"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
- Clinician Information:
Gentamicin Pediatric Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Gentamicin Injection (pediatric) is used to treat a variety of bacterial infections. It is an antibiotic. Common side effects include nausea, vomiting, stomach upset, or loss of appetite. Pain/irritation/redness at the injection site may infrequently occur. This medication can cause serious kidney problems and nerve damage, resulting in permanent hearing loss and balance problems. Tell your doctor if you notice ringing/roaring sounds in the ears, hearing loss, dizziness, or an unusual decrease in the amount of your urine.
The dose of Gentamicin in children is 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours). For infants and neonates, the dose is 7.5 mg/kg/day (2.5 mg/kg administered every 8 hours). Gentamicin may interact with amikacin, tobramycin, amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins, nonsteroidal anti-inflammatory drugs (NSAIDs), or diuretics. Tell your doctor all medications and supplements you use. During pregnancy, Gentamicin should be used only if prescribed and if the benefits outweigh the risks. It may harm a fetus. Some antibiotics may decrease the effectiveness of hormonal birth control; consult your doctor. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Gentamicin Injection (pediatric) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gentamicin Pediatric FDA Prescribing Information: Side Effects
Adverse renal effects, as demonstrated by the presence of casts, cells, or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients treated for longer periods or with larger dosages than recommended.
Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required), and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and hearing loss, which, as with other aminoglycosides, maybeirreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.
Note: The risk of toxic reactions is low in neo-nates,infantsandchildrenwithnormalrenalfunc-tion who do not receive Gentamicin (gentamicin injection pediatric) Injection at higher doses or for longer periods of time than recommended.
Other reported adverse reactions possibly related to gentamicin (gentamicin injection pediatric) include: respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weightloss, hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever and headache; nausea, vomiting, increased salivation and stomatitis; purpura, pseudotum or cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly and splenomegaly.
Laboratory abnormalities possibly related to gentamicin (gentamicin injection pediatric) include: increased levels of serum transaminase (SGOT,SGPT), serum LDH and bilirubin, decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia, and hypokalemia.
While local tolerance of Gentamicin (gentamicin injection pediatric) Injection is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.
Read the entire FDA prescribing information for Gentamicin Pediatric (Gentamicin Injection Pediatric) »
Additional Gentamicin Pediatric 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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