Tison

経口療法が実行不可能であり、薬物の強度、剤形および投与経路が状態の治療に準備を合理的に貸す場合、A-メタプレド(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末は、静脈内または筋肉内使用に適応されます以下の条件:。

1. 内分 ⁇ 障害。
   • 一次または二次副腎皮質機能不全(ヒドロコルチゾンまたはコルチゾンは最適な薬剤です。合成類似体は、該当する場合はミネラルコルチコイドと組み合わせて使用 できます。乳児期には、ミネラルコルチコイドの補給が特に重要です)。
   • 急性副腎皮質不全(ヒドロコルチゾンまたはコルチゾンは最適な薬剤です。特に合成類似体を使用する場合は、ミネラルコルチコイドの補給が必要になる場合があります)。
   • 術前および深刻な外傷または病気の場合、副腎不全が知られている患者、または副腎皮質予備が疑わしい場合。
   • 副腎皮質機能不全が存在するか、疑われる場合、従来の治療法に反応しないショック。
   • 先天性副腎過形成。
   • がんに伴う高カルシウム血症。
   • 非補給甲状腺炎。
2. リウマチ性障害。
   短期投与の補助療法として(急性エピソードまたは悪化で患者を潮 ⁇ するため):
   • 外傷後変形性関節症。
   • 変形性関節症の滑膜炎。
   • 若年性関節リウマチを含む関節リウマチ(選択された症例では、低用量の維持療法が必要になる場合があります)。
   • 急性および亜急性滑液包炎。
   • 精巣炎。
   • 急性非特異的テノシノビティス。
   • 急性痛風性関節炎。
   • 乾 ⁇ 性関節炎。
   • 強直性脊椎炎。
3. コラーゲン病。
   以下の選択されたケースでは、悪化中または維持療法として。
   • 全身性エリテマトーデス。
   • 全身性皮膚筋炎(多発性筋炎)。
   • 急性リウマチ性心炎。
4. 皮膚疾患。
   • 天 ⁇ 。
   • 重症紅斑多形(スティーブンスジョンソン症候群)。
   • 剥離性皮膚炎。
   • 残忍な皮膚炎ヘルペチフォルミス。
   • 重度の脂漏性皮膚炎。
   • 重度の乾 ⁇ 。
   • Mycosis fungoides。
5. アレルギー状態。
   以下における従来の治療の適切な試験に難治性の重度または無力なアレルギー状態の管理:
   • 気管支 ⁇ 息。
   • 接触性皮膚炎。
   • アトピー性皮膚炎。
   • 血清病。
   • 季節性または多年生のアレルギー性鼻炎。
   • 薬物過敏反応。
   • じんましん輸血反応。
   • 急性非感染性喉頭浮腫(エピネフリンが第一選択の薬です)。
6. 眼疾患。
   以下のような、目が関与する重度の急性および慢性アレルギーおよび炎症プロセス。
   • 帯状 ⁇ 疹眼 ⁇ 。
   • 尿道炎、 ⁇ 彩球炎。
   • ⁇ 毛虫炎。
   • 後部ブドウ膜炎と脈絡膜炎を拡散します。
   • 視神経炎。
   • 交感神経性眼球増加症。
   • 前部炎症。
   • アレルギー性結膜炎。
   • アレルギー性角膜限界 ⁇ 瘍。
   • 角膜炎。
7. 胃腸疾患。
   疾患の重要な期間にわたって患者を潮 ⁇ するには:
   • ⁇ 瘍性大腸炎(全身療法)。
   • 局所腸炎(全身療法)。
8. 呼吸器疾患。
   • 症候性サルコイドーシス。
   • ベリリオシス。
   • 適切な抗結核化学療法と同時に使用した場合、肺結核の ⁇ 養または ⁇ 種。
   • ロフラー症候群は他の手段では管理できません。
   • 誤 ⁇ 性肺炎。
9. 血液疾患。
   • 後天性(自己免疫性)溶血性貧血。
   • 成人の特発性血小板減少性紫斑病(IVのみ; IM投与は禁 ⁇ です)。
   • 成人の二次血小板減少症。
   • 尿道芽球減少症(RBC貧血)。
   • 先天性(赤血球)低形成性貧血。
10. 腫瘍性疾患。
    緩和管理の場合:。
    • 成人の白血病とリンパ腫。
    • 子供の頃の急性白血病。
11. 浮腫状態。
• 尿毒症のない、特発性型またはエリテマトーデス菌による腎症症候群におけるタンパク尿の利尿または寛解を誘発するため。
12. 神経系。
• 多発性硬化症の急性増悪。
13. その他。
    • 適切な抗結核化学療法と同時に使用した場合、くも膜下ブロックまたは切迫ブロックを伴う結核性髄膜炎。
    • 神経学的または心筋病変を伴う ⁇ 毛虫症。

注射/注入用のタイソンパウダーと溶媒は、次のような急速で強烈なコルチコステロイド効果が必要な状態を治療するために使用されます。

1。. 皮膚疾患。

多形性紅斑(スティーブンスジョンソン症候群)。

2。. アレルギー状態。

気管支 ⁇ 息。

重度の季節性および通年性のアレルギー性鼻炎。

血管神経性浮腫。

アナフィラキシー。

3。. 胃腸疾患。

⁇ 瘍性大腸炎。

クローン病。

4。. 呼吸器疾患。

胃内容物の吸引。

結核の完全化または ⁇ 種(適切な抗結核化学療法あり)。

5。. 神経障害。

脳腫瘍に続発する脳浮腫。

再発/寛解の背景に重ねられた多発性硬化症の急性増悪。.

6。. その他。

T.B.髄膜炎(適切な抗結核化学療法あり)。

移植。

タイソン(メチルプレドニゾロン)錠剤は、次の条件で示されています。

1。.  内分 ⁇ 障害。

一次または二次副腎皮質機能不全(ヒドロコルチゾンまたはコルチゾンが最初の選択肢です。合成類似体は、該当する場合はミネラルコルチコイドと組み合わせて使用 できます。乳児期では、ミネラルコルチコイドの補給が特に重要です)。.
先天性副腎過形成。
非補給甲状腺炎。
がんに伴う高カルシウム血症。

2。. リウマチ性障害。

短期投与の補助療法として(急性エピソードまたは悪化で患者を潮 ⁇ するため):
若年性関節リウマチを含む関節リウマチ(選択された症例では、低用量の維持療法が必要になる場合があります)。
強直性脊椎炎。
急性および亜急性滑液包炎。
変形性関節症の滑膜炎。
急性非特異的テノシノビティス。
外傷後変形性関節症。
乾 ⁇ 性関節炎。
精巣炎。
急性痛風性関節炎。

3。. コラーゲン病。

以下の選択されたケースでは、悪化中または維持療法として。
全身性エリテマトーデス。
全身性皮膚筋炎(多発性筋炎)。
急性リウマチ性心炎。

4。. 皮膚疾患。

残忍な皮膚炎ヘルペチフォルミス。
多形性の重度の紅斑。
(スティーブンス・ジョンソン症候群)。
重度の脂漏性皮膚炎。
剥離性皮膚炎。
Mycosis fungoides。
天 ⁇ 。
重度の乾 ⁇ 。

5。. アレルギー状態。

従来の治療の適切な試験では難治性の重度または無力なアレルギー状態の管理:
季節性または多年生のアレルギー性鼻炎。
薬物過敏反応。
血清病。
接触性皮膚炎。
気管支 ⁇ 息。
アトピー性皮膚炎。

6。. 眼疾患。

眼とその付属器を含む重度の急性および慢性アレルギーおよび炎症プロセス:アレルギー性角膜限界 ⁇ 瘍。
帯状 ⁇ 疹眼 ⁇ 。
前部炎症。
後部ブドウ膜炎と脈絡膜炎を拡散します。
交感神経性眼球増加症。
角膜炎。
視神経炎。
アレルギー性結膜炎。
⁇ 毛虫炎。
尿道炎と ⁇ 彩炎。

7。. 呼吸器疾患。

症候性サルコイドーシス。
ベリリオシス。
ロフラー症候群は他の手段では管理できません。
適切な抗結核化学療法と同時に使用した場合、肺結核の ⁇ 養または ⁇ 種。
誤 ⁇ 性肺炎。

8。. 血液疾患。

成人の特発性血小板減少性紫斑病。
成人の二次血小板減少症。
後天性(自己免疫性)溶血性貧血。
尿道芽球減少症(RBC貧血)。
先天性(赤血球)低形成性貧血。

9。.  腫瘍性疾患。

緩和管理の場合:。
成人の白血病とリンパ腫。
子供の頃の急性白血病。

10。. 浮腫状態。

尿毒症のない、特発性型またはエリテマトーデス菌による腎症症候群におけるタンパク尿の利尿または寛解を誘発するため。.

11。. 胃腸疾患。

疾患の重要な期間にわたって患者を潮 ⁇ するには:
⁇ 瘍性大腸炎。
局所腸炎。

12。. 神経系。

多発性硬化症の急性増悪。

13。. その他。

適切な抗結核化学療法と同時に使用した場合、くも膜下ブロックまたは切迫ブロックを伴う結核性髄膜炎。.
神経学的または心筋病変を伴う ⁇ 毛虫症。.

経口療法が実行不可能であり、薬物の強度、剤形および投与経路が状態の治療に準備を合理的に貸す場合、以下の条件での静脈内または筋肉内使用には、チソン(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末が適応されます。 。

1. 内分 ⁇ 障害。
   • 一次または二次副腎皮質機能不全(ヒドロコルチゾンまたはコルチゾンは最適な薬剤です。合成類似体は、該当する場合はミネラルコルチコイドと組み合わせて使用 できます。乳児期には、ミネラルコルチコイドの補給が特に重要です)。
   • 急性副腎皮質不全(ヒドロコルチゾンまたはコルチゾンは最適な薬剤です。特に合成類似体を使用する場合は、ミネラルコルチコイドの補給が必要になる場合があります)。
   • 術前および深刻な外傷または病気の場合、副腎不全が知られている患者、または副腎皮質予備が疑わしい場合。
   • 副腎皮質機能不全が存在するか、疑われる場合、従来の治療法に反応しないショック。
   • 先天性副腎過形成。
   • がんに伴う高カルシウム血症。
   • 非補給甲状腺炎。
2. リウマチ性障害。
   短期投与の補助療法として(急性エピソードまたは悪化で患者を潮 ⁇ するため):
   • 外傷後変形性関節症。
   • 変形性関節症の滑膜炎。
   • 若年性関節リウマチを含む関節リウマチ(選択された症例では、低用量の維持療法が必要になる場合があります)。
   • 急性および亜急性滑液包炎。
   • 精巣炎。
   • 急性非特異的テノシノビティス。
   • 急性痛風性関節炎。
   • 乾 ⁇ 性関節炎。
   • 強直性脊椎炎。
3. コラーゲン病。
   以下の選択されたケースでは、悪化中または維持療法として。
   • 全身性エリテマトーデス。
   • 全身性皮膚筋炎(多発性筋炎)。
   • 急性リウマチ性心炎。
4. 皮膚疾患。
   • 天 ⁇ 。
   • 重症紅斑多形(スティーブンスジョンソン症候群)。
   • 剥離性皮膚炎。
   • 残忍な皮膚炎ヘルペチフォルミス。
   • 重度の脂漏性皮膚炎。
   • 重度の乾 ⁇ 。
   • Mycosis fungoides。
5. アレルギー状態。
   以下における従来の治療の適切な試験に難治性の重度または無力なアレルギー状態の管理:
   • 気管支 ⁇ 息。
   • 接触性皮膚炎。
   • アトピー性皮膚炎。
   • 血清病。
   • 季節性または多年生のアレルギー性鼻炎。
   • 薬物過敏反応。
   • じんましん輸血反応。
   • 急性非感染性喉頭浮腫(エピネフリンが第一選択の薬です)。
6. 眼疾患。
   以下のような、目が関与する重度の急性および慢性アレルギーおよび炎症プロセス。
   • 帯状 ⁇ 疹眼 ⁇ 。
   • 尿道炎、 ⁇ 彩球炎。
   • ⁇ 毛虫炎。
   • 後部ブドウ膜炎と脈絡膜炎を拡散します。
   • 視神経炎。
   • 交感神経性眼球増加症。
   • 前部炎症。
   • アレルギー性結膜炎。
   • アレルギー性角膜限界 ⁇ 瘍。
   • 角膜炎。
7. 胃腸疾患。
   疾患の重要な期間にわたって患者を潮 ⁇ するには:
   • ⁇ 瘍性大腸炎(全身療法)。
   • 局所腸炎(全身療法)。
8. 呼吸器疾患。
   • 症候性サルコイドーシス。
   • ベリリオシス。
   • 適切な抗結核化学療法と同時に使用した場合、肺結核の ⁇ 養または ⁇ 種。
   • ロフラー症候群は他の手段では管理できません。
   • 誤 ⁇ 性肺炎。
9. 血液疾患。
   • 後天性(自己免疫性)溶血性貧血。
   • 成人の特発性血小板減少性紫斑病(IVのみ; IM投与は禁 ⁇ です)。
   • 成人の二次血小板減少症。
   • 尿道芽球減少症(RBC貧血)。
   • 先天性(赤血球)低形成性貧血。
10. 腫瘍性疾患。
    緩和管理の場合:。
    • 成人の白血病とリンパ腫。
    • 子供の頃の急性白血病。
11. 浮腫状態。
• 尿毒症のない、特発性型またはエリテマトーデス菌による腎症症候群におけるタンパク尿の利尿または寛解を誘発するため。
12. 神経系。
• 多発性硬化症の急性増悪。
13. その他。
    • 適切な抗結核化学療法と同時に使用した場合、くも膜下ブロックまたは切迫ブロックを伴う結核性髄膜炎。
    • 神経学的または心筋病変を伴う ⁇ 毛虫症。

When high dose therapy is desired, the recommended dose of A-Methapred (methylprednisolone sodium succinate) sterile powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.

In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.

Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

In other indications initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.

Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg/kg every 24 hours.

Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

A-Methapred (methylprednisolone sodium succinate) may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes.

To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

Directions for Reconstitution

1. Remove protective cap.
2. Cleanse stopper with suitable germicide.
3. Aseptically add 1 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 40 mg vial or 2 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 125 mg vial.
4. Agitate to effect solution.
5. Invert vial. Insert needle through target area of stopper until tip is just visible. Withdraw dose.

Storage Conditions

Protect from light.

Store unreconstituted product at 20 to 25°C (68 to 77°F).

Store solution at 20 to 25°C (68 to 77°F).

Use solution within 48 hours after mixing.

Posology

Tison powder for injection/infusion may be administered intravenously or intramuscularly, the preferred method for emergency use being intravenous injection given over a suitable time interval. When administering Tison sodium succinate in high doses intravenously it should be given over a period of at least 30 minutes. Doses up to 250 mg should be given intravenously over a period of at least five minutes.

For intravenous infusion the initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution. To avoid compatibility problems with other drugs Tison powder for injection/infusion should be administered separately, only in the solutions mentioned. Undesirable effects may be minimised by using the lowest effective dose for the minimum period (see Other special warnings and precautions).

Parenteral drug products should wherever possible be visually inspected for particulate matter and discoloration prior to administration.

Adults: Dosage should be varied according to the severity of the condition, initial dosage will vary from 10 to 500 mg. In the treatment of graft rejection reactions following transplantation, a dose of up to 1 gram/day may be required. Although doses and protocols have varied in studies using Tison sodium succinate in the treatment of graft rejection reactions, the published literature supports the use of doses of this level, with 500 mg to 1 g most commonly used for acute rejection.

Treatment at these doses should be limited to a 48 - 72 hour period until the patient's condition has stabilised, as prolonged high dose corticosteroid therapy can cause serious corticosteroid induced side effects (see Undesirable effects and Special warnings and special precautions for use).

Children: In the treatment of high dose indications, such as haematological, rheumatic, renal and dermatological conditions, a dosage of 30 mg/kg/day to a maximum of 1 g/day is recommended.

This dosage may be repeated for three pulses either daily or on alternate days. In the treatment of graft rejection reactions following transplantation, a dosage of 10 to 20 mg/kg/day for up to 3 days, to a maximum of 1 g/day, is recommended. In the treatment of status asthmaticus, a dosage of 1 to 4 mg/kg/day for 1- 3 days is recommended.

Elderly patients: Tison sodium succinate powder for injection/infusion is primarily used in acute short term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use).

Detailed recommendations for adult dosage are as follows:

In anaphylactic reactions adrenaline or noradrenaline should be administered first for an immediate haemodynamic effect, followed by intravenous injection of Tison sodium succinate with other accepted procedures. There is evidence that corticosteroids through their prolonged haemodynamic effect are of value in preventing recurrent attacks of acute anaphylactic reactions.

In sensitivity reactions Tison sodium succinate is capable of providing relief within one half to two hours.

In patients with status asthmaticus Tison sodium succinate may be given at a dose of 40 mg intravenously, repeated as dictated by patient response. In some asthmatic patients it may be advantageous to administer by slow intravenous drip over a period of hours.

In graft rejection reactions following transplantation doses of up to 1 g per day have been used to suppress rejection crises, with doses of 500 mg to 1 g most commonly used for acute rejection. Treatment should be continued only until the patient's condition has stabilised; usually not beyond 48 - 72 hours.

In cerebral oedema corticosteroids are used to reduce or prevent the cerebral oedema associated with brain tumours (primary or metastatic).

In patients with oedema due to tumour, tapering the dose of corticosteroid appears to be important in order to avoid a rebound increase in intracranial pressure. If brain swelling does occur as the dose is reduced (intracranial bleeding having been ruled out), restart larger and more frequent doses parenterally. Patients with certain malignancies may need to remain on oral corticosteroid therapy for months or even life. Similar or higher doses may be helpful to control oedema during radiation therapy.

The following are suggested dosage schedules for oedemas due to brain tumour.

Aim to discontinue therapy after a total of 10 days.

In the treatment of acute exacerbations of multiple sclerosis in adults, the recommended dose is 1000 mg daily for 3 days. Tison powder for injection/infusion should be given as an intravenous infusion over at least 30 minutes.

In other indications, initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated. Larger doses may be required for short term management of severe, acute conditions. The initial dose, up to 250 mg, should be given intravenously over a period of at least 5 minutes, doses exceeding 250 mg should be given intravenously over a period of at least 30 minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy.

Method of administration

To be administered intravenously or intramuscularly.

The initial dosage of Tison Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Tison (methylprednisolone) should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Tison (methylprednisolone) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

ADT® (Alternate Day Therapy)

Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

1. Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.
2. ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.
   Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
4. Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone).
6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
7. In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted.
9. Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

When high dose therapy is desired, the recommended dose of Tison (methylprednisolone sodium succinate) sterile powder is 30 mg/kg administered intravenously over at least 30 minutes. This dose may be repeated every 4 to 6 hours for 48 hours.

In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized; usually not beyond 48 to 72 hours.

Although adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

In other indications initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given intravenously over a period of several minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.

Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg/kg every 24 hours.

Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

Directions for Reconstitution

1. Remove protective cap.
2. Cleanse stopper with suitable germicide.
3. Aseptically add 1 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 40 mg vial or 2 mL Bacteriostatic Water for Injection, USP (with benzyl alcohol) for the 125 mg vial.
4. Agitate to effect solution.
5. Invert vial. Insert needle through target area of stopper until tip is just visible. Withdraw dose.

Storage Conditions

Protect from light.

Store unreconstituted product at 20 to 25°C (68 to 77°F).

Store solution at 20 to 25°C (68 to 77°F).

Use solution within 48 hours after mixing.

A-メタプレッド(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末の使用は、再構成希釈剤にベンジルアルコールが含まれているため、未熟児には禁 ⁇ です。. ベンジルアルコールは、未熟児の致命的な「あえぎ症候群」に関連していると報告されています。. A-メタプレド(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末は、全身性真菌感染症や、製品とその成分に対する過敏症が知られている患者にも禁 ⁇ です。.

注射/注入用のタイソンパウダーは禁 ⁇ です:。

-特定の抗感染症療法が採用されていない限り全身性真菌感染症の患者、およびマラリアの脳浮腫。.

-Tisonまたは製剤の任意の成分に対する過敏症が知られている患者。.

-髄腔内投与経路で使用するため。.

生または生で弱毒化されたワクチンの投与は、コルチコステロイドの免疫抑制用量を受けている患者には禁 ⁇ です。.

全身性真菌感染症とコンポーネントに対する既知の過敏症。.

再構成希釈剤にはベンジルアルコールが含まれているため、未熟児にはチソン(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末の使用は禁 ⁇ です。. ベンジルアルコールは、未熟児の致命的な「あえぎ症候群」に関連していると報告されています。. タイソン(メチルプレドニゾロンナトリウムコハク酸)滅菌粉末は、全身性真菌感染症や、製品とその成分に対する過敏症が知られている患者にも禁 ⁇ です。.