Acuvail 0.45% Eye Drops (Solution)
Ketorolac Tromethamine
4.5mg/ml
ALLERGAN SALES, LLC.
| Pack size | 0.4ml Single-Use Vial x 30 |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | AHMED KHALIL AL BAKER MEDICAL SUPPLIES COMPANY |
| Retail Price | 45.50 AED |
Indications
Acuvail 0.45% Eye Drops (Solution) is used for:
Moderate to severe pain
Adult Dose
Oral
Adult
Moderately Severe Acute Pain
Short-term (<5 days) management of moderately severe acute pain that requires analgesia at opioid level; not indicated for minor or chronic painful conditions
IV: 30 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day
IM: 60 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day
PO: 20 mg once after IV or IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day
Elderly
IV: 15 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day
IM: 30 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day
PO: 10 mg once after IV or IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day
Dosing Considerations
Always begin with parenteral therapy; oral administration indicated only as continuation of IV/IM dosing, if necessary
Duration of therapy should not exceed 5 days
Child Dose
<2 years
Safety and efficacy not established
2-16 years
Single dose: 0.5 mg/kg IV/IM once; not to exceed 15 mg
Multiple dose: 0.5 mg/kg IV/IM q6hr; not to exceed 5 days
Renal Dose
Renal impairment
Severe: Contraindicated
Moderate (moderately elevated serum creatinine): Use 50% of recommended dosage; not to exceed 60 mg/day IM/IV
Administration
Contra Indications
Hypersensitivity to aspirin or other NSAIDs, asthma. Hypovolaemia or dehydration. Do not give postoperatively to patients with high risk of haemorrhage. History of peptic ulcer or coagulation disorders. Nasal polyps, angioedema, bronchospasm. Labour. Moderate to severe renal impairment. GI bleeding, cerebrovascular bleeding. As prophylactic analgesic before surgery. Pregnancy, lactation.
Precautions
Elderly, patients weighing <50 kg, hepatic dysfunction, heart failure, predisposition to reduced blood volume or renal blood flow. Mild renal impairment; monitor renal function closely.
Lactation: Drug excreted in breast milk with multiple doses; use contraindicated
Pregnancy-Lactation
Pregnancy category: C; D in third trimester (may cause premature closure of ductus arteriosus)
Lactation: Drug excreted in breast milk with multiple doses; use contraindicated
Interactions
May reduce effects of antihypertensives eg ACE inhibitors or angiotensin II receptor antagonists (AIIA). Increased risk of renal toxicity with ACE inhibitors, diuretics. Increased adverse effects with aspirin or other NSAIDs. Hallucinations may occur when used with fluoxetine, thiothixene, alprazolam.
Potentially Fatal: Increased risk of GI bleeding with warfarin. May increase toxicity of methotrexate (MTX) and lithium. Increased plasma concentrations with probenecid.
Adverse Effects
Side effects of Ketorolac Tromethamine :
>10%
Headache (17%), Somnolence (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 blood urea nitrogen (BUN) (3%), Constipation (<3%), Purpura (<3%), Increased serum creatinine (2%), Drowsiness (6%), Hypertension (4%)
<1%
Abnormal thinking, Anaphylaxis, Blurred vision, Bronchospasm, Cholestatic jaundice, Depression, Difficulty in concentration, Dysgeusia, Euphoria, Hemolytic-uremic syndrome, Hepatitis, Hyperkalemia, Hyponatremia, Hypotension, Increased liver function test values, Insomnia, Laryngeal/lingual edema, Liver failure, Melena, Nervousness, Oliguria, Pallor, Peptic ulcer, Rash, Rectal bleeding, Stomatitis, Urinary frequency, Urinary retention, Vasodilation
Potentially Fatal: Anaphylaxis. Severe skin reactions. MI, stroke, GI bleeding.
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by decreasing the activity of the cyclooxygenase enzyme.
Note
Acuvail 0.45% 4.5mg/ml Eye Drops (Solution) manufactured by ALLERGAN SALES, LLC.. Its generic name is Ketorolac Tromethamine. Acuvail 0.45% is availble in United Arab Emirates.
Farmaco UAE drug index information on Acuvail 0.45% Eye Drops (Solution) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.