TORA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TORA (TORA).
Selective β2-adrenergic receptor agonist; relaxes bronchial smooth muscle by increasing intracellular cyclic AMP.
| Metabolism | Hepatic via sulfotransferase to sulfate conjugates; also metabolized by COMT and MAO. |
| Excretion | Renal excretion: 60% as unchanged drug; biliary/fecal: 30% as metabolites; 10% other. |
| Half-life | Terminal elimination half-life: 2.5 hours (range 2-3 hours); clinically, no accumulation with q4-6h dosing. |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd: 1.2 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral: 80% (range 70-90%); IV: 100%. |
| Onset of Action | Oral: 30-60 minutes; IV: 1-2 minutes. |
| Duration of Action | Oral: 4-6 hours; IV: 2-4 hours; clinical note: duration may be prolonged in hepatic impairment. |
| Action Class | Proteolytic Enzymes |
| Brand Substitutes | Serowel Tablet, Fastact 10mg Tablet, Kleezen 10mg Tablet, Basebard 10mg Tablet, Serdase 10mg Tablet, Xtra P 100 mg/500 mg Tablet, Acebloc P 100 mg/500 mg Tablet, Aceclomac Plus 100mg/500mg Tablet, A Plus 100mg/500mg Tablet, Aclomp P 100 mg/500 mg Tablet |
IV/IM: 30-60 mg loading dose, then 15-30 mg every 6 hours as needed; maximum 120 mg/day. Oral not available.
| Dosage form | TABLET |
| Renal impairment | CrCl <30 mL/min: contraindicated (risk of renal toxicity). No adjustment for CrCl 30-50 mL/min (use with caution). |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50% (e.g., 15 mg IV/IM q6h). Child-Pugh Class C: avoid use. |
| Pediatric use | Weight <50 kg: 0.5-1 mg/kg IV/IM as a single dose; maximum 30 mg per dose. Weight ≥50 kg: same as adult dosing. Do not exceed 72 hours of therapy. |
| Geriatric use | Age ≥65 years: starting dose 15 mg IV/IM every 6 hours as needed; maximum 60 mg/day due to increased risk of cardiovascular and GI adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TORA (TORA).
| Breastfeeding | TORA is excreted in breast milk in low concentrations; M/P ratio approximately 0.037. Avoid use in breastfeeding due to potential adverse effects in the infant (GI toxicity, platelet dysfunction). |
| Teratogenic Risk | TORA (ketorolac tromethamine) is an NSAID. First trimester: risk of spontaneous abortion and cardiac defects; avoid unless necessary. Second trimester: relatively safer but use at lowest effective dose. Third trimester: discontinue after 30 weeks due to risk of premature closure of the ductus arteriosus and oligohydramnios. |
■ FDA Black Box Warning
Not available.
| Serious Effects |
["Hypersensitivity to terbutaline or any component","Cardiac arrhythmias associated with tachycardia"]
| Precautions | ["Paradoxical bronchospasm","Cardiovascular effects (tachycardia, arrhythmia, hypertension)","Hypokalemia","Hyperglycemia","Immediate hypersensitivity reactions"] |
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| Fetal Monitoring |
| Monitor fetal heart tones, amniotic fluid index, and ductus arteriosus Doppler if used in second/third trimester. Maternal monitoring: renal function, blood pressure, signs of bleeding. |
| Fertility Effects | TORA may impair female fertility via inhibition of prostaglandin synthesis affecting ovulation. Reversible upon discontinuation. No specific data on male fertility. |