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In the PROSCAR Long-Term Efficacy and Safety StudyPLESSa 4-year controlled clinical study3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years1524 on PROSCAR 5 mg/day and 1516 on placebo3.757 patientstreated with PROSCAR 5 mg and 2.132 patientstreated with placebo discontinued therapy as a result of adverse reactions related to sexual functionwhich are the most frequently reported adverse reactions.

Although Propecia is not for use by womenthis medication can cause birth defects if a woman is exposed to it during pregnancyPropecia tablets should not be handled by a woman who is pregnant or who may become pregnantPropecia tablets are coated and will prevent contact with the active ingredient during normal handlingprovided that the tablets are not broken or crushedIf a woman accidentally comes into contact with this medication from a broken or crushed tabletwash the area with soap and water right away.

No adjustment in dosage is necessary in non-dialysed patients with renal impairment.

The following adverse reactions have been identified during post approval use of PROPECIABecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

In June 2011the FDA released a safety announcement warning that Propecia and other 5-alpha-reductase inhibitors may increase the risk for high-grade prostate cancerthe deadliest form of prostate cancer.

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Symptoms associated with serotonin syndrome may include the following combination of signs and symptomsmental status changese.gagitationhallucinationsdeliriumand comaautonomic instabilitye.gtachycardialabile blood pressuredizzinessdiaphoresisflushinghyperthermianeuromuscular symptomse.gtremorrigiditymyoclonushyperreflexiaincoordinationseizureswith or without gastrointestinal symptomse.gnauseavomitingdiarrheaPatients should be monitored for the emergence of serotonin syndromeespecially with concomitant use of ZOFRAN and other serotonergic drugsIf symptoms of serotonin syndrome occurdiscontinue ZOFRAN and initiate supportive treatmentPatients should be informed of the increased risk of serotonin syndromeespecially if ZOFRAN is used concomitantly with other serotonergic drugssee DRUG INTERACTIONSOVERDOSE

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FDA staff assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015In over 2.3 million pregnanciesthe prevalence of ondansetron was 15.2 percentaccording to the FDAUse was highest in the first trimester.

Daily fractions to abdomenAdminister 8 mg PO 1-2 hr before radiotherapyadminister subsequent doses every 8 hr after first dose each day radiotherapy is given.

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Be irritable and pull and tug at their ears Be fussy Have problems feeding or sleeping Complain about pain and fullness in the ear Have a fever A buildup of pus in the ear Have signs and symptoms of an upper respiratory infection.

Shake the oral suspensionliquidwell just before you measure a doseTo be sure you get the correct dosemeasure the liquid with a marked measuring spoon or medicine cupnot with a regular table spoonIf you do not have a dose-measuring deviceask your pharmacist for one.

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