Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for amikacin (amikacin sulphate), the active ingredient registered with NAFDAC.
LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease 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. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options . This drug is indicated for use in a limited and specific population of patients. …
The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Hypersensitivity pneumonitis [see Boxed Warning and Warnings and Precautions (5.1) ] Hemoptysis [see Boxed Warning and Warnings and Precautions (5.2) ] Bronchospasm [see Boxed Warning and Warnings and Precautions (5.3) ] Exacerbation of Underlying Pulmonary Disease [see Boxed Warning and Warnings and Precautions (5.4) ] Anaphylaxis and Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Ototoxicity [see Warnings and Precautions (5.6) ] Nephrotoxicity [see Warnings and Precautions (5.7) ] Neuromuscular Blockade [see Warnings and Precautions (5.8) ] Most common adv …
ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )
Hypersensitivity Pneumonitis : Reported with ARIKAYCE treatment; if hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. ( 5.1 ) Hemoptysis : Higher frequency of hemoptysis has been reported with ARIKAYCE treatment. If hemoptysis occurs, manage the patients as medically appropriate. ( 5.2 ) Bronchospasm : Higher frequency of bronchospasm has been reported with ARIKAYCE treatment. Treat patients as medically appropriate if this occurs during treatment with ARIKAYCE. ( 5.3 ) Exacerbations of Underlying Pulmonary Disease: Higher frequency of exacerbations of underlying pulmonary disease has been reported with ARIKAYCE treatment. …
8.1 Pregnancy Risk Summary There are no data on ARIKAYCE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Although systemic absorption of amikacin following oral inhalation is expected to be low [see Clinical Pharmacology (12.3) ], systemic exposure to aminoglycoside antibacterial drugs, including ARIKAYCE, may be associated with total, irreversible, bilatera …
Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. Once expired, discard any unused drug. ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks. …
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Amikacin Sulphate Injection contains Amikacin (Amikacin Sulphate) (500 mg/2 mL), as solution for injection, according to its NAFDAC registration record.
Yes. Amikacin Sulphate Injection is listed on the NAFDAC register under registration number A4-8442, and its registration is active as of 28 October 2026.
No WHO falsified or substandard medical product alert currently matches Amikacin Sulphate Injection in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-8442, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease 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. As only limited clinical safety (Summarised from the official U.S. FDA label for amikacin (amikacin sulphate). Always follow your doctor or pharmacist.)
Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.