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治療オプション:
Kovalenko Svetlana Olegovna 、薬局による医学的評価、 最終更新日:07.04.2022
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同じ成分を持つトップ20の薬:
⁇ ксиле ⁇ は、不在(プチマル)てんかんの制御に使用されます。.
ザロンチンは、不在(プチマル)てんかんの制御に適応されます。.
⁇ ксиле ⁇ は経口投与されます。. 。 初期。 3〜6歳の患者の用量は、1日あたり1カプセル(250 mg)です。 6歳以上の患者の場合、1日あたり2カプセル(500 mg)。. その後の用量は、患者の反応に応じて個別化する必要があります。. 投与量は少しずつ増やす必要があります。. 1つの有用な方法は、最小限の副作用で制御が達成されるまで、4〜7日ごとに1日量を250 mg増やすことです。. 分割投与で毎日1.5 gを超える投与量は、医師の最も厳しい監督の下でのみ投与する必要があります。. 。 最適。 ほとんどの小児患者の用量は20 mg / kg /日です。. この用量は、40〜100 mcg / mLの許容される治療範囲内の平均血漿レベルを示しています。その後の用量スケジュールは、有効性と血漿レベルの測定に基づくことができます。.
⁇ ксиле ⁇ は、他の形態のてんかんが欠如と共存する場合、他の抗けいれん薬と組み合わせて投与することができます(プチマル)。. 。 最適。 ほとんどの小児患者の用量は20 mg / kg /日です。.
ザロンチンは経口投与されます。. 。 初期。 3〜6歳の患者の用量は、1日あたり1カプセル(250 mg)です。 6歳以上の患者の場合、1日あたり2カプセル(500 mg)。. その後の用量は、患者の反応に応じて個別化する必要があります。. 投与量は少しずつ増やす必要があります。. 1つの有用な方法は、最小限の副作用で制御が達成されるまで、4〜7日ごとに1日量を250 mg増やすことです。. 分割投与で毎日1.5 gを超える投与量は、医師の最も厳しい監督の下でのみ投与する必要があります。. 。 最適。 ほとんどの小児患者の用量は20 mg / kg /日です。. この用量は、40〜100 mcg / mLの許容される治療範囲内の平均血漿レベルを示しています。その後の用量スケジュールは、有効性と血漿レベルの測定に基づくことができます。.
ザロンチンは、他の形態のてんかんが欠勤と共存する場合、他の抗けいれん薬と組み合わせて投与することができます(プチマル)。. 。 最適。 ほとんどの小児患者の用量は20 mg / kg /日です。.
エトスクシミドは、コハク酸イミドに対する過敏症の病歴のある患者には使用しないでください。.
WARNINGS
Blood dyscrasias
Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point.
Effects on Liver and Kidneys
Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.
Systemic Lupus Erythematosus
Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Суксилеп, 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 (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
Table 1 Risk by indication for antiepileptic drugs in the pooled analysis
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 Суксилеп or any other AED must balance the risk of suicidal thoughts and 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.
Serious Dermatologic Reactions
Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have been reported with ethosuximide treatment. SJS can be fatal. The onset of symptoms is usually within 28 days, but can occur later. Суксилеп should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS, use of this drug should not be resumed and alternative therapy should be considered.
Usage in Pregnancy
Ethosuximide crosses the placenta.
Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
Cases of birth defects have been reported with ethosuximide. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodological problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.
Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when ethosuximide is administered to a nursing mother. Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.
PRECAUTIONS
General
Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.
As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.
Information for Patients
Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Суксилеп. Instruct patients to take Суксилеп only as prescribed.
Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen.
Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection.
Patients, their caregivers, and families should be counseled that AEDs, including Суксилеп, 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.
Prior to initiation of treatment with Суксилеп, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
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).
Pregnancy
To provide information regarding the effects of in utero exposure to Суксилеп, physicians are advised to recommend that pregnant patients taking Суксилеп enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancvregistry.org/
See WARNINGS.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)
WARNINGS
Blood dyscrasias
Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point.
Effects on Liver and Kidneys
Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.
Systemic Lupus Erythematosus
Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Zarontin, 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 (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
Table 1 Risk by indication for antiepileptic drugs in the pooled analysis
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 Zarontin or any other AED must balance the risk of suicidal thoughts and 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.
Serious Dermatologic Reactions
Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have been reported with ethosuximide treatment. SJS can be fatal. The onset of symptoms is usually within 28 days, but can occur later. Zarontin should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS, use of this drug should not be resumed and alternative therapy should be considered.
Usage in Pregnancy
Ethosuximide crosses the placenta.
Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
Cases of birth defects have been reported with ethosuximide. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodological problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.
Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when ethosuximide is administered to a nursing mother. Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.
PRECAUTIONS
General
Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.
As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.
Information for Patients
Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Zarontin. Instruct patients to take Zarontin only as prescribed.
Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen.
Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection.
Patients, their caregivers, and families should be counseled that AEDs, including Zarontin, 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.
Prior to initiation of treatment with Zarontin, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
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).
Pregnancy
To provide information regarding the effects of in utero exposure to Zarontin, physicians are advised to recommend that pregnant patients taking Zarontin enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancvregistry.org/
See WARNINGS.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)
全体としての体:。 アレルギー反応。. 好酸球増加症および全身症状(DRESS)との薬物反応。.
消化器系:。 胃腸症状は頻繁に発生し、食欲不振、漠然とした胃の不調、吐き気と ⁇ 吐、けいれん、心 ⁇ 部および腹痛、体重減少、下 ⁇ が含まれます。. 歯肉肥大と舌の腫れの報告があります。.
造血システム:。 エトスクシミドの投与に関連する造血合併症には、白血球減少症、無 ⁇ 粒球症、汎血球減少症、骨髄抑制の有無にかかわらず、好酸球増加症が含まれています。.
神経系:。 エトスクシミドによる治療中に報告された神経反応および感覚反応には、眠気、頭痛、めまい、陶酔感、しゃっくり、過敏症、多動、 ⁇ 眠、疲労、および運動失調が含まれています。. エトスクシミド投与に関連する精神的または心理的異常には、睡眠障害、夜間恐怖、集中力低下、攻撃性が含まれています。. これらの影響は、特に以前に心理的異常を示した患者で特に注目されることがあります。. 妄想性精神病、性欲の増加、明白な自殺意図を伴ううつ病の状態の増加のまれな報告があります。.
整数システム:。 エトスクシミドの投与で発生した皮膚症状には、じんま疹、 ⁇ 性紅斑性発疹、多毛症が含まれます。.
特別感覚:。 近視。.
Genitourinary System:。 ⁇ 出血、微視的血尿。.
急性過剰摂取は、吐き気、 ⁇ 吐、呼吸抑制を伴う ⁇ 睡を含むCNSうつ病を引き起こす可能性があります。. エトスクシミド毒性とその血漿中濃度との関係は確立されていません。.
血清レベルの治療範囲は40 mcg / mL〜100 mcg / mLですが、毒性の兆候なしに150 mcg / mLもの高いレベルが報告されています。.
治療。
治療には、 ⁇ 吐(患者が鈍化、 ⁇ 睡、またはけいれんを起こす可能性がある場合を除く)または胃洗浄、活性炭、下剤、および一般的な支持策を含める必要があります。. 血液透析は、エトスクシミドの過剰摂取の治療に役立つ場合があります。. 強制利尿と交換輸血は効果がありません。.