Amikin

(Generic versions may still be available.)

DRUG DESCRIPTION

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.


Amikacin sulfate is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. D-Streptamine, O-3-amino-3-deoxy-a-b-glucopyranosyl)1>6)-O-[6-amino-6-deoxy-a-D-glucopyranosyl(1>4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-(S)-,sulfate (1:2)(salt).

It has the following molecular formula C22H43N5O13 2H2SO4 with a molecular weight of 781.75.

The dosage form is supplied as asterile, colorless to lightstraw colored solution for IM or IV use. The 100 mg per 2 mL vial, each mL contains: 50 mg Amikacin(as the sulfate), 0.13% Sodium Metabisulfite, 0.5% Sodium Citrate Dihydrate, Water for Injections, Air replaced with Nitrogen. pH is adjusted with Sulfuric Acid and/or if necessary Sodium Hydroxide. pH 3.5-5.5. The 500 mg per 2 mL vial and the 1 gram per 4 mL vial, each mL contains: 250 mg Amikacin(as the sulfate), 0.66% Sodium Metabisulfite, 2.5% Sodium Citrate Dihydrate, Water for Injection qs, Air replaced with Nitrogen. pH is adjusted with Sulfuric Acid and/or if necessary Sodium Hydroxide. pH 3.5-5.5.

What are the possible side effects of amikacin (Amikin, Amikin Pediatric)?

If you experience any of the following serious side effects, stop taking amikacin and seek emergency medical attention:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • little or no urine;
  • decreased hearing or ringing in the ears;
  • dizziness, clumsiness, or unsteadiness;
  • numbness, skin tingling, muscle twitching, or seizures; or
  • severe watery diarrhea and abdominal...

Read All Potential Side Effects and See Pictures of Amikin

What are the precautions when taking amikacin (Amikin)?

Before using amikacin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin, tobramycin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cystic fibrosis, hearing problems (including deafness, decreased hearing), kidney problems, low blood minerals (including potassium, magnesium, calcium), myasthenia gravis, Parkinson's disease.

Amikacin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any...

Read All Potential Precautions of Amikin


Amikin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, stomach upset, or loss of appetite may occur. Pain/irritation/redness at the injection site may infrequently occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling, muscle twitching or weakness, seizure.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using amikacin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin, tobramycin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cystic fibrosis, hearing problems (including deafness, decreased hearing), kidney problems, low blood minerals (including potassium, magnesium, calcium), myasthenia gravis, Parkinson's disease.

Amikacin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially kidney damage.

This medication is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, there have not been reports of harm in babies born to women using amikacin. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in small amounts. However, many doctors consider breastfeeding safe while using this medication. Consult your doctor before breastfeeding.


Amikin Patient Information Including Side Effects

Brand Names: Amikin, Amikin Pediatric

Generic Name: amikacin (Pronunciation: am E kay sin)

  • What is amikacin (Amikin)?
  • What are the possible side effects of amikacin (Amikin)?
  • What is the most important information I should know about amikacin (Amikin)?
  • What should I discuss with my healthcare provider before using amikacin (Amikin)?
  • How should I take amikacin (Amikin)?
  • What happens if I miss a dose (Amikin)?
  • What happens if I overdose (Amikin)?
  • What should I avoid while taking amikacin (Amikin)?
  • What other drugs will affect amikacin (Amikin)?
  • Where can I get more information?

What is amikacin (Amikin)?

Amikacin is an antibiotic. It fights bacteria in the body.

Amikacin is used to treat severe or serious bacterial infections.

Amikacin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of amikacin (Amikin)?

If you experience any of the following serious side effects, stop taking amikacin and seek emergency medical attention:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • little or no urine;
  • decreased hearing or ringing in the ears;
  • dizziness, clumsiness, or unsteadiness;
  • numbness, skin tingling, muscle twitching, or seizures; or
  • severe watery diarrhea and abdominal cramps.

Other, less serious side effects may be more likely to occur. Continue to take amikacin and talk to your doctor if you experience

  • increased thirst;
  • loss of appetite;
  • nausea or vomiting;
  • a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amikacin (Amikin)?

If you are injecting amikacin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Amikacin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

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