Sandetofen Dosage/Direction for Use

Dosage: 50 mg every 8-12 hours. If needed, the administration can be repeated every 6 hours. The total dosage per day may not exceed 150 mg.
SANDETOFEN Injection is not addressed for prolong administration, and the therapy should be limited for acute symptomatic period only.
For post operative pain, SANDETOFEN injection can be used with the opioid analgesic for the pain, particularly severe pain in the initial period after surgery.
Elderly: Adjustment doses usually not required in elderly patients. However, due to decreased physiological kidney function in the elderly patients, lower doses is recommended in the case of mild impairment of kidney functions. The total doses per day is 50 mg.
Hepatic Dysfunction: In patients with mild to moderate hepatic impairment (Child-Pugh Score 5-9), the doses should be lowered to 50 mg total daily dose, and the hepatic function be monitored strictly. SANDETOFEN Injection solution or concentrate solution for infusion should not be given for patient with severe hepatic dysfunction (Child-Pugh score 10-15).
Renal Dysfunction: In patients with reduced mild kidney function condition (creatinine clearance 50-80 mL/minutes), the doses should be lowered to 50 mg total daily dose. SANDETOFEN Injection or concentrate solutions concentrates for infusion should not be given to the patients with moderate to severe renal dysfunction (creatinine clearance 50 mL/minutes).
Children: This drug should not be used in children.
Administration: SANDETOFEN can be administered IM or IV route.
IM: SANDETOFEN Injection should be given with slow injection to the muscle.
IV Infusion: SANDETOFEN Injection should be diluted into 30 to 100 mL NaCl, Glucose or Ringer Lactate solution. Diluted solution should be given with slow intravenous infusion for 10 until 30 minutes. The solution must be protected from direct sunlight.
IV bolus: If needed, SANDETOFEN Injection can be administered as slow bolus intravenous with not more than 15 seconds administration.
When SANDETOFEN Injection is administered as IM or IV bolus, the solution should be directly injected after being removed from amber ampoules. In i.v. infusion administration, the solution should be diluted aseptically and protected form direct sunlight.