Amikacin nebuliser
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Nebuliser dispersion of amikacin sulfate in liposomal formulation.
Drugs List
Therapeutic Indications
Uses
Treatment of Mycobacterium infection (non-tuberculous)
Treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
Dosage
Liposomal amikacin sulfate should be used in combination with other antibacterial agents active against Mycobacterium avium Complex lung infections.
Adults
One vial (590mg) once daily.
Treatment should be continued for 12 months after sputum culture conversion.
Treatment should not be continued beyond a maximum of 6 months if sputum culture conversion (SCC) has not been confirmed.
Maximum duration of treatment should not exceed 18 months.
Additional Dosage Information
Missed doses
If a daily dose is missed, the next dose should be administered the next day. A double dose should not be given.
Administration
For inhalation use only.
To be administered by supplied nebuliser handset only.
Contraindications
Children under 18 years
Myasthenia gravis
Pregnancy
Severe renal impairment
Precautions and Warnings
Auditory impairment
Breastfeeding
Mild renal impairment
Neuromuscular disorder
Pulmonary disease
Vestibular impairment
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Treatment to be initiated and supervised by a specialist
Contains soya or soya derivative
Use designated delivery device only
Monitor auditory and vestibular function
Monitor neuromuscular function
Monitor renal function regularly
Advise patient to seek medical advice if COPD seems to be worsening
Consider discontinuation if nephrotoxicity occurs
Consider discontinuation if ototoxicity occurs
May cause bronchospasm
Discontinue if hypersensitivity reactions occur
Bronchodilator therapy may be used to reduce bronchospasm
Inhaled liposomal amikacin should be administered after using a short-acting bronchodilator in patients with a history of reactive airway disease, asthma or bronchospasm. If there is evidence of bronchospasm due to liposomal amikacin inhalation, the patient may be pre-treated with bronchodilators.
Exacerbation of underlying pulmonary disease (chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) was reported with a higher frequency in patients treated with inhaled liposomal amikacin. Caution should be exercised in patients presenting with these underlying conditions. Discontinuation of treatment should be considered if signs of exacerbation are observed.
Ototoxicity has been reported with inhaled liposomal amikacin. Auditory and vestibular function should be periodically monitored in all patients. Frequent monitoring is recommended in patients with known or suspected auditory or vestibular dysfunction.
Nephrotoxicity has been reported with inhaled liposomal amikacin. Renal function should be monitored periodically during treatment. In patients with pre-existing renal dysfunction, frequent monitoring is recommended.
Pregnancy and Lactation
Pregnancy
Liposomal amikacin is contraindicated during pregnancy.
The manufacturer does not recommend using liposomal amikacin during pregnancy.
At the time of writing, there is no data from the use of liposomal amikacin during pregnancy. Systemic exposure to amikacin following inhalation of inhaled liposomal amikacin is expected to be low compared to parental administration. Aminoglycosides can cause foetal harm and are known to cross the placenta, the potential for harm exists.
Lactation
Use liposomal amikacin with caution during breastfeeding.
The manufacturer advises that the patient either discontinues liposomal amikacin or discontinues breastfeeding.
At the time of writing, there is limited data regarding the presence of amikacin in human milk. Systemic exposure to amikacin following inhalation of inhaled liposomal amikacin is expected to be low compared to parental administration.
Side Effects
Allergic alveolitis
Anaphylactic reaction
Anxiety
Aphonia
Arthralgia
Bronchospasm
Candidiasis
Chest discomfort
Cough
Deafness
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dysphonia
Dyspnoea
Exacerbation of obstructive pulmonary disease
Fatigue
Haemoptysis
Headache
Hypersensitivity reactions
Increased sputum
Laryngitis
Loss of balance
Muscle weakness
Myalgia
Nausea
Nephrotoxicity
Oropharyngeal pain
Ototoxicity
Peripheral neuropathy
Pneumonitis
Presyncope
Productive cough
Pruritus
Pyrexia
Rash
Renal impairment
Throat irritation
Tinnitus
Vertigo
Vomiting
Weight loss
Wheezing
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2021
Reference Sources
Summary of Product Characteristics: Arikayce liposomal 590mg nebuliser dispersion. Insmed Limited. Revised September 2020.
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