Usual Adult Dose for Bowel Preparation

Proposed 8 AM surgery: 1 gram orally once at 1 PM, 2 PM, and 11 PM on the day preceding the surgery with erythromycin base

Comments:

• The local bowel preparation regimen protocol and/or the manufacturer product information should be consulted.
• Supplemental IV fluids should be given as needed.

Use: Adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel (e.g., preoperative preparation of the bowel)

American Society of Health-System Pharmacists (ASHP), Infectious Diseases Society of America (IDSA), Surgical Infection Society (SIS), and Society for Healthcare Epidemiology of America (SHEA) Recommendations:
1 gram orally, divided into 3 doses and given over approximately 10 hours the afternoon and evening before the operation and after the mechanical bowel preparation

Comment: This drug should be combined with oral erythromycin or metronidazole and given in addition to IV prophylaxis.

Use: Colorectal surgery prophylaxis when used in conjunction with a mechanical bowel preparation

Usual Adult Dose for Hepatic Encephalopathy

4 to 12 grams orally per day, given in divided doses

• Duration of therapy: 5 to 6 days

Comments:

• Prior to starting treatment, protein should be withdrawn from the diet and diuretic agents should be avoided.
• Supportive therapy should be provided as indicated.
• During treatment, protein should be incrementally returned to the diet.

Use: Adjunctive treatment in hepatic coma (portal-systemic encephalopathy)

Usual Adult Dose for Hepatic Coma

4 to 12 grams orally per day, given in divided doses

• Duration of therapy: 5 to 6 days

Comments:

• Prior to starting treatment, protein should be withdrawn from the diet and diuretic agents should be avoided.
• Supportive therapy should be provided as indicated.
• During treatment, protein should be incrementally returned to the diet.

Use: Adjunctive treatment in hepatic coma (portal-systemic encephalopathy)

Usual Pediatric Dose for Bacterial Infection

American Academy of Pediatrics (AAP) Recommendations:
Pediatric patients beyond the newborn period: 25 mg orally 4 times a day

Use: Treatment of some mild to severe enteric infections

Usual Pediatric Dose for Bowel Preparation

ASHP, IDSA, SIS, and SHEA Recommendations:
Pediatrics: 15 mg/kg orally, divided into 3 doses and given over approximately 10 hours the afternoon and evening before the operation and after the mechanical bowel preparation

• Maximum dose: 1 gram/day

Comment: This drug should be combined with oral erythromycin or metronidazole and given in addition to IV prophylaxis.

Use: Colorectal surgery prophylaxis when used in conjunction with a mechanical bowel preparation

Renal Dose Adjustments

Patients with renal dysfunction: Frequent monitoring recommended.

Renal dysfunction or nephrotoxicity occurring during treatment: The dose should be reduced OR treatment should be discontinued.

Liver Dose Adjustments

Chronic liver dysfunction:
Hepatic coma: Up to 4 grams orally per day

Comments:

• Frequent drug concentration monitoring should be performed.
• Toxicity progressively increases when this drug is used to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond.
• The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity, and neuromuscular blockade associated with drug accumulation in tissues.

Use: Management of hepatic coma (portal-systemic encephalopathy) in patients where potentially toxic drugs cannot be used for chronic liver dysfunction

Precautions

US BOXED WARNINGS:
TOXIC REACTIONS:

• Systemic absorption of this drug occurs following oral administration and toxic reactions may occur.
• Patients treated with this drug should be under close clinical observation because of the potential toxicity associated with their use.
• Neurotoxicity (including ototoxicity) and nephrotoxicity following the oral use of this drug have been reported, even when used in recommended doses.
• The potential for nephrotoxicity, permanent bilateral auditory ototoxicity, and sometimes vestibular toxicity is present in patients with normal renal function when treated with higher doses of this drug and/or for longer periods than recommended.
• Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients).
• The risk of nephrotoxicity is greater in patients with impaired renal function.
• Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after this drug has been discontinued.
• Concurrent and/or sequential systemic, oral, or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, and viomycin, should be avoided because the toxicity may be additive.
• Other factors which increase the risk of toxicity are advanced age and dehydration.
• The concurrent use of this drug with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity.
• In addition, when administered IV, diuretics may enhance the toxicity of this drug by altering the concentration of the antibiotic in serum and tissue.

NEUROMUSCULAR BLOCKADE:

• Neuromuscular blockage and respiratory paralysis have been reported following the oral use of this drug.
• The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if this drug is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood.
• If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• In the presence of intestinal obstruction
• Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides
• Patients with inflammatory/ulcerative gastrointestinal disease

NARROW THERAPEUTIC INDEX:

• This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.

Recommendations:

• Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
• Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be used at the lowest possible dose for the shortest possible time.
• Some experts recommend limiting use of treatment to 2 weeks or less.

Storage requirements:

• Protect from light.

General:

• This drug improves neurologic symptoms associated with hepatic coma by reducing ammonia-forming bacteria in the intestinal tract.
• Limitation of use: This drug should only be used to treat/prevent infections proven or strongly suspected to be caused by bacteria.

Monitoring:

• General: Peak and trough levels
• Genitourinary: Urine examined for specific gravity, protein excretion, presence of cells/casts
• Nervous system: Vestibular (eighth cranial nerve) function monitoring, especially in patients with risk factors
• Other: Auditory function monitoring, especially in patients with risk factors
• Renal: Renal function (e.g., blood urea nitrogen, serum creatinine, creatinine clearance) prior to starting treatment and regularly thereafter, especially in patients with risk factors

Patient advice:

• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Patients should be directed to take the full course of treatment, even if they feel better.

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