Usp 34 Monograph
Warning • Patients should be under close clinical observation because of potential ototoxicity and nephrotoxicity. 1 2 3 Safety of treatment for >14 days not established.
USP 34 Physical Tests / 〈621〉 Chromatography243 Figure 3. Compressibility Index—Calculate by the formula: ary phase may be packed in a column, spread as a layer. Deficiency in discriminatory effect of USP-34 dissolution monograph on immediate release Fenofibrate tablets having different particle sizes.
1 2 3 • Neurotoxicity (manifested as vestibular and permanent bilateral auditory ototoxicity) can occur in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended. 1 2 3 Risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. 1 2 3 • High-frequency deafness usually occurs first (detectable only by audiometric testing); vertigo may occur (may indicate vestibular injury). 1 2 3 Other neurotoxicity manifestations include numbness, skin tingling, muscle twitching, and seizures. 1 2 3 • Risk of hearing loss increases with degree of exposure to either high peak or high trough serum concentrations. 1 2 3 Patients developing cochlear damage may not have symptoms during aminoglycoside treatment to warn them of developing eighth nerve toxicity and total or partial irreversible bilateral deafness may occur after drug discontinued. 1 2 3 Aminoglycoside-induced ototoxicity usually is irreversible. Nikon Capture Nx2 Full Version.
1 2 3 • Potentially nephrotoxic. 1 2 3 Risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged treatment. 1 2 3 • Neuromuscular blockade and respiratory paralysis reported following parenteral, topical instillation (e.g., in orthopedic and abdominal irrigation, local treatment of empyema), or oral administration of aminoglycosides. 1 2 3 Consider possibility of neuromuscular blockade when any route is used, especially in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in those receiving massive transfusions of citrate-anticoagulated blood. 1 2 3 Calcium salts may reverse neuromuscular blockade, but mechanical respiratory assistance may be necessary. 1 2 3 • Monitor renal and eighth-nerve function closely, especially in patients with known or suspected renal impairment at start of treatment and also in those whose renal function is initially normal but develop renal dysfunction during treatment. Yesudas Mohan Babu Songs on this page. Professional Letter Of Reference For Masters Program here.
1 2 3 Monitor serum amikacin concentrations when feasible to assure adequate concentrations and avoid potentially toxic and prolonged peak concentrations (>35 mcg/mL). 1 2 3 Evaluate urine for decreased specific gravity and periodically determine BUN, serum creatinine, or Cl cr. 1 2 3 • Obtain serial audiograms if feasible in patients old enough to be tested, particularly high-risk patients. 1 2 3 Discontinue or adjust dosage if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss) or nephrotoxicity. 1 2 3 • Avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs (systemic, oral, or topical). 1 2 3 Other factors that may increase risk of toxicity are advanced age and dehydration. 1 2 3 • Avoid concurrent use of potent diuretics since diuretics themselves may cause ototoxicity and may enhance toxicity by altering serum and tissue aminoglycoside concentrations.