西藥品
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西藥品查詢
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外觀圖示

外觀描述:
透明凝膠狀.

醫令代碼:
28837

商品名:
voren-G 40GM(每月限壹支)

中文名:
非炎凝膠-外用消炎鎮痛劑

學名:
Diclofenac

劑型:
TUBE

孕婦用藥分級:
C 級

健保碼:
A039349345

藥品許可證:
衛署藥製字第039349號

仿單下載:

用藥指導單張:

ATC7藥理類別:

結構式 :

Image:Diclofenac.png

Diclofenac
2-(2-(2,6-dichlorophenylamino)phenyl)acetic acid


UpToDate:

藥理作用 :
1.本藥為非類固醇、非比林系之消炎鎮痛劑,具有優秀的鎮痛、抗炎作用。在非類固醇消炎劑中,本藥比其他同類藥物在消炎、止痛方面更具療效。
2.本藥為外用之抗發炎及止痛製劑,其含有主成分1%,的Diclofenac Sodium,同時本藥係以特殊的凝膠劑型為基劑,其可幫助活性成份及時發揮藥效,且使用感清涼不油膩。
3.本藥局部使用時,主成分可迅速滲透入皮膚,並分佈於皮下組織而能有效地對抗急性及慢性之發炎反應,故本藥可顯著地緩解因關節炎或運動傷害所造成之腫脹發炎及疼痛現象。

適應症:
暫時緩解局部疼痛。

用法用量:

視疼痛部位大小而定,取出適量塗於患處,使用時請輕輕按摩擦入。


副作用:
本藥耐受性良好,但偶而在便用期間會發生皮膚搔廣、灼熱感、局部發紅及過敏性皮膚炎之現象。

藥物動力學:

Absorption
Bioavailability is approximately 50% because of first-pass metabolism (oral doseforms). Food decreases T max and C max .

Immediate-release tablets
T max is approximately 1 h.

Extended-release (ER) tablets
T max is approximately 5.3 h.

Delayed-release tablets (50 mg dose)
T max is approximately 2.3 h.

Solaraze topical gel
Following application of 2 g 3 times daily for 6 days, mean AUC is 9 ng•h/mL, mean C max is 4 ng/mL, and mean T max is 4.5 h.

Topical patch
Following a single application of the patch on the upper inner arm, C max of 0.7 to 6 ng/mL was noted between 10 and 20 h of application. With twice-daily application of patch, plasma concentrations ranged from 1.3 to 8.8 ng/mL after 5 days.

Voltaren gel
C max with application of 160 mg/day is 15 ng/mL and 54 ng/mL with application of 480 mg/day. T max is 14 h with the application of 160 mg/day and 10 h with the application of 480 mg/day. The amount reaching the systemic circulation is 158 times lower with 160 mg/day compared with oral treatment.

Distribution
More than 99% protein bound (albumin). Vd is approximately 1.4 L/kg (oral).

Metabolism
Undergoes hepatic metabolism; metabolized to 5 metabolites.

Elimination
Approximately 65% is excreted in urine and 35% in the bile. The t ½ is 1 to 2 h. Plasma elimination t ½ after application of topical patch is approximately 12 h.

Special Populations
Renal Function Impairment
No differences in pharmacokinetics have been detected in studies with patients with renal function impairment.

Hepatic Function Impairment
Since hepatic metabolism accounts for 100% of diclofenac elimination, patients with hepatic disease may require reduced doses.


交互作用:

ACE inhibitors
Antihypertensive effect of ACE inhibitors may be diminished.

Aminoglycosides (eg, gentamicin)
Aminoglycoside concentrations may be elevated, increasing the risk of adverse reactions.

Aspirin
Protein binding of diclofenac may be reduced; in addition, the risk of gastric erosion and bleeding may be increased.

Azole antifungal agents (eg, fluconazole)
Diclofenac plasma concentrations may be elevated, increasing the risk of adverse reactions.

Bisphosphonates (eg, alendronate)
Coadministration may increase the risk of gastric ulceration.

Cyclosporine
May increase nephrotoxicity.

Digoxin
May increase digoxin serum concentrations.

Furosemide and thiazide diuretics
May inhibit diuretic and antihypertensive effects.

Heparin
Risk of hemorrhagic adverse reactions may be increased.

Lithium
May decrease lithium Cl.

Methotrexate
May increase methotrexate levels.

SSRIs (eg, fluoxetine)
Risk of upper GI bleeding may be increased.

Warfarin
May increase risk of gastric erosion and bleeding.


禁忌:

已知對本品之活性成分或任何賦形劑過敏者。


警語:
使用本品可能發生罕見但嚴重之皮膚不良/過敏反應,如用藥後發生喉痛、口腔/黏膜潰爛、皮疹等症狀,應考慮可能為藥品不良反應,宜立即就醫並考慮停藥。

注意事項:
1.本藥限於皮膚外用不得內服,或使用於眼睛內,亦不得施於眼睛四週或黏膜。
2.本藥勿使用於大面積之體表或皮膚深部感染。
3.使用後若自覺狀況未改善或更惡化時,應立即停藥並就醫。

藥品保存方式:
藥品應置於攝氏 15 ~ 25 度乾燥處所;如發生變質或過期,不可再使用。

給付規定:
1.1.疼痛解除劑 Drugs used for pain relief
1.1.1.非類固醇抗發炎劑外用製劑:(88/9/1、92/2/1、94/9/1、109/2/1)
1.外用非類固醇抗發炎軟膏,不得同時併用口服或其他外用非類固醇發炎製劑,每4週至多以處方一條為限(94/9/1、109/2/1)。

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