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DILANTIN
Overview
What is DILANTIN?
Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula:
Each Dilantin— Extended Phenytoin Sodium Capsule, USP—contains 30 mg phenytoin sodium, USP. Also contains lactose monohydrate,, NF; confectioner’s sugar, NF; talc, USP; and magnesium stearate, NF. The capsule shell cap and body components contain Titanium Dioxide (cap and body); gelatin (cap and body); D and C yellow No. 10 (cap); FD and C red No. 3 (cap).Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP witha rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.
What does DILANTIN look like?
What are the available doses of DILANTIN?
Sorry No records found.
What should I talk to my health care provider before I take DILANTIN?
Sorry No records found
How should I use DILANTIN?
Dilantin is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).
Serum concentrations should be monitored in changing from Extended Phenytoin Sodium Capsules, USP (Dilantin) to Prompt Phenytoin Sodium Capsules, USP, and from the sodium salt to the free acid form.
Dilantin® capsules are formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in Dilantin-125 Suspension and Dilantin Infatabs. 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.
General:
Adult Dosage:
Divided daily dosage:
Once-a-day dosage:
Only extended phenytoin sodium 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.
Loading dose:
Initially, one gram of phenytoin 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.
Pediatric Dosage:
What interacts with DILANTIN?
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
What are the warnings of DILANTIN?
Reports in the published literature have raised a question regarding the possible association between the use of methylxanthines and development of necrotizing enterocolitis, although a causal relationship between methylxanthine use and necrotizing enterocolitis has not been established. Therefore, as with all preterm infants, patients being treated with caffeine citrate should be carefully monitored for the development of necrotizing enterocolitis.
Effects of Abrupt Withdrawal
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 antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belongingto the hydantoin chemical class.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Dilantin, 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 anincrease 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 (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
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 Dilantin 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.
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 resembling serum sickness, e.g., fever,
rash, and liver involvement.
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.
Acute alcoholic intake may increase phenytoin serum levels, while
chronic alcohol use may decrease serum levels.
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.
What are the precautions of DILANTIN?
General
:
A small percentage of individuals who have been treated with phenytoin have been shown to metabolize the drug slowly. Slow metabolism may be due to limited enzyme availability and lack of induction; it appears to be genetically determined.
Phenytoin should be discontinued if a skin rash appears (see WARNINGS section regarding drug discontinuation). If the rash is exfoliative, purpuric, or bullous or if lupus erythematosus, Stevens-Johnson syndrome, or toxic epidermal necrolysis is suspected, use of this drug should not be resumed and alternative therapy should be considered. (See ADVERSE REACTIONS section.) If the rash is of a milder type (measles-like or scarlatiniform), therapy may beresumed after the rash has completely disappeared. If the rash recurs upon reinstitution of therapy, further phenytoin medication is contraindicated.
Published literature has suggested that there may be an increased, although still rare, risk of hypersensitivity reactions, including skin rash, SJS, TEN, hepatotoxicity, and Anticonvulsant Hypersensitivity Syndrome in black patients. (See WARNINGS section).
Phenytoin and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity (see CONTRAINDICATIONS). Additionally, caution should be exercised if using structurally similar compounds (e.g.,barbiturates, succinimides, oxazolidinediones, and other related compounds) in these same patients. 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.
Osteomalacia has been associated with phenytoin therapy and is considered to be due to phenytoin’s interference with vitamin D metabolism.
Phenytoin is not indicated for seizures due to hypoglycemic or other metabolic causes. Appropriate diagnostic procedures should be performed as indicated.
Phenytoin is not effective for absence (petit mal) seizures. If tonic-clonic (grand mal) and absence (petit mal) seizures are present, combined drug therapy is needed.
Serum levels of phenytoin sustained above the optimal range may produce confusional states referred to as “delirium,” “psychosis,” or “encephalopathy,” or rarely irreversible cerebellar dysfunction. Accordingly, at the first sign of acute toxicity, plasma levels are recommended. Dose reduction of phenytoin therapy is indicated if plasma levels are excessive; if symptoms persist, termination is recommended. (See WARNINGS section.)
Information for Patients:
Patients should also be cautioned on the use of other drugs or alcoholic beverages without first seeking the physician’s advice.
Patients should be instructed to call their physician if skin rash develops.
The
importance of good dental hygiene should be stressed in order to
minimize the development of gingival hyperplasia and its complications.
Patients,
their caregivers, and families should be counseled that AEDs, including
Dilantin, may increase the risk of suicidal thoughts and behavior and
should be advised 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.
Patients should be encouraged 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. To enroll, patients can
call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy
section).
What are the side effects of DILANTIN?
Sorry No records found
What should I look out for while using DILANTIN?
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.
Effects of Abrupt Withdrawal
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 antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belongingto the hydantoin chemical class.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Dilantin, 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 anincrease 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 (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
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 Dilantin 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.
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 resembling serum sickness, e.g., fever,
rash, and liver involvement.
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.
Acute alcoholic intake may increase phenytoin serum levels, while
chronic alcohol use may decrease serum levels.
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.
What might happen if I take too much DILANTIN?
Sorry No Records found
How should I store and handle DILANTIN?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551 A size 4 hemispherical Coni Snap capsule 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.NDC: 0179-0034-70 30 Capsules in 1 Box, UNIT-DOSEStore at20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx onlyREPACKAGED BY:KAISER FOUNDATION HOSPITALSLIVERMORE, CA 94551
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Phenytoin is an antiepileptic drug which can be used in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacentcortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonicclonic (grand mal) seizures.
The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours. 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. 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. For Dilantin capsules, peak serum levels occur 4 to 12 hours after administration.
Optimum control without clinical signs of toxicity occurs more often with serum levels between 10 and 20 mcg/mL, although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin.
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 benoncompliant or hypermetabolizers of phenytoin. Unusually high levels result from liver disease, congenital enzyme deficiency, or drug interactions which result in metabolic interference. The patient with large variations in phenytoin plasma 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. Because phenytoin is hydroxylated in the liver by an enzyme system which is saturable at high plasma levels, small incremental doses may increase the half-life and produce very substantialincreases 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.
Non-Clinical Toxicology
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.Effects of Abrupt Withdrawal
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 antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belongingto the hydantoin chemical class.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Dilantin, 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 anincrease 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 (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
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 Dilantin 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.
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 resembling serum sickness, e.g., fever, rash, and liver involvement.
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.
Acute alcoholic intake may increase phenytoin serum levels, while chronic alcohol use may decrease serum levels.
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.
Drug Interactions:
General
:
A small percentage of individuals who have been treated with phenytoin have been shown to metabolize the drug slowly. Slow metabolism may be due to limited enzyme availability and lack of induction; it appears to be genetically determined.
Phenytoin should be discontinued if a skin rash appears (see WARNINGS section regarding drug discontinuation). If the rash is exfoliative, purpuric, or bullous or if lupus erythematosus, Stevens-Johnson syndrome, or toxic epidermal necrolysis is suspected, use of this drug should not be resumed and alternative therapy should be considered. (See ADVERSE REACTIONS section.) If the rash is of a milder type (measles-like or scarlatiniform), therapy may beresumed after the rash has completely disappeared. If the rash recurs upon reinstitution of therapy, further phenytoin medication is contraindicated.
Published literature has suggested that there may be an increased, although still rare, risk of hypersensitivity reactions, including skin rash, SJS, TEN, hepatotoxicity, and Anticonvulsant Hypersensitivity Syndrome in black patients. (See WARNINGS section).
Phenytoin and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity (see CONTRAINDICATIONS). Additionally, caution should be exercised if using structurally similar compounds (e.g.,barbiturates, succinimides, oxazolidinediones, and other related compounds) in these same patients. 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.
Osteomalacia has been associated with phenytoin therapy and is considered to be due to phenytoin’s interference with vitamin D metabolism.
Phenytoin is not indicated for seizures due to hypoglycemic or other metabolic causes. Appropriate diagnostic procedures should be performed as indicated.
Phenytoin is not effective for absence (petit mal) seizures. If tonic-clonic (grand mal) and absence (petit mal) seizures are present, combined drug therapy is needed.
Serum levels of phenytoin sustained above the optimal range may produce confusional states referred to as “delirium,” “psychosis,” or “encephalopathy,” or rarely irreversible cerebellar dysfunction. Accordingly, at the first sign of acute toxicity, plasma levels are recommended. Dose reduction of phenytoin therapy is indicated if plasma levels are excessive; if symptoms persist, termination is recommended. (See WARNINGS section.)
Information for Patients:
Patients should also be cautioned on the use of other drugs or alcoholic beverages without first seeking the physician’s advice.
Patients should be instructed to call their physician if skin rash develops.
The importance of good dental hygiene should be stressed in order to minimize the development of gingival hyperplasia and its complications.
Patients, their caregivers, and families should be counseled that AEDs, including Dilantin, may increase the risk of suicidal thoughts and behavior and should be advised 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.
Patients should be encouraged 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. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section).
Central Nervous System:
Gastrointestinal System:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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