Be careful to avoid accidental injury or falls.

There are many drugs that may increase or decrease CEREBYX levels. Also, CEREBYX may affect the levels of many drugs. Therefore, tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines as there may be a need to adjust your medication or monitor you more carefully.

Interactions with this medication
  • Birth control pills.
  • Other anti-epileptic drugs (such as; ethosuximide, topiramate, phenobarbital, sodium Vvalproate, carbamazepine, valproic acid, felbamate, succinimides, oxycarbazepine, quetiapine, lamotrigine, methsuximide).,
  • Alcohol.
  • Drugs used to treat fungal infections (such as; amphotericin B,fluconazole, ketoconazole, miconazole, itraconazole, voriconazole).
  • Drugs used to treat heart problems.
  • Drugs used to treat HIV infection (such as; delavirdine, efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir).
  • Warfarin.
  • St. John’s Wort
  • Folic acid
  • This medication is an injections. It will be given to you by your healthcare professional to stop a seizure.
  • If you are taking this medication to control your seizures, do not stop taking CEREBYX without talking to your healthcare professional. Stopping a seizure medicine suddenly can cause serious problems, including seizures that will not stop. Your healthcare professional will tell you if and when you can stop taking this medicine.

Usual adult Dose

Your healthcare professional will decide the dose that is right for you.

Overdose

If you think you have been given too much CEREBYX contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Every dose should be administered under the supervision of a healthcare professional, if a dose is missed contact your healthcare professional immediately.

Proper use of this medication
  • This medication is an injections. It will be given to you by your healthcare professional to stop a seizure.
  • If you are taking this medication to control your seizures, do not stop taking CEREBYX without talking to your healthcare professional. Stopping a seizure medicine suddenly can cause serious problems, including seizures that will not stop. Your healthcare professional will tell you if and when you can stop taking this medicine.

Usual adult Dose

Your healthcare professional will decide the dose that is right for you.

Overdose

If you think you have been given too much CEREBYX contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Every dose should be administered under the supervision of a healthcare professional, if a dose is missed contact your healthcare professional immediately.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking CEREBYX. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

The most common side effects associated with the use of CEREBYX are:

  • Sleepiness/drowsiness, feeling tired/fatigue
  • Headache, dizziness along with the feeling of a spinning movement
  • Nausea/vomiting, constipation, dry mouth, changes in taste
  • Double vision, blurred vision
  • Poor coordination (dizzy)
  • Shakiness
  • Eyes moving involuntarily
  • Itching
  • Sensation of tingling, tickling, or burning of the skin
  • Ringing in the ears

CEREBRYX can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious Side Effects and What to do About Them
Symptom / effect Talk to your Healthcare Professional Only if severe Talk to your Healthcare Professional In all cases Get Immediate Medical Help
Common
Low sodium level in blood (symptoms like lack of energy, confusion, muscular twitching or convulsions)    
Nervous system problems (symptoms like dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, blurred vision, double vision etc.)    
Allergies (symptoms like fever, rash and swollen lymph nodes, and may be associated with symptoms involving other organs, e.g., liver)    
Swelling, irritation, redness and pain at the site of the injection or in the hand/arm where the injection was given    
Uncommon
Liver problems (symptoms like yellowing of your skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, dark tea-like urine etc.)    
Thoughts of suicide or self harm    
Thinning of the bone, bone softening, bone disease, or fractures (In situations where healthy people would not normally break a bone you may have sudden pain in any location and especially in the wrist, spine or hip. This may be a fracture.)    
Altered numbers and types of blood cells (symptoms like unexplained tiredness, weakness, shortness of breath, and sometimes, feeling like you are going to pass out and increased bruising, nosebleeds, sore throats, or infections)  

You should
tell your
healthcare
professional
who may
want to
perform a
blood test

 
Low blood pressure (dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up)    
Heart problems (symptoms like irregular heartbeat, shortness of breath, chest pain, etc.)    
Rare
Severe allergic reactions (symptoms like swelling of face, eyes, lips, or tongue, trouble swallowing or breathing, skin rash)    
A rare, serious disorder in which your skin reacts severely to a medication (Stevens Johnson Syndrome; SJS). If symptoms or signs of SJS (e.g. skin rash often with blisters or lesions) are present, CEREBYX treatment should be stopped right away.    
Severe skin reaction where the upper surface of your skin detaches like a patient who has suffered burns (Toxic Epidermal Necrolysis [TEN]). If symptoms or signs of TEN (e.g. skin rash often with blisters or mucosal lesions and lifting skin) are present, phenobarbital treatment should be stopped right away.    
Unknown
Respiratory depression (shallow slow, weak breathing)    

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store

Store under refrigeration at 2° to 8°C. The product should not be stored at room temperature for more than 48 hours.
Keep out of reach and sight of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:
  • Online at MedEffect
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to: 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information
  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.eci2012.net/index.php; or, by calling 1 888 922 3133.

This leaflet was prepared by ERFA Canada 2012 Inc.

Last Revised 07-04-2015

Date modified: