Amikin Pediatric Side Effects

Generic name: amikacin

Note: This document contains side effect information about amikacin. Some of the dosage forms listed on this page may not apply to the brand name Amikin Pediatric.

Some side effects of Amikin Pediatric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amikacin: compounding powder, intravenous solution

If you experience any of the following serious side effects, stop taking amikacin (the active ingredient contained in Amikin Pediatric) and seek emergency medical attention:

• an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

• little or no urine;

• decreased hearing or ringing in the ears;

• dizziness, clumsiness, or unsteadiness;

• numbness, skin tingling, muscle twitching, or seizures; or

• severe watery diarrhea and abdominal cramps.

Other, less serious side effects may be more likely to occur. Continue to take amikacin and talk to your doctor if you experience

• increased thirst;

• loss of appetite;

• nausea or vomiting;

• a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to amikacin: compounding powder, intravenous solution

General

All aminoglycosides have the potential to cause auditory, vestibular, and renal toxicity and neuromuscular blockade. Such side effects occurred more often in patients with current or past history of renal impairment, of treatment with other ototoxic or nephrotoxic agents, and in patients treated for longer periods and/or with higher doses than recommended.

Renal

Such renal function changes were usually reversible when the drug was discontinued.

Predisposing factors have included advanced age, preexisting renal insufficiency, dehydration, and concomitant use of other potentially nephrotoxic drugs. One study has shown that hyperbilirubinemia in patients with biliary obstruction may also be a predisposing factor to aminoglycoside nephrotoxicity.

In one prospective, nonrandomized study, patients developed nephrotoxicity in 25% of amikacin (the active ingredient contained in Amikin Pediatric) courses.

Frequency not reported: Nephrotoxicity, elevated serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, oliguria

Nervous system

Ototoxicity may be irreversible and usually includes loss of auditory function secondary to cochlear hair cell damage. Damage may also be vestibular.

High frequency deafness usually occurs before hearing loss can be detected. Hearing loss may be permanent.

Rare neurologic side effects have included neuromuscular blockade, particularly in patients who are predisposed, including patients with myasthenia gravis, hypocalcemia, and patients on concomitant neuromuscular blocking agents.

A case of irreversible sensorineural hearing loss has been reported in a patient with diabetic end stage renal disease, after using an amikacin-heparin lock for 16 weeks (25 mg amikacin (the active ingredient contained in Amikin Pediatric) three times a week).

Rare (less than 0.1%): Headache, paresthesia, tremor
Frequency not reported: Neurotoxicity, ototoxicity (including vestibular and permanent bilateral auditory ototoxicity), neuromuscular blockade, toxic effects on the eighth cranial nerve, hearing loss, loss of balance, cochlear damage, high frequency deafness, total or partial irreversible bilateral deafness, acute muscular paralysis due to neuromuscular blockade, numbness, skin tingling, muscle twitching, convulsions, dizziness, vertigo, tinnitus, roaring in the ears

Respiratory

Frequency not reported: Respiratory paralysis/apnea due to neuromuscular blockade

Musculoskeletal

Rare (less than 0.1%): Arthralgia

Gastrointestinal

Rare (less than 0.1%): Nausea, vomiting

Hematologic

Rare (less than 0.1%): Anemia, eosinophilia

Cardiovascular

Rare (less than 0.1%): Hypotension
Frequency not reported: Hypersensitivity myocarditis

Dermatologic

Rare (less than 0.1%): Skin rash, pruritus, exfoliative dermatitis

Other

Rare (less than 0.1%): Fever, drug fever

Hypersensitivity

Rare (less than 0.1%): Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome (at least 1 case)

Hepatic

Frequency not reported: Elevations in liver function tests (clinical significance unknown)

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