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Rx Item-Gentamicin 0.3% Drops 5Ml By Valeant Gen Garamycin

RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Gentamicin 0.3% Drops 5Ml By Valeant Gen Garamycin

$42.85$14.99

Item No.:RX913863/A, Item No. RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608, Rx Item-Gentamicin 0.3% Drops 5Ml By Valeant Only Physician, Pharmacy Or Licensed Facility Can purchase this RX Item Brand/Generic: , Drug Category: Opthalmlogy-AntibioticDrug Class: 52040400 Antibacterials (Eent)

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Clinical Information
Gen. Code and Des.
7984 gentamicin sulfate OPHTHALMIC DROPS 0.3 %
GCN and Des.
33600 gentamicin sulfate OPHTHALMIC DROPS 0.3 %
Strength
0.3%
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
52040400 ANTIBACTERIALS (EENT)
Active Ingredients
2778 gentamicin sulfate 1405410
Inactive Ingredients
3141 benzalkonium chloride 8001545




GENTAMICIN- gentamicin sulfate injection, solution
APP Pharmaceuticals, LLC


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS

Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.



As with other aminoglycosides, Gentamicin Injection is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy.

Neurotoxicity manifested by ototoxicity, both vestibular and auditory, can occur in patients treated with gentamicin, primarily in those with pre-existing renal damage and in patients with normal renal function treated with higher doses and/or for longer periods than recommended. Aminoglycoside-induced ototoxicity is usually irreversible. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

Renal and eighth cranial nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Urine should be examined for decreased specific gravity, increased excretion of protein, and the presence of cells or casts. Blood urea nitrogen (BUN), serum creatinine, or creatinine clearance should be determined periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug. As with the other aminoglycosides, on rare occasions changes in renal and eighth cranial nerve function may not become manifest until soon after completion of therapy.

Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. When monitoring gentamicin peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided.

When monitoring gentamicin trough concentrations, dosage should be adjusted so that levels above 2 mcg/mL are avoided. Excessive peak and/or trough serum concentrations of aminoglycosides may increase the risk of renal and eighth cranial nerve toxicity. In the event of overdose or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, especially if renal function is, or becomes, compromised. The rate of removal of gentamicin is considerably less by peritoneal dialysis than by hemodialysis.

In the newborn infant, exchange transfusions may also be considered.

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as cisplatin, cephaloridine, kanamycin, amikacin, neomycin, polymyxin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin, and viomycin, should be avoided. Other factors which may increase patient risk of toxicity are advanced age and dehydration.

The concurrent use of gentamicin with potent diuretics, such as ethacrynic acid or furosemide, should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering the antibiotic concentration in serum and tissue.

Aminoglycosides can cause fetal harm when administered to a pregnant woman (see WARNINGS section).

DESCRIPTION

Gentamicin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from Micromonospora purpurea, an actinomycete.

It has the following structural formula:

Gentamicin Structure
(click image for full-size original)
Gentamicin Injection is a sterile, nonpyrogenic, aqueous solution for parenteral administration and is available both with and without preservatives.

Each mL of the preserved product contains: Gentamicin sulfate equivalent to gentamicin 10 mg; methylparaben 1.3 mg and propylparaben 0.2 mg as preservatives; sodium metabisulfite 3.2 mg; edetate disodium 0.1 mg; Water for Injection q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment (3.0 to 5.5).

CLINICAL PHARMACOLOGY

After intramuscular administration of gentamicin sulfate, peak serum concentrations usually occur between 30 and 60 minutes and serum levels are measurable for 6 to 8 hours. In infants, a single dose of 2.5 mg/kg usually provides a peak serum level in the range of 3 to 5 mcg/mL. When gentamicin is administered by intravenous infusion over a two-hour period, the serum concentrations are similar to those obtained by intramuscular administration. Age markedly affects the peak concentrations: in one report, a 1 mg/kg dose produced mean peak concentrations of 1.58, 2.03, and 2.81 mcg/mL in patients six months to five years old, 5 to 10 years old, and over 10 years old, respectively.

In infants one week to six months of age, the half-life is 3 to 3 � hours. In full-term and large premature infants less than one week old, the approximate serum half-life of gentamicin is 5 � hours. In small premature infants, the half-life is inversely related to birth weight. In premature infants weighing less than 1500 grams, the half-life is 11 � hours; in those weighing 1500 to 2000 grams, the half-life is eight hours; in those weigh�ing over 2000 grams, the half-life is approximately five hours. While some variation is to be expected due to a number of variables such as age, body temperature, surface area and physiologic differences, the individual patient given the same dose tends to have similar levels in repeated determinations.

Gentamicin, like all aminoglycosides, may accumulate in the serum and tissues of patients treated with higher doses and/or for prolonged periods, particularly in the presence of impaired or immature renal function. In patients with immature or impaired renal function, gentamicin is cleared from the body more slowly than in patients with normal renal function. The more severe the impairment, the slower the clearance. (Dosage must be adjusted.)

Since gentamicin is distributed in extracellular fluid, peak serum concentrations may be lower than usual in patients who have a large volume of this fluid. Serum concentrations of gentamicin in febrile patients may be lower than those in afebrile patients given the same dose. When body temperature returns to normal, serum concentrations of the drug may rise. Febrile and anemic states may be associated with a shorter than usual serum half-life. (Dosage adjustment is usually not necessary.) In severely burned patients, the half-life may be significantly decreased and resulting serum concentrations may be lower than anticipated from the mg/kg dose.

RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608
RX ITEM-Gentamicin 0.3% Drops 5Ml By Val
RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608

RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608
Gentamicin 0.3% Drops 5Ml By Valeant
RX913863, 913863, NDC No.: 24208-0580-60, 24208-580-60, 2420858060, 24208058060, 0580-60, 058060 UPC No. 3-24208-58060-8, 324208-580608, 324208580608

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
GENTAMICIN SULFATE OPHTHA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.