【药品名称】

通用名称：醋酸曲安奈德注射液
英文名称：Triamcinolone Acetonide Acetate Injection

【成份】

本品主要成分为醋酸曲安奈德。

【 适应症 】

适用于各种皮肤病、过敏性鼻炎、关节痛、支气管哮喘、肩周炎、腱鞘炎、滑膜炎、急性扭伤、类风湿性关节炎等。 

【用法用量】

肌注：一周一次，一次20-100mg关节腔或皮下注射：一般一次2.5-5mg。

【不良反应】

糖皮质激素在应用生理剂量替代治疗时无明显不良反应，不良反应多发生在应用药理剂量时，而且与疗程，剂量、用药种类、用法及给药途径等有密切关系。常见不良反应有以下几类： 1长期使用可引起以下副作用：医源性库欣综合症面容和体态、体重增加、下肢浮肿、紫纹、易出血倾向、创口愈合不良、痤疮、月经紊乱、肱或股骨头缺血性坏死、骨质疏松及骨折(包括脊椎压缩性骨折、长骨病理性骨折)、肌无力、肌萎缩、低血钾综合症、胃肠道刺激(恶心、呕吐)、胰腺炎、消化性溃疡或穿孔，儿童生长受到抑制、青光眼、白内障、良性颅内压升高综合症、糖耐量减 

【禁忌】

对本品及甾体激素类药物过敏者禁用，以下疾病患者一般不宜使用，特殊情况下应权衡利弊使用，注意病情恶化的可能：严重的精神病(过去或现在)和癫痫，活动性消化性溃疡病，新近胃肠吻合手术，骨折，创伤修复期，角膜溃疡，肾上腺皮质机能亢进症，高血压，糖尿病，孕妇，抗菌药物不能控制的感染如水痘、麻疹、霉菌感染、较重的骨质疏松症等。

【注意事项】

1.诱发感染： 在激素作用下，原来已被控制的感染可活动起来、最常见者为结核感染复发。在某些感染时应用激素可减轻组织的破坏、减少渗出、减轻感染中毒症状，但必须同时用有效的抗生素治疗、密切观察病情变化，在短期用药后，即应迅速减量、停药。 2.对诊断的干扰： 1.糖皮质激素可使血糖、血胆固醇和血脂肪酸、血钠水平升高、使血钙、血钾下降。 2.对外周血象的影响为淋巴细胞、真核细胞及嘻酸、嗜碱细胞数下降，多核白细胞和血小板增加，后者也可下降。 3.长期大剂量服用糖皮质激素可使皮肤试验结果呈假阴性，如结核菌素试验、组织 

【特殊人群用药】

儿童注意事项：

小儿如长期使用肾上腺皮质激素，须十分慎重。

妊娠与哺乳期注意事项：

1.妊娠期用药：

糖皮质激素可通过胎盘。动物实验研究证实孕期给药可增加胚胎腭裂，胎盘功能不全、自发性流产和子宫内生长发育迟缓的发生率。人类使用药理剂量的糖皮质激素可增加胎盘功能不全、新生儿体重减少或死胎的发生率。

2.哺乳期用药：

由于糖皮质激素可由乳汁中排泄，对婴儿造成不良影响，如生长受抵制、肾上腺皮质功能抑制等。孕妇及哺乳期妇女在权衡利弊情况下，尽可能避免使用。

老人注意事项：

老年患者用糖皮质激素易发生高血压和糖尿病。老年患者尤其是更年期后的女性应用糖皮质激素易加重骨质疏松。

【药物相互作用】

1.非甾体消炎镇痛药可加强其致溃疡作用。

2.可增强对乙酰氨基酚的肝毒性。

3.与两性霉素B或碳酸酐酶抵制剂合用，可加重低钾血症。长期与碳酸酐酶抑制剂合用，易发生低血钙和骨质疏松。

4.与蛋白质同化激素合用，可增加水肿的发生率，使痤疮加重。

5.与抗胆碱能药(如阿托品)长期合用，可致眼压增高。

6.三环类抗抑郁药可使其引起的精神症状加重。

7.与降糖药如胰岛素合用时，因可使糖尿病患者血糖升高，应适当调整降糖药剂量。

8.甲状腺激素可使其代谢清除率增加，故甲状腺激素或抗甲状腺药与其合用，应适当调整后者的剂量。

9.与避孕药或雌激素制剂合用，可加强其治疗作用和不良反应。

10.与强心苷合用，可增加洋地黄毒性及心律紊乱的发生。

11.与排钾利尿药合用，可致严重低血钾，并由于水钠潴留而减弱利尿药的排钠利尿效应。

12.与麻黄碱合用，可增强其代谢清除。

13.与免疫抑制剂合用，可增加感染的危险性，并可能诱发淋巴瘤或其他淋巴细胞增生性疾病。

14.可增加强异烟肼在肝脏代谢和排泄，降低异烟肼的血药浓度和疗效。

15.可促进美西律在体内代谢，降低血药浓度。

16.与水杨酸盐合用，可减少血浆水杨酸盐的浓度。

17.与生长激素合用，可抑制后者的促生长作用。

【药理作用】

本品为肾上腺皮质激素类药物。具有抗炎、抗过敏和抑制免疫等多种药理作用。

1.抗炎作用：

糖皮质激素减轻和防止组织对炎症的反应，从而减轻炎症的表现。

2.免疫抑制作用：

防止或抑制细胞中介的免疫反应，延迟性的过敏反应，并减轻原发免疫反应的扩展。

3.抗毒、抗休克作用：

糖皮质激素能对抗细菌内毒紊对机体的刺激反应，减轻细胞损伤，发挥保护机体的作用。

【贮藏】

遮光、密闭保存。 

TriamHEXAL

TriamHEXAL may be available in the countries listed below.

Ingredient matches for TriamHEXAL

Triamcinolone 

Triamcinolone 16α,17α-acetonide (a derivative of Triamcinolone) is reported as an ingredient of TriamHEXAL in the following countries:

· Germany

曲安奈德  丙炎松，去炎松缩酮;

Brand name: TriamHexal

Active ingredient (generic name): Triamcinolone  Acetonide

Manufacturer: Hexal

Importer: Behestan Darou

Pharmacotherapeutic group: Antineoplastic agents

Pharmaceutical form: 40mg/1ml ampoule

Pharmacodynamic:  

Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions.

Intra-Articular Injection: Following local injection, relief of pain and swelling and greater freedom of movement are usually obtained within a few hours.

Intramuscular Injection: Provides an extended duration of therapeutic effect and fewer side effects of the kind associated with oral corticosteroid therapy, particularly gastro-intestinal reactions such as peptic ulceration. Studies indicate that, following a single intramuscular dose of 80mg triamcinolone acetonide, adrenal suppression occurs within 24 - 48 hours and then gradually returns to normal, usually in approximately three weeks. This finding correlates closely with the extended duration of therapeutic action of triamcinolone acetonide.

Pharmacokinetic:

Triamcinolone acetonide is absorbed slowly, though almost completely, following depot administration by deep intramuscular injection; biologically active levels are achieved systemically for prolonged periods (weeks to months). Half life is about 2 to 5 hours.  In common with other corticosteroids, triamcinolone is metabolised largely hepatically but also by the kidney and is excreted in urine.

Therapeutic indication:

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required:Allergic states, e.g. bronchial asthma, seasonal or perennial allergic rhinitis. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection (see Dosage);Endocrine disorders,e.g. primary or secondary adrenocortical insufficiency.Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis;Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome;Rheumatic, Gastrointestinal or Respiratory disorders - as an adjunctive, short-term therapy;Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia;Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas;Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

Dosage and administration:

Intra-Articular Injection: For intra-articular administration or injection into tendon sheaths and bursae, 2.5 to 15mg, subcutaneous or direct  Injection  up to 40mg (1.0ml) for larger joints, depending on the specific disease entity being treated. Single injections into several sites for multiple joint involvement, up to a total of 80mg, have been given without undue reactions.

Adults and Children over 12 Years: The suggested initial dose is 40mg (1.0ml) injected deeply into the upper, outer quadrant of the gluteal muscle. Subsequent dosage depends on the patient's response and period of relief. Patients with hay fever or pollen asthma who do not respond to conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single dose of 40-100mg given when allergic symptoms appear.

Children from 6-12 Years of Age: 2.5 to 15 ml which might be repeated if needed.

Adverse reaction:

Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis in long period treatments. High dosage administration may cause a wide range of psychiatric reactions including affective disorders, peptic ulcer, hypertension and thrombophlebitis.

Pharmacokinetic interactions:

Aminoglutethimide, Amphotericin B injection and potassium-depleting agents, Antidiabetics, Insulin, Digitalis glycosides, diuretics, hepatic enzyme inducers, Ritodrin, Sodium containing food or medicaments, Sumatrom, Sumatropin and live vaccines cause contraindications.

Special warnings:

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment.

During treatment with Triamhexal, Sodium intake should be limited and Potassium containing supplements should be increased.

During long term therapy with Tramhexal, regular ophthalmic monitoring is indicated.

Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible, therefore growth and development of children on prolonged corticosteroid therapy should be carefully observed.

Pregnancy and lactation:

The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta. Triamhexal is in group C. Corticosteroids may pass into breast milk, although no data are available for triamcinolone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression, therefore not recommended while lactation.

Storage temperature:   

Do not store above 25°C. Protect from light and frost.