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Author: Admin | 2025-04-28
On the safety of CIALIS in patients with severe hepatic insufficiency (Child-Pugh class C). If CIALIS is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment. If CIALIS is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.Patients with DiabetesTadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects. This difference in exposure does not warrant a dose adjustment. Urologicals, Drugs used in erectile dysfunction. ATC code: G04BE08. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.There was no evidence of teratogenicity, embryotoxicity, or foetotoxicity in rats or mice that received up to 1000 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 30 mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 18-times the human AUC at a 20 mg dose.There was no impairment of fertility in male and female rats. In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7-18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs. Tablet core:lactose monohydratecroscarmellose sodiumhydroxypropylcellulosemicrocrystalline cellulosesodium laurilsulfatemagnesium stearate2.5 mg Film-coat: lactose monohydratehypromellose triacetin titanium dioxide (E171) iron oxide yellow (E172) iron oxide red (E172)talc5 mg, 10 mg and 20 mg Film-coat:lactose monohydratehypromellosetriacetintitanium dioxide (E171)iron oxide yellow (E172)talc Store in the original package in order to protect from moisture. For Tadalafil 5 mg - Do not store above 25°C. For Tadalafil 2.5 mg, 10 mg and 20 mg - Do not store above 30°C. Aluminium/PVC blisters in cartons of
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