OPIGESIC SUPP 125 (SUPPOSITORY)

Special Precautions: Impairment of kidney or liver. Patients w/ hereditary G6PD deficiency (risk of hemolytic anemia); w/ Gilbert syndrome. Not to be taken for >3-5 days. May elevate serum ALT. Side Effects / Adverse Reactions Blood & lymphatic system disorders (changes in blood count including thrombocytopenia, thrombocytopenic purpura, leukopenia, pancytopenia); GI disorders (nausea, vomiting, stomach discomfort, diarrhea & abdominal pain); hepatobiliary disorders [hepatic impairment, hepatitis, as well as dose-dependent hepatic failure, hepatic necrosis (including fatal outcome)]. Hepatic fibrosis, hepatic cirrhosis (chronic unapproved use). Allergic reactions, anaphylaxis, dizziness, somnolence, renal damage, bronchospasm, asthma, skin reactions. Dosage / Direction for Use: Adult 300-1,000 mg as a single dose, to be repeated at intervals of 4-6 hr. Max: 4 g daily. Childn & infants <60 kg 10-15 mg/kg/dose every 4-6 hr, max of 75 mg/kg/day for infants & lesser of 100 mg/kg/day or 4,000 mg/day in childn.