DILANTIN- phenytoin sodium capsule, extended release
Aphena Pharma Solutions - Tennessee, Inc.
DILANTIN (Dī lan' tĭn)
(Phenytoin and Phenytoin sodium)
Oral Suspension, Tablets, Extended Oral Capsules
Read this Medication Guide before you start taking DILANTIN and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about DILANTIN, ask your healthcare provider or pharmacist.
Do not stop taking DILANTIN without first talking to your healthcare provider.
Stopping DILANTIN suddenly can cause serious problems.
DILANTIN can cause serious side effects including:
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop taking DILANTIN without first talking to a healthcare provider.
Stopping DILANTIN suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
Call your healthcare provider right away if you have any of the symptoms listed above.
What is DILANTIN?
DILANTIN is a prescription medicine used to treat tonic-clonic (grand mal), complex partial (psychomotor or temporal lobe) seizures, and to prevent and treat seizures that happen during or after brain surgery.
Who should not take DILANTIN?
Do not take DILANTIN if you:
What should I tell my healthcare provider before taking DILANTIN?
Before you take DILANTIN, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking DILANTIN with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take DILANTIN?
What should I avoid while taking DILANTIN?
Do not drink alcohol while you take DILANTIN without first talking to your healthcare provider. 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.
What are the possible side effects of DILANTIN?
DILANTIN may cause other serious side effects including:
Call your healthcare provider right away, if you have any of the symptoms listed above.
The most common side effects of DILANTIN include:
These are not all the possible side effects of DILANTIN. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store DILANTIN?
Keep DILANTIN and all medicines out of the reach of children.
General information about DILANTIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DILANTIN for a condition for which it was not prescribed. Do not give DILANTIN to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about DILANTIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DILANTIN that was written for healthcare professionals.
For more information about DILANTIN, visit http://www.pfizer.com or call 1-800-438-1985.
What are the ingredients in DILANTIN?
Active ingredient: phenytoin
Inactive ingredients: USP; alcohol, USP (maximum content not greater than 0.6 percent); banana flavor; carboxymethylcellulose sodium, USP; citric acid, anhydrous, USP; glycerin, USP; magnesium aluminum silicate, NF; orange oil concentrate; polysorbate 40, NF; purified water, USP; sodium benzoate, NF; sucrose, NF; vanillin, NF; and FD&C yellow No. 6.
Each tablet is a yellow triangular scored chewable tablet.
Active ingredient: 50 mg phenytoin
Inactive ingredients: D & C yellow No. 10, A1 lake, FD&C yellow No. 6, flavor, saccharin sodium, sucrose, talc, and other ingredients.
Extended Oral Capsule
Dilantin 100mg: Each capsule contains a white powder. The medium orange cap has "PD" imprinted in black ink and the white, opaque body has "DILANTIN" over "100 mg" printed in black ink.
Active ingredient: 100 mg phenytoin sodium
Inactive ingredients: lactose monohydrate, confectioner's sugar, talc, and magnesium stearate. The capsule body contains titanium dioxide and gelatin. The capsule cap contains FD&C red No. 28, FD&C yellow No. 6, and gelatin.
Dilantin 30mg: Each capsule contains a white powder. The small pale pink opaque cap has "PD" imprinted in black ink and the white, opaque body has "Dilantin 30 mg" printed in black ink.
Active ingredient: 30 mg phenytoin sodium
Inactive ingredients: lactose monohydrate, confectioner's sugar, talc, and magnesium stearate. The capsule shell cap and body contain Titanium Dioxide (cap and body); gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap).
This Medication Guide has been approved by the U.S. Food and Drug Administration.