自從Clarinase離開台灣後,好久沒有找到一個像樣的替代藥了,

幸好這次出國時在加拿大有看到 Allegra D。

Allegra在台灣還算是常見,學名是 fexofenadine hydrochloride

結構

與loratadine一樣是第二代抗組織胺

至於後面的D,就是decongestant的意思,指的是裡面的第二個成分

pseudoephedrine hydrochloride 

 

你如果想要回憶一下Clarinase,可以看這邊

Clarinase 與 finska LP

外盒包裝是這樣:

 

 

藥錠是雙色錠

 

放大給各位看:

 

 

切開看剖面

 

這次買藥經驗讓我發現一件事,就是加拿大的藥物裡面幾乎都沒有仿單,正確地說,加拿大的OTC裡面幾乎都沒有提供仿單。

所以購買藥物時,你唯一的資訊來源,除了包裝上面的標示以外,就是藥師(當然你也可以自己上網,但是官網的資料可能更會混淆你

以AllegraD來說,他的上面標記就是

不嗜睡(non-drowsy)

藥物成分 :(fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg)

藥物功能:(antihistamine抗組織胺+ Decongestant去充血劑)

適應症: allergies過敏,nasal congestion鼻塞

優點:fast action快速作用

relief of allergy symptoms快速解除過敏症狀

hay fever 枯草熱以及seasonal allergies季節性過敏

至於用法還有其他的注意事項,一概沒有!

我不清楚這是不是刻意,如果是特地這樣做,我相信是為了讓患者能夠與藥師有充分的溝通之後才進行購買,或是患者已經很清楚自己需要買的藥物及用法才會進行購買。

這樣的做法有好有壞,但是我覺得如果因為這樣患者會增加與專業人士討論的機會也未嘗不可。

畢竟自我藥療的精髓就是要與專業人士討論(可以參考這邊:我藥療 Self-medication

我簡單從原廠的技術文件中補充一些相關藥理資訊:

Allegra®-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg)

Pharmacokinetics and Metabolism 藥物動力學與代謝

Fexofenadine HCl + Pseudoephedrine HCl Fexofenadine hydrochloride was rapidly absorbed following multiple dose administration of the 60 mg fexofenadine hydrochloride/120 mg pseudoephedrine hydrochloride caplet to healthy volunteers with a mean peak fexofenadine plasma concentration 233 ng/mL, which occurred 2.1 hours postdose. Pseudoephedrine hydrochloride, in the same study, produced a mean peak pseudoephedrine plasma concentration of 405 ng/mL which occurred 4.8 hours postdose. Co-administration of ALLEGRA-D with a high fat meal decreased fexofenadine bioavailability; however, the rate or extent of pseudoephedrine absorption was not affected. ALLEGRA-D should be taken on an empty stomach. Fexofenadine HCl Fexofenadine hydrochloride is rapidly absorbed following oral administration. The single and multiple dose pharmacokinetics of fexofenadine hydrochloride were linear from 20 mg to 120 mg doses. Tmax occurs at approximately 2.6 hours and Cmax is approximately 209 ng/mL following oral administration of a single 60 mg dose.

Following a single 60 mg oral dose, 80% of the total fexofenadine HCl dose was recovered in the feces and 11% was recovered in the urine. Following multiple dosing, fexofenadine has an apparent elimination half-life of 11 to 16 hours. Steady state pharmacokinetic parameters following 60 mg bid dosing are:

AUCss (0-12h) = 1367 ng/mL!h, Cmax = 299 ng/mL, Cmin = 29 ng/mL, tmax = 1 h.

The pharmacokinetics of fexofenadine HCl in seasonal allergic rhinitis patients are similar to that of otherwise healthy subjects. Peak fexofenadine plasma concentrations were similar between adolescent (12-16 years of age) and adult patients.

Pseudoephedrine

Pseudoephedrine HCl has been shown to have a mean elimination half-life of 4-8 hours which is dependent on urine pH. The elimination half-life is decreased at urine pH lower than 6 and may be increased at urine pH higher than 8. About 43% to 96% of an administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver. 

INDICATIONS AND CLINICAL USE  臨床使用適應症

ALLEGRA-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) sustained-release caplets is indicated for the effective relief of sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes, and temporary relief of nasal congestion associated with seasonal allergic rhinitis in adults and children 12 years of age and older.

ALLEGRA-D is indicated for patients who may not receive complete relief from antihistamines alone and in whom both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired. 

CONTRAINDICATIONS 禁忌

ALLEGRA-D (fexofenadine HCl 60 mg/pseudoephedrine 120 mg) is contraindicated in patients with known hypersensitivity or idiosyncrasy to any of its ingredients, to adrenergic agents or to other drugs of similar chemical structures.

ALLEGRA-D is also contraindicated in the following patients:

  • patients with severe hypertension, or severe coronary artery disease, narrow-angleglaucoma or urinary retention.

  • patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14)days of stopping such treatment.

  • Patients who have shown sensitivity to adrenergic agents (manifestations include insomnia,dizziness, weakness, tremor, or arrhythmias). 

Use in Pregnancy 懷孕

There are no adequate and well controlled studies in pregnant women. ALLEGRA-D should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 

Lactation授乳

ALLEGRA-D is not recommended for nursing women unless the potential benefit to the patient outweighs the potential risk to the infant. Following administration of terfenadine to nursing mothers, fexofenadine crosses into human breast milk and pseudoephedrine administered alone, distributes into breast milk. 

SYMPTOMS AND TREATMENT OF OVERDOSAGE 過量的症狀與處置

In the event of overdosage, treatment which should be started immediately, is symptomatic and supportive. Discontinuation of use, gastric lavage or induction of emesis (except in patients with impaired consciousness) and support of vital functions are advised.

Fexofenadine
Most reports of fexofenadine hydrochloride overdose contain limited information. However, dizziness, drowsiness, and dry mouth have been reported. Single doses up to 800 mg and doses up to 690 mg BID for one month or 240 mg QD for one year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo. The maximum tolerated dose of fexofenadine hydrochloride was not established.

Pseudoephedrine
Serious effects associated with pseudoephedrine overdosage include respiratory difficulty, convulsions, arrhythmias, hypertension and cardiovascular collapse. 

Manifestations

These may vary from CNS depression (sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to stimulation (insomnia, hallucination, tremors or convulsions) to death. Other signs and symptoms may be euphoria, excitement, tachycardia, palpitations, thirst, perspiration, nausea, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia; and gastrointestinal symptoms).

In large doses, sympathomimetics may give rise to giddiness, heachache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

Treatment

The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologically-induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240 to 360 milliliters of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children. Following emesis, adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible of the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and therefore may be valuable for their action in rapid dilution of bowel content. 

Fexofenadine is not effectively cleared by hemodialysis from the blood. The effect of hemodialysis on pseudoephedrine is unknown.

Excretion of pseudoephedrine is increased by lowering the pH of the urine.

After emergency treatment, the patient should continue to be medically monitored.

Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermic blanket. Apnea is treated with ventilatory support. 

DOSAGE AND ADMINISTRATION 劑量與使用

Adults and Children 12 years of age and older

One ALLEGRA-D (fexofenadine HCl 60 mg/pseudoephedrine 120 mg) sustained-release caplet twice daily, swallowed whole on an empty stomach.

Children under 12 years of age

Safety and effectiveness of ALLEGRA-D have not been established in this population.

Use in renal impairment

A dose of one caplet once daily is recommended as a starting dose   

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