Garamycin 40 mg / 1 ml
Each ml contains gentamicin sulfate, equivalent to 40 mg gentamicin base
Company Name
Memphis/Schering
Therapeutic Group
AMINOGLYCOSIDES
Pharmaceutical form
Ampoule
Package
Carton box containing 6 Ampoules each of 1 ml
Indications
Garamycin injection is indicated in the treatment of infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus sp. (indole-positive and indole-negative), Escherichia coli, Klebsiella, Enterobacter -Serratia Sp.,Citrobacter sp., Providensia sp., Staphylococcus sp. (coagulase-positive and coagulase-negative, including penicillin and methicillin-resistant strains), and Neisseria gonorrhoeae. Clinical studies have shown
Garamycin injection to be effective in: - Septicemia, bacteremia (including neonatal sepsis) - Serious infections of the central nervous system (CNS) (including meningitis) - Infections of the kidney and genito-urinary tract (including pelvic) - Respiratory tract infections - Infections of the gastrointestinal tract. - Skin, bone or soft tissue infections (including infected burns and wounds) - Intra-abdominal 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
Garamycin injection should be based on results of susceptibility tests and the patient's clinical response and tolerance to the drug. In serious infections, when the causative micro-organisms are unknown,
Garamycin injection may be administered as initial therapy in conjunction with a penicillin or cephalosporin type drug before obtaining results of susceptibility testing. If anaerobic micro-organisms are suspected, suitable antimicrobial therapy in conjunction with
Garamycin injection or other appropriate antibiotic therapy should then be continued.
Garamycin injection has been used effectively in combination with carbenicillin ot ticarcillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. In the neonate with suspected sepsis or staphylococcl pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with
gentamicin.
Garamycin injection has been shown to be effective in the treatment of serious staphylococcal infections. In the peri-operative period,
Garamycin injection may be started preoperatively and continued postoperatively for treatment of suspected or proven infection due to susceptible microorganisms. Subconjunctival administration of
gentamicin is recommended for treatment of endophthalmitis caused by sensitive microorganisms. It may be used prophylactically in patients undergoing high risk intraocular surgery, especially if preoperative cultures or smears contain Gram-negative microorganisms.
Garamycin injection may also be administered by direct endotracheal instillation or by nebulization as an adjunct to systemic therapy in the treatment of serious pulmonary infections.
Garamycin intrathecal injection is indicated as an adjunct to systemic therapy in the treatment of serious CNS infections, such as meningitis and ventriculitis caused by susceptible Gram-negative microorganisms. A preservative free intrathecal presentation is available.
Warning & Precautions
Neurotoxic and nephrotoxic antibiotics may be absorbed from body surface after local irrigation or application. The potential toxic effect of antibiotics administered in this fashion should be considered. Increased nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and some cephalosporins. Neuromuscular blockade and respiratory paralysis have been reported in the cat receving 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 neuromuscular blocking agents, such as succiylcholine, tubocurarine or decamethonium; anesthetics or massive transfusions of citrate-anticoagulated blood. If blockade occurs, calcium salts may reverse these phenomena. Elderly patients may have reduced renal function which may not be evident in the results of routine screening tests, such as BUN or serum creatinine .A creatinine clearance determination may be more useful .Monitoring of renal function during
gentamicin treatment , as with other aminoglycosides is particularly important in such patients . A fanconi-like syndrome with aminoaciduria and metabolic acidosis has been reported in some adults and infants treated with
gentamicin. Cross allergenicity among aminoglycosides has been demonstrated. Patients should be well hydrated during treatment. In vitro mixing of an aminoglycoside with beta-lactam type antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation .Even when an aminoglycoside and a penicillin - type drug are administered separately by different routes,a reduction in aminoglycosides serum half-life or serum levels has been reported in patients with impaired renal function and in some patients with normal renal function.A reduction in
gentamicin serum half-life has been reported in patients with severe renal impairment who received carbinicillin concomitantly with
gentamicin Usually , such inactivation of the aminoglycoside is clinically significant only in patients with severely impaired renal function. Treatment with
gentamicin may result in overgrowth of non- susceptible microorganisms . If this occure, appropriate therapy is indicated.
Garamycin injection contains 3.2 mg/ml sodium bisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. Aminoglycoside antibiotics cross the placenta and may cause fetal harm when administered to pregnant women. It is not known whether
gentamicin sulphate can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Because of the potential for serious adverse reactions from aminoglycoside in nursing infants, a decision should be made to discontinue nursing or therapy taking into account the importance of the drug to the mother. In the event of overdose or toxic reactions, hemodialysis will aid in the removal of
gentamicin from the blood. The rate of removal of
gentamicin is considerably less by peritonial dialysis than it is by hemodialysis. In the newborn infants, exchange transfusions may be considered. These procedures are of particular importance for patients with impaired renal function.
Product Type
Human
Dosage
The recommended dosage for intravenous and intramuscular administration is identical.
Garamycin injection also may be administered by subconjunctival or subtenon injection, nebulization or direct endotracheal instillation. The patient pretreatment body weight should be obtained for calculation of correct dosage.
Garamycin injection should not be physically premixed with other drugs but should be administered separately in accordance with the recommended route of administration and dosage schedule. It is 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/ml. Trough levels above 2 mcg/ml should be avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration susceptibility of the causative microorganism, severity of infection, and the status of the patient's 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 cases monitoring of renal, auditory and vestibular functions is recommended, since toxicity is more likely to occur with treatment extended over ten days. Dosage should be reduced if clinically indicated. Intramuscular Administration: Patients with Normal Renal Function: Adults: Recommended dosage of
Garamycin 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 times daily or a dose of 120 mg may be given every 12 hours, for adults weighing 60 kg or less, 60 mg 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 life-threatening infections, dosages up to 5 mg/kg/day may administered three or four equal doses. This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. When systemic or urinary tract infections are of moderate severity and the causative microorganism is likely 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 without evidence of impairment of renal function,
Garamycin 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 daily dose should be 3 mg/Kg of body weight. Pediatric Patients: Premature or full term neonates one week of age or less: 5 to 6 mg/kg/day (2.5 to 3 mg/kg administered every 12 hours) Neonates over one week of age and infants: 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 hours) Patients with impaired Renal function: Dosage must be adjusted in patients with impaired renal function. Whenever possible, serum concentrations of
gentamicin should be monitored. Dosage schedules are not intended as rigid recommendations, but are provided as guides to dosage when the measurements of
gentamicin serum levels is not feasible. One method of dosage adjustment is to increase the interval between administration of the usual doses. Since the serum creatinine concentration has a high correlation with the serum half-life of
gentamicin, this laboratory test may provide guidance for adjustment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100ml) by 8 (Table I). For example, a patient weighing 60 Kg with a serum creatinine level of 2 mg/100 ml could be given 60 mg (1 mg/Kg) every 16 hours (2 mg/100 ml x 8). Table 1 Dosage adjustment Guide For Patients With Renal Impairment. interval of administration between usual doses is prolonged. Frequency of administration Every 8 hours Every 12 hours Every 18 hours Every 24 hours Every 36 hours Every 48 hours Same as above Blood Urea Nitrogen (mg/100 ml) Less than 18 18-29 30-39 40-49 50-74 75-100 Same as above Creatinine( mg / 100 ml ) Less than 1.4 1.4-1.9 2.0-2.8 2.9-3.7 3.8-5.3 5.4-7.2 Same as above Creatinine clearance rate( ml / min ) Over 70 35-70 24-34 16-23 10-15 5-9 Same as above Dose 80 mg (2ml) 60 mg (1.5ml) Body weight of Adult Patients Over 60 kg 60 kg or less ( Interval of administration between usual doses is prolonged) In patients with serious systemic infections and renal impairment, it may be desirable to administer the antibiotic more frequently but in reduced dosage. In such patients,
gentamicin serum concentrations should be measured. After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level (Table II). For example, after an initial dose of 60 mg (1 mg / kg), a patient weighing 60 kg with a serum creatinine level of 2.0 mg / 100 ml could be given 30 mg every eight hours (60:2). It should be noted that the status of renal function may be changing over the course of the infectious process. Table II Dosage adjustment Guide For Patients With Renal Impairment ( Decreased Dosage at Eight - Hour Intervals After the usual Initial Dose) Percent of usual dose 100 80 65 85 50 40 35 30 25 20 15 10 Approximate Creatinine Clearance Rate( ml / min / 1.73 m2 ) >100 70-100 55-70 45-55 40-45 35-40 30-35 25-30 20-25 15-20 10-15 < 1.0 1.1-1.3 1.4-1.6 1.7-1.9 2.0-2.2 2.3-2.5 2.6-3.0 3.1-3.5 3.6-4.0 4.1-5.1 5.2-6.6 6.7-8.0 In adults with renal failure undergoing hemodialysis, the amount of
gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. A six-hour hemodialysis may reduce
gentamicin serum concentrations by approximately 50 %. Shorter dialysis sessions will remove less drug. Recommended dosage at the 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.Aminoglycosides are also removed by peritoneal dialysis but at a rate considerably less than by hemodialysis. Intravenous Administration: Intravenous administration of
gentamicin is useful for treating patients with septicemia or those in shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe burns, or those with reduced muscle mass. For intravenous administration in adults, a single dose of
Garamycin injection may be diluted in 50 to 200 ml of sterile normal saline or in a sterile solution of dextrose 5 % in water; in infants and children, the volume of diluent should be less. The solution may be infused over a period of one half to two hours. In certain circumstances a single dose of
Garamycin injection may also be given directly into a vein or I.V. tubing slowly over a period of 2 to 3 minutes. Concomitant therapy: In combination with other antibiotics, the dosage of
Garamycin injection must not be reduced.
Adverse Reactions
Nephrotoxicity: 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. Neurotoxicity: Adverse effects on both vestibular and auditory branches of the eight cranial nerve have been reported primarily in patients with renal impairment and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and hearing loss.Hearing loss is usually manifested initially by diminution of high tone acuity and may be irreversible. As with other aminoglycosides vestibular abnormalities also may be irreversible. Other factors that may increase the risk of aminoglycoside induced ototoxicity include dehydration, concomitant administration of ethacrynic acid or furosemide or previous exposure to other ototoxic drugs. Numbness, skin tingling, muscle twitching, convulsions and myasthenia gravis like syndrome also have been reported. Other reported adverse reactions possibly related to
gentamicin include : respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss, hypotension and hypertension, rash itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever, and headache, nausea, vomiting, increased salivation, and stomatitis, purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain , transient hepatomegaly, and splenomegaly. Laboratory abnormalities possibly related to
gentamicin include: increased serum transaminase ( SGOT , SGPT ) , and increased serum lactic dehydrogenase (LDH ) and bilirubin ,decreased serum calcium, magnesium , sodium and potassium , anemia, leukopenia, granulocytopenia, transient agranulocytosia, eosinophilia, increased and decreased reticulocyte counts, and thrombocytopenia.While clinical laboratory test abnormalities may be isolated findings they may be associated with clinically related signs and symptoms. While local tolerance to
Garamycin injection is generally excellent, there has been occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.
Contra Indications
Hypersensitivity or serious toxic reactions to
gentamicin or other aminoglycosides contraindicates its use.
Drug Interactions
NA
