CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(六)
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CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see WARNINGS AND PRECAUTIONS (5.5) and CLINICAL PHARMACOLOGY (12.3)].
8.7 Hepatic Impairment
No studies with CLARINEX-D 12 HOUR Extended Release Tablets or pseudoephedrine were conducted in subjects with hepatic impairment.
CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see WARNINGS AND PRECAUTIONS (5.6) and CLINICAL PHARMACOLOGY (12.3)].
8.8 Gender
No clinically significant gender-related differences were observed in the pharmacokinetic parameters of desloratadine, 3-hydroxydesloratadine or pseudoephedrine following administration of CLARINEX-D 12 HOUR Extended Release Tablets.
8.9 Race
No studies have been conducted to eva luate the effect of race on the pharmacokinetics of CLARINEX-D 12 HOUR Extended Release Tablets.
9 DRUG ABUSE AND DEPENDENCE
There is no information to indicate that abuse or dependency occurs with CLARINEX or CLARINEX-D 12 HOUR Extended Release Tablets.
10 OVERDOSAGE
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
10.1 Desloratadine
Information regarding acute overdosage with desloratadine is limited to experience from postmarketing adverse event reports and from clinical trials conducted during the development of the CLARINEX product. In the reported cases of overdose, there were no significant adverse events that were attributed to desloratadine. In a dose-ranging trial, at doses of 10 mg and 20 mg/day, somnolence was reported.
In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of CLARINEX 45 mg for 10 days [see CLINICAL PHARMACOLOGY (12.2)].
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated desloratadine exposure was approximately 290 times the human daily oral dose on an mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposure was approximately 810 times the human daily oral dose on an mg/m2 basis).
10.2 Sympathomimetics
In large doses, sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle 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.
11 DESCRIPTION
CLARINEX-D 12 HOUR Extended Release Tablets are oval-shaped blue and white bilayer tablets containing 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate, USP in the white extended-release layer which is released slowly, allowing for twice-daily administration.
The inactive ingredients contained in CLARINEX-D 12 HOUR Extended Release Tablets are hypromellose USP, microcrystalline cellulose NF, povidone USP, silicon dioxide NF, magnesium stear |
