MedWatch - July 2002 Safety-Related Drug Labeling Changes
...Patients treated with Aredia for bone metastases should have the dose withheld if renal.....In general, dose selection for an elderly patient should be cautious, usually starting at.....04 times the estimated maximum clinical topical dose from ELOCON Lotion on a mcg/m 2 basis..
http://www.fda.gov/medwatch/SAFETY/2002/jul02.htm (score=100)

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...all moxifloxacin concentrations were measured after a single 400 mg dose, except the sinus.....In a single oral dose study of 24 patients with varying degrees of renal function from.....Serious anaphylactic reactions, some following the first dose, have been reported in..
http://www.fda.gov/cder/foi/label/2002/21085s6s7lbl.pdf (score=98)

20509LBL.PDF
...Patients receiving Gemzar should be monitored prior to each dose with a complete blood.....Patients treated with Gemzar who complete an entire cycle of therapy may have the dose for.....dose, the dose for the next cycle can be further increased by 20%, provided again that the..
http://www.fda.gov/cder/foi/label/1998/20509lbl.pdf (score=98)

REGULATORY PROJECT MANAGER
...Cmax after 5 days of BID dosing relative to the first dose, suggesting extensive and.....change in initial dose of either drug is necessary and dose adjustments should be made on..the basis of clinical response.HMG.....was seen in rats at a dose approximately five times the maximum human dose, and..decreased..
http://www.fda.gov/medwatch/SAFETY/2002/serzone_label.pdf (score=98)

Guidance for Industry
...Agency's current recommendations regarding the integration of dose-counting mechanisms.....For the purposes of this guidance, the term dose counter includes both mechanisms that use.....numeric count to indicated doses remaining, as well as dose-indicating mechanisms that do..
http://www.fda.gov/cder/guidance/5308FNL.pdf (score=98)

Cardiovascular Risks to Patients who Exceed the Recommended Dose
...Some patients have reportedly increased the dose of Hismanal in the belief that this would.....It is important for patients not to exceed the recommended dose of 10 mg daily (one tablet.....dose. Rare cases of serious cardiovascular events, including death, cardiac arrest and..
http://www.fda.gov/bbs/topics/NEWS/NEW00289.html (score=98)

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...In dose proportionality studies utilizing 600, 1200 and 1800 mg doses, the.....dose exposure related increase in the clearance of total drug and decrease in the.....Daypro was given as a once-a-day dose of 1200 mg in most of the clinical trials, but..
http://www.fda.gov/cder/foi/label/2002/18841s12s16lbl.pdf (score=97)

REGULATORY PROJECT MANAGER
...Cmax after 5 days of BID dosing relative to the first dose, suggesting extensive and.....change in initial dose of either drug is necessary and dose adjustments should be made on..the basis of clinical response.HMG.....was seen in rats at a dose approximately five times the maximum human dose, and..decreased..
http://www.fda.gov/medwatch/safety/2002/serzone_label.pdf (score=97)

Single Dose Acute Toxicity Testing
...information on acute effects in nonrodent species, including preliminary dose-range.....The information obtained from these studies is useful in choosing doses for repeat-dose.....For compounds with low toxicity, the maximum feasible dose should be administered. Acute..
http://www.fda.gov/cder/guidance/pt1.pdf (score=97)

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...In the other 3 patients, the events did not lead to discontinuation or dose reduction. The.....25 mg dose every day. Coadministration of digoxin did not influence the pharmacokinetics.....decreased fetal weights and increased incidences of fetal malformations at a dose of 1800..
http://www.fda.gov/cder/foi/label/1999/21035lbl.pdf (score=97)

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...Following single intravenous doses, dose-proportional pharmacokinetics were shown in the.....After multiple oral doses the pharmacokinetics of meloxicam capsules were dose.....absorption was not affected by multiple dose administration, suggesting linear..
http://www.fda.gov/cder/foi/label/2000/20938lbl.pdf (score=97)

uspiup.PDF
...Figure 3, for the pooled results of 5 fixed-dose, dose-response studies of greater than one.....noted with 25 mg, 50 mg and 100 mg of VIAGRA, therefore the effects are not related to.....than the mean maximum plasma concentrations following a single oral dose of 100 mg in..
http://www.fda.gov/cder/foi/label/1998/viagralabel2.pdf (score=96)

0352G206-Rezulin 6-11
...The maximum recommended daily dose is 600 mg.It is recommended that the insulin dose be.....may be at risk for hypoglycemia and a reduction in the dose of the concomitant agent may.....exposure to parent compound and active metabolite at the 400 mg dose did not reveal..
http://www.fda.gov/medwatch/safety/1999/Rezupi.pdf (score=96)

April 2000 Safety-Related Drug Labeling Changes
...The recommended daily dose of Agenerase Oral Solution of 22.5 mg/kg twice daily.....The choice of progestin, its dose, and its regimen may be important in minimizing these.....In general, dose selection for an elderly patient should be cautious, usually starting at..
http://www.fda.gov/medwatch/safety/2000/apr00.htm (score=96)

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...and female subjects, respectively, following a 100 mg intravenous dose. 101.. The binding.....mL/min/kg in females following a 100 mg IV dose of tramadol. 168.. Following a single oral.....following the first dose. Other reported reactions include pruritus, hives, 251..
http://www.fda.gov/cder/foi/label/1999/20281S16LBL.PDF (score=95)

...Comparison of an Anti-Inflammatory Dose of Ibuprofen, An Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment.....The petition recommended a minimum effective dose of 200 mg ibuprofen for use by adults.....Rats receiving ibuprofen grew normally except for male rats receiving the 180-mg/kg/day..
http://www.fda.gov/OHRMS/DOCKETS/98fr/082102a.htm (score=95)

/a//content.28503
...Clinically, all benzodiazepines cause a dose-related cen- patients whose diagnoses.....clearly occurred during abrupt dose reduction, or discon- Relapse or return of illness was.....Rebound refers to a return of symptoms of panic dis- a single dose of 1 mg after tapering..
http://www.fda.gov/cder/ogd/rld/18276S35.pdf (score=95)

intron a pi
...The appropriate INTRON A dose should then be withdrawn and injected intramuscularly.....Based on the desired dose, the appropriate vial strengths should be reconstituted and.....The majority were mod-erate to severe and resolved upon dose reduction or drug discon..
http://www.fda.gov/medwatch/safety/2002/Intron_A_PI.pdf (score=95)

Document Information Page
...dogs treated with lovastatin at a dose of 180 mg/kg/day, a dose which produced plasma drug.....clinically normal dogs in a dose-dependent fashion starting at 60 mg/kg/day, a dose that.....dose range is 10 to 80 mg/day, linearity of inhibitory activity in the general circulation..
http://www.fda.gov/cder/foi/label/2002/19643s71lbl.pdf (score=95)

Maximum Recommended Therapeutic Dose (MRTD) Database
...The pharmaceuticals were given as single or divided dose treatment regimens to achieve.....In contrast, the dose unit for most antineoplastic drug MRTDs is reported as mg/m2 which.....The MRDD is an estimated upper dose limit beyond which a drug's efficacy is not increased..
http://www.fda.gov/cder/Offices/OPS_IO/MRTD.htm (score=95)

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