33.依析芬

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第176页(4306字)

【中文释文】:

片剂,(三苯氧胺10mg)

〔成分〕

三苯氧胺枸橼酸,相等于10mg三苯氧胺,辅料适量。

〔适应证〕

适用于治疗乳腺癌。在推荐的剂量,三苯氧胺通过与雌激素竞争靶器官的雌激素受体而具有抗雌激素作用。没有雄激素作用。

〔剂量〕

剂量20~40mg/d,每日二次,每次服用10~20mg(1~2片)。

〔禁忌证〕

孕妇禁用,对于停经前的病人在治疗开始前需细心检查,以排除怀孕的可能性。

〔副作用〕

用三苯氧胺治疗一些停经前的妇女月经可能会受抑制。在服用40mg三苯氧胺每天2次于一段短时间,较少观察到可逆性的卵巢肿大。有少部分骨转移的病人在治疗开始时会发生高血钙。

长期服用三苯氧胺时副作用的发生率和严重程度比用雄激素和雌激素低很多。通常分为以下几大类:

因抗雌激素的作用引起:发热、阴道出血和外阴瘙痒;

普通的症状:如肠胃道不适、肿瘤疼痛、头晕和偶尔液体滞留。

在一些病例,如副作用严重,可通过降低剂量来控制而毋须中断治疗。如此方法无效,则须中断治疗。

在一些女病人中,可能会出现短暂的血小板减少(通常80000~90000mm3),偶然可能会更低,出血倾向未见报道。当继续用三苯氧胺治疗,血小板的数目会自然回复正常。

〔中毒及治疗〕

理论上过量服用会呈现较大的抗雌激素作用。动物实验证实100~200倍于推荐的每天剂量可产生雌激素作用。过量服用并无解药,只能对症治疗。

长期用高剂量治疗病人,很少一部分病例可能会出现一些视觉障碍,角膜变化和/或视网膜病。

〔贮存效期〕

本品在室温贮存有效期3年。

〔包装〕

本品有30片或100片装。

贮存于儿童不能触及处。

〔生产厂家〕

西班牙 巴塞罗那LABORATORIO

(附本品别名:抑乳瘤,ICI46474,他莫昔芬,Tamofen,Noltam,Nolvadex,zitazonium

【外文释文】:

(tamoxifen 10 mg)

Composition per tablet

Tamoxifen citrate,equivalent to 10 mg Tamoxifen(DCI)Excipient,s.q.

Indications

Breast cancer.At the recommended dose,Tamoxifen has an antiestrogenic activity derived from competition with estrogens for the fixation sites in the target organs.Lacks androgenic properties.

Dosage

The dose oscillates between 20-40 mg administering 10 or 20 mg twice a day.

Contraindications

Tamoxifen must not be administered during pregnancy.Premenopausal patients will be carefully examined before the start of treatment in order to exclude the possibility of pregnancy.

Secondary effects

In a certain number of premenopausal women treated with Tamoxifen,menstruation is suppressed.A reversible tumefaction of cystous ovaries has been very rarely observed in these women,undergoing a 40mg Tamoxifen treatment twice a day during short periods of time.A reduced number of patients with bone metastasis has presented hypercalcemia at the start of treatment.

The number and seriousness of secondary effects is much lower in long-term treatments with Tamoxifen than with androgens and estrogens.Reported cases can be classified in thefollowing way:due to the antiestrogenic action of the drug(i.e;heat waves,vaginal hemorrhage and pruritus vulvae);as more general effects(i.e;gastrointestinal intolerance,tumor explosion,dizziness,and occasionally,fluid retention).

In some cases,when secondary effects are severe,it is possible to control them simply reducing the dose without loosing control on the disease.In the absence of response to this measure,it could be necessary to interrupt the treatment.

In some female patients some transitory decreases of the platelets count have been found:generally 80 000-90 000 mm3,although much lower levels have been detected in some occasions.A hemorrhagic tendency is not mentioned and the platelets counts are recovered ever when the treatment with Tamoxifen is continued.

Intoxication and treatment

Theoretically,overdosage will manifest itself through an exaggeration of the antiestrogenic effects.Studies in animals demonstrated that an extreme overdosage(100-200 times the recommended daily dose)may produce estrogenic effects.There is no specific antidote and the treatment must be symptomatic.

In patients treated with exceptionally high doses during prolonged periods of time,it was possible to find a small number of cases with visual disorders,corneal alterations and/or retinopathy.

Shelf life

3 years at room temperature.

Presentation

Containing 30 tablets or 100 tablets.

Keep medicaments out of children’s reach

Manufacturer

Laboratorio Prodes,S.A.

San Justo Desvern(Barcelona)-spain

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