Amikacin

Amikacin is a prescription drug used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract. Amikacin belongs to a class of medications called aminoglycoside antibiotics. These work by killing bacteria that cause infections.

This medication is available in an injectable form to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional.

Common side effects of amikacin include nausea, vomiting, diarrhea, headache, and fever.

Amikacin can also cause dizziness. Do not drive or operate heavy machinery until you know how amikacin affects you.

Amikacin is a prescription drug used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Amikacin may be found in some form under the following brand names:

• Amikin

• Arikayce

Serious side effects have been reported with amikacin. See the “Amikacin Precautions” section.

Common side effects of amikacin include the following:

• rash
• fever
• headache
• tingling or numbness in the extremities
• tremor
• nausea
• vomiting
• joint pain
• decreased blood pressure
• vision changes

This is not a complete list of amikacin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acyclovir (Zovirax, Sitavig)
• amphotericin (Abelcet, Ambisome, Amphotec)
• bacitracin
• capreomycin (Capastat)
• certain cephalosporin antibiotics such as cefazolin (Ancef, Kefzol), cefixime (Suprax), or cephalexin (Keflex)
• cisplatin (Platinol, Platinol-AQ)
• colistin (Coly-Mycin S)
• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune)
• diuretics ('water pills') such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), or torsemide (Demadex)
• other aminoglycoside antibiotics such as gentamicin, kanamycin, neomycin (Neo-Fradin), paromomycin, streptomycin, or tobramycin
• polymyxin B
• vancomycin 
• other antibiotics such as amoxicillin (Amoxil, Moxatag, in Augmentin, in Prevpac), ampicillin, or penicillin
• dimenhydrinate (Dramamine)
• meclizine (Bonine)
• nonsteroidal anti-inflammatory drugs such as indomethacin (Indocin)

This is not a complete list of amikacin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with amikacin including the following:

• neurotoxicity. Tell your healthcare provider right away if you have some or all of the following symptoms of damage to the central nervous system:
  • hearing loss
  • loss of balance
  • muscular paralysis

Kidney damage has also been associated with the use of amikacin. Your kidney function and blood tests should be monitored while receiving amikacin.

Amikacin can cause dizziness. Do not drive or operate heavy machinery until you know how amikacin affects you.

Do not take amikacin if you are allergic to amikacin or to any of its ingredients or to any other aminoglycoside antibiotics such as gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Nes-RX, Neo-Fradin), paromomycin (Humatin), streptomycin, and tobramycin (Tobi, Nebcin).

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of amikacin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking amikacin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to amikacin or to any of its ingredients
• are allergic to any other aminoglycoside antibiotics such as gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Nes-RX, Neo-Fradin), paromomycin (Humatin), streptomycin, and tobramycin (Tobi, Nebcin)
• have cystic fibrosis
• have conditions that affect your muscles such as Parkinson’s disease or myasthenia gravis
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amikacin falls into category D. It has been shown that use of amikacin in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if amikacin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using amikacin.

Take amikacin exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight

The recommended dose of amikacin for injection into a muscle or a vein is 15 mg/kg per day divided into 2 or 3 equal doses. Treatment duration will depend on the severity of the infection, other medical conditions you have, and how you respond to this medication.

If you take too much amikacin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If amikacin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store amikacin at room temperature.
• Keep this and all medicines out of the reach of children.

WARNINGS

Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.

Neurotoxicity, manifested as vestibular and permanent bilateral auditory ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or for periods longer than those recommended. The risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during therapy to warn them of developing eighth-nerve toxicity, and total or partial irreversible bilateral deafness may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible.

Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy.

Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides. The possibility of these phenomena should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary.

Renal and eighth-nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels and prolonged peak concentrations above 35 micrograms per mL. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment.

Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. Other factors that may increase risk of toxicity are advanced age and dehydration.

The concurrent use of amikacin with potent diuretics (ethacrynic acid, or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.