Dilantin

DRUG DESCRIPTION

Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the
barbiturates in chemical structure, but has a five-membered ring. The chemical
name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural
formula:

Each Dilantin (phenytoin) — 100 mg Extended Oral Capsule—contains 100 mg phenytoin
sodium. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc,
USP; and magnesium stearate, NF. The capsule body contains titanium dioxide,
USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C
yellow No. 6; and gelatin NF. Product in vivo performance is characterized
by a slow and extended rate of absorption with peak blood concentrations expected
in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP
with a rapid rate of absorption with peak blood concentration expected in 1%
to 3 hours.

What are the possible side effects of phenytoin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• swollen glands, easy bruising or bleeding;,...

Read All Potential Side Effects and See Pictures of Dilantin »

What are the precautions when taking phenytoin (Dilantin)?

Before taking phenytoin, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., ethotoin, phenobarbital, ethosuximide, trimethadione); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, certain blood conditions (porphyria), diabetes, liver disease, lupus, folate or vitamin B-12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit...

Read All Potential Precautions of Dilantin »

Dilantin Consumer (continued)

SIDE EFFECTS: Headache, nausea, vomiting, constipation, dizziness, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Phenytoin may cause swelling and bleeding of the gums. Massage your gums and brush and floss your teeth regularly to minimize this problem. See your dentist regularly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual eye movements, loss of coordination, slurred speech, confusion, muscle twitching, double or blurred vision, tingling of the hands/feet, facial changes (e.g., swollen lips, butterfly-shaped rash around the nose/cheeks), excessive hair growth, increased thirst or urination, unusual tiredness, bone or joint pain, easily broken bones.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: uncontrolled muscle movements, swollen glands (lymph nodes), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, easy bruising/bleeding, signs of infection (e.g., persistent sore throat or fever).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, high fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking phenytoin, tell your doctor or pharmacist if you are allergic to it; or to other anti-seizure medications (e.g., ethotoin, phenobarbital, ethosuximide, trimethadione); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, certain blood conditions (porphyria), diabetes, liver disease, lupus, folate or vitamin B-12 deficiency (megaloblastic anemia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Alcohol may also affect your blood levels of this drug.

Tell your doctor you are using phenytoin prior to surgery or any procedure that makes you unable to take it by mouth.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood (or urine) glucose level frequently, as directed by your doctor. Promptly report any abnormal results as directed. Your medicine, exercise plan, or diet may need to be adjusted.

Vitamin D supplements may be necessary to prevent weakening of the bones (osteomalacia). Discuss this with your doctor.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

Phenytoin passes into breast milk. Consult your doctor before breast-feeding.

Dilantin Patient Information Including Side Effects

Brand Names: Dilantin, Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, Phenytoin Sodium, Prompt

Generic Name: phenytoin (oral) (Pronunciation: FEN i toyn)

• What is phenytoin (Dilantin)?


• What are the possible side effects of phenytoin?


• What is the most important information I should know about phenytoin?


• What should I discuss with my healthcare provider before taking phenytoin?


• How should I take phenytoin?


• What happens if I miss a dose?


• What happens if I overdose?


• What should I avoid while taking phenytoin?


• What other drugs will affect phenytoin?


• Where can I get more information?

What is phenytoin (Dilantin)?

Phenytoin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures.

Phenytoin is used to control seizures. Phenytoin is not made to treat all types of seizures, and your doctor will determine if it is the right medication for you.

Phenytoin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of phenytoin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• swollen glands, easy bruising or bleeding;, swollen or tender gums;


• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;


• the first sign of any skin rash, no matter how mild;


• confusion, hallucinations, unusual thoughts or behavior;


• slurred speech, loss of balance or coordination;


• tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;


• extreme thirst or hunger, urinating more than usual;


• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or


• changes in the shape of your face or lips.

Less serious side effects may include:

• mild skin rash or itching;


• dizziness, nervousness, sleep problems (insomnia);


• nausea, vomiting, constipation; or


• headache, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about phenytoin?

If you are taking phenytoin to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking phenytoin.

Do not change your dose of phenytoin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Related Drug Centers

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