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Therefore, from a microbiological point of view, once reconstituted, the product should be used immediately. As there are no food effects on bioavailability, patients can be instructed that CLARINEX Tablets or Oral Solution may be taken without regard to meals.
200 mg q12h x 7 days to healthy subjects. In subjects 2 to 5 years old, a single dose of 2. The mean plasma elimination half-life of desloratadine was 33.
Increased sleepiness or tiredness can happen if you take more CLARINEX than your doctor prescribed to you. CLARINEX is not for children younger than 6 months of age. In these studies, the inhibition potency of voriconazole for CYP3A4 metabolic activity was significantly less than that of two other azoles, ketoconazole and itraconazole.
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2 years of age and older. Varying degrees of hepatic and renal impairment do not affect the protein binding of voriconazole. Visual Disturbances The effect of VFEND on visual function is not known if treatment continues beyond 28 days. Pharmacokinetics The pharmacokinetics of voriconazole have been characterized in healthy subjects, special populations and patients. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VFEND and any potential adverse effects on the breastfed child from VFEND or from the underlying maternal condition. Pediatrics Two hundred and forty-six pediatric subjects 6 months to 11 years of age received CLARINEX Oral Solution for 15 days in three placebo-controlled clinical trials. For more information, ask your doctor or pharmacist. 5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. The mechanism underlying these dermatologic adverse events remains unknown.
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Sparse plasma sampling for pharmacokinetics in adolescents was conducted in the therapeutic studies . Call your doctor for medical advice about side effects. OVERDOSE In clinical trials, there were three cases of accidental overdose.
Do not administer as an IV bolus injection. L of sulfobutyl ether beta-cyclodextrin sodium. When initiating therapy with VFEND in patients already receiving omeprazole doses of 40 mg or greater, reduce the omeprazole dose by one-half. The shelf-life of the powder for oral suspension is 18 months. Frequent monitoring of blood glucose and for signs and symptoms of hypoglycemia.
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Drug Resistance A potential for development of resistance to voriconazole is well known. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. Although refrigerated storage is recommended following reconstitution, use of this diluent is not recommended as a precautionary measure. Advise females of reproductive potential to use effective contraception during treatment with VFEND. Monitoring Of Renal Function Acute renal failure has been observed in patients undergoing treatment with VFEND.
Doubling the dose of voriconazole to 400 mg q12h does not restore adequate exposure to voriconazole during coadministration with rifampin. In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole. Voriconazole drug substance is a white to light-colored powder. Talk to your doctor before taking this medicine if you have any questions about whether or not to take this medicine. Arrhythmias And QT Prolongation Some azoles, including voriconazole, have been associated with prolongation of the QT interval on the electrocardiogram. 5 mg of desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults administered a single 5-mg CLARINEX Tablet.
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Frequent monitoring for adverse events and toxicity related to calcium channel blockers. Clinical cases where azole cross-resistance is demonstrated may require alternative antifungal therapy. Storage And Handling Powder For Solution For Injection VFEND I. Adjustment of calcium channel blocker dosage may be needed. Skeletal Adverse Events Fluorosis and periostitis have been reported during long-term voriconazole therapy.
5 mg of CLARINEX Oral Solution was administered to 60 pediatric subjects 6 to 11 years of age. CLINICAL PHARMACOLOGY Mechanism Of Action Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. This Patient Information leaflet summarizes the most important information about CLARINEX. In CLARINEX-treated subjects, there was an increase in mean heart rate of 9. Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the CLARINEX product. There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema.
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Serious cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have been reported during treatment with VFEND. USP, sodium citrate dihydrate USP, sodium benzoate NF, disodium edetate USP, purified water USP. The background risk of major birth defects and miscarriage for the indicated populations is unknown. The relevance of cross-resistance and clinical outcome has not been fully characterized.
Although not studied in vitro or in vivo, concomitant administration of voriconazole with terfenadine, astemizole, cisapride, pimozide or quinidine may result in inhibition of the metabolism of these drugs. Urogenital: anuria, blighted ovum, creatinine clearance decreased, dysmenorrhea, dysuria, epididymitis, glycosuria, hemorrhagic cystitis, hematuria, hydronephrosis, impotence, kidney pain, kidney tubular necrosis, metrorrhagia, nephritis, nephrosis, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine hemorrhage, vaginal hemorrhage. The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina.
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In patients receiving 5 mg daily, the rate of adverse events was similar between CLARINEX and placebo-treated patients. In animals, voriconazole administration was associated with teratogenicity, embryotoxicity, increased gestational length, dystocia and embryomortality . Visual Disturbances Voriconazole treatment-related visual disturbances are common. Distributed by: Roerig, Division of Pfizer Inc, NY 10017.
The frequency of phototoxicity reactions is higher in the pediatric population. Dose reduction of NSAIDs may be needed . This subgroup does not include healthy subjects and patients treated in the compassionate use and non-therapeutic studies.
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Other reported clinical experience has not identified differences between the elderly and younger patients. In order to allow the required volume of VFEND concentrate to be added, withdraw and discard at least an equal volume of diluent from the infusion bag or bottle to be used. ATCC is a registered trademark of the American Type Culture Collection. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.
Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data . Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Endocrine: adrenal cortex insufficiency, diabetes insipidus, hyperthyroidism, hypothyroidism. Pediatric Patients Sparse plasma sampling for pharmacokinetics was conducted in the therapeutic studies in patients aged 12-18 years. Clinical Laboratory Values The overall incidence of clinically significant transaminase abnormalities in all therapeutic studies was 12. Pediatric Use The recommended dose of CLARINEX Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of CLARINEX in adults and pediatric subjects.
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For the diffusion technique using the 1 mcg disk, the criteria in Table 11 should be achieved. A total of 22 patients aged 12 to 18 years with invasive aspergillosis were included in the therapeutic studies. Instructions For Use Shake the closed bottle of reconstituted suspension for approximately 10 seconds before each use.
A reduction in ibuprofen and diclofenac dosage may be needed during concomitant administration with voriconazole. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. CLARINEX in 4 double-blind, randomized, placebocontrolled clinical trials of 2 to 4 weeks’ duration conducted in the United States. For more information, go to www. It has an empirical formula: C19H19ClN2 and a molecular weight of 310. A 4-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment .
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With Other Parenteral Drug Products Blood Products And Concentrated Electrolytes VFEND I. All occurred in pediatric patients who received up to five times the recommended intravenous dose of voriconazole. Treatment Of Patients With Invasive Aspergillosis Who Were Refractory To, Or Intolerant Of, Other Antifungal Therapy Additional data regarding response rates in patients who were refractory to, or intolerant of, other antifungal agents are also provided in Table 15. There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema .
In patients with photosensitivity skin reactions, squamous cell carcinoma of the skin and melanoma have been reported during long-term therapy. 6 months of age and older. Clinical Studies Seasonal Allergic Rhinitis The clinical efficacy and safety of CLARINEX Tablets were evaluated in over 2300 patients 12 to 75 years of age with seasonal allergic rhinitis. Metabolic and Nutritional: albuminuria, BUN increased, creatine phosphokinase increased, edema, glucose tolerance decreased, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypomagnesemia, hyponatremia, hypophosphatemia, peripheral edema, uremia.