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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded ophthalmic solution containing amikacin sulfate, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing amikacin are listed in injection and suspension forms. No finished amikacin product of any kind is listed in solution form. None of the FDA-approved amikacin products is for use in the eye.
This is a sterile preparation, so its beyond-use date falls under USP <797>, the chapter for sterile compounding, rather than USP <795>. The date printed on the label is the one to follow.
Amikacin is an aminoglycoside antibiotic that compounding pharmacies prepare as sterile injections, nebulized inhalation solutions and intravitreal or intrathecal preparations.
Amikacin is a semisynthetic aminoglycoside antibiotic. It binds the bacterial 30S ribosome, scrambling how the cell reads its genetic code and halting protein synthesis, which kills susceptible bacteria. It is not absorbed from the gut, so there is no oral form. Manufactured amikacin sulfate injection (for example Sagent) is FDA-approved for short-term treatment of serious infections caused by susceptible Gram-negative bacteria, including Pseudomonas, E. coli, Proteus, Klebsiella, Enterobacter, Serratia and Acinetobacter species, given intramuscularly or intravenously. Arikayce (Insmed) is an amikacin liposome inhalation suspension approved for a limited population of adults with refractory Mycobacterium avium complex lung disease. Prescribers may order amikacin compounded as a preservative-free sterile solution for nebulization, intravitreal injection or intrathecal use, forms the manufactured injection is not labeled for. Compounded preparations are not FDA-approved and require a prescription.
Amikacin injection carries an FDA boxed warning for kidney damage, hearing and balance damage that can be permanent, and neuromuscular blockade that can stop breathing. Arikayce, the inhaled liposomal form, carries a separate boxed warning for breathing-related reactions, including lung inflammation, coughing up blood, bronchospasm and worsening lung disease, that have led to hospitalization. Risk rises with dehydration, older age, kidney disease, high blood levels and treatment beyond 14 days. The boxed warning says to avoid other kidney- or nerve-toxic drugs such as vancomycin, amphotericin B, cisplatin, polymyxin B, colistin, bacitracin and other aminoglycosides, and potent diuretics such as furosemide. Anesthetics and muscle relaxants raise the risk of breathing paralysis, so tell your prescriber before any surgery. Do not use amikacin if you have had an allergic or serious toxic reaction to any aminoglycoside. Tell your prescriber about myasthenia gravis, Parkinson's disease or cystic fibrosis. Aminoglycosides can cause fetal harm, including congenital deafness. Amikacin passes poorly into breast milk and the nursing infant absorbs little; watch for diarrhea or thrush. Call your prescriber or pharmacist right away for reduced urination, hearing loss, ringing in the ears, dizziness, tingling or muscle weakness.
Amikacin is bactericidal with concentration-dependent killing and a post-antibiotic effect. Because it resists many aminoglycoside-modifying enzymes it may retain activity against gentamicin- and tobramycin-resistant isolates. It is not absorbed orally; the label notes high concentrations in the renal excretory system and a prolonged half-life in neonates and in renal impairment, where serum creatinine tracks aminoglycoside half-life. Labeled indications: amikacin sulfate injection (IM or IV) for serious susceptible Gram-negative infections, and Arikayce liposomal inhalation for refractory MAC lung disease under accelerated approval. Prescribers have ordered compounded amikacin for intravitreal injection in bacterial endophthalmitis, for intrathecal or intraventricular administration in meningitis, and for nebulization; StatPearls lists the intravitreal and intrathecal or intraventricular routes as off-label and notes that amikacin can be given by nebulization. Dosing, interval and route are per prescriber. Monitoring per the label: renal function before and during therapy, peak and trough serum levels when feasible, serial audiograms in high-risk patients, hydration status and signs of vestibular toxicity. Cephalosporins may add nephrotoxicity, and beta-lactams can inactivate amikacin in vitro, so do not premix. Amikacin is not a controlled substance.
Wash your hands. Tilt your head back, pull your lower eyelid down to form a pocket, and squeeze the number of drops on your label into the pocket without letting the tip touch your eye or anything else. Close your eye for 2 to 3 minutes and press gently on the inner corner. If you need more than one drop, wait at least 5 minutes between drops. Recap tightly without wiping the tip, and wash your hands. Do not use drops that have changed color or become cloudy.
Sterile preparations carry a beyond-use date set under USP <797> based on how they were made and tested; many are kept refrigerated (2 to 8 C), and the label states the storage. Keep the bottle tightly closed, out of reach of children, and discard after the beyond-use date, which may be short.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Instill 1 drop into affected eye(s)
