AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical safety rating
safeNo significant drug interactions Can cause hypernatremia and fluid overload.
Aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibition of protein synthesis.
| Metabolism | Primarily excreted unchanged by glomerular filtration. Minimal hepatic metabolism. |
| Excretion | Renal excretion of unchanged drug via glomerular filtration; >90% eliminated unchanged in urine within 24 hours. Biliary/fecal excretion <1%. |
| Half-life | Terminal elimination half-life: 2–3 hours in patients with normal renal function; may be prolonged to 30–60 hours in anuria. |
| Protein binding | Low protein binding; 0–11% bound, primarily to albumin. |
| Volume of Distribution | Vd: 0.25–0.4 L/kg; approximates extracellular fluid volume. Increased in edema, ascites; decreased in dehydration. |
| Bioavailability | Intravenous: 100% bioavailable. Not administered orally (negligible absorption). |
| Onset of Action | Intravenous: Peak serum concentrations achieved within 30 minutes after infusion completion; clinical effect onset within 30–60 minutes. |
| Duration of Action | Duration varies with renal function; typically 6–8 hours after IV dose, but prolonged in renal impairment. Requires therapeutic drug monitoring. |
| Molecular Weight | 585.6 |
15 mg/kg/day IV divided every 8-12 hours (usual adult dose: 15 mg/kg/day).
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: extend interval to every 12-24 hours; GFR 15-29 mL/min: every 24-48 hours; GFR <15 mL/min (not on dialysis): every 48-96 hours or consider dosing based on serum levels. |
| Liver impairment | No specific Child-Pugh based modifications; monitor renal function and drug levels. |
| Pediatric use | Neonates: 15-20 mg/kg/day IV divided every 12 hours; Infants and Children: 15-22.5 mg/kg/day IV divided every 8-12 hours. |
| Geriatric use | Adjust dose based on renal function; monitor serum creatinine and trough levels; usual starting dose: 15 mg/kg/day with extended intervals per renal function. |
| 1st trimester | Avoid unless no alternative; crosses placenta; risk of ototoxicity and nephrotoxicity to fetus. |
| 2nd trimester | Use only if clearly needed; may cause fetal harm. |
| 3rd trimester | Use only if clearly needed; possible fetal ototoxicity and nephrotoxicity. |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Placental transfer | Amikacin crosses the placenta; fetal serum concentrations may reach 15-50% of maternal levels. |
| Breastfeeding | Amikacin is excreted into breast milk in low concentrations. Absorption by the infant is minimal due to poor oral bioavailability. However, consider the risk of alteration of gut microbiota and potential for allergic reactions. Use with caution. |
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | Aminoglycosides like amikacin cross the placenta. First trimester: No evidence of major malformations, but risk cannot be excluded. Second and third trimesters: Potential for fetal ototoxicity (eighth cranial nerve damage) and nephrotoxicity, especially with high doses or prolonged use. Avoid unless compelling indication. |
| Fetal Monitoring | Monitor maternal serum amikacin trough and peak levels to avoid toxicity (target trough <2-4 mg/L, peak 20-30 mg/L). Assess renal function (serum creatinine, BUN, urinalysis) before and during therapy. Monitor fetal well-being with ultrasound if prolonged use. Newborn hearing screen after birth if prolonged exposure. |
| Fertility Effects | Animal studies show no significant impact on fertility. Human data limited; no known adverse effects on spermatogenesis or ovulation. |
■ FDA Black Box Warning
Aminoglycosides can cause nephrotoxicity and ototoxicity. Neurotoxicity (including vestibular and auditory) may occur even at normal doses. Risk is greater in patients with renal impairment, pre-existing hearing loss, or prolonged use. Monitor renal function and eighth cranial nerve function.
| Common Effects | fluid replacement |
| Serious Effects |
Hypersensitivity to amikacin or other aminoglycosidesMyasthenia gravis (may exacerbate muscle weakness)
| Precautions | Monitor renal function and audiometric tests, Adjust dose based on renal function, Risk of neuromuscular blockade, especially in patients with neuromuscular disorders, Avoid concurrent use of other nephrotoxic or ototoxic drugs, Use caution in neonates, elderly, and patients with dehydration |
| Food/Dietary | No clinically significant food interactions. Maintain adequate hydration. Avoid excessive alcohol consumption. |
| Clinical Pearls | Amikacin is an aminoglycoside antibiotic with concentration-dependent bactericidal activity. Monitor peak (20-30 mcg/mL) and trough (<10 mcg/mL) serum levels to optimize efficacy and minimize toxicity. Adjust dose based on renal function (CrCl). Ototoxicity (vestibular and cochlear) and nephrotoxicity are dose-limiting; audiometry and renal function tests are mandatory. Extended-interval dosing (15-20 mg/kg once daily) is preferred for most indications. Avoid concurrent use with other nephrotoxic drugs (e.g., vancomycin, loop diuretics). |
| Patient Advice | Take exactly as prescribed; do not skip doses or stop early. · Drink plenty of fluids to stay hydrated. · Report hearing changes (ringing in ears, dizziness) immediately. · Report decreased urine output or swelling in legs. · Avoid taking other medications without consulting your doctor, especially pain relievers like ibuprofen. · This medication is given intravenously; you may feel warmth or tingling during infusion. |
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