Monday, July 17, 2023

AMINOGLYCOSIDES amikacin, Amikin gentamicin, Garamycin neomycin, streptomycin, tobramycin, Bethkis, Kitabis Pak, TOBI, TOBI Podhaler

 Indications

Amikacin, gentamicin, and tobramycin: Treatment

of serious gram-negative bacterial infections and infections

caused by staphylococci when penicillins or other

less toxic drugs are contraindicated. Streptomycin: In

combination with other agents in the management of

active tuberculosis. Neomycin: Used orally to prepare

the GI tract for surgery, to decrease the number of ammonia-

producing bacteria in the gut as part of the management

of hepatic encephalopathy, and to treat diarrhea

caused by Escherichia coli. Tobramycin by inhalation: Management of Pseudomonas aerugi- A

nosa in cystic fibrosis patients. Gentamicin, streptomycin:

In combination with other agents in the management

of serious enterococcal infections.

Gentamicin IV: Prevention of infective endocarditis.

Gentamicin (topical): Treatment of localized infections

caused by susceptible organisms. Unlabeled

Use: Amikacin: In combination with other agents in

the management of Mycobacterium avium complex

infections.

Action

Inhibits protein synthesis in bacteria at level of 30S ribosome.

Therapeutic Effects: Bactericidal action.

Spectrum: Most aminoglycosides notable for activity

against: P. aeruginosa, Klebsiella pneumoniae, E.coli,

Proteus, Serratia, Acinetobacter, Staphylococcus aureus.

In treatment of enterococcal infections, synergy

with a penicillin is required. Streptomycin and amikacin

also active against Mycobacterium.

Pharmacokinetics

Absorption: Well absorbed after IM administration.

IV administration results in complete bioavailability.

Some absorption follows administration by other

routes. Minimal systemic absorption with neomycin

(may accumulate in patients with renal failure).

Distribution: Widely distributed throughout extracellular

fluid; cross the placenta; small amounts enter

breast milk. Poor penetration into CSF (qwhen meninges

are inflamed).

Metabolism and Excretion: Excretion is 90%

renal.

Half-life: 2–4 hr (qin renal impairment).

TIME/ACTION PROFILE (blood levels*)

ROUTE ONSET PEAK DURATION

PO (neomycin)

rapid 1–4 hr N/A

IM rapid 30–90 min 6–24 hr

IV rapid 15–30 min† 6–24 hr

*All parenterally administered aminoglycosides.

†Postdistribution peak occurs 30 min after the end of a 30-

min infusion and 15 min after the end of a 1-hr infusion.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to aminoglycosides;

Most parenteral products contain bisulfites

and should be avoided in patients with known intolerance;

Pedi: Products containing benzyl alcohol should

be avoided in neonates; Intestinal obstruction (neomycin

only).

Use Cautiously in: Renal impairment (dose adjustments

necessary; blood level monitoring useful in preventing

ototoxicity and nephrotoxicity); Hearing impairment;

Neuromuscular diseases such as myasthenia gravis; Obese patients (dose should be based on ideal

body weight); OB: Tobramycin and streptomycin may

cause congenital deafness; Lactation: Safety not established;

Pedi: Neonates haveqrisk of neuromuscular

blockade; difficulty in assessing auditory and vestibular

function and immature renal function; Geri: Difficulty in

assessing auditory and vestibular function and age-related

renal impairment.

Adverse Reactions/Side Effects

CNS: ataxia, vertigo. EENT: ototoxicity (vestibular

and cochlear). GU: nephrotoxicity. GI: Neomycin—

diarrhea, nausea, vomiting. F and E: hypomagnesemia.

MS: muscle paralysis (high parenteral doses).

Neuro:qneuromuscular blockade. Resp: apnea;

Tobramycin, Inhaln only, bronchospasm, wheezing.

Misc: hypersensitivity reactions.

Interactions

Drug-Drug: Inactivated by penicillins and cephalosporins

when coadministered to patients with renal

insufficiency. Possible respiratory paralysis after inhalation

anesthetics or neuromuscular blocking

agents.qincidence of ototoxicity with loop diuretics

or mannitol (IV).qincidence of nephrotoxicity with

other nephrotoxic drugs. Neomycin mayqanticoagulant

effects of warfarin. Neomycin maypabsorption

of digoxin and methotrexate.

Route/Dosage

Amikacin

IM, IV (Adults and Children): 5 mg/kg every 8 hr or

7.5 mg/kg every 12 hr (not to exceed 1.5 g/day). Mycobacterium

avium complex—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.

Renal Impairment

IM, IV (Adults): Loading dose—7.5 mg/kg, further

dosing based on blood level monitoring and renal function

assessment.

Gentamicin

Many regimens are used; most involve dosing adjusted

on the basis of blood level monitoring and assessment

of renal function.

IM, IV (Adults): 1–2 mg/kg every 8 hr (up to 6 mg/

kg/day in 3 divided doses); Once-daily dosing (unlabeled)—

4–7 mg/kg every 24 hr.

IM, IV (Children 5 yr): 2–2.5 mg/kg/dose every 8

hr; Once daily—5–7.5 mg/kg/dose every 24 hr; Cystic

fibrosis—2.5–3.3 mg/kg/dose every 6–8 hr; Hemodialysis—

1.25–1.75 mg/kg/dose postdialysis.

IM, IV (Children 1 mo–5 yr): 2.5 mg/kg/dose every

8 hr; Once daily—5–7.5 mg/kg/dose every 24 hr;

Cystic fibrosis—2.5–3.3 mg/kg/dose every 6–8 hr;

Hemodialysis—1.25–1.75 mg/kg/dose postdialysis.

IM, IV (Neonates full term and/or 1 wk): Weight

1200 g—2.5 mg/kg/dose every 18–24 hr; Weight

1200–2000 g—2.5 mg/kg/dose every 8–12 hr;

Weight2000 g—2.5 mg/kg/dose every 8 hr;

ECMO—2.5 mg/kg/dose every 18 hr, subsequent

doses based on serum concentrations; Once daily—

3.5–5 mg/kg/dose every 24 hr.

IM, IV (Neonates premature and/or 1 wk):

Weight1000 g—3.5 mg/kg/dose every 24 hr;

Weight 1000–1200 g—2.5 mg/kg/dose every 18–24

hr; Weight 1200 g—2.5 mg/kg/dose every 12 hr;

Once daily—3.5–4 mg/kg/dose every 24 hr.

IT (Adults): 4–8 mg/day.

IT (Infants 3 mo and Children): 1–2 mg/day.

IT (Neonates): 1 mg/day.

Topical (Adults and Children 1mo): Apply cream

or ointment 3–4 times daily.

Renal Impairment

IM, IV (Adults): Initial dose of 2 mg/kg. Subsequent

doses/intervals based on blood level monitoring and renal

function assessment.

Neomycin

PO (Adults): Preoperative intestinal antisepsis—1

g every hr for 4 doses, then 1 g every 4 hr for 5 doses or

1 g at 1 PM, 2 PM, and 11 PM on day before surgery;

Hepatic encephalopathy—1–3 g every 6 hr for 5–6

days; may be followed by 4 g/day chronically.

PO (Children): Preoperative intestinal antisepsis—

15 mg/kg every 4 hr for 2 days or 25 mg/kg at 1 PM, 2

PM, and 11 PM on day before surgery; Hepatic encephalopathy—

12.5–25 mg/kg every 6 hr for 5–6

days (maximum dose12 g/day).

Streptomycin

IM (Adults): Tuberculosis—1 g/day initially,pto 1 g

2–3 times weekly; Other infections—250 mg–1 g

every 6 hr or 500 mg–2 g every12 hr.

IM (Children): Tuberculosis—20 mg/kg/day (not to

exceed 1 g/day); Other infections—5–10 mg/kg

every 6 hr or 10–20 mg/kg every 12 hr.

Renal Impairment

IM (Adults): 1 g initially, further dosing determined by

blood level monitoring and assessment of renal function.

Tobramycin

IM, IV (Adults): 1–2 mg/kg every 8 hr or 4–6.6 mg/

kg/day every 24 hr.

IM, IV (Adults): 3–6 mg/kg/day in 3 divided doses,

or 4–6.6 mg/kg once daily.

IM, IV (Children 5 yr): 6–7.5 mg/kg/day divided

every 8 hr, up to 13 mg/kg/day divided every 6–8 hr in

cystic fibrosis patients (dosing interval may vary from every 6 hr–every 24 hr, depending on clinical situation).

IM, IV (Children 1 mo–5 yr): 7.5 mg/kg/day divided

every 8 hr, up to 13 mg/kg/day divided every 6–8

hr in cystic fibrosis.

IM, IV (Neonates): Preterm 1000 g—3.5 mg/kg/

dose every 24 hr; 0–4 weeks, 1200 g—2.5 mg/kg/

dose every 18 hr; Postnatal age 7 days—2.5 mg/

kg/dose every 12 hr; Postnatal age 8 days, 1200–

2000 g—2.5 mg/kg/dose every 8–12 hr; Postnatal

age 8 days, 2000 g—2.5 mg/kg/dose every 8 hr.

Inhaln (Adults and Children 6 yr): Nebulizer solution—

300 mg twice daily for 28 days, then off for 28

days, then repeat cycle; Powder for inhalation—Inhale

contents of four 28-mg capsules twice daily for 28

days, then off for 28 days, then repeat cycle.

Renal Impairment

IM, IV (Adults): 1 mg/kg initially, further dosing determined

by blood level monitoring and assessment of

renal function.

Availability

Amikacin (generic available)

Injection: 250 mg/mL.

Gentamicin (generic available)

Injection: 10 mg/mL, 40 mg/mL. Premixed injection:

60 mg/50 mL, 80 mg/50 mL, 80 mg/100 mL, 100

mg/50 mL, 100 mg/100 mL, 120 mg/100 mL. Topical

cream: 0.1%. Topical ointment: 0.1%.

Neomycin (generic available)

Tablets: 500 mg. In combination with: other topical

antibiotics or anti-inflammatory agents for skin, ear,

and eye infections. See Appendix B.

Streptomycin (generic available)

Lyophilized powder for injection: 1 g/vial.

Tobramycin (generic available)

Injection: 10 mg/mL, 40 mg/mL. Nebulizer solution

(TOBI, Kitabis Pak): 300 mg/5 mL. Nebulizer solution

(Bethkis): 300 mg/4 mL. Powder for inhalation

(TOBI Podhaler): 28 mg/capsule. Powder for

injection: 1200 mg/vial. Premixed injection: 80 mg/

100 mL.

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