Generic Name: phenytoin (Oral route)
Commonly used brand name(s)
In the U.S.
- Dilantin Infatabs
- Dilantin Kapseals
Available Dosage Forms:
- Tablet, Chewable
- Capsule, Extended Release
Therapeutic Class: Anticonvulsant
Chemical Class: Hydantoin (class)
Uses For Dilantin-125
Phenytoin is used to control seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.
This medicine is available only with your doctor's prescription.
Before Using Dilantin-125
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of phenytoin in children.
No information is available on the relationship of age to the effects of phenytoin in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients taking phenytoin.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isavuconazonium Sulfate
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Calcium Carbonate
- Dabigatran Etexilate
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Doxorubicin Hydrochloride Liposome
- Eslicarbazepine Acetate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- St John's Wort
- Vincristine Sulfate Liposome
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Folic Acid
- Medroxyprogesterone Acetate
- Valproic Acid
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Enteral Nutrition
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bone problems (eg, osteomalacia, osteoporosis) or
- Depression or mental illness, history of or
- Diabetes or
- Lymphadenopathy (lymph node problems) or
- Porphyria (an enzyme problem) or
- Vitamin D deficiency—Use with caution. May make these conditions worse.
- Hypoalbuminemia (low albumin in the blood) or
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal from the body.
Proper Use of phenytoin
This section provides information on the proper use of a number of products that contain phenytoin. It may not be specific to Dilantin-125. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.
Do not change brands or dosage forms of phenytoin without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.
Swallow the tablet whole or chew it thoroughly before being swallowed together with a glass of water.
Measure the oral suspension with a marked measuring spoon, oral syringe, or medicine cup. Rinse the dosing spoon or cup with water after each use.
If you are receiving tube feeding preparations, it is best to take this medicine before or after a feeding.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For seizures:
- For oral dosage form (extended-release capsules):
- Adults—At first, 100 milligrams (mg) three times a day or 300 mg once a day. Your doctor may increase your dose as needed. For patients in the clinic or hospital (except with a history of liver or kidney disease), a loading dose of 1000 mg is divided into three doses (400 mg, 300 mg, 300 mg) and given every 2 hours. Then, normal maintenance dose may be started 24 hours after the loading dose.
- Teenagers and children older than 6 years of age—300 mg per day. Your doctor may adjust your dose as needed.
- Children 6 years of age and below—Dose is based on body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. The doctor may adjust the dose as needed.
- For oral dosage form (suspension):
- Adults—At first, 5 milliliters (mL) or one teaspoonful three times a day. Your doctor may adjust your dose as needed.
- Teenagers and children older than 6 years of age—300 mg per day. Your doctor may adjust your dose as needed.
- Children 6 years of age and below—Dose is based on age and body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. Your doctor may adjust your dose as needed.
- For oral dosage form (tablets):
- Adults—At first, 100 milligrams (mg) three times a day. Your doctor may adjust your dose as needed.
- Teenagers and children older than 6 years of age—300 mg per day, given in two or three divided doses per day. Your doctor may adjust your dose as needed.
- Children 6 years of age and below—Dose is based on age and body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) of body weight given in two or three divided doses per day. The doctor may adjust the dose as needed.
- For oral dosage form (extended-release capsules):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Dilantin-125
It is very important that your doctor check your progress at regular visits while you or your child are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine if you or your child are also using delavirdine (Rescriptor®). Using these medicines together may cause unwanted effects.
Lymph node problems may occur while using this medicine. Check with your doctor right away if you or your child have swollen, painful, or tender lymph glands in your neck, armpit, or groin.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping completely.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
Tell your doctor right away if you or your child develop a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin after taking this medicine. These may be symptoms of a serious and life-threatening condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
This medicine may cause liver damage. 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. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may decrease bone mineral density. A low bone mineral density can cause weak bones or osteoporosis. If you or your child have any questions about this ask your doctor.
This medicine may affect blood sugar levels. If you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your or your child's doctor right away.
In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums (gingival hyperplasia) may appear soon after phenytoin treatment is started. To help prevent this, brush and floss your teeth carefully and regularly and massage your gums. Also, see your dentist every 6 months to have your teeth cleaned. If you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums, check with your doctor or dentist.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
This medicine may cause drowsiness, trouble thinking, or trouble in controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Avoid drinking alcohol while you are taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Dilantin-125 Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Decreased coordination
- mental confusion
- slurred speech
- trouble with breathing, speaking, or swallowing
- unsteadiness, trembling, or other problems with muscle control or coordination
- Inability to move the eyes
- increased blinking or spasms of the eyelid
- shakiness and unsteady walk shakiness in the legs, arms, hands, or feet
- sticking out of the tongue
- trembling or shaking of the hands or feet
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- Abdominal or stomach pain
- bleeding gums
- blistering, peeling, or loosening of the skin
- blisters, hives, or itching
- bloating of the abdomen or stomach
- blood in the urine or stools
- bloody, black, or tarry stools
- chest pain
- cough or hoarseness
- dark urine
- difficulty with moving
- fainting spells
- fever with or without chills
- general feeling of discomfort or illness
- general feeling of tiredness or weakness
- hair loss
- high fever
- irregular heartbeat
- irritation in the mouth
- joint or muscle pain
- light-colored stools
- lower back or side pain
- muscle stiffness
- nausea or vomiting
- numbness, tingling, or pain in the hands or feet
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- red skin lesions, often with a purple center
- red, irritated eyes
- redness and swelling of the gums
- skin blisters
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unusual bleeding or bruising
- unusual tiredness
- upper right abdominal or stomach pain
- weight loss
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Trouble sleeping
- uncontrolled eye movements
- Difficulty having a bowel movement (stool)
- enlarged lips
- feeling of constant movement of self or surroundings
- increased hair growth on the forehead, back, arms, or legs
- pain of the penis on erection
- sensation of spinning
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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