【分类】抗生素/β-内酰胺类/头孢菌素类

【别名】头孢布烯

【外文名】Ceftibuten，cedax，CEDAX

【药理与应用】本品系第三代头孢菌素，对多种β-内酰胺酶稳定.对大多数G-菌如嗜血杆菌类、卡拉莫拉氏菌类等有效；对G 菌中的肺炎链球菌和化脓性链球菌有很强的杀菌作用，对厌氧菌没有作用。对葡萄球菌、肠球菌、不动杆菌、假单胞菌无效。

【适应症】上呼吸道感染如咽炎、扁桃体炎、猩红热、副鼻窦炎、中耳炎。下呼吸道感染如急性支气管炎、慢性支气管炎急性发作、肺炎。泌尿道感染。肠炎及胃肠炎。

【用量用法】成人200-400mgqd.儿童9mg/kg体重/日。

【禁忌】对头孢菌素类过敏者。

【不良反应】胃肠道反应，偶见惊厥，暂时性肝酶升高。

【注意事项】严重肾功能不全者以及进行透析患者需调节剂量。对头孢菌素过敏者禁用，有胃肠道疾病史者，特别是慢性结肠炎患者，对青霉素已知或疑有过敏患者应慎用。

【原产地英文商品名】:CEDAX SUSPENSION 180MG/5ML 30MLS/bottle
【原产地英文药品名】:CEFTIBUTEN DIHYDRATE
【中文参考商品译名】:先力腾混悬剂 180毫克/5毫升 30毫升/瓶
【中文参考药品译名】:头孢布烯二水物
【生产厂家中文参考译名】:PERNIX THERAP
【生产厂家英文名】:PERNIX THERAP

CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, dihydrate. Its molecular formula is C15H14N4O6S2•2H2O. Its molecular weight is 446.43 as the dihydrate

CEDAX Capsules contain ceftibuten dihydrate equivalent to 400 mg of ceftibuten. Inactive ingredients contained in the capsule formulation include: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell and/or band contains gelatin, sodium lauryl sulfate, titanium dioxide, and polysorbate 80. The capsule shell may also contain benzyl alcohol, sodium propionate, edetate calcium disodium, butylparaben, propylparaben, and methylparaben.

CEDAX Oral Suspension after reconstitution contains ceftibuten dihydrate equivalent to 90 mg of ceftibuten per 5 mL. CEDAX Oral Suspension is cherry flavored and contains the inactive ingredients: cherry flavoring, polysorbate 80, silicon dioxide, simethicone, sodium benzoate, sucrose (approximately 1 g/5 mL), titanium dioxide, and xanthan gum.

CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and Clinical Studies sections).

Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.

Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.

NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.

Pharyngitis and Tonsillitis due to Streptococcus pyogenes.

NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.

HOW SUPPLIED：CEDAX Capsules, containing 400 mg of ceftibuten (as ceftibuten dihydrate) are white, opaque capsules imprinted with the product name and strength, are available as follows:

20 Capsules/Bottle (NDC 45809-401-20)

Store the capsules between 2° and 25°C (36° and 77°F). Replace cap securely after each opening.

CEDAX Oral Suspension is an off-white to cream-colored powder that, when reconstituted as directed, contains ceftibuten equivalent to 90 mg/5 mL, supplied as follows:

90 mg/5 mL

18 mg/mL 60-mL Bottle (NDC 45809-801-60)
18 mg/mL  90-mL Bottle (NDC 45809-801-90)
18 mg/mL 120-mL Bottle (NDC 45809-801-12)

Prior to reconstitution, the powder must be stored between 2° and 25°C (36° and 77°F). Once it is reconstituted, the oral suspension is stable for 14 days when stored in the refrigerator between 2° and 8°C (36° and 46°F).