Ketolab 60

• Short-term management of moderate to severe acute postoperative pain
• Acute pain requiring opioid-level analgesia

Tablet (Adult):

• 10 mg every 4-6 hours
• Short-term use only (up to 7 days)
• Maximum daily dose: 40 mg

Injection (Adult):

• Under 65 years: IM 60 mg single/30 mg q6hr; IV 30 mg single/30 mg q6hr
• Over 65 years or renal impairment or <50 kg: IM 30 mg/15 mg q6hr; IV 15 mg/15 mg q6hr
• Maximum daily dose: 120 mg (under 65) / 60 mg (over 65)

Children (2-16 years):

• Single dose: IM 1 mg/kg (max 30 mg); IV 0.5 mg/kg (max 15 mg)
• Multiple dose: 0.5 mg/kg IV/IM q6hr; max 5 days

Renal Impairment:

• Moderate: Use 50% of recommended dose; not to exceed 60 mg/day
• Severe: Contraindicated

>10%:

• Headache (17%)
• Somnolence/Insomnia (3-14%)
• Dyspepsia (12-13%)
• GI pain (12-13%)
• Nausea (12-13%)

1-10%:

• Diarrhea (3-9%), Dizziness (3-9%), Pruritus (3-9%)
• Edema (1-3%), Increased BUN (3%), Constipation (<3%)
• Increased serum creatinine (2%), Hypertension (4%)

<1%: Abnormal thinking, Anaphylaxis, Blurred vision, Bronchospasm, Cholestatic jaundice, Depression, Hepatitis, Hyperkalemia, Hyponatremia, Hypotension, Liver failure, Melena, Peptic ulcer, Rash, Urinary retention, etc.

Potentially Fatal: Anaphylaxis, Severe skin reactions, MI, Stroke, GI bleeding.

Pregnancy Category: C; D in third trimester (may cause premature closure of ductus arteriosus)

Should be avoided during pregnancy, especially in the third trimester.

• Use with caution in elderly patients
• Use with caution in patients weighing <50 kg
• Use with caution in hepatic dysfunction, heart failure
• Use with caution if predisposition to reduced blood volume or renal blood flow
• Monitor renal function closely in mild renal impairment
• Lactation: Drug excreted in breast milk with multiple doses; contraindicated
• May cause premature closure of ductus arteriosus in third trimester of pregnancy