Gentamytrex Ophtiole Uses

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What is Gentamytrex Ophtiole?

Treating surface eye infections caused by certain bacteria.

Gentamytrex Ophtiole is a topical antibiotic. It works by slowing the growth of, or killing, sensitive bacteria.

Gentamytrex Ophtiole 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 Gentamytrex Ophtiole and other antibacterial drugs, Gentamytrex Ophtiole 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.

Gentamytrex Ophtiole 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 Gentamytrex Ophtiole 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 Gentamytrex Ophtiole, 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 Gentamytrex Ophtiole.

Gentamytrex Ophtiole 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 “WARNINGS box”. If the causative organisms are resistant to Gentamytrex Ophtiole, other appropriate therapy should be instituted.

In serious infections when the causative organisms are unknown, Gentamytrex Ophtiole 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 Gentamytrex Ophtiole. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.

Gentamytrex Ophtiole 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.

Gentamytrex Ophtiole Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, Gentamytrex Ophtiole 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 Gentamytrex Ophtiole.

In this dosage form, Gentamytrex Ophtiole Injection, USP is to be used with an ADD-Vantage antibiotic diluent flexible plastic container..

How should I use Gentamytrex Ophtiole?

Use Gentamytrex Ophtiole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Gentamytrex Ophtiole.

Uses of Gentamytrex Ophtiole 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 treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). Gentamytrex Ophtiole 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 Gentamytrex Ophtiole 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.

Gentamytrex Ophtiole description

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Gentamytrex Ophtiole 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.

Gentamytrex Ophtiole injection is a sterile solution of Gentamytrex Ophtiole water for injection. It contains the equivalent of not less than 90% and not more than 125% of the labeled amount of Gentamytrex Ophtiole. It may contain suitable buffers, preservatives, sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.

Gentamytrex Ophtiole dosage

Gentamytrex Ophtiole Injection, USP is administered by intravenous infusion only after dilution in a 50 or 100 mL ADD-Vantage Flexible Diluent Container of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.

The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term.

Patients with Normal Renal Function

Adults: The recommended dosage of Gentamytrex Ophtiole for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 3).

For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 3).

It is desirable to measure both peak and trough serum concentrations of Gentamytrex Ophtiole to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. When monitoring peak concentrations after intravenous administration, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration the susceptibility of the causative organism, the severity of the infection, and the status of the patient’s host-defense mechanisms. In patients with extensive burns, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with Gentamytrex Ophtiole, measurement of serum concentrations is recommended as a basis for dosage adjustment.

Table 3 Dosage Schedule Guide For Adults With Normal Renal Function
* The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass.

** For q6h schedules, dosage should be recalculated.

(Dosage at Eight-Hour Intervals)

Patient’s

Weight*

Usual Dose

for Serious Infections

Dose for Life-Threatening

Infections (Reduce as Soon as Clinically Indicated)

kg

(lb)

1 mg/kg q8h

(3 mg/kg/day)

1.7 mg/kg q8h**

(5 mg/kg/day)

mg/dose

q8h

mg/dose

q8h

40

(88)

40

66

45

(99)

45

75

50

(110)

50

83

55

(121)

55

91

60

(132)

60

100

65

(143)

65

108

70

(154)

70

116

75

(165)

75

125

80

(176)

80

133

85

(187)

85

141

90

(198)

90

150

95

(209)

95

158

100

(220)

100

166

NOTE: For further information concerning the use of Gentamytrex Ophtiole in infants and children, see pediatric Gentamytrex Ophtiole injection product information.

The usual duration of treatment for all patients is seven to ten days. In difficult and 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 apt to occur with treatment extended for more than ten days. Dosage should be reduced if clinically indicated.

For

Intravenous Administration

The intravenous administration of Gentamytrex Ophtiole may be particularly useful for treating patients with bacterial 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 intermittent intravenous administration in adults, a single dose of Gentamytrex Ophtiole may be diluted in 50 or 100 mL of sterile 0.9% Sodium Chloride Injection, USP or in a sterile solution of 5% Dextrose Injection, USP. The solution may be infused over a period of one-half to two hours.

Gentamytrex Ophtiole should not be physically premixed with other drugs, but should be administered separately in accordance with the recommended route of administration and dosage schedule.

Patients with Impaired Renal Function

Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels. Whenever possible, serum concentrations of Gentamytrex Ophtiole should be monitored. 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 Gentamytrex Ophtiole, 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/100 mL) by 8. For example, a patient weighing 60 kg with a serum creatinine level of 2.0 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2x8).

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, serum concentrations of Gentamytrex Ophtiole should be measured so that adequate, but not excessive levels result. A peak and trough concentration measured intermittently during therapy will provide optimal guidance for adjusting dosage. 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 4). 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.

It is important to recognize that deteriorating renal function may require a greater reduction in dosage than that specified in the above guidelines for patients with stable renal impairment.

Table 4 Dosage Adjustment Guide for Patients with Renal Impairment

(Dosage at Eight-Hour Intervals After the Usual Initial Dose)

Serum

Creatinine

(mg%)

Approximate Creatinine

Clearance Rate

(mL/min/1.73M2)

Percent of Usual Doses

Shown in Table 3

≤1.0

>100

100

1.1 — 1.3

70 —100

80

1.4 — 1.6

55 — 70

65

1.7 — 1.9

45 — 55

55

2.0 — 2.2

40 — 45

50

2.3 — 2.5

35 — 40

40

2.6 — 3.0

30 — 35

35

3.1 — 3.5

25 — 30

30

3.6 — 4.0

20 — 25

25

4.1 — 5.1

15 — 20

20

5.2 — 6.6

10 — 15

15

6.7 — 8.0

<10

10

In adults with renal failure undergoing hemodialysis, the amount of Gentamytrex Ophtiole removed from the blood may vary depending upon several factors including the dialysis method used. An eight-hour hemodialysis may reduce serum concentrations of Gentamytrex Ophtiole by approximately 50%. The recommended dose at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of infection.

The above dosage schedules are not intended as rigid recommendations but are provided as guides to dosage when the measurement of Gentamytrex Ophtiole serum levels is not feasible.

A variety of methods are available to measure Gentamytrex Ophtiole concentrations in body fluids; these include microbiologic, enzymatic and radioimmunoassay techniques.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Gentamytrex Ophtiole interactions

See also:
What other drugs will affect Gentamytrex Ophtiole?

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The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: aminoglycoside antibiotics given by injection (such as amikacin, Gentamytrex Ophtiole, tobramycin).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Gentamytrex Ophtiole side effects

See also:
What are the possible side effects of Gentamytrex Ophtiole?

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 Gentamytrex Ophtiole at higher doses or for longer periods of time than recommended.

Other reported adverse reactions possibly related to Gentamytrex Ophtiole 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 Gentamytrex Ophtiole 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 Gentamytrex Ophtiole 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.

Gentamytrex Ophtiole contraindications

See also:
What is the most important information I should know about Gentamytrex Ophtiole?

Gentamytrex Ophtiole Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

Active ingredient matches for Gentamytrex Ophtiole:

Gentamicin sulfate in Taiwan.


Unit description / dosage (Manufacturer)Price, USD
Gentamytrex Ophtiole 5 mg/1 mL x 5 mL
Gentamytrex Ophtiole 5 mg/1 mL x 5 mL x 1's

List of Gentamytrex Ophtiole substitutes (brand and generic names):

Gentamycin Ophth Oint 3 mg/1 g x 3.5 g
Gentamycin Ophth Oint 3 mg/1 g x 5 g
Gentamycin Ophth Soln 3 mg/1 mL x 3 mL
Gentamycin Ophth Soln 3 mg/1 mL x 5 mL
Gentamycin Ophthalmic / Wu-Fu 3 mg/1 mL x 5 mL
Gentamycin Sulfate Shandong 80 mg/2 mL x 10 tube 2mL
Gentrobex 40 mg/1 mL x 10's
Migentax 40 mg/1 mL x 2 mL x 10's (Geofman)
Obogen / amp 40 mg/1 mL x 2 mL x 10's (Oboi)
Opthagen 0.3 % x 5 mL (Pascual)
Ottogenta Cream 0.1 % x 5 g x 1's$ 0.66
Phil Pharmawealth/Karnataka Gentamicin / vial 40 mg/1 mL x 2 mL x 50's
Refobacin Bone Cement R 40 g x 2's (Biomet)
Refobacin Bone Cement R 20 mL x 2's (Biomet)
Ridhay 0.3 % w/v x 1 Bottle 10 mL
Rotexmedica Gentamicin 1 tube
Sagestam Ear Drops 3 mg/1 mL x 5 mL x 1's (Sanbe Vision)$ 2.02
Sagestam Eye Drops 3 mg/1 mL x 5 mL x 1's$ 2.02
Salticin Cream 1 mg/1 g x 5 g$ 1.18
T P Gentamicin Sulfate 80 mg/2 mL x 10 tube
T P Gentamicin Sulfate 80 mg/2 mL x 50 tube
Topigen Eye Drops 3 mg/1 mL x 5 mL x 1's$ 4.36

References

  1. 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).
  2. PubChem. "gentamicin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "gentamicin". http://www.drugbank.ca/drugs/DB00798 (accessed September 17, 2018).

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