Pediatric Formulation in the U.S. - Fagron
Pediatric Formulation in the U.S. - Fagron
Pediatric Formulation in the U.S. - Fagron
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Examples of medications not <strong>in</strong> a<br />
suitable dosage form for children<br />
Famiciclovir<br />
Glutam<strong>in</strong>e<br />
Hydroxyurea<br />
Irbesartan<br />
Lansoprazole<br />
Leucovor<strong>in</strong><br />
Lis<strong>in</strong>opril<br />
Lomust<strong>in</strong>e<br />
Mefloqu<strong>in</strong>e<br />
Methimazole<br />
Methotrexate<br />
Methylphenidate<br />
M<strong>in</strong>oxidil<br />
Neomyc<strong>in</strong><br />
Nicardip<strong>in</strong>e<br />
Nimodip<strong>in</strong>e<br />
Ofloxac<strong>in</strong><br />
Olanzap<strong>in</strong>e<br />
Pancrelipase<br />
Paramomyc<strong>in</strong><br />
Examples of medications not <strong>in</strong> a<br />
suitable dosage form for children<br />
Phenobarbital<br />
Phenoxybenzam<strong>in</strong>e<br />
Prazos<strong>in</strong><br />
Primidone<br />
Probenecid<br />
Procarbaz<strong>in</strong>e<br />
Propafenone<br />
Pyridox<strong>in</strong>e<br />
Riboflav<strong>in</strong><br />
Saqu<strong>in</strong>avir<br />
Scopolam<strong>in</strong>e<br />
Sertral<strong>in</strong>e<br />
Sildenafil<br />
Sodium benzoate<br />
Sotalol<br />
Spironolactone<br />
Testosterone<br />
Tiagab<strong>in</strong>e<br />
Topiramate<br />
Ursodiol<br />
Examples of medications not <strong>in</strong> a<br />
suitable dosage form for children<br />
Verapamil<br />
Vigabatr<strong>in</strong><br />
Warfar<strong>in</strong><br />
Z<strong>in</strong>c sulfate<br />
Government-PHARMA Approaches<br />
Patent extension benefits<br />
Non-compete benefits<br />
Problems to overcome<br />
Patient swallow<strong>in</strong>g<br />
Taste<br />
Odor<br />
Most are “off-label” use<br />
– >75% drugs <strong>in</strong> US not labeled for use <strong>in</strong><br />
children less than 12 yo<br />
Problems with <strong>Pediatric</strong><br />
<strong>Formulation</strong>s<br />
May lack stability studies<br />
May lack bioavailability <strong>in</strong>formation<br />
May lack pk/pd <strong>in</strong>formation<br />
May lack efficacy <strong>in</strong>formation<br />
May lack tolerability <strong>in</strong>formation<br />
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