"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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 Gentamicin Pediatric (gentamicin injection pediatric) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2008
Additional Gentamicin Pediatric Information
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