Gentamicin Astar is an antibiotic. It fights bacteria in the body.
Gentamicin Astar is used to treat severe or serious bacterial infections.
Gentamicin Astar may also be used for purposes other than those listed in this medication guide.
Gentamicin Astar indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Astar and other antibacterial drugs, Gentamicin Astar should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Gentamicin Astar Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).
Clinical studies have shown Gentamicin Astar Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).
Aminoglycosides, including Gentamicin Astar, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.
Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to Gentamicin Astar.
Gentamicin Astar Sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the box. If the causative organisms are resistant to Gentamicin Astar, other appropriate therapy should be instituted.
In serious infections when the causative organisms are unknown, Gentamicin Astar Sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with Gentamicin Astar. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.
Gentamicin Astar Sulfate has been used effectively in combination with carbenicillin 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.
Gentamicin Astar Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, Gentamicin Astar may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.
In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with Gentamicin Astar.
How should I use Gentamicin Astar?
Use Gentamicin Astar drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Gentamicin Astar drops is for use in the eye. Avoid contact with other mucous membranes.
Soft contact lenses may absorb a chemical in Gentamicin Astar drops. Do not wear contact lenses while you are using Gentamicin Astar drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
To use Gentamicin Astar drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
To clear up your infection completely, use Gentamicin Astar drops for the full course of treatment. Keep using it even if you feel better in a few days.
Using Gentamicin Astar drops at the same times each day will help you to remember to use it.
If you miss a dose of Gentamicin Astar drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Gentamicin Astar drops.
Uses of Gentamicin Astar in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
This medication is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). Gentamicin Astar works by stopping the growth of certain bacteria. It belongs to a class of drugs known as aminoglycoside antibiotics.
This antibiotic only treats bacterial infections. It will not work for virus or fungus infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
How to use Gentamicin Astar topical
This medication is for use on the skin only.
Wash your hands before using. Clean and dry the affected area as directed. If you are treating impetigo, remove any dried, crusty skin to increase contact between the antibiotic and the infected area. Then gently apply a small amount of medication in a thin layer as directed by your doctor, usually 3 to 4 times a day. You may cover the area with a sterile gauze bandage if so directed. Keep the infected area clean. Wash your hands after use, unless you are using this product to treat the hands.
Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water.
Dosage and length of treatment is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.
Continue to use this medication for the full length of treatment prescribed, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.
Tell your doctor if your skin infection persists or if it worsens.
Gentamicin Astar description
Gentamicin Astar also contains the following ingredients: Methyl paraben 1.8 mg, propyl paraben 0.2 mg, sodium bisulfite 3.2 mg, disodium ethylenediaminetetraacetate 0.1 mg and water for injection.
Gentamicin Astar sulfate injection is a sterile solution of Gentamicin Astar sulfate water for injection. It contains the equivalent of not less than 90% and not more than 125% of the labeled amount of Gentamicin Astar. It may contain suitable buffers, preservatives, sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.
Gentamicin Astar dosage
Each ampoule is for use in a single patient on 1 occasion only.
Adults:Serious Infections (Systemic and Urinary Tract Infections): 3 mg/kg/day in 3 doses given every 8 hrs.
Life-Threatening Infections: Up to 5 mg/kg/day in 3 or 4 equal doses with reduction to 3 mg/kg/day as soon as clinically indicated. Doses should never exceed 5 mg/kg/day unless serum levels are monitored.
The following table should be used as a guide: See Table 1.
Children: The following table should be used as a guide: See Table 2.
Patients with Renal Impairment: Dosage should be adjusted to minimise the risk of toxicity. The 1st dose should be as normal eg, 80 mg (body weight >60 kg) and subsequent doses should be given less frequently, depending on the degree of renal impairment.
Table 3 should be used as a guide: See Table 3.
When only a serum urea concentration is available, this value may be utilized initially, however, it should be supplemented with a serum creatinine level or creatinine clearance rate whenever possible.
Note: The standard dose of 80 mg 3 times a day may be inappropriate and a more appropriate dose can be calculated using a nomogram which takes into account the patient's serum creatinine levels, body weight and age. This dose can be adjusted if necessary following determination of serum creatinine levels. Desirable serum levels of Gentamicin Astar are 5-8 mcg/mL as a peak and 1-2 mcg/mL as a trough.
Note: In children with impaired renal function, serum levels should be monitored and frequency of dosage reduced if indicated.
Adults with Renal Failure Undergoing
The amount of Gentamicin Astar removed from the blood may vary depending upon several factors including the dialysis method used. An 8-hr haemodialysis may reduce serum concentrations of Gentamicin Astar by approximately 50%. The recommended dosage at the end of each dialysis period is 1-1.7 mg/kg depending upon the severity of infection.
Administration: Gentamicin Astar is normally given by IM injection.
Intravenous administration may be used for particular indications when the IM route is not appropriate. The dosage is the same for either route of administration. It is desirable to measure both peak and trough serum levels during treatment. Prior to administration, the patient's body weight should be measured for the correct calculation of dosage. In obese patients, the appropriate dose can be calculated by assuming the body weight is the patient's estimated lean body weight plus 40% of the excess. Blood specimens for the determination of peak Gentamicin Astar concentrations should be obtained approximately 1 hr following IM administration and 30-min after completion of a 30-min infusion. Blood specimens for the trough Gentamicin Astar concentration should be obtained immediately prior to the next IM or IV dose.
For IV administration, the prescribed dose of Gentamicin Astar may be diluted in 100-200 mL of sterile normal saline or 5% glucose in water. The concentration of Gentamicin Astar in the solution should not exceed 1 mg/mL. Infusion periods of 30 min to 2 hrs have been advocated. Administration of the dose by bolus injection produces serum levels which are initially in excess of what is regarded as being safe from toxic side effects. The high serum level does however rapidly fall and the potential danger or safety of this method is yet to be established. Gentamicin Astar Pfizer must not be mixed with other drugs, but should be administered by separate infusion.
Penicillins: Gentamicin Astar is inactivated by solutions containing β-lactam antibiotics (penicillins and cephalosporins) so the 2 drugs should not be administered simultaneously nor should they be combined in the IV fluid. The inactivation of Gentamicin Astar by penicillins may occur in vivo, especially in patients with renal failure who maintain a higher level of the penicillin for a longer period of time. Therefore, when Gentamicin Astar and penicillins are used together in patients with renal failure, the time of administration of each drug should be staggered so that several hours separate each infusion.
Diuretics: Potent diuretics eg, ethacrynic acid or frusemide may potentiate the ototoxic effects of Gentamicin Astar.
Other Neurotoxic and/or Nephrotoxic Agents: Since the ototoxic or nephrotoxic effects of Gentamicin Astar may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin, clindamycin and cephalosporins.
Neuromuscular-Blocking Agents: Respiratory paralysis and prolongation of neuromuscular blockade may occur if a neuromuscular-blocking agent eg, suxamethonium (succinylcholine), tubocurarine, decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics or massive transfusions with citrated anticoagulated blood are administered to a patient receiving Gentamicin Astar.
Vitamin K: Gentamicin Astar may inhibit the action of IV vitamin K upon the synthesis of clotting factors.
Potential Interactions: In vitro synergism and antagonism have been found between various antineoplastic agents and aminoglycosides.
Incompatibilities. When Gentamicin Astar is used in combination with any other drug, mixing the drugs before administration should be avoided at all costs.
Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger dosages than recommended.
Neurotoxicity: Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.
Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported.
NOTE: The risk of toxic reactions is low in patients with normal renal function who do not receive Gentamicin Astar Sulfate at higher doses or for longer periods of time than recommended.
Other reported adverse reactions possibly related to Gentamicin Astar include: Respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss and 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 Astar include: Increased levels of serum transaminase (SGOT, SGPT), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia and hypokalemia.
While local tolerance of Gentamicin Astar Sulfate is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.
Known hypersensitivity to Gentamicin Astar or aminoglycosides and/or preserving agents (para group allergy); patients with preexisting vestibular and/or cochlear disease should be given aminoglycosides for life-threatening conditions only.
Administration of other ototoxic and/or nephrotoxic antibiotics together with or immediately after Gentamicin Astar should be avoided.
Caution should be exercised in patients with reduced renal function to avoid drug cumulation. Caution is also indicated in patients with milder degrees of renal insufficiency, neuromuscular disease (eg, myasthenia gravis or Parkinson's disease) and at an advanced age. As Gentamicin Astar contains sulfite, it must not be used in asthmatics hypersensitive to sulfite.
Use in pregnancy & lactation: During pregnancy, Gentamicin Astar should only be given for life-threatening conditions or if other antibiotics are ruled out. As Gentamicin Astar is known to be present in breast milk, breastfeeding should be suspended if Gentamicin Astar is administered during lactation.
DailyMed. "GENTAMICIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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