Details for: PHENYTOIN SODIUM INJECTION, USP
Company: STERIMAX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02431378 | PHENYTOIN SODIUM INJECTION, USP | PHENYTOIN SODIUM | 50 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02431378 | PHENYTOIN SODIUM INJECTION, USP | PHENYTOIN SODIUM | 50 MG / ML | SOLUTION | INTRAVENOUS |
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
Phenytoin Sodium Injection USP is used for:
- the control of generalized tonic-clonic seizures, and psychomotor seizures
- the prevention and treatment of seizures that may begin during or after surgery to the brain or nervous system
What it does
Phenytoin Sodium Injection USP belong to the family of medicines called anticonvulsants. It acts in the brain to block the spread of seizure activity.
When it should not be used
- Is allergic to the active ingredient (phenytoin sodium), phenobarbital, or any of the other ingredients.
- Have a serious heart condition (such as; sinus bradycardia, sino-atrial block, second and third degree A.V. block, and Adams-Stokes syndrome).
- Is taking delavirdine, a drug used to treat HIV.
What the medicinal ingredient is
phenytoin sodium.
What the non-medicinal ingredients are
Glycol USP 40% and Alcohol USP 10% in Water for Injection.
What dosage form it comes in
Sterile Solution: 50 mg/mL
Warnings and precautions
Serious Warnings and Precautions
Cardiovascular Risk
You will receive Phenytoin Sodium Injection USP through injection into the vein or
muscle. If your doctor 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 doctor should observe you closely while you are receiving Phenytoin
Sodium Injection USP and after.
To help avoid side effects and ensure proper use, talk to your healthcare professional about any health conditions or problems you or your child may have BEFORE taking Phenytoin Sodium Injection, USP, including if you or your child:
- Have ever had a rash or unusual reaction while taking phenytoin sodium or any other antiepileptic drug.
- Have kidney or liver problems. Your doctor may need to adjust the dose.
- Drink alcohol. Drinking alcohol with Phenytoin Sodium Injection USP 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 Phenytoin Sodium Injection USP during pregnancy if your doctor tells you to.
- If you become pregnant while taking Phenytoin Sodium Injection, USP, talk to your healthcare professional about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The 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 Phenytoin Sodium Injection USP is not recommended.
- Are taking birth control. Phenytoin Sodium Injection USP may make hormonal birth control such as “the pill” less effective. Use other forms of safe and effective birth control when taking Phenytoin Sodium Injection USP until the end of your menstrual cycle after stopping treatment.
- Are diabetic.
- Have a blood disorder (such as porphyria).
- Have Asian ancestry. You may be at an increased risk of developing serious skin reactions.
- Suffer from absence seizures or seizures caused by low blood sugar (hypoglycaemia) or other metabolic causes.
- Have low blood pressure.
Other warnings you should know about:
- Ask your health 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 Phenytoin Sodium Injection USP 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, Phenytoin Sodium Injection USP 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).
- Antiepileptic drugs, including Phenytoin Sodium Injection, USP, should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus.
DURING treatment with Phenytoin Sodium Injection, USP, tell your health professional if you or your child develops:
- 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
Phenytoin Sodium Injection, USP. Being dizzy or drowsy can occur. Be careful to avoid accidental
injury or falls.
Interactions with this medication
There are many drugs that may increase or decrease Phenytoin Sodium Injection USP levels. Also, Phenytoin Sodium Injection USP may affect the levels of many drugs. Therefore, tell your healthcare professional about all the medicines you or your child are taking, 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.
The following may interact with Phenytoin Sodium Injection, USP:
- Birth control pills
- Other anti-seizure drugs (such as ethosuximide, felbamate, topiramate, oxcarbazepine, quetiapine, lamotrigine, methsuximide)
- Alcohol
- Delavirdine
- Warfarin
- Drugs used to treat fungal infections (such as fluconazole, ketoconazole, itraconazole, voriconazole)
- St. John’s Wort
- Drugs used to treat HIV infection (such as efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir)
- Beta-Blockers used to treat heart problems
Proper use of this medication
This medication is an injection. It will be given to you by your healthcare professional to stop a seizure.
Usual Dose
Your healthcare professional will decide the dose that is right for you.
Overdose
Missed Dose
If you feel that a dose has been missed, contact your healthcare professional.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Phenytoin Sodium Injection, USP. If you or your child 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 Phenytoin Sodium Injection USP are:
- Sleepiness/drowsiness, feeling tired/fatigue
- Headache, dizziness along with the feeling of a spinning movement
- Nausea/vomiting
- Changes in taste (metallic taste)
- Double vision, blurred vision
- Poor coordination (dizzy)
- Shakiness
- Unwanted, male-pattern hair growth in women
- Thickening of the gums
Phenytoin Sodium Injection USP can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and 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) | ✔ | ||
| 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 | ||
| 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, Phenytoin Sodium Injection USP 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, Phenytoin Sodium Injection USP treatment should be stopped right away. | ✔ | ||
| Respiratory depression (shallow slow, weak breathing) | ✔ | ||
| Heart problems (symptoms like irregular heartbeat, shortness of breath, chest pain etc.) | ✔ | ||
| Swelling, irritation, redness and pain at the site of the injection or in the hand/arm where the injection was given | ✔ | ||
If you or your child 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
The healthcare professional will store Phenytoin Sodium Injection USP at a temperature between 15°C and 30°C; freezing should be avoided.
Keep out of reach and sight of children
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll free at 1-866-234-2345 (toll-free);
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 Prescribing Information that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.sterimaxinc.com); or, by calling 1-800-881-3550.
This leaflet was prepared by SteriMax Inc.
Last Revised: August 30, 2018