Dilantin - Consumer Medicine Information
|Condition:||Epilepsy, Neurosurgery, Seizure Prophylaxis During or Following Neurosurgery, Seizures (Convulsions), Status Epilepticus|
|Class:||Group I antiarrhythmics, Hydantoin anticonvulsants|
|Ingredients:||phenytoin sodium, lactose, magnesium stearate, sugar, talc|
(30 mg and 100mg Extended Phenytoin Sodium Capsules)
About This Medication
What the Medication is Used For
DILANTIN has been prescribed to you by our doctor to control seizures. It is specifically 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
DILANTIN Capsules belong to the family of medicines called anticonvulsant. It acts in the brain to block the spread of seizure activity.
When it Should not Be Used
If you are allergic to phenytoin or other medicines of the hydantoin family, including fosphenytoin (CEREBRYX), or to any of the nonmedicinal ingredients in the formulations (see what the nonmedicinal ingredients are).
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
The non-medicinal ingredients are: lactose, magnesium stearate, sugar and talc.
Capsule shells (30mg): D&C Yellow No. 10, FD&C Red No. 3, gelatin and titanium dioxide
Capsule shells (100 mg): FD&C Yellow No. 6, D&C red No. 28, gelatin and titanium dioxide.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What Dosage Forms it Comes In
Extended Phenytoin Sodium Capsules (30 and 100 mg).
DILANTIN is also available in a phenytoin free acid form, as 50 mg flavoured Infatab and an oral suspension of 30 mg /5 mL or 125 mg/5 mL.
Warnings and Precautions
Do not stop your treatment with DILANTIN without first checking with your doctor as that could cause sudden worsening of your seizure. If you/your child are experiencing any side effects please see "Side Effects and What To Do About Them" section for guidance.
BEFORE you use DILANTIN talk to your doctor or pharmacist if:
- You/your child are diabetic,
- You/your child are anemic.
- You/your child have low bone density,
- You/your child have or have had any liver disease or blood disorders (including porphyria),
- You/your child have had an allergy to this drug, or other drugs used to treat your condition,
- You are pregnant or thinking about becoming pregnant. If you take DILANTIN during pregnancy your baby is at risk for serious birth defects, such as cleft lip or cleft palate. Birth defects may happen even in children born to women who are not taking any medicines and do not have any other risk factors. All women of child-bearing age who are being treated for epilepsy should talk to their healthcare providers about using other possible treatments instead of DILANTIN. If the decision is made to use DILANTIN, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking DILANTIN
- You are breast-feeding.
- You/your child are taking other drugs (prescription and overthe-counter medicines), dietary or herbal supplements.
- You consume alcohol on a regular or occasional basis.
- Certain individuals of Asian and /or of black origin may be at an increased risk of developing serious skin reactions during treatment with DILANTIN.
- You/your child have experienced in the past or have a family history of anticonvulsant hypersensitivity syndrome. This may occur rarely in patients treated with anticonvulsant medications and includes symptoms such as fever, rash, hepatitis (such as yellowing of skin and eyes) and lymph node swelling, among other symptoms.
- You/your child are currently being treated with cranial irradiation and corticosteroids.
- You/your child suffer from absence seizures (petit mal) or seizures caused by low blood sugar (hypoglycemia) or other metabolic causes, as DILANTIN is not effective in controlling these types of seizures.
- You/your child have or have had depression, mood problems, or suicidal thoughts or behavior.
- You/your child have lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because DILANTIN capsules contain lactose.
When Taking Dilantin
- Always take DILANTIN as your doctor has prescribed. If it is not possible for you to take DILANTIN as prescribed, tell your doctor.
- Tell your doctor if you develop a skin rash while taking DILANTIN.
- Tell your doctor right away if you develop serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling that may be accompanied by fever. These reactions may be more frequent in patients of Asian origin. Reports of these reactions have been highest in patients from Taiwan, Malaysia and the Philippines.
- Tell your doctor if you become pregnant while taking DILANTIN. You and your doctor should decide if you will continue to take DILANTIN while you are pregnant. If you become pregnant while taking DILANTIN, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information about the registry can also be found at the website: http://www.massgeneral.org/aed/.
- Talk to your doctor about the best way to care for your teeth, gums, and mouth during your treatment with DILANTIN. It is very important that you care for your mouth properly to decrease the risk of gum damage.
- It is recommended that you do not drink alcohol while taking DILANTIN, without first talking to your doctor. Drinking alcohol while taking DILANTIN may change your blood levels of DILANTIN, which can cause serious problems.
- Do not drive, operate heavy machinery or do other dangerous activities until you know how DILANTIN affects you. DILANTIN can slow your thinking and motor skills.
Interactions With This Medication
There are many drugs that may increase or decrease phenytoin levels. Also, DILANTIN may affect the levels of many drugs. Therefore, tell your doctor or pharmacist about all other prescription and non-prescriptions medication you are talking, as well as dietary and herbal supplements, enteral feeding preparations or nutritional drinks, as there may be a need to adjust your medication or monitor you more carefully.
Proper Use of This Medication
It is very important that you take DILANTIN exactly as your doctor has prescribed. Never increase or decrease the dose yourself. Do not stop taking it abruptly unless directed by your doctor as your seizures may increase. Tell your doctor if you cannot take the drug as prescribed, for example if you will be having surgery. You should always check that you have an adequate supply of DILANTIN.
Dosage adjustments are required when switching from the DILATIN Capsules to DILANTIN Infatabs/Oral suspension.
Do not use capsules that are discoloured.
Starting dose: One capsule (100 mg) three times daily. The dose is adjusted according to your response to treatment. In some cases, blood level assessment may be necessary to adjust the dose optimally.
Maintenance dose: Usually, 3-4 capsules (300 -400 mg) in divided doses daily. Some adult patients can be maintained on 300 mg once-a-day (3 capsules of 100 mg, taken together once-a-day).
Starting dose: 5 mg/kg/day in two or three equally divided doses. The dose is adjusted according to response, to a maximum of 300 mg daily. In some cases, blood level assessment may be necessary to adjust the dose optimally.
Maintenance dose: 4 to 8 mg/kg/day. Children over 6 years old may require the minimum adult dose (300 mg/day).
Very high doses can cause toxicity or death.
In case of drug overdose, contact the regional Poison Control Centre and talk to a health care practitioner right away, or go to a hospital emergency department, even if there are no symptoms. Take your medicine bottle with you to show the doctor.
If you/your child miss/misses a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.
Side Effects And What to Do About Them
Like all medicines, DILANTIN can cause side effects, although not everybody gets them.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your|
|Skin rash and|
the first two
eyelids, face or
lips, rash or
looking pale or
|Seizures or fits||✓||✓|
|Liver failure or|
skin and eyes)
the bones (bone
Other Side Effects
If you experience any side effects such as unusual eye movement, changes in muscle movements or co-ordination, slurred speech, dizziness, vertigo, trouble sleeping (insomnia), changes to facial skin, rash, headache, nausea or vomiting, consult your doctor.
This is not a complete list of side effects. For any unexpected effects, or effects that worry you while taking DILANTIN, contact your doctor or pharmacist.
How to Store It
Store at controlled room temperature 15-30°C. Protect from light and moisture.
Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.website.document or by contacting the sponsor, Pfizer Canada, at: 1-800-463-6001