"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
(Generic versions may still be available.)
Amikin Consumer (continued)
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.
Read the Amikin (amikacin) Side Effects Center for a complete guide to possible side effects
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.
Additional Amikin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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