Zovirax Duo-Activ (Aciclovir,Hydrocortisone)

Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)(アシクロビルおよびヒドロコルチゾンクリーム)は、 ⁇ 瘍性ヘルペス(口唇ヘルペス)の早期治療に適応があり、 ⁇ 瘍性ヘルペスの可能性を減らし、成人および青年の病変治癒時間を短縮します(12歳以上)。.

Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)(アシクロビルおよびヒドロコルチゾンクリーム)を1日5回5日間局所的に塗布します。. 治療は、最初の兆候と症状(すなわち、.、プロドローム中または病変が現れたとき)。.

各用量について、外縁を含む患部をカバーするのに十分な量のゾビラックスデュオアクティフ(アシクロビル、ヒドロコルチゾン)(アシクロビルおよびヒドロコルチゾンクリーム)を局所的に適用します。. 感染の悪化や移動を避けるために、患部の不必要な摩 ⁇ を避けてください。. 12歳以上の青年の場合、投与量は成人と同じです。.

無し。.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General

Zovirax Duo-Activ (Aciclovir,Hydrocortisone) is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Zovirax Duo-Activ (Aciclovir,Hydrocortisone) should not be used in the eye, inside the mouth or nose, or on the genitals. There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

Zovirax Duo-Activ (Aciclovir,Hydrocortisone) has a potential for irritation and contact sensitization.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION)

General

Patients should be informed that Zovirax Duo-Activ (Aciclovir,Hydrocortisone) is not a cure for cold sores. Patients should be instructed that Zovirax Duo-Activ (Aciclovir,Hydrocortisone) is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that Zovirax Duo-Activ (Aciclovir,Hydrocortisone) should not be used in the eye, inside the mouth or nose, or on the genitals.

Instructions for Use

Patients should be advised to apply Zovirax Duo-Activ (Aciclovir,Hydrocortisone) topically 5 times per day for 5 days. Patients should be instructed to topically apply a quantity of Zovirax Duo-Activ (Aciclovir,Hydrocortisone) sufficient to cover the affected area, including the outer margin. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Systemic exposure following topical administration of acyclovir is minimal. Results from previous studies of carcinogenesis, mutagenesis and fertility for acyclovir and hydrocortisone are not included in the full prescribing information for Zovirax Duo-Activ (Aciclovir,Hydrocortisone) due to the minimal exposures that result from dermal application. Information on these studies following systemic exposure is available in the full prescribing information for acyclovir and hydrocortisone products approved for oral or parenteral administration. Dermal carcinogenicity studies have not been conducted.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category B. Acyclovir was not teratogenic in the mouse, rabbit or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled trials of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy between 1984 and 1999 followed 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Animal reproduction studies have not been conducted with Zovirax Duo-Activ (Aciclovir,Hydrocortisone). No trials have been performed in pregnant women. Systemic exposure of acyclovir and hydrocortisone following topical administration of Zovirax Duo-Activ (Aciclovir,Hydrocortisone) is minimal.

Nursing Mothers

It is not known whether topically applied acyclovir or hydrocortisone is excreted in breast milk. Systemic exposure following topical administration of either drug is expected to be below detection limits. Because many drugs are excreted in human milk, caution should be exercised when Zovirax Duo-Activ (Aciclovir,Hydrocortisone) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.

Geriatric Use

In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of Zovirax Duo-Activ (Aciclovir,Hydrocortisone) in this group, although the available results were similar to lower age subjects.

Immunocompromised Subjects

Even though the safety of Zovirax Duo-Activ (Aciclovir,Hydrocortisone) has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.

Benefit has not been adequately assessed in immunocompromised patients. A randomized, double-blind trial was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian. Median CD4+ T-cell count at screening was 344/mm³ (range 100-500/mm³ ). Subjects were treated with Zovirax Duo-Activ (Aciclovir,Hydrocortisone) or 5% acyclovir in Zovirax Duo-Activ (Aciclovir,Hydrocortisone) vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm. The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for Zovirax Duo-Activ (Aciclovir,Hydrocortisone) and 6.9 days for 5% acyclovir in Zovirax Duo-Activ (Aciclovir,Hydrocortisone) vehicle.

臨床試験における副作用。

臨床試験はさまざまな条件下で行われるため、観察された副作用率は他の臨床試験の率と直接比較することはできず、臨床診療で観察された率を反映しない場合があります。.

Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)の臨床試験から得られた安全性データは、1056人の被験者がZovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)に5日間毎日5回治療されたヘルペスを投与した場合の暴露を反映しています。. 最も一般的な副作用(<1%)は局所的な皮膚反応であり、以下を含む適用部位の領域で発生しました。

• 皮膚の乾燥または剥離;塗布後の ⁇ 熱感またはチクチクする;紅斑;色素沈着の変化;炎症の兆候や症状を含む塗布部位の反応。.

皮膚安全性試験で閉塞下で適用された場合、適用後の接触性皮膚炎が観察されています。. 接触感度試験が実施された場合、反応性物質はヒドロコルチゾンまたはクリームベースの成分でした。.

225人の健康な成人を登録する試験が行われ、繰り返し侮辱パッチ試験方法を使用して、Zovirax Duo-Activ(Aciclovir、Hydrocortisone)の接触感作の可能性を評価しました。. 評価可能な205人の被験者のうち、ヒドロコルチゾンへの感作の確認された1例(0.5%)とZovirax Duo-Activ(Aciclovir、Hydrocortisone)ベースへの感作の可能性のある2つの追加例(1.0%)が確認されました。. さらに、1人の被験者が、写真の安全性調査で、クリームベースの不活性成分の1つであるプロピレングリコールに接触アレルギーを発症しました。.

皮膚耐性は、36人の健康な被験者を対象とした21日間の累積刺激試験で評価されました。. Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)、そのクリームベース、およびZovirax®(アシクロビル)クリーム5%はすべて、閉塞性および半閉塞性の条件下で、高い累積刺激の可能性を示しました。.

フォトアレルギーの可能性と光毒性は、それぞれ50人と30人の健康なボランティアを対象とした2つの試験で評価されました。. Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)の光アレルギーまたは光毒性の可能性は確認されていません。.

Zovirax Duo-Activ(アシクロビル、ヒドロコルチゾン)の局所適用による過剰摂取は、全身曝露が最小限であるため、起こりそうにありません。.

アシクロビルとヒドロコルチゾンの血漿濃度は、ゾビラックスデュオアクティフ(アシクロビル、ヒドロコルチゾン)の口腔内投与後に寒冷に測定されませんでした。.

局所コルチコステロイドの経皮吸収の程度は、車両、表皮バリアの完全性、閉塞性包帯の使用など、多くの要因によって決まります。.

局所コルチコステロイドは正常な無傷の皮膚から吸収され、コルチコステロイドの効力と適用表面積の両方に応じて全身的な副作用を引き起こす可能性があります。. 皮膚の炎症および/または他の疾患プロセスが皮膚のバリアを乱す場合、経皮吸収が増加する可能性があります。.

皮膚から吸収されると、局所コルチコステロイドは、全身投与されたコルチコステロイドと同様の薬物動態経路で処理されます。. コルチコステロイドは、さまざまな程度で血漿タンパク質に結合します。. それらは主に肝臓で代謝され、腎臓から排 ⁇ されます。. 局所コルチコステロイドとその代謝産物の一部も胆 ⁇ に排 ⁇ されます。.