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Duac na pryszcze - Skuteczne rozwiązanie dla piękniejszej skóry
Use In Specific Populations
8.1 Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women treated with DUAC Gel. DUAC Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) revealed no evidence of teratogenicity.
8.3 Nursing Mothers
It is not known whether DUAC Gel is excreted into human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, caution should be exercised when DUAC Gel is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness of DUAC Gel in pediatric patients below the age of 12 have not been established.
8.5 Geriatric Use
Clinical studies of DUAC Gel did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.
Použitie
Dávkovanie a dávkovacie schémy
Dospelí a dospievajúci (vo veku 12 rokov a starší):
Liek sa nanáša 1x denne večer pred spaním na celú postihnutú plochu.
Liečba nemá presiahnuť 12 týždňov nepretržitého používania. Účinok sa môže zaznamenať už po 2 - 5 týždňoch liečby
Spôsob použitia
Gél je určený na vonkajšie dermálne použitie.
Gél sa má aplikovať v tenkej vrstve po jemnom umytí pokožky šetrným čistiacim prípravkom a po úplnom vysušení. Ak sa gél do pokožky ľahko nevstrebáva, bolo aplikované priveľké množstvo. Po aplikácii si treba umyť ruky.
Má sa zamedziť kontaktu gélu s ústami, očami, perami, inými sliznicami alebo s miestami, na ktorých je pokožka podráždená alebo porušená.
Upozornenie
Liek môže byť predpísaný tehotným alebo dojčiacim ženám až po starostlivom zhodnotení prínosu a rizika.
Ak sa liek používa počas dojčenia, nemá sa aplikovať na oblasť prsníkov, aby sa zabránilo jeho náhodnému požitiu dieťaťom.
Liek sa neodporúča používať u detí vo veku do 12 rokov.
Počas prvých týždňov liečby dôjde u väčšiny pacientov k zintenzívneniu olupovania a začervenania pokožky.
Počas liečby sa nemajú používať horské slnká a treba sa vyhnúť úmyselnému a dlhotrvajúcemu vystavovaniu sa slnku alebo ho treba minimalizovať. Pokiaľ nie je možné vyhnúť sa silnému slnečnému žiareniu, majú sa používať prípravky na opaľovanie a nosiť ochranný odev. Ak má pacient popáleninu od slnka, pred použitím lieku musí byť vyliečená.
Liek môže odfarbovať vlasy alebo farebné tkaniny.
Uchovávať v chladničke (2 o C - 8 o C). Po prvom otvorení uchovávať pri teplote neprevyšujúcej 25 °C.
Použiteľnosť po 1. otvorení je 2 mesiace.
Ďalšie osobitné upozornenia sú uvedené v SPC (časť 4.4).
Highlights of Prescribing Information
These highlights do not include all the information needed to use DUAC Gel safely and effectively. See full prescribing information for DUAC Gel.
Indications and Usage for Duac
DUAC Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1)
Limitation of Use:
DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2)
Duac Dosage and Administration
• Apply a thin layer of DUAC Gel to the face once daily, in the evening. (2) • Not for oral, ophthalmic, or intravaginal use. (2)
Dosage Forms and Strengths
Gel, 1.2%/5%: Each gram of DUAC Gel contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide. (3)
Contraindications
DUAC Gel is contraindicated in:
• Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis). (4)
Warnings and Precautions
• Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. DUAC Gel should be discontinued if significant diarrhea occurs. (5.1) • Ultraviolet light and environmental exposure (including use of tanning beds or sun lamps): Minimize sun exposure following drug application. (5.2)
Adverse Reactions/Side Effects
• The most common local adverse reactions (≥5%) are erythema, peeling, dryness and burning. (6.1)Drug Interactions
• DUAC Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. (7.1)
Adverse Reactions/Side Effects
The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: • Colitis [see Warnings and Precautions (5.1)] .
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1. Local Skin Reactions with Use of DUAC Gel
Combined Results from Five Trials (n = 397)
% of Subjects Using DUAC Gel with Symptom Present
Before Treatment (Baseline)
(Percentages derived by number of subjects receiving DUAC Gel with symptom score/number of enrolled subjects receiving DUAC Gel).
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of DUAC Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel.
Urticaria, application site reactions, including discoloration have been reported.
Duac gel za akne upotreba
Kako je u pitanju medicinski preparat veoma je bitno koristiti ga na način koji je propisan.
To podrazumeva sledeću upotrebu:
- samo na koži,
- ne upotrebljavati na iritiranim delovima kože,
- efekti su vidljivi u periodu od 4 do 6 nedelja,
- ne duže od 12 nedelja.
Duac gel upotreba postupak:
- umijte se i očistite lice dobro, da bude čisto,
- dobro osušite lice ili deo kože gde ćete naneti gel,
- jednom dnevno nanositi gel, najbolje uveče,
- malu količinu gela je potrebno lagano utiljati na mesto zahvaćeno aknama, ali i oko akni.
Veoma je bitno napomenuti da se gel ne nanosi samo ciljano na bubuljice, već i na predeo oko bubuljica. Na taj način će efekat biti kompletan. Ukoliko se nanosi samo na predeo gde je bubuljica, efekat može izostati.
Obavezno dobro isprati ruke nakon nanošenja Duac gela.
