Nelin

Nelin Special Precautions

netilmicin

Manufacturer:

Biolab

Distributor:

Biopharm
Full Prescribing Info
Special Precautions
Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.
As with other aminoglycosides, renal function should be closely monitored during therapy. The risk of nephrotoxicity is greater in patients with impaired renal function, in those who receive high dosage or prolonged therapy and the elderly, concurrent use of other nephrotoxic agents, frequent dosing, potassium depletion and decreased intravascular volume. Renal toxicity, may characterized by decreased creatinine clearance, cells or casts in the urine, decreased urine specific gravity, oliguria, proteinuria or evidence of nitrogen retention (increasing BUN, nonprotein nitrogen [NPN] or serum creatinine). Renal damage is usually reversible.
Neurotoxicity, manifested as both auditory (cochlear) and vestibular ototoxicity, can occur with any of these agents. Auditory changes are irreversible, usually bilateral and may be partial or total. Risk of hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations and continues to progress after drug withdrawal. The risk is greater in patients with renal-impairment and with preexisting hearing loss. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
Monitoring of renal and eighth cranial nerve functions is recommended during therapy particularly for patients with known or suspected reduced renal function and also in those renal function is initially normal, but who develops signs of renal dysfunction.
Evidence of renal impairment or ototoxicity requires drug discontinuation or appropriate dosage adjustments. When feasible, monitor, drug serum concentrations. Avoid concomitant use with other ototoxic, neurotoxic or nephrotoxic drugs. Other factors which may increase risk of toxicity are dehydration and advanced age. Patients should be well hydrated during treatment.
Aminoglycosides should be used with caution in patients with neuromuscular disorders, such as Myasthenia gravis, Parkinsonism or infant botulism since these drugs theoretically may aggravate muscle weakness because of their potential curare-like effects on the neuromuscular junction. Neuromuscular blockage resulting in respiratory, paralysis has occurred with aminoglycosides, especially if given with or soon after anesthesia or muscle relaxants.
Extemporaneous admixtures of aminoglycosides with beta-lactam-type antibiotics (penicillins or cephalosporins) may result in inactivation.
NELIN injection contains sodium metabisulfite and sodium sulfite; these may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
Use in Children: Use with caution in premature infants and neonates because of their renal immaturity and the resulting prolongation of serum half-life of these drugs.
Use in the Elderly: These patients may have reduced renal function. Monitoring renal function and drug levels during treatment is particularly important.
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