Reviews on People Who Take 100mg of Lamitcal and Dilantin

What is Dilantin and how is it used?

Dilantin is a prescription medicine used to treat the symptoms of seizures as a anticonvulsant. Dilantin may be used alone or with other medications.

Dilantin belongs to a class of drugs called Anticonvulsants, Hydantoins; Antidysrhythmics, Ib.

It is not known if Dilantin is safe and constructive in children younger than 6 months of historic period.

What are the possible side effects of Dilantin?

Dilantin may cause serious side furnishings including:

• slow or uneven heartbeats,
• chest hurting,
• fluttering in your breast,
• dizziness,
• any skin rash,
• fever,
• chills,
• sore throat,
• swollen glands,
• crimson or bloated gums,
• rima oris sores,
• easy bruising,
• unusual haemorrhage,
• purple or red spots under your peel,
• loss of appetite,
• upper stomach pain,
• dark urine,
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Become medical help right abroad, if y'all have any of the symptoms listed above.

The most mutual side effects of Dilantin include:

• drowsiness,
• confusion,
• slurred speech,
• abnormal eye movement, and
• bug with balance or muscle move

Tell the doctor if y'all have any side effect that bothers y'all or that does not go away.

These are not all the possible side effects of Dilantin. For more information, ask your doctor or pharmacist.

Telephone call your doctor for medical advice well-nigh side effects. You lot may study side furnishings to FDA at one-800-FDA-1088.

WARNING

CARDIOVASCULAR Take chances ASSOCIATED WITH RAPID INFUSION

The rate of intravenous DILANTIN administration should not exceed 50 mg per minute in adults and 1 to iii mg/kg/min (or fifty mg per minute, whichever is slower) in pediatric patients because of the chance of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous DILANTIN. Although the risk of cardiovascular toxicity increases with infusion rates higher up the recommended infusion rate, these events accept besides been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

DESCRIPTION

DILANTIN (phenytoin sodium) injection, USP is a sterile solution of 50 mg phenytoin sodium per milliliter for intravenous or intramuscular assistants. The solution is in a vehicle containing xl% propylene glycol and 10% alcohol in water for injection, adjusted to pH 12 with sodium hydroxide. 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 represented by the following structural formula:

3 pharmacies near 11430 have coupons for Dilantin (Brand Names:Dilantin for 50MG)

INDICATIONS

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.

DOSAGE AND Assistants

Adult Dosage

Divided Daily Dosage

The recommended starting dose for adult patients who have received no previous treatment is 1 100-mg DILANTIN (extended phenytoin sodium capsule, USP) past mouth three times daily. Adjust the dosage to suit private requirements up to a maximum of ii capsules three times a day. For near adults, the satisfactory maintenance dosage will be one capsule three to four times a 24-hour interval.

Once-A-Day Dosage

In adults, if seizure command is established with divided doses of three 100-mg DILANTIN (extended phenytoin sodium capsules, USP) daily, one time-a-mean solar day dosage with 300 mg of DILANTIN (extended phenytoin sodium capsules, USP) may be considered. Studies comparing divided doses of 300 mg with a single daily dose of this quantity indicated assimilation, peak serum levels, biologic halflife, difference between elevation and minimum values, and urinary recovery were equivalent. Once-a-day dosage offers a convenience to the individual patient or to nursing personnel for institutionalized patients and is intended to be used only for patients requiring this amount of drug daily. A major problem in motivating noncompliant patients may also be lessened when the patient can have this drug in one case a day. Still, patients should be cautioned not to miss a dose, inadvertently.

But DILANTIN (extended phenytoin sodium capsules, USP) are recommended for once-a-twenty-four hour period dosing. Inherent differences in dissolution characteristics and resultant absorption rates of phenytoin due to different manufacturing procedures and/or dosage forms preclude such recommendation for other phenytoin products. When a change in the dosage course or make is prescribed, careful monitoring of phenytoin serum levels should be carried out.

Loading Dose

Some authorities have advocated use of an oral loading dose of phenytoin in adults who crave rapid steady-state serum levels and where intravenous administration is not desirable. This dosing regimen should be reserved for patients in a clinic or hospital setting where phenytoin serum levels can be closely monitored. Patients with a history of renal or liver illness should not receive the oral loading regimen.

Initially, one gram of DILANTIN (extended phenytoin sodium capsules, USP) is divided into iii doses (400 mg, 300 mg, 300 mg) and administered at 2-hour intervals. Normal maintenance dosage is then instituted 24 hours after the loading dose, with frequent serum level determinations.

Pediatric Dosage

The recommended starting dosage for pediatric patients is 5 mg/kg/24-hour interval by oral fissure in 2 or 3 equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily in divided doses. A recommended daily maintenance dosage is unremarkably 4 to eight mg/kg/day in as divided doses. Children over six years and adolescents may require the minimum developed dosage (300 mg/mean solar day).

Dosage Adjustments

Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments. Trough levels provide information about clinically effective serum level range and ostend patient compliance, and are obtained only prior to the patient'southward adjacent scheduled dose. Peak levels indicate an private'southward threshold for emergence of dose-related side furnishings and are obtained at the fourth dimension of expected peak concentration. Therapeutic effect without clinical signs of toxicity occurs more oftentimes with serum total concentrations between 10 and twenty mcg/mL (unbound phenytoin concentrations between i and 2 mcg/mL), although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin. In patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of unbound phenytoin concentrations may be more relevant [run across Dosing In Patients With Renal Or Hepatic Impairment Or Hypoalbuminemia].

With recommended dosage, a catamenia of seven to ten days may be required to achieve steady-state blood levels with phenytoin and changes in dosage (increase or decrease) should not be carried out at intervals shorter than seven to ten days.

Switching Between Phenytoin Formulations

The free acid form of phenytoin is used in DILANTIN-125 Intermission and DILANTIN Infatabs. DILANTIN extended capsules and parenteral DILANTIN are formulated with the sodium common salt of phenytoin. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium table salt and vice versa.

Dosing In Patients With Renal Or Hepatic Harm Or Hypoalbuminemia

Considering the fraction of unbound phenytoin is increased in patients with renal or hepatic affliction, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Geriatric Dosage

Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may exist required [see CLINICAL PHARMACOLOGY].

Dosing During Pregnancy

Decreased serum concentrations of phenytoin may occur during pregnancy because of contradistinct phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations should be performed during pregnancy, and the DILANTIN dosage should be adapted equally necessary. Postpartum restoration of the original dosage will probably exist indicated [see Utilise In Specific Populations]. Because of potential changes in protein binding during pregnancy, the monitoring of phenytoin serum levels should exist based on the unbound fraction.

HOW SUPPLIED

Dosage Forms And Strengths

DILANTIN extended phenytoin sodium capsules are available as:

• 30 mg: size 4 hemispherical Coni-Snap capsule with a white opaque body and pale pinkish opaque cap containing a white powder. Capsule is imprinted with black rectified radial print, "PD" on cap and "DILANTIN 30 mg" on body.
• 100 mg: hard, filled No. 3 capsules with a white, opaque body and a medium orange cap containing a white pulverization. Capsule is imprinted with blackness rectified radial print, "PD" on cap and "DILANTIN 100 mg" on body.

DILANTIN (extended phenytoin sodium capsules, USP) is supplied equally follows:

Package Configuration	Forcefulness	NDC
100's	30 mg	NDC 0071-3740-66
100's	100 mg	NDC 0071-0369-24
grand'south	100 mg	NDC 0071-0369-32
Unit Dose 100's	100 mg	NDC 0071-0369-40

DILANTIN 30 mg extended capsules are available as a size 4 hemispherical Coni-Snap sheathing with a white opaque body and pale pink opaque cap containing a white powder. Capsule is imprinted with black rectified radial print, "PD" on cap and "DILANTIN 30 mg" on body.

DILANTIN 100 mg extended capsules are available as difficult, filled No. three capsules containing a white powder. The medium orange cap having "PD" printed in black ink and the white, opaque body having "DILANTIN" over "100 mg" printed in blackness ink.

Storage And Handling

Store at twenty to 25°C (68 to 77°F) [Come across USP Controlled Room Temperature]. Preserve in tight, low-cal-resistant containers. Protect from moisture.

This Medication Guide has been approved by the U.S. Nutrient and Drug Administration Revised: Dec 2018

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments Encounter Slideshow

SIDE EFFECTS

The following serious agin reactions are described elsewhere in the labeling:

• Withdrawal Precipitated Seizure, Status Epilepticus [run into WARNINGS AND PRECAUTIONS]
• Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
• Serious Dermatologic Reactions [run into WARNINGS AND PRECAUTIONS]
• Drug Reaction with Eosinophilia and Systemic Symptoms (Clothes)/Multiorgan Hypersensitivity [come across WARNINGS AND PRECAUTIONS]
• Hypersensitivity [see WARNINGS AND PRECAUTIONS]
• Cardiac Effects [encounter WARNINGS AND PRECAUTIONS]
• Angioedema [see WARNINGS AND PRECAUTIONS]
• Hepatic Injury [encounter WARNINGS AND PRECAUTIONS]
• Hematopoietic Complications [see WARNINGS AND PRECAUTIONS]
• Furnishings on Vitamin D and Bone [come across WARNINGS AND PRECAUTIONS]
• Exacerbation of Porphyria [meet WARNINGS AND PRECAUTIONS]
• Teratogenicity and Other Harm to the Newborn [run into WARNINGS AND PRECAUTIONS]
• Hyperglycemia [see WARNINGS AND PRECAUTIONS]

The following adverse reactions associated with the use of DILANTIN were identified in clinical studies or postmarketing reports.

Because these reactions are reported voluntarily from a population of uncertain size, it is non e'er possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Torso equally a Whole: Allergic reactions in the form of rash and rarely more serious forms and Dress have been observed, as has angioedema [see WARNINGS AND PRECAUTIONS]. Anaphylaxis has also been reported.

In that location have too been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities.

Digestive System: Acute hepatic failure, toxic hepatitis, liver damage, nausea, vomiting, constipation, enlargement of the lips, and gingival hyperplasia.

Hematologic and Lymphatic System: Hematopoietic complications, some fatal, have occasionally been reported in clan with administration of phenytoin. These accept included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. While macrocytosis and megaloblastic anemia accept occurred, these conditions usually answer to folic acid therapy. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's illness have been reported [see WARNINGS AND PRECAUTIONS].

Laboratory Test Abnormality: Phenytoin may decrease serum concentrations of thyroid hormone (T4 and T3), sometimes with an accompanying increase in thyroid-stimulating hormone (TSH), but commonly in the absence of clinical hypothyroidism. Phenytoin may also produce lower than normal values for dexamethasone or metyrapone tests. Phenytoin may cause increased serum levels of glucose [see WARNINGS AND PRECAUTIONS], alkaline phosphatase, and gamma glutamyl transpeptidase (GGT).

Nervous Arrangement: The most common agin reactions encountered with phenytoin therapy are nervous system reactions and are commonly dose-related. Reactions include nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. Dizziness, vertigo, insomnia, transient nervousness, motor twitchings, paresthesias, and headaches accept also been observed. There have too been rare reports of phenytoin-induced dyskinesias, including chorea, dystonia, tremor and asterixis, like to those induced by phenothiazine and other neuroleptic drugs. Cerebellar atrophy has been reported, and appears more likely in settings of elevated phenytoin levels and/or long-term phenytoin use [see WARNINGS AND PRECAUTIONS].

A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.

Skin and Appendages: Dermatological manifestations sometimes accompanied past fever have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common; other types of dermatitis are seen more than rarely. Other more serious forms which may be fatal have included bullous, exfoliative or purpuric dermatitis, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis [meet WARNINGS AND PRECAUTIONS]. There accept also been reports of hypertrichosis and urticaria.

Special Senses: Altered gustation sensation including metallic taste.

Urogenital: Peyronie's disease

DRUG INTERACTIONS

Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19, and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce meaning increases in circulating phenytoin concentrations and raise the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected.

Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes.

Drugs That Touch on Phenytoin Concentrations

Table ii includes unremarkably occurring drug interactions that affect phenytoin concentrations. Still, this list is non intended to be inclusive or comprehensive. Individual prescribing data from relevant drugs should be consulted.

The addition or withdrawal of these agents in patients on phenytoin therapy may crave an adjustment of the phenytoin dose to achieve optimal clinical outcome.

Table 2: Drugs That Affect Phenytoin Concentrations

Interacting Agent	Examples
Drugs that may increase phenytoin serum levels
Antiepileptic drugs	Ethosuximide, felbamate, oxcarbazepine, methsuximide, topiramate
Azoles	Fluconazole, ketoconazole, itraconazole, miconazole, voriconazole
Antineoplastic agents	Capecitabine, fluorouracil
Antidepressants	Fluoxetine, fluvoxamine, sertraline
Gastric acid reducing agents	H2 antagonists (cimetidine), omeprazole
Sulfonamides	Sulfamethizole, sulfaphenazole, sulfadiazine, sulfamethoxazoletrimethoprim
Other	Astute booze intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines, salicylates, ticlopidine, tolbutamide, trazodone, warfarin
Drugs that may subtract phenytoin serum levels
Antacids*	Calcium carbonate, aluminum hydroxide, magnesium hydroxide Prevention or Management: Phenytoin and antacids should not be taken at the same time of day
Antineoplastic agents usually in combination	Bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate
Antiviral agents	Fosamprenavir, nelfinavir, ritonavir
Antiepileptic drugs	Carbamazepine, vigabatrin
Other	Chronic alcohol abuse, diazepam, diazoxide, folic acid, reserpine, rifampin, St. John's wort†, sucralfate, theophylline
Drugs that may either increase or decrease phenytoin serum levels
Antiepileptic drugs	Phenobarbital, valproate sodium, valproic acid
* Antacids may touch absorption of phenytoin. † The consecration potency of St. John's wort may vary widely based on preparation.

Drugs Affected By Phenytoin

Table 3 includes commonly occurring drug interactions affected by phenytoin. However, this list is not intended to be inclusive or comprehensive. Individual drug package inserts should be consulted. The addition or withdrawal of phenytoin during concomitant therapy with these agents may require aligning of the dose of these agents to achieve optimal clinical outcome.

Table 3: Drugs Affected past Phenytoin

Interacting Agent	Examples
Drugs whose efficacy is impaired by phenytoin
Azoles	Fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
Antineoplastic agents	Irinotecan, paclitaxel, teniposide
Delavirdine	Phenytoin tin substantially reduce the concentrations of delavirdine. This can lead to loss of virologic response and possible resistance [meet CONTRAINDICATIONS].
Neuromuscular blocking agents	Cisatracurium, pancuronium, rocuronium and vecuronium: resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents has occurred in patients chronically administered phenytoin. Whether or non phenytoin has the aforementioned effect on other non-depolarizing agents is unknown.
	Prevention or Management : Patients should exist monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may exist higher.
Warfarin	Increased and decreased PT/INR responses accept been reported when phenytoin is coadministered with warfarin
Other	Corticosteroids, doxycycline, estrogens, furosemide, oral contraceptives, paroxetine, quinidine, rifampin, sertraline, theophylline, and vitamin D
Drugs whose level is decreased by phenytoin
Antiepileptic drugs*	Carbamazepine, felbamate, lamotrigine, topiramate, oxcarbazepine,
Antilipidemic agents	Atorvastatin, fluvastatin, simvastatin
Interacting Agent	Examples
Antiviral agents	Efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir
	Fosamprenavir: phenytoin when given with fosamprenavir lonely may subtract the concentration of amprenavir, the active metabolite. Phenytoin when given with the combination of fosamprenavir and ritonavir may increase the concentration of amprenavir
Calcium aqueduct blockers	Nifedipine, nimodipine, nisoldipine, verapamil
Other	Albendazole (decreases agile metabolite), chlorpropamide, clozapine, cyclosporine, digoxin, disopyramide, folic acid, methadone, mexiletine, praziquantel, quetiapine
* The issue of phenytoin on phenobarbital, valproic acid and sodium valproate serum levels is unpredictable

Drug Enteral Feeding/Nutritional Preparations Interaction

Literature reports advise that patients who have received enteral feeding preparations and/or related nutritional supplements have lower than expected phenytoin serum levels. It is therefore suggested that phenytoin not exist administered concomitantly with an enteral feeding preparation. More frequent serum phenytoin level monitoring may be necessary in these patients.

Drug/Laboratory Test Interactions

Care should be taken when using immunoanalytical methods to mensurate serum phenytoin concentrations.

WARNINGS

Included as part of the "PRECAUTIONS" Section

PRECAUTIONS

Withdrawal Precipitated Seizure, Status Epilepticus

Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When, in the judgment of the clinician, the demand for dosage reduction, discontinuation, or substitution of culling anticonvulsant medication arises, this should be done gradually. However, in the outcome of an allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary. In this case, culling therapy should be an anticonvulsant drug not belonging to the hydantoin chemical grade.

Suicidal Behavior And Ideation

Antiepileptic drugs (AEDs), including DILANTIN, increase the chance of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should exist monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or whatever unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of xi different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Gamble 1.viii, 95% CI:one.two, 2.seven) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median handling duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately i case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, only the number is too modest to let whatsoever conclusion about drug upshot on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed equally early as 1 week after starting drug treatment with AEDs and persisted for the elapsing of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior across 24 weeks could not be assessed.

The adventure of suicidal thoughts or behavior was mostly consistent among drugs in the information analyzed. The finding of increased risk with AEDs of varying mechanisms of activity and across a range of indications suggests that the risk applies to all AEDs used for whatsoever indication. The risk did not vary substantially by historic period (5 to 100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Tabular array ane Adventure by indication for antiepileptic drugs in the pooled analysis

Indication	Placebo Patients with Events Per one thousand Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients	Adventure Divergence: Boosted Drug Patients with Events Per 1000 Patients
Epilepsy	1.0	three.4	3.5	2.4
Psychiatric	five.7	8.v	1.5	2.9
Other	1.0	ane.8	1.ix	0.9
Total	ii.4	4.3	1.eight	1.9

The relative gamble for suicidal thoughts or beliefs was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other weather condition, simply the accented risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing DILANTIN or whatsoever other AED must residual the risk of suicidal thoughts or beliefs with the risk of untreated disease. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased take a chance of suicidal thoughts and beliefs. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in whatsoever given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of business organisation should be reported immediately to healthcare providers.

Serious Dermatologic Reactions

DILANTIN can cause astringent cutaneous adverse reactions (SCARs), which may be fatal. Reported reactions in phenytoin-treated patients have included toxic epidermal necrolysis (X), Stevens-Johnson syndrome (SJS), astute generalized exanthematous pustulosis (AGEP), and Drug Reaction with Eosinophilia and Systemic Symptoms (Clothes) [see Drug Reaction With Eosinophilia And Systemic Symptoms (Wearing apparel)/Multiorgan Hypersensitivity]. The onset of symptoms is usually within 28 days, but can occur later. DILANTIN should be discontinued at the commencement sign of a rash, unless the rash is clearly non drug-related. If signs or symptoms suggest a astringent cutaneous adverse reaction, utilise of this drug should non be resumed and culling therapy should be considered. If a rash occurs, the patient should exist evaluated for signs and symptoms of SCARs.

Studies in patients of Chinese ancestry accept found a stiff association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA B factor, in patients using carbamazepine. Limited evidence suggests that HLAB* 1502 may be a chance gene for the development of SJS/10 in patients of Asian ancestry taking other antiepileptic drugs associated with SJS/X, including phenytoin. Consideration should be given to avoiding phenytoin every bit an alternative for carbamazepine in patients positive for HLA-B*1502.

The utilise of HLA-B*1502 genotyping has important limitations and must never substitute for advisable clinical vigilance and patient direction. The part of other possible factors in the evolution of, and morbidity from, SJS/10, such as antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring accept not been studied.

Drug Reaction With Eosinophilia And Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known equally Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including DILANTIN. Some of these events accept been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such equally hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an astute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems non noted hither may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may exist nowadays even though rash is non evident. If such signs or symptoms are present, the patient should exist evaluated immediately. DILANTIN should exist discontinued if an alternative etiology for the signs or symptoms cannot exist established.

Hypersensitivity

DILANTIN and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity [see CONTRAINDICATIONS and Angioedema]. Additionally, consider alternatives to structurally similar drugs such equally carboxamides (eastward.chiliad., carbamazepine), barbiturates, succinimides, and oxazolidinediones (e.chiliad., trimethadione) in these same patients. Similarly, if at that place is a history of hypersensitivity reactions to these structurally similar drugs in the patient or firsthand family members, consider alternatives to DILANTIN.

Cardiac Furnishings

Cases of bradycardia and cardiac arrest have been reported in DILANTIN-treated patients, both at recommended phenytoin doses and levels, and in association with phenytoin toxicity [see OVERDOSE]. Most of the reports of cardiac abort occurred in patients with underlying cardiac disease.

Angioedema

Angioedema has been reported in patients treated with DILANTIN in the postmarketing setting. DILANTIN should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. DILANTIN should exist discontinued permanently if a clear alternative etiology for the reaction cannot be established.

Hepatic Injury

Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, accept been reported with DILANTIN. These events may exist part of the spectrum of DRESS or may occur in isolation [run into Drug Reaction With Eosinophilia And Systemic Symptoms (Apparel)/Multiorgan Hypersensitivity]. Other common manifestations include jaundice, hepatomegaly, elevated serum transaminase levels, leukocytosis, and eosinophilia. The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes. In these patients with acute hepatotoxicity, DILANTIN should be immediately discontinued and non readministered.

Hematopoietic Complications

Hematopoietic complications, some fatal, have occasionally been reported in clan with administration of DILANTIN. These accept included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression.

There have been a number of reports suggesting a human relationship between phenytoin and the development of lymphadenopathy (local or generalized) including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin'south affliction. Although a cause and effect human relationship has not been established, the occurrence of lymphadenopathy indicates the need to differentiate such a condition from other types of lymph node pathology. Lymph node interest may occur with or without symptoms and signs of DRESS [run across Drug Reaction With Eosinophilia And Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity].

In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs.

Furnishings On Vitamin D And Bone

The chronic utilise of phenytoin in patients with epilepsy has been associated with decreased bone mineral density (osteopenia, osteoporosis, and osteomalacia) and bone fractures. Phenytoin induces hepatic metabolizing enzymes. This may enhance the metabolism of vitamin D and subtract vitamin D levels, which may atomic number 82 to vitamin D deficiency, hypocalcemia, and hypophosphatemia. Consideration should be given to screening with bone-related laboratory and radiological tests as advisable and initiating handling plans co-ordinate to established guidelines.

Renal Or Hepatic Impairment Or Hypoalbuminemia

Because the fraction of unbound phenytoin is increased in patients with renal or hepatic affliction, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients.

Exacerbation Of Porphyria

In view of isolated reports associating phenytoin with exacerbation of porphyria, caution should be exercised in using this medication in patients suffering from this disease.

Teratogenicity And Other Harm To The Newborn

DILANTIN may cause fetal impairment when administered to a meaning woman. Prenatal exposure to phenytoin may increase the risks for congenital malformations and other agin developmental outcomes [see Use In Specific Populations].

Increased frequencies of major malformations (such as orofacial clefts and cardiac defects), and abnormalities characteristic of fetal hydantoin syndrome, including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits, accept been reported among children born to epileptic women who took phenytoin lonely or in combination with other antiepileptic drugs during pregnancy. In that location have been several reported cases of malignancies, including neuroblastoma.

A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero. This drug-induced condition can be prevented with vitamin K assistants to the mother before delivery and to the neonate afterwards nascency.

Wearisome Metabolizers Of Phenytoin

A small percentage of individuals who take been treated with phenytoin have been shown to metabolize the drug slowly. Slow metabolism may be acquired by express enzyme availability and lack of induction; information technology appears to exist genetically determined. If early signs of dose-related fundamental nervous organisation (CNS) toxicity develop, serum levels should be checked immediately.

Hyperglycemia

Hyperglycemia, resulting from the drug'southward inhibitory furnishings on insulin release, has been reported. Phenytoin may also enhance the serum glucose level in diabetic patients.

Serum Phenytoin Levels Above Therapeutic Range

Serum levels of phenytoin sustained above the therapeutic range may produce confusional states referred to as "delirium," "psychosis," or "encephalopathy," or rarely irreversible cerebellar dysfunction and/or cerebellar atrophy. Accordingly, at the first sign of acute toxicity, serum levels should be immediately checked. Dose reduction of phenytoin therapy is indicated if serum levels are excessive; if symptoms persist, termination is recommended.

Patient Counseling Information

Advise patients to read the FDA-canonical patient labeling (Medication Guide).

Administration Information

Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage regimen, and of informing the dr. of any clinical status in which information technology is not possible to have the drug orally every bit prescribed, eastward.g., surgery, etc.

Advise patients not to apply capsules which are discolored.

Withdrawal Of Antiepileptic Drugs

Advise patients non to discontinue use of DILANTIN without consulting with their healthcare provider. DILANTIN should usually be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see WARNINGS AND PRECAUTIONS].

Suicidal Ideation And Behavior

Counsel patients, their caregivers, and families that AEDs, including DILANTIN, may increase the risk of suicidal thoughts and beliefs and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or beliefs, or the emergence of suicidal thoughts, beliefs, or thoughts about self-impairment. Behaviors of business concern should exist reported immediately to healthcare providers [see WARNINGS AND PRECAUTIONS].

Serious Dermatologic Reactions

Advise patients of the early signs and symptoms of astringent cutaneous adverse reactions and to report whatever occurrence immediately to a physician [see WARNINGS AND PRECAUTIONS].

Potential Signs Of Drug Reaction With Eosinophilia And Systemic Symptoms (Dress) And Other Systemic Reactions

Advise patients of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not express to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy, facial swelling, and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Advise the patient that, because these signs and symptoms may signal a serious reaction, that they must report whatsoever occurrence immediately to a physician. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring subsequently extended utilise [come across WARNINGS AND PRECAUTIONS].

Cardiac Effects

Counsel patients that cases of bradycardia and cardiac arrest take been reported, both at recommended phenytoin doses and levels, and in association with phenytoin toxicity. Patients should written report cardiac signs or symptoms to their healthcare provider [see WARNINGS AND PRECAUTIONS and OVERDOSE].

Angioedema

Advise patients to discontinue DILANTIN and seek firsthand medical care if they develop signs or symptoms of angioedema, such as facial, perioral, or upper airway swelling [see WARNINGS AND PRECAUTIONS].

Furnishings Of Alcohol Employ And Other Drugs And Over-The-Counter Drug Interactions

Caution patients confronting the employ of other drugs or alcoholic beverages without showtime seeking their physician'southward communication [DRUG INTERACTIONS].

Inform patients that certain over-the-counter medications (e.g., antacids, cimetidine, and omeprazole), vitamins (due east.g., folic acid), and herbal supplements (e.g., St. John'south wort) can change their phenytoin levels.

Hyperglycemia

Advise patients that DILANTIN may cause an increment in claret glucose levels [see WARNINGS AND PRECAUTIONS].

Gingival Hyperplasia

Propose patients of the importance of good dental hygiene in order to minimize the development of gingival hyperplasia and its complications.

Neurologic Furnishings

Counsel patients that DILANTIN may cause dizziness, gait disturbance, decreased coordination and somnolence. Advise patients taking DILANTIN not to drive, operate circuitous machinery, or appoint in other hazardous activities until they have get accustomed to any such effects associated with DILANTIN.

Use In Pregnancy

Inform pregnant women and women of childbearing potential that use of DILANTIN during pregnancy tin can cause fetal harm, including an increased risk for fissure lip and/or cleft palate (oral clefts), cardiac defects, dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits. When appropriate, counsel pregnant women and women of childbearing potential well-nigh alternative therapeutic options. Advise women of childbearing potential who are not planning a pregnancy to utilize effective contraception while using DILANTIN, keeping in listen that in that location is a potential for decreased hormonal contraceptive efficacy [see DRUG INTERACTIONS].

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their dr. if they are breastfeeding or intend to breastfeed during therapy [run across Use In Specific Populations].

Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become meaning. This registry is collecting information well-nigh the condom of antiepileptic drugs during pregnancy [run into Employ In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis [Run across WARNINGS AND PRECAUTIONS]

In carcinogenicity studies, phenytoin was administered in the diet to mice (10, 25, or 45 mg/kg/day) and rats (25, 50, or 100 mg/kg/twenty-four hour period) for two years. The incidences of hepatocellular tumors were increased in male person and female person mice at the highest dose. No increases in tumor incidence were observed in rats. The highest doses tested in these studies were associated with peak serum phenytoin levels below human therapeutic concentrations.

In carcinogenicity studies reported in the literature, phenytoin was administered in the nutrition for 2 years at doses up to 600 ppm (approximately 160 mg/kg/day) to mice and up to 2400 ppm (approximately 120 mg/kg/day) to rats. The incidences of hepatocellular tumors were increased in female mice at all only the lowest dose tested. No increases in tumor incidence were observed in rats.

Mutagenesis

Phenytoin was negative in the Ames exam and in the in vitro clastogenicity assay in Chinese hamster ovary (CHO) cells.

In studies reported in the literature, phenytoin was negative in the in vitro mouse lymphoma assay and the in vivo micronucleus assay in mouse. Phenytoin was clastogenic in the in vitro sister chromatid commutation analysis in CHO cells.

Fertility

Phenytoin has not been adequately assessed for effects on male or female person fertility.

Utilize In Specific Populations

Pregnancy

Pregnancy Exposure Registry

In that location is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such every bit DILANTIN, during pregnancy. Physicians are brash to recommend that significant patients taking DILANTIN enroll in the Due north American Antiepileptic Drug (NAAED) Pregnancy Registry. This tin be done past calling the tollfree number 1-888-233-2334, and must exist done by patients themselves. Data on the registry can also exist found at the website http://www.aedpregnancyregistry.org/

Chance Summary

In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. In add-on, the fetal hydantoin syndrome, a design of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children built-in to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [meet Data]. There accept been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy.

Administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal expiry, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see Data].

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to xx%, respectively. The background chance of major birth defects and miscarriage for the indicated population is unknown.

Clinical Considerations

Disease-associated maternal run a risk

An increase in seizure frequency may occur during pregnancy considering of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations may exist valuable in the direction of pregnant women as a guide to appropriate aligning of dosage [see DOSAGE AND Administration]. However, postpartum restoration of the original dosage volition probably be indicated [see CLINICAL PHARMACOLOGY].

Fetal/Neonatal Adverse Reactions

A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero. This drug-induced condition can be prevented with vitamin K assistants to the female parent before delivery and to the neonate afterward nascency.

Data

Human Data

Meta-analyses using information from published observational studies and registries have estimated an approximately ii.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. An increased risk of eye defects, facial clefts, and digital hypoplasia has been reported. The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, smash and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies.

Animal Data

Administration of phenytoin to significant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. Malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low every bit 100, 75, and 12.five mg/kg, respectively.

Lactation

Risk Summary

Phenytoin is secreted in homo milk. The developmental and health benefits of breastfeeding should exist considered along with the mother's clinical need for DILANTIN and any potential adverse effects on the breastfed babe from DILANTIN or from the underlying maternal status.

Pediatric Use

Initially, 5 mg/kg/twenty-four hour period in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over vi years and adolescents may require the minimum adult dosage (300 mg/twenty-four hours) [come across DOSAGE AND ADMINISTRATION].

Geriatric Utilize

Phenytoin clearance tends to subtract with increasing age [meet CLINICAL PHARMACOLOGY]. Lower or less frequent dosing may exist required [see DOSAGE AND Administration].

Renal And/Or Hepatic Damage Or Hypoalbuminemia

The liver is the primary site of biotransformation of phenytoin; patients with impaired liver part, elderly patients, or those who are gravely ill may bear witness early signs of toxicity.

Considering the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients.

Overdosage & Contraindications

OVERDOSE

The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to exist 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred spoken communication, blurred vision, nausea, and vomiting. The patient may get comatose and hypotensive. Bradycardia and cardiac arrest have been reported [see WARNINGS AND PRECAUTIONS]. Death is caused by respiratory and circulatory depression.

There are marked variations amongst individuals with respect to phenytoin serum levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL; dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL, but every bit high a concentration as 50 mcg/mL has been reported without prove of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery. Irreversible cerebellar dysfunction and cloudburst have been reported.

Treatment

Handling is nonspecific since there is no known antidote.

The capability of the respiratory and circulatory systems should exist carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of astringent intoxication in pediatric patients.

In acute overdosage the possibility of other CNS depressants, including booze, should be borne in mind.

CONTRAINDICATIONS

DILANTIN is contraindicated in patients with:

• A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [come across WARNINGS AND PRECAUTIONS].
  Reactions take included angioedema.
• A history of prior acute hepatotoxicity owing to phenytoin [see WARNINGS AND PRECAUTIONS].
• Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the form of non-nucleoside contrary transcriptase inhibitors.

CLINICAL PHARMACOLOGY

Mechanism Of Action

The precise machinery past which phenytoin exerts its therapeutic effect has not been established only is idea to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained loftier-frequency neuronal discharges.

Pharmacokinetics

Absorption

For DILANTIN capsules, peak serum levels occur 4 to 12 hours after administration. Steady-state therapeutic levels are achieved at least 7 to ten days (5–7 one-half-lives) later on initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should exist obtained at to the lowest degree 5–7 half-lives afterwards treatment initiation, dosage change, or add-on or subtraction of another drug to the regimen so that equilibrium or steady-country will have been achieved.

Distribution

Phenytoin is extensively jump to serum plasma proteins.

Elimination

The plasma one-half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours.

Metabolism

Phenytoin is metabolized past hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19. Considering phenytoin is hydroxylated in the liver by an enzyme system which is saturable at high serum levels, small incremental doses may increase the half-life and produce very substantial increases in serum levels, when these are in the upper range. The steady-state level may be unduly increased, with resultant intoxication, from an increase in dosage of ten% or more.

In most patients maintained at a steady dosage, stable phenytoin serum levels are accomplished. There may be wide interpatient variability in phenytoin serum levels with equivalent dosages. Patients with unusually low levels may exist noncompliant or hypermetabolizers of phenytoin. Unusually high levels upshot from liver disease, variant CYP2C9 and CYP2C19 alleles, or drug interactions which result in metabolic interference. The patient with large variations in phenytoin serum levels, despite standard doses, presents a difficult clinical problem. Serum level determinations in such patients may be particularly helpful. As phenytoin is highly poly peptide spring, free phenytoin levels may exist altered in patients whose poly peptide binding characteristics differ from normal.

Excretion

Virtually of the drug is excreted in the bile as inactive metabolites which are so reabsorbed from the intestinal tract and excreted in the urine. Urinary excretion of phenytoin and its metabolites occurs partly with glomerular filtration but, more chiefly, past tubular secretion.

Specific Populations

Age

Geriatric Population

Phenytoin clearance tends to subtract with increasing age (20% less in patients over 70 years of historic period relative to that in patients 20 to 30 years of age). Since phenytoin clearance is decreased slightly in elderly patients, lower or less frequent dosing may be required [see DOSAGE AND Assistants].

Sex/Race

Gender and race have no pregnant impact on phenytoin pharmacokinetics.

Renal Or Hepatic Impairment

Increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia has been reported.

Pregnancy

It has been reported in the literature that the plasma clearance of phenytoin generally increased during pregnancy, reached a summit in the third trimester and returned to the level of pre-pregnancy after few weeks or months of delivery.

Drug Interaction Studies

Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19. Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes [meet DRUG INTERACTIONS].

PATIENT INFORMATION

DILANTIN
(DÏ lan' can)
(extended phenytoin sodium capsules)

What is the most important information I should know virtually DILANTIN?

Phone call your healthcare provider between visits as needed, peculiarly if you are worried about symptoms.

Call your healthcare provider even if the symptoms are mild or if you have been taking DILANTIN for an extended menses of fourth dimension.

These symptoms can be a sign of a serious allergic reaction.

1. 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 yous to take seizures more than frequently or seizures that will not stop (status epilepticus).
2. Like other antiepileptic drugs, DILANTIN may cause suicidal thoughts or actions in a very pocket-size number of people, about i in 500. Call a healthcare provider right away if you lot have any of these symptoms, peculiarly 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
   • Problem sleeping (insomnia)
   • New or worse irritability
   • Acting ambitious, being aroused, or violent
   • Acting on unsafe impulses
   • An farthermost increase in activity and talking (mania)
   • Other unusual changes in behavior or mood

   Suicidal thoughts or deportment tin can be acquired by things other than medicines. If y'all have suicidal thoughts or actions, your healthcare provider may check for other causes.

   How can I watch for early symptoms of suicidal thoughts and deportment?

   • Pay attending to whatsoever changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
   • Continue all follow-up visits with your healthcare provider as scheduled.
3. DILANTIN tin can cause a type of serious allergic reaction that may affect dissimilar parts of the body such as your liver, kidneys, blood, centre, skin or other parts of your body. These tin can be very serious and crusade decease. Call your healthcare provider right away if you lot take any or all of these symptoms:
   • Fever
   • Rash
   • Bloated lymph glands
   • Swelling of your face, eye, lips, or natural language
   • Problem swallowing or breathing
   • Sore pharynx
   • Sores in your mouth
   • Bruise hands
   • Purple or red spots on your pare
   • Increase infections
   • Non wanting to swallow (anorexia)
   • Nausea
   • Airsickness
   • Yellowing of the peel and the white function of your eyes (jaundice)
4. DILANTIN tin cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have any of these symptoms:
   • dizziness
   • tiredness
   • feeling like your heart is chirapsia slowly or skipping beats
   • chest pain

What is DILANTIN?

DILANTIN is a prescription medicine used to treat certain types of seizures chosen tonic-clonic (k mal) and psychomotor (temporal lobe) seizures.

Do not take DILANTIN if you lot:

• Are allergic to phenytoin or whatever of the ingredients in DILANTIN. Run into the end of this leaflet for a consummate list of ingredients in DILANTIN.
• Have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin).
• Accept had liver problems from taking phenytoin.
• Take delavirdine.

Before taking DILANTIN, tell your healthcare provider about all of your medical weather condition, including if you:

• Have or have had depression, mood issues, or suicidal thoughts or beliefs
• Have had an allergic reaction to a medicine similar to DILANTIN called carboxamides, barbiturates, succinimides, and oxazolidinediones
• Have or had liver or kidney problems
• Have or had an enzyme problem called porphyria
• Have or had high claret sugar (hyperglycemia)
• Beverage alcohol
• Are pregnant or program to go pregnant. DILANTIN may damage your unborn baby.

  The purpose of this registry is to collect data well-nigh the safety of antiepileptic drugs during pregnancy.

  • If you lot take DILANTIN during pregnancy, your baby is at risk for serious birth defects.
  • If you lot 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.
  • If you lot take DILANTIN during pregnancy, your infant is likewise at gamble for bleeding problems right later on nascency. Your healthcare provider may give you and your baby medicine to prevent this.
  • All women of changeable age should talk to their healthcare provider about using other possible treatments instead of DILANTIN.
  • If you are of childbearing historic period and are not planning on getting pregnant, you should use effective birth control (contraception) while taking DILANTIN.
  • Pregnancy Registry: If you become significant while taking DILANTIN, talk to your healthcare provider near registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry past calling 1-888-233-2334.
• Are breastfeeding or programme to breastfeed. DILANTIN can pass into breast milk. You and your healthcare provider should determine if you volition accept DILANTIN while y'all are breastfeeding.

Tell your healthcare provider virtually all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medicines tin change the levels of DILANTIN in your blood.

Taking DILANTIN with sure other medicines can cause side effects or affect how well they piece of work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Go along a list of them and show it to your healthcare provider and pharmacist when you lot go a new medicine.

How should I have DILANTIN?

• Take DILANTIN exactly every bit your healthcare provider tells you.
• Your healthcare provider will tell you lot how much DILANTIN to take and when to take it.
• Your healthcare provider may alter your dose if needed. Practise not change your dose of DILANTIN without talking to your healthcare provider.
• If your healthcare provider has prescribed DILANTIN oral suspension, ask your pharmacist for a medicine dropper or medicine cup to help yous measure the correct amount of DILANTIN. Do not utilise a household teaspoon. Enquire your chemist for instructions on how to use the measuring device the right style.
• Practice not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly tin can crusade serious issues.

What should I avoid while taking DILANTIN?

• Practise non potable alcohol while you take DILANTIN without showtime talking to your healthcare provider. Drinking alcohol while taking DILANTIN may modify your blood levels of DILANTIN which can cause serious problems.
• Do not drive, operate heavy machinery, or practice other dangerous activities until yous know how DILANTIN affects you. DILANTIN can slow your thinking and motor skills.

What are the possible side effects of DILANTIN?

Run across "What is the most important information I should know most DILANTIN?"

DILANTIN may crusade other serious side effects including:

• Liver bug.
• Low blood count which could increase your chance of getting infections, bruising, haemorrhage and increased fatigue
• Softening of your bones (osteopenia, osteoporosis, and osteomalacia) can cause your basic to break (fractures).
• High claret sugar (hyperglycemia).
• Loftier levels of DILANTIN in your blood that could cause defoliation also known every bit delirium, psychosis or a more serious condition that affects how your brain works (encephalopathy).

Call your healthcare provider right away, if you take any of the symptoms listed to a higher place.

The nigh mutual side effects of DILANTIN include:

• Irregular movement of the eye (nystagmus)
• Bug with motion and residual (clutter)
• Slurred speech
• Decrease in coordination
• Drowsiness (somnolence)
• Defoliation

DILANTIN can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking DILANTIN can aid prevent this from happening.

These are not all of the possible side furnishings of DILANTIN.

Phone call your doctor for medical advice about side effects. Yous may report side effects to FDA at one-800-FDA-1088.

How should I shop DILANTIN?

• Store DILANTIN Capsules at room temperature between 68°F to 77°F (twenty°C to 25°C).
• Store in tight, calorie-free-resistant containers.
• Protect from moisture.

Continue DILANTIN and all medicines out of the attain of children.

General data most the safety and effective employ of DILANTIN.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Exercise not use DILANTIN for a condition for which information technology was non prescribed. Do not give DILANTIN to other people, fifty-fifty if they have the same symptoms that you have. It may impairment them. Yous can inquire your pharmacist or healthcare provider for information almost DILANTIN that is written for health professionals.

What are the ingredients in DILANTIN Capsules?

DILANTIN xxx mg:

Active ingredient: thirty mg phenytoin sodium, USP

Inactive ingredients: lactose monohydrate, confectioner'southward 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).

DILANTIN 100 mg:

Agile ingredient: 100 mg phenytoin sodium, USP

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. half-dozen, and gelatin.

From

Encephalon & Nervous Resources

Written report Problems to the Food and Drug Assistants

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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Source: https://www.rxlist.com/dilantin-drug.htm

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