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Amikacin (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Aug 28, 2020.

Pronunciation

(am i KAY sin)

Index Terms

  • Amikacin Sulfate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Inhalation, as sulfate:

Arikayce: 590 mg/8.4 mL (8.4 mL)

Brand Names: U.S.

  • Arikayce

Pharmacologic Category

  • Antibiotic, Aminoglycoside

Pharmacology

Inhibits protein synthesis in susceptible bacteria by binding to 30S ribosomal subunits

Absorption

Variable

Excretion

Urine (7.42% as unchanged drug)

Half-Life Elimination

~5.9 to 19.5 hours

Protein Binding

≤10%

Use: Labeled Indications

Mycobacterium avium complex: Treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options, as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

Limitation of use: Amikacin oral inhalation has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of amikacin is not recommended for patients with non-refractory MAC lung disease.

Contraindications

Hypersensitivity to aminoglycosides

Dosing: Adult

Mycobacterium avium complex: Inhalation: One vial (590 mg) once daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Administration

Inhalation: To be inhaled using the Lamira Nebulizer System over 14 to 20 minutes. Vial should be at room temperature prior to use (if refrigerated, remove at least 45 minutes before use). Shake vial for at least 10 to 15 seconds (until contents appear uniform and well mixed) prior to opening. Refer to the manufacturer's labeling for detailed administration instructions using the nebulizer system. Patients instructed to also use a bronchodilator should administer the bronchodilator prior to using the nebulizer.

Storage

Store vials at 2°C to 8°C (36°F to 46°F); do not freeze. May be stored at room temperature (≤25°C [77°F]) for up to 4 weeks.

Drug Interactions

Loop Diuretics: May enhance the nephrotoxic effect of Amikacin (Oral Inhalation). Loop Diuretics may enhance the ototoxic effect of Amikacin (Oral Inhalation). Monitor therapy

Mannitol (Systemic): Amikacin (Oral Inhalation) may enhance the nephrotoxic effect of Mannitol (Systemic). Avoid combination

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Diarrhea (13%), nausea (12%)

Nervous system: Fatigue (≤16%), voice disorder (47%)

Neuromuscular & skeletal: Asthenia (≤16%), musculoskeletal pain (17%)

Otic: Ototoxicity (17%)

Respiratory: Bronchospasm (29%), cough (39%), exacerbation of pulmonary symptoms (15%; including chronic obstructive pulmonary disease and bronchiectasis), hemoptysis (18%), pneumonia (10%), upper respiratory system symptoms (17%; including irritation, pain, inflammation, edema)

1% to 10%:

Cardiovascular: Chest discomfort (5%)

Dermatologic: Skin rash (6%)

Endocrine & metabolic: Weight loss (6%)

Gastrointestinal: Dysgeusia (3%), oral candidiasis (4%), vomiting (7%), xerostomia (2%)

Nervous system: Anxiety (5%), balance impairment (1%), dizziness (6%), headache (10%)

Neuromuscular & skeletal: Neuromuscular symptoms (2%; including myasthenia, peripheral neuropathy)

Otic: Tinnitus (8%)

Respiratory: Bronchitis (4%), change in bronchial secretions (5%), epistaxis (3%), hypersensitivity pneumonitis (3% to 4%), pneumothorax (2%), respiratory failure (3%)

Miscellaneous: Decreased exercise tolerance (1%), fever (7%)

Frequency not defined: Genitourinary: Nephrotoxicity

Postmarketing: Hypersensitivity: Anaphylaxis, hypersensitivity reaction

ALERT: U.S. Boxed Warning

Risk of increased respiratory adverse reactions

Amikacin oral inhalation has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have been reported. Carefully screen for previous hypersensitivity reactions to aminoglycosides prior to administration.

• Bronchospasm: Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, exertional dyspnea, prolonged expiration, throat tightness, wheezing) has been reported; manage as medically appropriate.

• Hemoptysis: Hemoptysis has been reported; manage as medically appropriate.

• Hypersensitivity pneumonitis: Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction) has been reported; manage as medically appropriate.

• Nephrotoxicity: Nephrotoxicity has been reported with aminoglycosides; use with caution in patients with known or suspected renal dysfunction.

• Neuromuscular blockade: May cause neuromuscular blockade and aggravate muscle weakness. Neuromuscular blockade is reversible but may require treatment (eg, administration of calcium salts, mechanical respiratory assistance).

• Ototoxicity: Ototoxicity (including deafness, dizziness, presyncope, tinnitus, vertigo) has been reported. Use with caution in patients with known or suspected auditory or vestibular dysfunction; if ototoxicity occurs, manage as medically appropriate.

Disease-related concerns:

• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis; patients with neuromuscular disorders were not studied.

• Pulmonary disease: Exacerbation of underlying pulmonary disease (reported as chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) has been reported; manage as medically appropriate.

Pregnancy Considerations

Aminoglycosides may cause fetal harm if administered to a pregnant woman. Systemic absorption of amikacin following oral inhalation is expected to be low compared to intravenous administration; however, systemic exposure was associated with total irreversible bilateral congenital deafness in children whose mothers received a different aminoglycoside during pregnancy.

Refer to the Amikacin (Systemic) monograph for details.

Patient Education

What is this drug used for?

• It is used to treat a type of bacterial infection.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Voice changes

• Throat pain

• Mouth irritation

• Mouth pain

• Throat irritation

• Muscle pain

• Joint pain

• Back pain

• Loss of strength and energy

• Headache

• Weight loss

• Increased sputum

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain

• Lung problems like shortness of breath or other trouble breathing, cough that is new or worse

• Muscle weakness

• Change in balance

• Dizziness

• Passing out

• Noise or ringing in the ears

• Hearing loss

• Hearing changes

• Trouble speaking

• Chest pain

• Fast heartbeat

• Flushing

• Diarrhea

• Nausea

• Vomiting

• Abdominal cramps

• Abdominal pain

• Urinary incontinence

• Bowel incontinence

• High-pitched abnormal breathing sound

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.