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.
What is the most important information I should know about DILANTIN?
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:
- 1.
- Like other antiepileptic drugs, DILANTIN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
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.
- 2.
- Dilantin may harm your unborn baby.
- If you take DILANTIN during pregnancy, your baby is at risk for serious birth defects.
- Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors
- If you take DILANTIN during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this.
- All women of child-bearing age should talk to their healthcare provider 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.
- Tell your healthcare provider right away if you become pregnant while taking DILANTIN. You and your healthcare provider should decide if you will take DILANTIN while you are pregnant.
- Pregnancy Registry: If you become pregnant while taking DILANTIN, talk to your healthcare provider 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 drugs during pregnancy.
- 3.
- Swollen glands (lymph nodes)
- 4.
- Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Symptoms include:
- swelling of your face, eyes, lips, or tongue
- trouble swallowing or breathing
- a skin rash
- hives
- fever, swollen glands, or sore throat that do not go away or come and go
- painful sores in the mouth or around your eyes
- yellowing of your skin or eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- severe muscle pain
- frequent infections or an infection that does not go away
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:
- are allergic to phenytoin or any of the ingredients in DILANTIN. See the end of this leaflet for a complete list of ingredients in DILANTIN.
- have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin).
What should I tell my healthcare provider before taking DILANTIN?
Before you take DILANTIN, tell your healthcare provider if you:
- Have or had liver disease
- Have or had porphyria
- Have or had diabetes
- Have or have had depression, mood problems, or suicidal thoughts or behavior
- Are pregnant or plan to become pregnant.
- If you become pregnant while taking DILANTIN, the level of DILANTIN in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of DILANTIN.
- Are breast feeding or plan to breastfeed. DILANTIN can pass into breast milk. You and your healthcare provider should decide if you will take DILANTIN or breastfeed. You should not do both.
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?
- Take DILANTIN exactly as prescribed. Your healthcare provider will tell you how much DILANTIN to take.
- Your healthcare provider may change your dose. Do not change your dose of DILANTIN without talking to your healthcare provider.
- DILANTIN can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking DILANTIN can help prevent this.
- If you take too much DILANTIN, call your healthcare provider or local Poison Control Center right away.
- Do not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly can cause serious problems.
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?
See "What is the most important information I should know about DILANTIN?"
DILANTIN may cause other serious side effects including:
- Softening of your bones (osteomalacia). This can cause broken bones.
Call your healthcare provider right away, if you have any of the symptoms listed above.
The most common side effects of DILANTIN include:
- problems with walking and coordination
- slurred speech
- confusion
- dizziness
- trouble sleeping
- nervousness
- tremor
- headache
- nausea
- vomiting
- constipation
- rash
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?
- Store DILANTIN-125 Suspension at room temperature between 68°F to 77°F (20°C to 25°C). Protect from light. Do not freeze.
- Store DILANTIN INFATABS at room temperature between 68°F to 77°F (20°C to 25°C). Protect from moisture.
- Store DILANTIN Capsules at room temperature between 68°F to 77°F (20°C to 25°C) in tight, light-resistant containers. Protect from moisture.
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?
Oral Suspension
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.
Tablet
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.
LAB-0398-2.0
July 2011
FAQs
DailyMed - DILANTIN- phenytoin sodium capsule, extended release? ›
DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
What is Dilantin capsule 100 mg phenytoin sodium extended? ›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.
What are the side effects of phenytoin extended release? ›- Headaches. Make sure you rest and drink plenty of fluids. ...
- Feeling drowsy, sleepy or dizzy. As your body gets used to phenytoin, these side effects should wear off. ...
- Feeling nervous, unsteady or shaky. ...
- Feeling or being sick (nausea or vomiting) ...
- Constipation. ...
- Sore or swollen gums.
Extended Phenytoin Sodium Capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
What is the generic for phenytoin sodium extended? ›Phenytoin (FEN-ih-toe-in) is the generic name (non–brand name) of a widely used seizure medicine. Common brand names for this type of medicine include Dilantin, but it is also sold using the name phenytoin or phenytoin sodium.
Is Dilantin a good seizure medication? ›Dilantin is one of the most widely prescribed drugs in the world. It is now often used as a second-line approach to seizures, but it still remains very crucial in the treatment of status epilepticus, seizures that occur following surgery, or seizures that occur in a hospital.
What are the side effects of Dilantin 100 mg capsule? ›The most common side effects of DILANTIN include irregular movement of the eye, problems with walking and coordination, slurred speech, trouble sleeping, confusion, dizziness, nervousness, tremor, headache, and nausea.
Why is phenytoin a high risk medication? ›Taking phenytoin may increase the risk that you will develop osteopenia, osteoporosis, or osteomalacia and problems with your lymph nodes including Hodgkin's disease (cancer that begins in the lymph system). Talk to your doctor about the risks of using this medication to treat your condition.
What should you not take with Dilantin? ›Avoid taking antacids at the same time you take Dilantin. Antacids can make it harder for your body to absorb the medication.
Does phenytoin cause memory loss? ›Phenytoin has been implicated in declines in concentration, memory, visuomotor functions and mental speed [Pulliainen and Jokelainen, 1995; Gillham et al. 1990; Andrewes et al. 1986]. These effects may be dose related [Gillham et al.
How long should you take Dilantin? ›
Continue taking DILANTIN for as long as your doctor tells you to. DILANTIN helps control your condition but does not cure it. Therefore, you must take your medicine every day, even if you feel well. Do not stop taking DILANTIN, or lower the dosage, without checking with your doctor.
Can you take phenytoin long term? ›Many people can take phenytoin safely for several months or years. But there are some side effects that might happen over a long time. Long-term treatment with phenytoin can: decrease the amount of vitamin D in your blood and might lead to osteoporosis and osteopenia, increasing your risk of breaking a bone.
What happens if you take Dilantin and don't need it? ›Although Dilantin is not a major drug of abuse, Dilantin toxicity can occur and can lead to death. Overdose symptoms may include: Fainting. Feeling light-headed.
Is there a difference between phenytoin and Dilantin? ›Dilantin (phenytoin) is an anti-epileptic drug, also called an anticonvulsant, used to control seizures. Dilantin is available in generic form.
Is phenytoin the same as Keppra? ›Are Keppra and Dilantin the Same Thing? Dilantin (phenytoin) and Keppra (levetiracetam) are anti-epileptic drugs (anticonvulsants) used to control seizures. Side effects of Dilantin and Keppra that are similar include dizziness, drowsiness, and nervousness.
What are the precautions for phenytoin sodium? ›Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. Phenytoin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection.
What is the best seizure medication on the market? ›Levetiracetam (Keppra)
This is one of the most commonly prescribed anti-seizure drugs because it is effective against many seizure types and has a relatively low risk of causing cognitive (thinking) side effects. Common side effects of levetiracetam include fatigue, dizziness, insomnia, and mood changes.
Dilantin has an average rating of 7.4 out of 10 from a total of 82 ratings on Drugs.com. 65% of reviewers reported a positive effect, while 20% reported a negative effect. Keppra has an average rating of 5.6 out of 10 from a total of 300 ratings on Drugs.com.
Is Dilantin hard on kidneys? ›DILANTIN can cause a type of serious allergic reaction that may affect different parts of the body such as your liver, kidneys, blood, heart, skin or other parts of your body. These can be very serious and cause death.
When is the best time of day to take Dilantin? ›You'll usually take phenytoin once or twice a day. You can take it with or without food. If you take it twice a day, try to space your doses evenly through the day. For example, take it first thing in the morning and in the evening.
Can Dilantin cause permanent damage? ›
For decades, Dilantin has been associated with cerebellar atrophy or degeneration, a type of brain damage caused by the deterioration of neurons (nerve cells) in the cerebellum (the area of the brain that controls balance and muscle coordination).
Does Dilantin cause weight gain? ›i am able to do so much more on dilantin than on any experimental drug due to its lack of control to your mind dilantin doesnt make you gain weight, it gives you facial hair as well as puffy gums. over time it can affect your bones but like any drug used in long term control.
What is the most serious complication of phenytoin? ›The neurotoxic effects are concentration dependent and can range from mild nystagmus to ataxia, slurred speech, vomiting, lethargy and eventually coma and death. Paradoxically, at very high concentrations, phenytoin can lead to seizures.
Why is phenytoin given at night? ›Why Is Phenytoin Given At Night? Phenytoin is commonly administered in the evening or at night. So that by the morning, there is sufficient concentration of the drug in the tissues and blood. This would reduce the risk or chances of a morning epileptic seizure.
Does Dilantin make you sleepy? ›Headache, nausea, vomiting, constipation, dizziness, feeling of spinning, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Can you drink coffee while taking Dilantin? ›Notes for Consumers: Hydantoins may decrease the actions of Caffeine; if you have a high intake of caffeinated foods or beverages you may experience a headache or irritability from decreased caffeine levels while taking these drugs until your body adjusts.
Can you take vitamin D with Dilantin? ›Using phenytoin together with cholecalciferol may decrease the effects of cholecalciferol. Contact your doctor if your condition changes. If your doctor does prescribe these medications together, you may need a dose adjustment or special test to safely use both medications.
Can you take Tylenol while on Dilantin? ›Examples of medications that can increase the risk of side effects from acetaminophen include phenobarbital, phenytoin (Dilantin), and carbamazepine (Tegretol). These medications may make liver damage from acetaminophen more likely.
Can Dilantin cause dementia? ›Phenobarbital and phenytoin have good antiepileptic effect, but clinically significant untoward effects occur during their long-term use. Phenobarbital may cause hyperactivity, behavioral problems, sedation, and even dementia; these effects are dose related to some extent.
Can phenytoin cause brain damage? ›Introduction. The antiseizure medication phenytoin has been associated with changes in the cerebellum, cerebellar signs, and permanent cerebellar damage.
What is the 5 word memory test? ›
Administration: The examiner reads a list of 5 words at a rate of one per second, giving the following instructions: “This is a memory test. I am going to read a list of words that you will have to remember now and later on. Listen carefully. When I am through, tell me as many words as you can remember.
Is Dilantin hard on teeth? ›Dilantin is a common drug used to treat certain forms of epilepsy. Gingival overgrowth is considered a common side effect, this can cause the mouth to become very painful and swollen. It can even cause a change in how your teeth fit together when you bite down on something.
What is a typical reaction to long term Dilantin therapy? ›The most common adverse reactions encountered with phenytoin therapy are nervous system reactions and are usually dose-related. Reactions include nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion.
Is phenytoin safe for elderly? ›The older antiepileptic drugs, which include phenytoin (Dilantin), valproic acid (Depakene), and carbamazepine (Tegretol), are less expensive than the newer agents and are considered appropriate selections for the initial treatment of seizures in older adults.
Can phenytoin damage the liver? ›Phenytoin is an anticonvulsant that in rare cases can cause acute idiosyncratic drug-induced liver disease that can be severe or even fatal. The liver injury caused by phenytoin appears to be due to a hypersensitivity reaction and resembles cases of immunoallergic hepatotoxicity.
Is phenytoin toxic to the liver? ›Most cases of liver injury are self-limiting and resolve within 1 to 2 months of stopping phenytoin. However, the liver injury can be severe and many fatal instances have been reported, phenytoin usually appearing in the top 10 causes of drug induced acute liver failure.
Can you stop Dilantin cold turkey? ›Do not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause you to have seizures more often or seizures that will not stop (status epilepticus).
What type of seizures does Dilantin treat? ›DILANTIN is a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and to prevent and treat seizures that happen during or after brain surgery.
Why avoid phenytoin? ›There is evidence that it causes cancer of the lymphatic system (Hodgkin's disease and non-Hodgkin's lymphoma) in humans and it has been shown to cause cancer of the lymphatic system and liver in animals. a carcinogen. exposed during pregnancy. ► Phenytoin may cause a skin allergy.
Can Dilantin cause neuropathy? ›Abstract. Purpose: Peripheral neuropathy is a rare adverse effect associated with phenytoin (PHT), and it usually occurs after the prolonged use of PHT. Acute PHT-induced peripheral neuropathy is extremely rare.
How do I wean myself off Dilantin? ›
If the patient has been on the medication for a long time and the goal is to stop medication, the dose should be decreased once a week over a few weeks before finally stopping the medication.
Is phenytoin better than lorazepam for seizures? ›Lorazepam was significantly superior to phenytoin in a pairwise comparison (P=0.002). Among the 134 patients with a verified diagnosis of subtle generalized convulsive status epilepticus, no significant differences among the treatments were detected (range of success rates, 7.7 to 24.2 percent).
Is phenytoin or lorazepam better for seizure? ›Lorazepam, when available, is thought to be the most effective and has a longer seizure half-life than diazepam. Because the effect is time limited, loading of a traditional AED, such as phenytoin, is recommended soon after administration to help mitigate seizure recurrence.
What is the major side effect of phenytoin? ›- Headaches. Make sure you rest and drink plenty of fluids. ...
- Feeling drowsy, sleepy or dizzy. As your body gets used to phenytoin, these side effects should wear off. ...
- Feeling nervous, unsteady or shaky. ...
- Feeling or being sick (nausea or vomiting) ...
- Constipation. ...
- Sore or swollen gums.
Headache, nausea, vomiting, constipation, dizziness, feeling of spinning, drowsiness, trouble sleeping, or nervousness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
What not to give with phenytoin? ›Antacids and nutritional tube-feeding (enteral) products may decrease the absorption of phenytoin. Do not take these products at the same time as your phenytoin dose. Separate liquid nutritional products at least 1 hour before and 1 hour after your phenytoin dose, or as directed by your doctor.
What is Dilantin 100MG used for? ›DILANTIN 100MG CAPSULE contains Phenytoin which belongs to the group of medicines called Anti-epileptic drugs. It is used to treat certain forms of epilepsy (fits or seizures) during or after brain surgery or severe head injury.
What is phenytoin 100MG used for? ›Phenytoin sodium tablets are indicated for control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and for prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury.
How often can you take 100 mg of phenytoin? ›Adults—At first, 100 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed. Children older than 6 years of age—300 mg per day, given in 2 or 3 divided doses per day. Your doctor may adjust your dose as needed.
Is Dilantin a high risk medication? ›Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including DILANTIN. Some of these events have been fatal or life-threatening.
What to avoid when taking Dilantin? ›
Avoid driving or hazardous activity until you know how Dilantin will affect you. Your reactions could be impaired. Avoid taking antacids at the same time you take Dilantin. Antacids can make it harder for your body to absorb the medication.
What drugs should not be taken with Dilantin? ›Some products that may interact with this drug include: colesevelam, orlistat, sucralfate. Other medications can affect the removal of phenytoin from your body, which may affect how phenytoin works.
How long can phenytoin be given? ›Many people can take phenytoin safely for several months or years. But there are some side effects that might happen over a long time. Long-term treatment with phenytoin can: decrease the amount of vitamin D in your blood and might lead to osteoporosis and osteopenia, increasing your risk of breaking a bone.
When is the best time to take phenytoin? ›You'll usually take phenytoin once or twice a day. You can take it with or without food. If you take it twice a day, try to space your doses evenly through the day. For example, take it first thing in the morning and in the evening.
How long should I take DILANTIN for? ›Continue taking DILANTIN for as long as your doctor tells you to. DILANTIN helps control your condition but does not cure it. Therefore, you must take your medicine every day, even if you feel well. Do not stop taking DILANTIN, or lower the dosage, without checking with your doctor.
Why take phenytoin at night? ›Why Is Phenytoin Given At Night? Phenytoin is commonly administered in the evening or at night. So that by the morning, there is sufficient concentration of the drug in the tissues and blood. This would reduce the risk or chances of a morning epileptic seizure.
What is the brand name for extended phenytoin? ›DILANTIN is a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and to prevent and treat seizures that happen during or after brain surgery.
What type of seizures does phenytoin treat? ›Phenytoin is a medication used in the management and treatment of epilepsy, generalized tonic-clonic seizures, complex partial seizures, and status epilepticus. It is in the anticonvulsants class of drugs.