Ro-Gentycin is an antibiotic. It fights bacteria in the body.
Ro-Gentycin is used to treat severe or serious bacterial infections.
Ro-Gentycin may also be used for purposes other than those listed in this medication guide.
Ro-Gentycin 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.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ro-Gentycin and other antibacterial drugs, Ro-Gentycin 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.
Ro-Gentycin 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 Ro-Gentycin 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 Ro-Gentycin, 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 Ro-Gentycin.
Ro-Gentycin 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 Ro-Gentycin, other appropriate therapy should be instituted.
In serious infections when the causative organisms are unknown, Ro-Gentycin 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 Ro-Gentycin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.
Ro-Gentycin 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.
Ro-Gentycin Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, Ro-Gentycin 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 Ro-Gentycin.
How should I use Ro-Gentycin?
Use Ro-Gentycin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ro-Gentycin solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Ro-Gentycin solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Ro-Gentycin solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Ro-Gentycin solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Drinking extra fluids while you are using Ro-Gentycin solution is recommended. Check with your doctor for instructions.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Do not mix Ro-Gentycin solution with cephalosporins (eg, cephalothin) or penicillins (eg, penicillin), as it may inactivate Ro-Gentycin solution. Administer separately.
If you miss a dose of Ro-Gentycin solution, use it as soon as possible. Check with your doctor, pharmacist, or nurse for instructions on scheduling other doses.
Ask your health care provider any questions you may have about how to use Ro-Gentycin solution.
Uses of Ro-Gentycin 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.
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This medication is used to prevent or treat a wide variety of bacterial infections. Ro-Gentycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.
How to use Ro-Gentycin injection
This medication is given by injection into a vein or muscle as directed by your doctor, usually every 8 hours. The dosage is based on your medical condition, weight, and response to treatment. Laboratory tests (such as kidney function, levels of drug in the blood) may be performed to help find the best dose for your condition.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.
Continue to use this medication until the full prescribed amount is finished, 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 condition persists or worsens.
Ro-Gentycin description
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Ro-Gentycin 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.
Ro-Gentycin injection is a sterile solution of Ro-Gentycin water for injection. It contains the equivalent of not less than 90% and not more than 125% of the labeled amount of Ro-Gentycin. It may contain suitable buffers, preservatives, sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.
Ro-Gentycin 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 Ro-Gentycin 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
Haemodialysis:
The amount of Ro-Gentycin removed from the blood may vary depending upon several factors including the dialysis method used. An 8-hr haemodialysis may reduce serum concentrations of Ro-Gentycin 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: Ro-Gentycin 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 Ro-Gentycin 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 Ro-Gentycin concentration should be obtained immediately prior to the next IM or IV dose.
Intravenous Administration:
For IV administration, the prescribed dose of Ro-Gentycin may be diluted in 100-200 mL of sterile normal saline or 5% glucose in water. The concentration of Ro-Gentycin 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. Ro-Gentycin Pfizer must not be mixed with other drugs, but should be administered by separate infusion.
Penicillins: Ro-Gentycin 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 Ro-Gentycin 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 Ro-Gentycin 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 Ro-Gentycin.
Other Neurotoxic and/or Nephrotoxic Agents: Since the ototoxic or nephrotoxic effects of Ro-Gentycin 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 Ro-Gentycin.
Vitamin K: Ro-Gentycin 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 Ro-Gentycin is used in combination with any other drug, mixing the drugs before administration should be avoided at all costs.
Applies to Ro-Gentycin ophthalmic: ophthalmic ointment, ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Ro-Gentycin ophthalmic. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Ro-Gentycin ophthalmic:
Less common:
Itching, redness, swelling, or other sign of irritation not present before use of this medicine
redness of eye, eyelid, or inner lining of eyelid
Rare
Black, tarry stools; blood in urine or stools; or unusual bleeding or swelling
blurred vision, eye pain, sensitivity to light, and/or tearing
seeing, hearing, or feeling things that are not there
hallucinations
Minor Side Effects
Some of the side effects that can occur with Ro-Gentycin ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
Burning or stinging
After application, eye ointments usually cause your vision to blur for a few minutes.
Known hypersensitivity to Ro-Gentycin 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 Ro-Gentycin 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 Ro-Gentycin contains sulfite, it must not be used in asthmatics hypersensitive to sulfite.
Use in pregnancy & lactation: During pregnancy, Ro-Gentycin should only be given for life-threatening conditions or if other antibiotics are ruled out. As Ro-Gentycin is known to be present in breast milk, breastfeeding should be suspended if Ro-Gentycin 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).
The results of a survey conducted on ndrugs.com for Ro-Gentycin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ro-Gentycin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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