PHENYTEK ® capsules (extended phenytoin sodium capsules) are 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.
The recommended starting dose for adult patients who have received no previous treatment is one 100-mg extended phenytoin sodium capsule by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of two capsules three times a day. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day. In adults, if seizure control is established with d...
PHENYTEK ® CAPSULES (extended phenytoin sodium capsules, USP) are available containing 200 mg or 300 mg of phenytoin sodium, USP. The 200 mg capsules have a dark blue opaque cap and a blue opaque body. The hard-shell gelatin capsules are filled with two white to off-white round tablets. The capsules are rectified radial printed with BERTEK over 670 in black ink on both the cap and the body. They are available as f...
www.fda.gov/medwatch
www.aedpregnancyregistry.orgPHENYTEK® capsules (extended phenytoin sodium capsules) are 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.
The recommended starting dose for adult patients who have received no previous treatment is one 100-mg extended phenytoin sodium capsule by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of two capsules three times a day. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day.
In adults, if seizure control is established with divided doses of three 100-mg extended phenytoin sodium capsules daily, once-a-day dosage with 300 mg of PHENYTEK® capsules may be considered. Studies comparing divided doses of 300 mg with a single daily dose of this quantity indicated absorption, peak serum levels, biologic half-life, difference between peak 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 take this drug once a day. However, patients should be cautioned not to miss a dose, inadvertently. Only PHENYTEK® capsules are recommended for once-a-day 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 form or brand is prescribed, careful monitoring of phenytoin serum levels should be carried out.
Some authorities have advocated use of an oral loading dose of phenytoin in adults who require 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 disease should not receive the oral loading regimen. Initially, one gram of PHENYTEK® capsules is divided into three doses (400 mg, 300 mg, 300 mg) and administered at two-hour intervals. Normal maintenance dosage is then instituted 24 hours after the loading dose, with frequent serum level determinations.
The recommended starting dosage for pediatric patients is 5 mg/kg/day by mouth in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily in divided doses. A recommended daily maintenance dosage is usually 4 to 8 mg/kg/day in equally divided doses. Children over 6 years and adolescents may require the minimum adult dosage (300 mg/day).
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 confirm patient compliance, and are obtained just prior to the patient’s next scheduled dose. Peak levels indicate an individual’s threshold for emergence of dose-related side effects and are obtained at the time of expected peak concentration. Therapeutic effect without clinical signs of toxicity occurs more often with serum total concentrations between 10 and 20 mcg/mL (unbound phenytoin concentrations between 1 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 [see Dosage and Administration (2.5)].
With recommended dosage, a period 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.
The free acid form of phenytoin is used in DILANTIN-125® Suspension and DILANTIN® Infatabs®. PHENYTEK® capsules and parenteral phenytoin are formulated with the sodium 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 salt and vice versa.
Because 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 [see Warnings and Precautions (5.11) and Use in Specific Populations (8.6)].
Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required [see Clinical Pharmacology (12.3)].
Decreased serum concentrations of phenytoin may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations should be performed during pregnancy, and the phenytoin sodium dosage should be adjusted as necessary. Postpartum restoration of the original dosage will probably be indicated [see Use in Specific Populations (8.1)]. Because of potential changes in protein binding during pregnancy, the monitoring of phenytoin serum levels should be based on the unbound fraction.
PHENYTEK® CAPSULES (extended phenytoin sodium capsules, USP) are available containing 200 mg or 300 mg of phenytoin sodium, USP.
PHENYTEK® capsules are contraindicated in patients with:
Abrupt withdrawal of phenytoin in epileptic patients may precipitate status epilepticus. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative anticonvulsant medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an anticonvulsant drug not belonging to the hydantoin chemical class.
Antiepileptic drugs (AEDs), including PHENYTEK® capsules, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment 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 one 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, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
Indication | Placebo Patients with Events Per 1000 Patients | Drug Patients with Events Per 1000 Patients | Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients | Risk Difference: Additional Drug Patients with Events Per 1000 Patients |
Epilepsy | 1.0 | 3.4 | 3.5 | 2.4 |
Psychiatric | 5.7 | 8.5 | 1.5 | 2.9 |
Other | 1.0 | 1.8 | 1.9 | 0.9 |
Total | 2.4 | 4.3 | 1.8 | 1.9 |
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing PHENYTEK® capsules or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any 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 concern should be reported immediately to healthcare providers.
PHENYTEK® capsules can cause severe cutaneous adverse reactions (SCARs), which may be fatal. Reported reactions in phenytoin-treated patients have included toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4)]. The onset of symptoms is usually within 28 days, but can occur later. PHENYTEK® capsules should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a severe cutaneous adverse reaction, use of this drug should not be resumed and alternative therapy should be considered. If a rash occurs, the patient should be evaluated for signs and symptoms of SCARs.
Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA B gene, in patients using carbamazepine. Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Asian ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin. In addition, retrospective, case-control, genome-wide association studies in patients of southeast Asian ancestry have also identified an increased risk of SCARs in carriers of the decreased function CYP2C9*3 variant, which has also been associated with decreased clearance of phenytoin. Consider avoiding PHENYTEK® capsules as an alternative to carbamazepine in patients who are positive for HLA-B*1502 or in CYP2C9*3 carriers [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.5)].
The use of HLA-B*1502 or CYP2C9 genotyping has important limitations and must never substitute for appropriate clinical vigilance and patient management. The role of other possible factors in the development of, and morbidity from, SJS/TEN, such as antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring have not been studied.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including phenytoin. Some of these events have 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 as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. PHENYTEK® capsules should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
PHENYTEK® capsules and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.7)]. Additionally, consider alternatives to structurally similar drugs such as carboxamides (e.g., carbamazepine), barbiturates, succinimides, and oxazolidinediones (e.g., trimethadione) in these same patients. Similarly, if there is a history of hypersensitivity reactions to these structurally similar drugs in the patient or immediate family members, consider alternatives to PHENYTEK® capsules.
Cases of bradycardia and cardiac arrest have been reported in PHENYTEK® capsules-treated patients, both at recommended phenytoin doses and levels, and in association with phenytoin toxicity [see Overdosage (10)]. Most of the reports of cardiac arrest occurred in patients with underlying cardiac disease.
Angioedema has been reported in patients treated with PHENYTEK® capsules in the postmarketing setting. PHENYTEK® capsules should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. PHENYTEK® capsules should be discontinued permanently if a clear alternative etiology for the reaction cannot be established.
Cases of acute hepatotoxicity, including infrequent cases of acute hepatic failure, have been reported with PHENYTEK® capsules. These events may be part of the spectrum of DRESS or may occur in isolation [see Warnings and Precautions (5.4)]. 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, PHENYTEK® capsules should be immediately discontinued and not readministered.
Hematopoietic complications, some fatal, have occasionally been reported in association with administration of PHENYTEK® capsules. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression.
There have been a number of reports suggesting a relationship between phenytoin and the development of lymphadenopathy (local or generalized) including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin’s disease. Although a cause and effect 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 involvement may occur with or without symptoms and signs of DRESS [see Warnings and Precautions (5.4)].
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.
The chronic use 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 decrease vitamin D levels, which may lead to vitamin D deficiency, hypocalcemia, and hypophosphatemia. Consideration should be given to screening with bone-related laboratory and radiological tests as appropriate and initiating treatment plans according to established guidelines.
Because 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.
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.
PHENYTEK® capsules may cause fetal harm when administered to a pregnant woman. Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes [see Use in Specific Populations (8.1)].
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, have been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy. There 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 administration to the mother before delivery and to the neonate after birth.
Hyperglycemia, resulting from the drug’s inhibitory effects on insulin release, has been reported. Phenytoin may also raise the serum glucose level in diabetic patients.
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.
The following serious adverse reactions are described elsewhere in the labeling:
The following adverse reactions associated with the use of PHENYTEK® capsules were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as 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 (5.3, 5.4, 5.7)]. Anaphylaxis has also been reported.
There have also 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 association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. While macrocytosis and megaloblastic anemia have occurred, these conditions usually respond to folic acid therapy.
Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin’s disease have been reported [see Warnings and Precautions (5.9)]. Pure red cell aplasia has also been reported.
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 usually 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 (5.14)], alkaline phosphatase, and gamma glutamyl transpeptidase (GGT).
Nervous System: 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. Dizziness, vertigo, insomnia, transient nervousness, motor twitchings, paresthesias, and headaches have also been observed. There have also been rare reports of phenytoin-induced dyskinesias, including chorea, dystonia, tremor and asterixis, similar 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 (5.15)].
A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.
Skin and Appendages: Dermatological manifestations sometimes accompanied by fever have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common; other types of dermatitis are seen more 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 [see Warnings and Precautions (5.3)]. There have also been reports of hypertrichosis and urticaria.
Special Senses: Altered taste sensation including metallic taste.
Urogenital: Peyronie’s disease
Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19, and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance 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.
Table 2 includes commonly occurring drug interactions that affect phenytoin concentrations. However, this list is not intended to be inclusive or comprehensive. Individual prescribing information from relevant drugs should be consulted.
The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve optimal clinical outcome.
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, sulfamethoxazole-trimethoprim |
Other | Acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines, salicylates, ticlopidine, tolbutamide, trazodone, warfarin |
Drugs that may decrease 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 | 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 |
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 adjustment of the dose of these agents to achieve optimal clinical outcome.
Interacting Agent | Examples |
Drugs whose efficacy is impaired by phenytoin | |
Azoles | Fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole |
Antineoplastic agents | Irinotecan, paclitaxel, teniposide |
Delavirdine | Phenytoin can substantially reduce the concentrations of delavirdine. This can lead to loss of virologic response and possible resistance [see Contraindications (4)]. |
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 not phenytoin has the same effect on other non-depolarizing agents is unknown. Prevention or Management: Patients should be monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher. |
Warfarin | Increased and decreased PT/INR responses have 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 | |
Anticoagulants | Apixaban, dabigatran, edoxaban, rivaroxaban |
Antiepileptic drugs* | Carbamazepine, felbamate, lamotrigine, topiramate, oxcarbazepine, lacosamide |
Antilipidemic agents | Atorvastatin, fluvastatin, simvastatin |
Antiplatelets | Ticagrelor |
Antiviral agents | Efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir Fosamprenavir: phenytoin when given with fosamprenavir alone may decrease the concentration of amprenavir, the active metabolite. Phenytoin when given with the combination of fosamprenavir and ritonavir may increase the concentration of amprenavir |
Calcium channel blockers | Nifedipine, nimodipine, nisoldipine, verapamil |
Other | Albendazole (decreases active metabolite), chlorpropamide, clozapine, cyclosporine, digoxin, disopyramide, folic acid, methadone, mexiletine, praziquantel, quetiapine |
* The effect of phenytoin on phenobarbital, valproic acid and sodium valproate serum levels is unpredictable
Concomitant administration of phenytoin and valproate has been associated with an increased risk of valproate-associated hyperammonemia. Patients treated concomitantly with these two drugs should be monitored for signs and symptoms of hyperammonemia.
Literature reports suggest 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 be administered concomitantly with an enteral feeding preparation. More frequent serum phenytoin level monitoring may be necessary in these patients.
Care should be taken when using immunoanalytical methods to measure serum phenytoin concentrations.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as PHENYTEK® capsules, during pregnancy. Physicians are advised to recommend that pregnant patients taking PHENYTEK® capsules enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website www.aedpregnancyregistry.org
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 addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see Data]. There have 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 death, 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 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see Dosage and Administration (2.3, 2.7)]. However, postpartum restoration of the original dosage will probably be indicated [see Clinical Pharmacology (12.3)].
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 administration to the mother before delivery and to the neonate after birth.
Meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. An increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies.
Administration of phenytoin to pregnant 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 as 100, 75, and 12.5 mg/kg, respectively.
Phenytoin is secreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PHENYTEK® capsules and any potential adverse effects on the breastfed infant from PHENYTEK® capsules or from the underlying maternal condition.
Initially, 5 mg/kg/day 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 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see Dosage and Administration (2.2)].
Phenytoin clearance tends to decrease with increasing age [see Clinical Pharmacology (12.3)]. Lower or less frequent dosing may be required [see Dosage and Administration (2.6)].
The liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity.
Because 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.
Patients who are intermediate or poor metabolizers of CYP2C9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). Thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. If early signs of dose-related central nervous system (CNS) toxicity develop, serum concentrations should be checked immediately [see Clinical Pharmacology (12.5)].
The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred speech, blurred vision, nausea, and vomiting. The patient may become comatose and hypotensive. Bradycardia and cardiac arrest have been reported [see Warnings and Precautions (5.6)]. Death is caused by respiratory and circulatory depression.
There are marked variations among 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 as high a concentration as 50 mcg/mL has been reported without evidence 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 atrophy have been reported.
Treatment: Treatment is nonspecific since there is no known antidote.
The adequacy of the respiratory and circulatory systems should be 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 severe intoxication in pediatric patients.
In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin sodium salt, having the following structural formula:
Each 200 mg or 300 mg PHENYTEK® capsule (extended phenytoin sodium capsule, USP) for oral administration contains 200 mg or 300 mg phenytoin sodium, USP. Also contains colloidal silicon dioxide, FD&C Blue No. 1, gelatin, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and titanium dioxide.
In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to prompt phenytoin sodium capsules with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.
Meets USP Dissolution Test 3.
The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.
For PHENYTEK® capsules, peak serum levels occur 4 to 12 hours after administration. Steady-state therapeutic levels are achieved at least 7 to 10 days (5-7 half-lives) after initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should be obtained at least 5-7 half-lives after treatment initiation, dosage change, or addition or subtraction of another drug to the regimen so that equilibrium or steady-state will have been achieved.
Phenytoin is extensively bound to serum plasma proteins.
The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours.
Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19. Because 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 disproportionately increased, with resultant intoxication, from an increase in dosage of 10% or more.
In most patients maintained at a steady dosage, stable phenytoin serum levels are achieved. There may be wide interpatient variability in phenytoin serum levels with equivalent dosages. Patients with unusually low levels may be noncompliant or hypermetabolizers of phenytoin. Unusually high levels result 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 protein bound, free phenytoin levels may be altered in patients whose protein binding characteristics differ from normal.
Most of the drug is excreted in the bile as inactive metabolites which are then reabsorbed from the intestinal tract and excreted in the urine. Urinary excretion of phenytoin and its metabolites occurs partly with glomerular filtration but, more importantly, by tubular secretion.
Phenytoin clearance tends to decrease with increasing age (20% less in patients over 70 years of age 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 Administration (2.6)].
Gender and race have no significant impact on phenytoin pharmacokinetics.
Increased fraction of unbound phenytoin in patients with renal or hepatic disease, or in those with hypoalbuminemia has been reported.
It has been reported in the literature that the plasma clearance of phenytoin generally increased during pregnancy, reached a peak in the third trimester and returned to the level of pre-pregnancy after few weeks or months of delivery.
Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19.
Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes [see Drug Interactions (7.1, 7.2)].
CYP2C9 activity is decreased in individuals with genetic variants such as the CYP2C9*2 and CYP2C9*3 alleles. Carriers of variant alleles, resulting in intermediate (e.g., *1/*3, *2/*2) or poor metabolism (e.g., *2/*3, *3/*3) have decreased clearance of phenytoin. Other decreased or nonfunctional CYP2C9 alleles may also result in decreased clearance of phenytoin (e.g., *5, *6, *8, *11).
The prevalence of the CYP2C9 poor metabolizer phenotype is approximately 2-3% in the White population, 0.5-4% in the Asian population, and < 1% in the African American population. The CYP2C9 intermediate phenotype prevalence is approximately 35% in the White population, 24% in the African American population, and 15-36% in the Asian population [see Warnings and Precautions (5.3) and Use in Specific Populations (8.7)].
[see Warnings and Precautions (5.9)] 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/day) for 2 years. The incidences of hepatocellular tumors were increased in male and female 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 diet 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 but the lowest dose tested. No increases in tumor incidence were observed in rats.
Phenytoin was negative in the Ames test 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 exchange assay in CHO cells.
Phenytoin has not been adequately assessed for effects on male or female fertility.
PHENYTEK® CAPSULES (extended phenytoin sodium capsules, USP) are available containing 200 mg or 300 mg of phenytoin sodium, USP.
The 200 mg capsules have a dark blue opaque cap and a blue opaque body. The hard-shell gelatin capsules are filled with two white to off-white round tablets. The capsules are rectified radial printed with BERTEK over 670 in black ink on both the cap and the body. They are available as follows:
NDC 0378-2670-93
bottles of 30 capsules
NDC 0378-2670-01
bottles of 100 capsules
The 300 mg capsules have a blue opaque cap and a blue opaque body. The hard-shell gelatin capsules are filled with three white to off-white round tablets. The capsules are rectified radial printed with BERTEK over 750 in black ink on both the cap and the body. They are available as follows:
NDC 0378-3750-93
bottles of 30 capsules
NDC 0378-3750-01
bottles of 100 capsules
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
PHARMACIST: Dispense a Medication Guide with each prescription.
Advise patients to read the FDA-approved 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 physician of any clinical condition in which it is not possible to take the drug orally as prescribed, e.g., surgery, etc.
Advise patients not to use capsules which are discolored.
Withdrawal of Antiepileptic Drugs: Advise patients not to discontinue use of PHENYTEK® capsules without consulting with their healthcare provider. PHENYTEK® capsules should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions (5.1)].
Suicidal Ideation and Behavior: Counsel patients, their caregivers, and families that AEDs, including PHENYTEK® capsules, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.2)].
Serious Dermatologic Reactions: Advise patients of the early signs and symptoms of severe cutaneous adverse reactions and to report any occurrence immediately to a physician [see Warnings and Precautions (5.3)].
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 limited 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 any occurrence immediately to a physician. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended use [see Warnings and Precautions (5.3, 5.4, 5.5, 5.8, 5.9 )].
Cardiac Effects: Counsel patients that cases of bradycardia and cardiac arrest have been reported, both at recommended phenytoin doses and levels, and in association with phenytoin toxicity. Patients should report cardiac signs or symptoms to their healthcare provider [see Warnings and Precautions (5.6) and Overdosage (10)].
Angioedema: Advise patients to discontinue PHENYTEK® capsules and seek immediate medical care if they develop signs or symptoms of angioedema, such as facial, perioral, or upper airway swelling [see Warnings and Precautions (5.7)].
Effects of Alcohol Use and Other Drugs and Over-the-Counter Drug Interactions: Caution patients against the use of other drugs or alcoholic beverages without first seeking their physician’s advice [Drug Interactions (7.1, 7.2)].
Inform patients that certain over-the-counter medications (e.g., antacids, cimetidine, and omeprazole), vitamins (e.g., folic acid), and herbal supplements (e.g., St. John’s wort) can alter their phenytoin levels.
Hyperglycemia: Advise patients that PHENYTEK® capsules may cause an increase in blood glucose levels [see Warnings and Precautions (5.14)].
Gingival Hyperplasia: Advise patients of the importance of good dental hygiene in order to minimize the development of gingival hyperplasia and its complications.
Neurologic Effects: Counsel patients that PHENYTEK® capsules may cause dizziness, gait disturbance, decreased coordination and somnolence. Advise patients taking PHENYTEK® capsules not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with PHENYTEK® capsules.
Use in Pregnancy: Inform pregnant women and women of childbearing potential that use of PHENYTEK® capsules during pregnancy can cause fetal harm, including an increased risk for cleft 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 about alternative therapeutic options. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using PHENYTEK® capsules, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy [see Drug Interactions (7.2)].
Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breastfeeding or intend to breastfeed during therapy [see Use in Specific Populations (8.1, 8.2)].
Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1)].
PHENYTEK® CAPSULES | |
What is the most important information I should know about PHENYTEK® CAPSULES? 1. Do not stop taking PHENYTEK® CAPSULES without first talking to your healthcare provider.
2. Like other antiepileptic drugs, PHENYTEK® CAPSULES 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: | |
|
|
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.
How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
3. PHENYTEK® CAPSULES 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. Call your healthcare provider right away if you have any or all of these symptoms: | |
|
|
Call your healthcare provider even if the symptoms are mild or if you have been taking PHENYTEK® CAPSULES for an extended period of time. These symptoms can be a sign of a serious allergic reaction. 4. PHENYTEK® CAPSULES can cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have any of these symptoms:
| |
What are PHENYTEK® CAPSULES? PHENYTEK® CAPSULES are a prescription medicine used to treat certain types of seizures called tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. | |
Do not take PHENYTEK® CAPSULES if you:
| |
Before taking PHENYTEK® CAPSULES, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These medicines can change the levels of phenytoin sodium in your blood.
Taking PHENYTEK® CAPSULES 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 PHENYTEK® CAPSULES?
| |
What should I avoid while taking PHENYTEK® CAPSULES?
| |
What are the possible side effects of PHENYTEK® CAPSULES? See “What is the most important information I should know about PHENYTEK® CAPSULES?” PHENYTEK® CAPSULES may cause other serious side effects including:
Call your healthcare provider right away, if you have any of the symptoms listed above. The most common side effects of PHENYTEK® CAPSULES include: | |
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|
PHENYTEK® CAPSULES can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking PHENYTEK® CAPSULES can help prevent this from happening.
These are not all of the possible side effects of PHENYTEK® CAPSULES.
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 PHENYTEK® CAPSULES?
Keep PHENYTEK® CAPSULES and all medicines out of the reach of children. | |
General information about the safe and effective use of PHENYTEK® CAPSULES.
| |
What are the ingredients in PHENYTEK® CAPSULES?
PHENYTEK® CAPSULES 200 mg and 300 mg: Active ingredient: phenytoin sodium Inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, gelatin, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and titanium dioxide.
In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
For more information about PHENYTEK® CAPSULES, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). | |
This Medication Guide has been approved by the U.S. Food and Drug Administration
The brands listed are trademarks of their respective owners.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India
75098963
Revised: 10/2024
MX:PHTK:R5m/MX:MG:PHTK:R5m
NDC 0378-2670-93
PHENYTEK®
(extended phenytoin
sodium capsules, USP)
200 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only 30 Capsules
Each capsule contains:
Phenytoin sodium, USP 200 mg
DOSAGE AND USAGE: See accompanying
prescribing information.
NOTE TO PHARMACISTS – Do not dispense
capsules which are discolored.
Keep this and all medication out of the
reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light and moisture.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMX2670H1
Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89
NDC 0378-3750-93
PHENYTEK®
(extended phenytoin
sodium capsules, USP)
300 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only 30 Capsules
Each capsule contains:
Phenytoin sodium, USP 300 mg
DOSAGE AND USE: See accompanying
prescribing information.
NOTE TO PHARMACISTS – Do not dispense
capsules which are discolored.
Keep this and all medication out of the
reach of children.
Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from light and moisture.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMX3750H1
Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 855863 | Phenytek 200 MG Extended Release Oral Capsule | PSN | 21 |
| 855875 | Phenytek 300 MG Extended Release Oral Capsule | PSN | 21 |
| 855861 | phenytoin sodium 200 MG Extended Release Oral Capsule | PSN | 21 |
| 855873 | phenytoin sodium 300 MG Extended Release Oral Capsule | PSN | 21 |
| 855863 | phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek] | SBD | 21 |
| 855875 | phenytoin sodium 300 MG Extended Release Oral Capsule [Phenytek] | SBD | 21 |
| 855861 | phenytoin sodium 200 MG Extended Release Oral Capsule | SCD | 21 |
| 855873 | phenytoin sodium 300 MG Extended Release Oral Capsule | SCD | 21 |
| 855861 | DPH sodium 200 MG Extended Release Oral Capsule | SY | 21 |
| 855863 | DPH sodium 200 MG Extended Release Oral Capsule [Phenytek] | SY | 21 |
| 855873 | DPH sodium 300 MG Extended Release Oral Capsule | SY | 21 |
| 855875 | DPH sodium 300 MG Extended Release Oral Capsule [Phenytek] | SY | 21 |
| 855863 | Phenytek 200 MG Extended Release Oral Capsule | SY | 21 |
| 855875 | Phenytek 300 MG Extended Release Oral Capsule | SY | 21 |
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYTOIN Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20181113 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be8c0c29-be12-4cae-8e3b-1c71ed6b952c | Product name | 2 | 20250626 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| e3d31abf-5149-4e77-89a8-0dc73ec106f9 | Product name | 1 | 20210525 |
| b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb | Product name | 2 | 20200303 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 031bbc61-0564-1f35-2716-aa5c1d139248 | Product name | 2 | 20141218 |
| cc830ceb-037c-a5c3-ee14-3d82c0e89e70 | Product name | 1 | 20140508 |
| eafc3fd3-6834-3129-5bbb-8a9a495691ab | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-2670-01 | Phenytek | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 21 | |
| 0378-2670-93 | Phenytek | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 21 | |
| 0378-3750-01 | Phenytek | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 21 | |
| 0378-3750-93 | Phenytek | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 21 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0378-2670 | PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241113_0f94c791-8b07-4b41-927e-c9f28bec5f60.zip |
| 0378-3750 | PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20241113_0f94c791-8b07-4b41-927e-c9f28bec5f60.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-2670-01 | EA - Each | 0378-2670 | ff485407-1d5c-4df7-8de5-8a4480d1c3c5 | 1 | 2012-07-24 |
| 0378-2670-93 | EA - Each | 0378-2670 | 614c3857-18c6-4c3b-bfee-f88f26e660c3 | 1 | 2012-07-24 |
| 0378-3750-01 | EA - Each | 0378-3750 | d4822c25-d0f2-4146-82fc-7819a2735bfb | 1 | 2012-07-24 |
| 0378-3750-93 | EA - Each | 0378-3750 | 91c265a7-9190-4ef0-bc4e-0b2a300a516f | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENYTOIN SODIUM | ACTIVE INGREDIENT | 4182431BJH | 7 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 7 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | 7 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 7 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0378-2670 | 0378-2670-93, 0378-2670-01 |
| 0378-3750 | 0378-3750-93, 0378-3750-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | TABLET, EXTENDED RELEASE / ORAL | 350 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / ORAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / ORAL | 3 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SOLUTION / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE, EXTENDED RELEASE / ORAL | 75 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, EXTENDED RELEASE / ORAL | 75.01 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SUSPENSION / ORAL | 100 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, EXTENDED RELEASE / ORAL | 75.01 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SYRUP / ORAL | 2 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SUSPENSION / ORAL | 100 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SYRUP / ORAL | 2 mg/5ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, EXTENDED RELEASE / ORAL | 166 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | TABLET, CHEWABLE / ORAL | 5.9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, EXTENDED RELEASE / ORAL | 166 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | TABLET, EXTENDED RELEASE / ORAL | 350 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE, EXTENDED RELEASE / ORAL | 75 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | S38J6RZN16 | SYRUP / ORAL | 2 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, EXTENDED RELEASE / ORAL | 75.01 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, EXTENDED RELEASE / ORAL | 166 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE, EXTENDED RELEASE / ORAL | 75 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040298-001 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | ||
| A040298-002 | PHENYTEK | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | ||
| A040298-003 | PHENYTEK | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | 2001-12-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | RS | 2001-12-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040298-002 | PHENYTEK | 200MG EXTENDED | CAPSULE / ORAL | AB | 2001-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-003 | PHENYTEK | 300MG EXTENDED | CAPSULE / ORAL | AB | RS | 2001-12-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-001 | EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE / ORAL | 1998-12-28 | 79d66fd596c7… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040298-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040298-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040298-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040298-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040298-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040298-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040298-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040298-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040298-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040298-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040298-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040298-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040298-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040298-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040298-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040298-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040298-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040298-002 | AB | 1 | 8869cabd3fbd… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phenytek | EXTENDED PHENYTOIN SODIUM | Mylan Pharmaceuticals Inc. | 0f94c791-8b07-4b41-927e-c9f28bec5f60 | 2024-10-15 | Warnings, Adverse reactions | 0378-2670-01 0378-2670-93 0378-3750-01 0378-3750-93 0378-2670 0378-3750 00378375093 00378375001 00378267001 00378267093 a532ea94-0186-4554-969c-66ff80f95c94 0f94c791-8b07-4b41-927e-c9f28bec5f60 |
Adverse event summaries are temporarily unavailable. Other product information remains available.