Garamycin

Garamycin

Garamycin* injection 40 mg per ml & 80 mg per 2 ml. Brand of gentamicin sulfate injection, aqueous solution FOR PARENTRAL ADMINISTRATION (Intramuscular and Intravenous) Description: Each ml of Goanyon intection contains the ontinoglycoside antibiotic gentamicin sato*, equivalent M 40 ring gentamicin base, methaaroben and propylparaben as preservatives, salurn Wulf tie and disodiurn edetate. Actions: Microbiology:1n vitro tests have demonstrated that gentamicin Is a bactericidal antibiotic which acts by inhibiting protein synthesis in susceptible microorganisms. It 8 active against a wide variety of pathogenic Gram-negative and Gram-positive bacteria, Including Escherlchia Proteus sp (mdole - positive and indole • negative). Pseudomonas rkeruginosa, species of the Kiebsiella -EnterobaCter - Serratia group, Chrobacter sp., Providencia sp.. Staphylococcus so (coagulase.posilive and coogulasenegatrve including penicillin and methIcinn - resistant strains). and Massed° gonorrhoeoe. Gentornicin is also active In vitro against species of Salmonella and Shigella. In vitro Mares have shown mat on crminoglycoside combined with an antibiotic Mat Interferes with cell wall synthesis may act synergistically against some group D streptococcal Cans The combination of gentamicin and penicillin G has a synergistic bactericidal effect against Wrtally all strains of Streptococcus faecalis and Is varieties (S. faecalls varliquifaciens S. faecalis var. 2yrnogenes), S. foeciurn and S.durons. An enhanced ding effect against many of Mese strains also has been shown in vitro with combinations of gentamicin and ampicillh carbenicillin, nofcillin or oxacillin.lbe combined effect of gentamicin and carbenicillin Is synergistic for many strains of PseudOmonas aeruginosa. In via synergism against other Gram-negative organisms has been shown wth combinations of gentamicin and cepholosporins. Gentomicin may be active against clinical Isolates of bacteria resistant to other aminoglycosides. Bacteria resistant to one arninoglycosIde may be resistant to one or more other arnInoglycodes. Bacterial resistance to gentamicin is generalry developed slowly Indications and Usage: Goramycin injection is indicated In the treatment of infections caused by susceptible strains of Me following microorganisms: Pseudornonas aeruginosa. Proteus sp. (node-posit/0 and indole-negative), Escherichia colt Klebslello-Enterobacter -Serroth Sp. ProAdencia sp., Staphylococcus sp. (coagulase-postlive and coogulase-negative, Including penicillin and methicillin -resistant strains), and Neisserla gonorrhoea°. Clinical studies hove shown Garamycin Injection to be effective In - Septicemia, anteremia (including neonatal sepsis). - Serious infections of the central nervous system (CNS) (including meningitis). - infections of the kidney and gentto - urinary tract (Including peMc). - Respiratory tract Infections. - Infections of the gastrointestinal tract - Skin, bone or soft tissue infections (Including Infected bums and wounds). -Intra-abdominol infections (Including peritonitis) - Ocular Infections. Garamycin injection may be considered as initial therapy in suspected or confirmed Gram-negative infections. In suspected Gram-negative Infections, the decision to continue therapy with Garamycln injection should be based on results of susceptibility tests and me patients clinical response and tolerance to the drug. In serious infections. when the causative micro-organisms are unknown GararnyctinjeCtiOn may be administered as (noel therapy In conjunction with a penicillin or cepholosporin type drug before obtaining result of susceptibility testing. If anaerobic micro-organisms are suspected, sundae antimicrobial therapy in conlunction with Garamycln intechon or other approprae antibiotic therapy should then be continued. Garanycin injection has been used effectively in combination with car/penicillin or ficamillin for the treatment of lifearecrlening infections caused by Pseudomonas aeruginosa. It has also been found effective when used' n conjunction with a penicillin-type drug for me treatment of endocarditis caused by group ID streptococci. In the neonate with suspected sepsis or staphylococci pneumonia a pentillinin/pe drug is also usuoly indicated as concomitant therapy with gentamicin.Garamycin injection has been shown to be effective in the treatment of serious staphylococcal infections. In the pied-operative period, Garanyan Infection may be staffed Prearaatihery and continued postoperonvely for treatment of suspected a proven Infection due to susceptible microorganisms. Subconjunclival administration of gentammn is recommended for treatment of endoplehalmitis caused by sensitive microorganisms. timay be used prophylactically in patients undergoing high risk intraccular surgery, especially if preoperative cultures or smears contain Gram-negative microorganisms. Garanycin injection may aso be administered by direct endoacheol instillation or by nebutarlon as an adjunct to systemic titeroPY in the hmstment 01neria.P0monanf infections. GeramYcin Intralnecal injection is indicated as an adjunct to systemic therapy in Me treatment of serious CNS infections, such as meningitis and ventriculMs caused by susceptible Gram-negative microorganisms, A preservative free intrathecal presentation is available. Dosage and Administration: The recommended dosage for Intravenous and intramuscular adminishalion is identical. Gararnyon injecfion also may be administered by subconiunctival or subtenon Injection. nebulization or direct endatracheal Instillation. The patient OreBedO,OO) body weight should be obtained for calculation of correct dosage. Garomycin injection should not be physically premixed with other drugs but should be administered separately In accordance with The recommended mute of administration and dosage schedule. It R desirable to measure peak and trough gentamicin serum concentration to assure adequate, but not excessive levels. The peak concentration is expected to be in the range of 4 to 6 mcg/a. Trough levels above 2 mcg/mi should be avoided. Determination of the adequacy of a serum Mal for a particular parent must take into consideration susceptibility of the causative microorganism, severity of infection, and me status of the patients host-defense mechanisms. The usual duration of treatment for all patients is seven to ten days. In complicated infections, a longer course of therapy may be necessary. In such cams montioring of renal, auditory and vestibular functions 8 recommended, since toxicrry is more likely to occur with treatment extended oAp ten days. Dosage should be reduced if clinically indicated. Intramuscular Administration: Patients with Normal Renal Function: Adults: Recommended dosage of Gararnycln injection for patients with serious infections and normal renal function is 3 mg/Kg/day, administered in three equal doses every eight hours or two equal doses every 12 hours. A simplified dosing may be used for adults weighing over 60 Kg, 80 mg three limes daily or a dose of 120 mg may be given every 12 hours, for adults weighing 60 kg or less, 60 rim three times daily For very small or very large adults, dosage should be calculated in milligram per kilogram of lean body weight. For patients with Be-threatening Infections, dosages up to 5 mg/kg/day may be administered In three or four equal doses. this dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. When systemic or urinary haat infections are of moderate severity and me causative microorganism is KernI to be highly responsive a dosage of 2 mg/kg/day administered in two equal doses may be considered. However, if prompt clinical response is not apparent, dosage should be increased to 3 mg/kg/day administered in three equal doses. Gentamicin is highly concentrated in urine and renal tissue. In patients with urinary tract infection, particularly If chronic or recurrent and wrihout evidence of impairment of renal function Garamych injection may be administered Intramuscularly in a dose of 160 mg once a day for 7 to 10 days. For adults weighing less than 50 Kg the single dal)/ dose should be 3 mg/Kg of booty weight Pediatric Patients: emand° or fur term neonates one week of age or less: 5 to 6 mg/kg/clay (2.5 to 3 mg/kg administered every 12 hours) Neonates over one week of age and Wont: 7.5 mg/kg/day (2.5 mg/kg administered every 8 hours) Children.' 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hourstA goramycin pediatric injection formulation is available. Patients with impaired Renal function: Dosage must be adjusted in patients with Impaired renal function. Whenever possible serum concentrations of gentarnicln shout] be monttored. Dosage schedules are not intended as rigid recommendations, but are provided as guides to dosage when the measurements of gentamee serum levels 8 not feasible. One method of dosage adjustment is to increase the Interval between administration of the usual doses. Since Me serum crealinlne concenhation has a high correlation with the serum half-life of genfamicln this laboratory test may provide gudance for adjustment of the Interval between doses The Interval between doses fin hour, may be approximated by multiplAng the serum creatinine eve (mg/100 mil by 8 (Table It For example, a patient weighing 60 Kg with a serum creatinine level of 2 mg/I00 ml could be given 60 mg (I mg/Kg( every 16 hours (2 mai 00 ml x 8). Table I Dosage adjustment Guide For Patients With Renal impairment I Interval of adminishation between usual doses is prolonged)
AMKB-80-3/40-6-in-11B
Body
"s•
Croallnino
creutinirre
(mg 1100 mil
Blood IVgg„ (mg 1100 mil
Over 60 kg
loos 1 5-3 7 38-5
Boro 0 hours Soars koos
60 kg or loos
60 mg ( 1
agave
n patients with serous systemic infections and renal impairment t may be desirable to administer Me antibiotic more keg/Jenny but in reamed dosage. In such patients,gentomicn serum concentrations should be measured. After the usual mita dose, a rough guide for determining reduced dosage al eight-hour intervals is to dMde Me normally recommended dose by the serum creatinine level ( Table 2). For example, after an mrtial dose of 60 mg (1 mg / kg ), a patient weighing 60 kg wait a serum creatinine level of 2.0 mg / 100 ml could be given 30 mg every eight hours (60'21. It should be noted that the status of renal function may be changing over the course of the infectious process. Table 2 Dosage adjustment Guide For Pallenh With Renal impairment( Decreased Dosage at Eight - Slour Intervals Alter Me usual Meal Dose)
Serum Creatuae ( mg ' 100 ml i Approximate Crenate Clearance Rate ( ml / nun ' 1.73 m2) Percent of usual dose _ _��- >100 100 70-100 80 55-70 65 45-55 55 4045 50 35-40 40 30-35 35 25-30 30 20-25 25 15-20 20 10-15 15 <10 10
In adults v4th end failure undergoing hemodlaysls, the amount of gee amble removed horn the blood may vary depending upon several memrs including the dialysis method used A six-hour hemodalysis may reduce gentamicin serum concentrations by approximately 50 98.Shorter dMilysis .sessions will remand less drug Recommended dosage at tile end of each dialysis period is 1 to 1.7 mg / kg depending upon the severity of infection. In children, a dose of 2.0 to 2.5 mg / kg may be administered. raanoghmosicles are also removed by portioned dkrlysis but at a rate considerobry less tan by hemodialysis. Intravenous Adminisirahon: Intravenous administration of gentamicin is useful for treating patents with septicemia or more In shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe bums, or those with reduced mumle mass. For intravenous administration In °Mitts, a single dose of Garamycin injection may be diluted n 50 to 200 ml of sterile normal seine or in a sterile solution of deem. 5 % in water in infants and children, the volume of diluent should be has The solution may be infused over a period of one halt to Iwo hoursin certain circumstances a single dose of Garamycln Injection may also be given directly into a vein or LV tubing slowly over a period of 2 to 3 minutes. Concomitant Itterapyrn combination with other antibiotics, me dosage of Gararnycln Injection most not be reduced. Adverse reactions: Nephrotoxicily Adverse renal effects occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger than recommended dosage-Neurotoxictly : Adverse effects on both vestibular and auditory branches of the eight cranial nerve have been reported rvimarily In patients with rend Impairment and in patients on high doses and/or prolonged therapy Symptoms Include dulness, vertigo tinnilus. roaring in the ears and hearing loss. Hearing loss is usually manifested Initially by diminution of high tone acuity and may be irreversible. Other factors that may Increase the risk of aminogrycoside educed ototoxicity Include dehydration, concomitant administration of eMacrynic acid or furosemide a prewous exposure to other otoloxlc drugs. Numbness, skin tingling, muscle leeching, convulsions and myasthenia groAs like syndrome also have been reported reported adverse reactions possibly related to gentance Include'. respiratory depression, lethargy confusion, depression, visual disturbances. decreased appetite. weight loss. hypotension, hypertension, rase rtching urticaria generalized burning, laryngeal edema, anaphylactoid reaction, fever, and headache, nausea vomiting, increased salivation, strewth, purpuro, pseudotumor cerebra, acute organic bran syndrome. pulmonary fibrosis. alopecia, Mint pain, transient hepotomegaly and spleenornegarv. Laboratory abnormalities possibly related to gentamicin Include( increased serum hansaminam I SGOT . SGPT and increased serum lactic dehydrogerrose (LDH ) and bilirubin, decreased serum calcium, magnesium, sodium and potassium, anemia, leukopenia, granulocytopenia, transient agranulocylosia, eosinophilm, increased and decreased reticulocyte counts, and thrombacytopenia. While clinicallaboratow tests obnormalllies may be iulated findings they may be associated with clinically related signs and symptorns.While local tolerance to Gammycin injection Is generally excellent there has been an occasional report of pain at the injection site. Subcutaneous atrophy a fat necrosis suggesting local Irritation has been reported ram6 Conhalndlcallons Hypersen,tithry or serious toxic reactions to gentamich or other aminoglycoskiles contraindicates Its use. Precautions: - Naito-toxic and nephrotorac antibiotics may be absorbed from body surface after local inigation a application. The potential toxic effect of antibiotics administered in this fashion should be considered. Increased nephrofoxicIty has been reported following -concomitant administration of aminoglycoskie antibiotics and some cepholosporinstNeuromuscular blockade and respiratory paralysis have been reported in the cat receiving high doses ( 40 mg/kg( of gentamicin. The possibility of these phenomena occurring in man should be considered If gentamicin is administered to patients receiving neuromuscuiar bloating agents, such as succinylchoine, tubocurorine or decamethoniurni anesthetics a massive transfusions of citragaianticoaguloted blood. It blockade occurs, calcium salts moo reverse mese phenomena -Elderly patients may have reduced renal function which may not be evident in the results of routine screening test, such as BUN Of serum creatinine A crealinine clearance determination may be more useful. Monitoring of renal function during gentamicin treatment , as with other ammoglycosides is particularly Important In such patient. -A Fancontlike syndrome with crancacdurio and metabolic acidosis has been reported in some adults and infants heated with gentamicin. -Onus allergencily among aminoglycosides hos been demonstrated. -Patient should be well hydrated during treatment. -In Ara mixing of on ominogrvcosIde with beta-lantern type antibiotics (penicillin or cephalosporins) may remit nignflicant mutual inayhoahon • Even when an aminoglycoside and a penicillin - hype drug are administered separately by different routes of reduction in aminogrvcosides serum hathilfe or serve levels has been reported In patients wtth impaired renal function and in some patients with normal renal function. A reduction in gentamicin serum half-he has been reported in patients eeh severe renal impairment who received carbenicillin ConcomitanItY with gentamthin Usually such inactlyalton or the aminoglycoside Is clInicatty significant only In patients 00th severely impaired renal function. -Treatment with gentamicin may result in overgrowth of non- susceptible microorganisms. It this occurs. appropriate therapy ts indicated. -Gararnycin injection contains 3.2 mg/m sodium bisuffite , a sulfa that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. -AminogycosIde antibiotics cross the placenta and mar cause fetal harm when administered to pregnant women. It is not known whether gentamicin sulphate can cause fetal ham when administered to pregnant women or can affect reproduction capacity--Because or the potential tor serous adverse reactions from arninoglycoside in nursing Infants, a decision should be made to discontinue nursing Or therapy taking into account the importance of the drug tome mother. 3n the event of overdose a toxic Inactions, hemodialysis 8811 aid in the removal of gentamicin from the blood. The rate of removal of gentamicin is considerably less by pertionial dtalysts Man It is by hernodialysis. In the newborn Infants, exchange transfusions may be considered. These procedures are of particular importonce for patients with Impaired renal function.