amikacin

IM:

REMS

IV: Serious infections for which treatment with less toxic anti-infectives is contraindicated or known to be ineffective.
Inhaln:
Mycobacterium avium
complex (MAC) lung disease in patients who have limited or no other treatment options and who do not achieve negative sputum cultures after ≥6 consecutive months of a multidrug treatment regimen (in combination with other antibacterial drugs).

Action ⬆ ⬇

Inhibits protein synthesis in bacteria at the level of the 30S ribosome.
Resists the action of enzymes known to inactivate other aminoglycosides.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Notable for activity against:
- Pseudomonas aeruginosa,
- Klebsiella pneumoniae,
- Escherichia coli,
- Proteus,
- Providencia ,
- Enterobacter,
- Citrobacter freundii,
- Serratia,
- Acinetobacter,
- Mycobacterium.
Amikacin is also active against Staphylococci (including methicillin-resistant strains).
Acts synergistically with beta-lactam anti-infectives against gram-negative organisms.
In the treatment of enterococcal infections, synergy with a penicillin is required.

Pharmacokinetics ⬆ ⬇

Absorption: Poorly absorbed from the GI tract. Well absorbed after IM administration. IV administration results in complete bioavailability. Absorption variable after administration via inhalation.

Distribution: Widely distributed throughout extracellular fluid. Crosses the placenta; small amounts enter breast milk. Poor penetration into CSF (↑ when meninges inflamed).

Metabolism/Excretion: Excretion is mainly (>90%) renal; minimal amounts are metabolized by the liver.

Half-Life: Infants >7 days: 4–5 hr; Children: 1.6–2.5 hr; Adolescents: 0.5–2.5 hr; Adults: 2–3 hr (↑ in renal impairment, ↓ in patients with burns); 6–20 hr (with inhalation).

Time/Action Profile ⬆ ⬇

(peak blood levels)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	0.75–2 hr	12–24 hr
IV	rapid	within 30 min of 30 min infusion	12–24 hr
Inhaln	Unknown	Unknown	Unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to amikacin, other aminoglycosides, or bisulfites;
OB: Pregnancy ;
Lactation: Lactation.

Use Cautiously in:

Renal or auditory impairment of any kind (dose adjustments necessary—blood level monitoring useful in preventing ototoxicity and nephrotoxicity);
Mitochondrial DNA variants in the 12S rRNA gene (MTRNR1) or maternal history of ototoxicity (↑ risk of ototoxicity);
Neuromuscular diseases such as myasthenia gravis or Parkinson's disease;
Patients with burns (may require larger, more frequent doses);
COPD or asthma (inhalation may worsen condition);
Pedi: Neonates have prolonged half-life due to renal immaturity; safety and effectiveness of inhalation not established in children;
Geri: Older adults due to age-related renal impairment; may be difficult to assess vestibular and auditory function in geriatric or debilitated patients.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash (inhalation only)

EENT: ototoxicity (vestibular and cochlear), voice alteration (inhalation only), epistaxis(inhalation only), oral candidiasis(inhalation only)

GI: diarrhea (inhalation only), nausea (inhalation only), dry mouth (inhalation only), metallic taste (inhalation only), vomiting(inhalation only)

GU: nephrotoxicity

Metab: ↓weight (inhalation only)

Neuro: headache (inhalation only), enhanced neuromuscular blockade, anxiety(inhalation only), vertigo

Resp: bronchospasm(inhalation only), cough (inhalation only), hemoptysis (inhalation only), apnea, hypersensitivity pneumonitis(inhalation only)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Inactivated by extended-spectrum penicillins when coadministered to patients with renal insufficiency.
May potentiate effects of inhalation anesthetics or neuromuscular blockers.
↑incidence of ototoxicity with loop diuretics .
↑incidence of nephrotoxicity with other nephrotoxic drugs, such as amphotericin, vancomycin, acyclovir, cisplatin, or cephalosporins.

Route/Dosage ⬆ ⬇

IM IV (Adults and Children ): 15 mg/kg/day divided every 8–12 hr (not to exceed 1.5 g/day). Mycobacterium avium complex infection: 7.5–15 mg/kg/day divided every 12–24 hr.
IM IV (Neonates ): Loading dose: 10 mg/kg. Maintenance dose: 7.5 mg/kg every 12 hr.
Inhaln
(Adults ): 590 mg once daily.

Renal Impairment

IM IV (Adults ): Loading dose: 7.5 mg/kg; further dosing based on serum levels.

Availability ⬆ ⬇

(Generic available)

Solution for injection: 250 mg/mL
Suspension for oral inhalation: 590 mg/8.4 mL

Assessment ⬆ ⬇

Assess for infection (vital signs; wound appearance; sputum, urine, and stool; WBCs at beginning and throughout therapy.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Evaluate eighth cranial nerve function by audiometry before and throughout therapy. Hearing loss is usually in the high-frequency range. Prompt recognition and intervention are essential in preventing permanent damage. Also monitor for vestibular dysfunction (vertigo, ataxia, nausea, vomiting). Eighth cranial nerve dysfunction is associated with persistently elevated peak amikacin levels. Amikacin should be discontinued if tinnitus or subjective hearing loss occurs.
Monitor intake and output and daily weight to assess hydration status and renal function.
Assess for signs of superinfection (fever, upper respiratory infection, vaginal itching or discharge, increasing malaise, diarrhea).

Lab Test Considerations:

Monitor renal function by urinalysis, specific gravity, BUN, serum creatinine, and CCr before and during therapy.
- May cause ↑ BUN and creatinine concentrations.

Toxicity and Overdose:

Monitor therapeutic blood levels periodically during therapy. Timing of blood levels is important in interpreting results. Draw blood for peak levels 1 hr after IM injection and 30 min after a 30-min IV infusion is completed. Trough levels should be drawn just before next dose. Peak level range 20–30 mcg/mL; trough level <10 mcg/mL.

Implementation ⬆ ⬇

Keep patient well hydrated (1500–2000 mL/day) during therapy.
IV: If aminoglycosides and penicillins or cephalosporins must be administered concurrently, administer in separate sites, at least 1 hr apart.

IV Administration:

Intermittent Infusion: Diluent: Dilute with D5W, D10W, 0.9% NaCl, dextrose/saline combinations, or LR. Solution may be pale yellow without decreased potency. Stable for 24 hr at room temperature.Concentration: 10 mg/mL.
Rate: Infuse over 30–60 min.
Inhaln: Consider pre-treatment with short-acting selective beta-2 agonists for patients with hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm.
- For patients taking bronchodilators, use bronchodilator before amikacin inhalation.
- Administer by nebulization only with Lamira^TM Nebulizer System. Nebulizer should be at room temperature. Shake well for at least 10–15 sec until contents appear uniform. Flip plastic top of vial up then pull down to loosen metal ring. Remove ring and rubber stopper carefully. Pour into medication reservoir of nebulizer handset.

Patient/Family Teaching ⬆ ⬇

Instruct patient to report signs of hypersensitivity, tinnitus, vertigo, muscle weakness/twitching, feeling of fullness in the head, or hearing loss.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
Rep: May cause permanent fetal deafness. Advise female patients of reproductive potential to notify health care professional immediately of pregnancy is planned or suspected or if breastfeeding.
Inhaln: Instruct patient in correct use of nebulizer. If dose is missed administer dose next day; do not double doses.
Advise patient to notify health care professional if fever, coughing, fast breathing, shortness of breath, wheezing, coughing up blood, difficulty speaking, worsening of lung disease, ringing in ears, or dizziness occur.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of the signs and symptoms of infection. If no response is seen within 3–5 days, new cultures should be obtained.

US Brand Names ⬆ ⬇

~~Amikin,~~ Arikayce

Code ⬆

NDC Code

0641- West-Ward Pharmaceuticals Corp.
- 0641-6166- Amikacin Sulfate
  - 0641-6166-10- 10 VIAL in 1 CARTON (0641-6166-10) > 4 mL in 1 VIAL (0641-6166-01)

0641- West-Ward Pharmaceuticals Corp.
- 0641-6167- Amikacin Sulfate
  - 0641-6167-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) > 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)

0703- Teva Parenteral Medicines, Inc.
- 0703-9032- Amikacin Sulfate
  - 0703-9032-03- 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9032-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-9032-01)

0703- Teva Parenteral Medicines, Inc.
- 0703-9040- Amikacin Sulfate
  - 0703-9040-03- 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9040-03) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-9040-01)

23155- Heritage Pharmaceuticals Inc.
- 23155-290- Amikacin Sulfate
  - 23155-290-41- 10 VIAL, GLASS in 1 CARTON (23155-290-41) > 2 mL in 1 VIAL, GLASS (23155-290-31)

23155- Heritage Pharmaceuticals Inc.
- 23155-290- Amikacin Sulfate
  - 23155-290-42- 10 VIAL, GLASS in 1 CARTON (23155-290-42) > 4 mL in 1 VIAL, GLASS (23155-290-32)

25021- Sagent Pharmaceuticals
- 25021-173- amikacin sulfate
  - 25021-173-02- 10 VIAL in 1 CARTON (25021-173-02) > 2 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-173- amikacin sulfate
  - 25021-173-04- 10 VIAL in 1 CARTON (25021-173-04) > 4 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-815- Amikacin Sulfate
  - 63323-815-02- 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) > 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)

63323- Fresenius Kabi USA, LLC
- 63323-815- Amikacin Sulfate
  - 63323-815-04- 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) > 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)

71558- Insmed Incorporated
- 71558-590- ARIKAYCE
  - 71558-590-28- 28 VIAL in 1 CARTON (71558-590-28) > 8.4 mL in 1 VIAL

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇