What is Ofloxacine Aguettant?
Ofloxacine Aguettant is an antibiotic that treats infections caused by bacteria.
Ofloxacine Aguettant otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofloxacine Aguettant otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).
Ofloxacine Aguettant otic may be used on a long-term basis to treat an infection that causes a hole in the ear drum (ruptured ear drum) in adults and children who are at least 12 years old.
Ofloxacine Aguettant may also be used for purposes not listed in this medication guide.
Ofloxacine Aguettant indications
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofloxacine Aguettant tablets and other antibacterial drugs, Ofloxacine Aguettant tablets 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.
Ofloxacine Aguettant tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae.
Because fluoroquinolones, including Ofloxacine Aguettant, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Ofloxacine Aguettant for treatment of ABECB in patients who have no alternative treatment options.
Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.
Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.
Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae.
Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis.
Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae.
Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae.
NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.
Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
Because fluoroquinolones, including Ofloxacine Aguettant, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Ofloxacine Aguettant for treatment of uncomplicated cystitis in patients who have no alternative treatment options.
Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,* or Pseudomonas aeruginosa.*
Prostatitis due to Escherichia coli.
* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Ofloxacine Aguettant, USP. Therapy with Ofloxacine Aguettant, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Ofloxacine Aguettant, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
How should I use Ofloxacine Aguettant?
Use Ofloxacine Aguettant drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- To use Ofloxacine Aguettant 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.
- Do not wear contact lenses while you are using Ofloxacine Aguettant drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
- Ofloxacine Aguettant drops works best if used at the same time each day.
- To clear up your infection completely, use Ofloxacine Aguettant drops for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Ofloxacine Aguettant 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 Ofloxacine Aguettant drops.
Uses of Ofloxacine Aguettant in details
Use: Labeled Indications
Treatment of acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections (uncomplicated), urethral and cervical gonorrhea (acute, uncomplicated), urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection, mixed infections of the urethra and cervix, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis
Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.
Off Label Uses
Epididymitis
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, Ofloxacine Aguettant is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Ofloxacine Aguettant in combination with ceftriaxone for acute epididymitis likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex.
Leprosy (multibacillary)
Data from a limited number of patients in an open-label, parallel assessment study suggest that Ofloxacine Aguettant, in combination with rifampin and minocycline (ROM), may be beneficial for the treatment of multibacillary leprosy. Additional trials may be necessary to further define the role of multiple and single dose Ofloxacine Aguettant regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Ofloxacine Aguettant for the treatment of paucibacillary leprosy.
Spontaneous bacterial peritonitis (treatment)
According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Ofloxacine Aguettant may be considered as an alternative therapy to IV third-generation cephalosporins in patients with uncomplicated SBP who are not infected with a suspected quinolone-resistant organism. If fluoroquinolone-resistant, gram-negative bacteria are suspected as the causative organisms, when fluoroquinolones have been used for prophylaxis, or when patients are located in areas where incidence of quinolone-resistant bacterial infections are high, cefotaxime is the treatment of choice.
Traveler's diarrhea
Based on the Infectious Diseases Society of America Guidelines for the Practice of Travel Medicine and the American College of Gastroenterology (ACG) Guideline for the Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults, Ofloxacine Aguettant is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.
Ofloxacine Aguettant description
Ofloxacine Aguettant Solution also contains benzalkonium chloride as inactive ingredient.
Ofloxacine Aguettant is (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3,-de][1,4]benzoxazine-6-carboxylic acid.
Ofloxacine Aguettant has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Ofloxacine Aguettant occurs as pale yellowish-white to light yellowish-white crystals or crystalline powder, is odorless and has a bitter taste. It is freely soluble in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in water, methanol, ethanol and acetone and very slightly soluble in ethyl acetate. It is slowly colorized by light and has no specific rotation.
Partition Coefficient: Chloroform: 0.1 mol/L phosphate buffer (pH 7.4):4.95. N-Octanol: 0.1 mol/L phosphate buffer (pH 7):0.33.
pH: 6-7. Osmotic pressure ratio (to physiological saline) 1-1.2.
Ofloxacine Aguettant dosage
Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is:
Acute Otitis Media in pediatric patients with tympanostomy tubes:The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:
Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:
How supplied
Ofloxacine Aguettant® Otic (Ofloxacine Aguettant otic) solution 0.3% is supplied in plastic dropper bottles containing 5 mL and 10 mL.
NDC 63395-101-05 Ofloxacine Aguettant® Otic (Ofloxacine Aguettant otic solution) 5 mL
NDC 63395-101-10 Ofloxacine Aguettant® Otic (Ofloxacine Aguettant otic solution) 10 mL
Storage Conditions: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Protect from light.
Daiichi Pharmaceutical Corporation., Montvale, NJ 07645. Revised: April 2005. FDA revision date: 5/4/2005
Ofloxacine Aguettant interactions
See also:
What other drugs will affect Ofloxacine Aguettant?
Drugs Known to Prolong QT Interval: Ofloxacine Aguettant, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Prolongation of bleeding time has been reported during concomitant administration of Ofloxacine Aguettant and anticoagulants.
There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold eg, theophylline. However, Ofloxacine Aguettant is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones.
Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs.
In case of convulsive seizures, treatment with Ofloxacine Aguettant should be discontinued.
Ofloxacine Aguettant may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.
Vitamin K Antagonists: Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.
Cimetidine: Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in t½ and AUC of some quinolones. The potential for interaction between Ofloxacine Aguettant and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofloxacine Aguettant, may increasethe risk of CNS stimulation and convulsive seizures.
Probenecid: The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of Ofloxacine Aguettant has not been reported.
Theophylline: Steady-state theophylline levels may increase when Ofloxacine Aguettant and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofloxacine Aguettant may prolong the t½ of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.
Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when Ofloxacine Aguettant is co-administered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.
Warfarin: Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored.
Antidiabetic Agents (eg, Insulin, Glyburide/Glibenclamide): Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.
Cyclosporine: Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones. The potential for interaction between Ofloxacine Aguettant and cyclosporine has not been reported.
Drugs Metabolized by Cytochrome P450 (CYP450) Enzymes: Most quinolone antimicrobial drugs inhibit CYP450 enzyme activity. This may result in a prolonged t½ for some drugs that are also metabolized by this system (eg, cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent of this inhibition varies among different quinolones.
Interactions with Laboratory Tests: Some quinolones, including Ofloxacine Aguettant, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.
Ofloxacine Aguettant side effects
See also:
What are the possible side effects of Ofloxacine Aguettant?
Applies to Ofloxacine Aguettant otic: otic solution
In addition to its needed effects, some unwanted effects may be caused by Ofloxacine Aguettant otic (the active ingredient contained in Ofloxacine Aguettant). 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 Ofloxacine Aguettant otic:
Less common:
- Burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine
Severity: Moderate
If any of the following side effects occur while taking Ofloxacine Aguettant otic, check with your doctor or nurse as soon as possible:
Less common:
- Dizziness
- Bleeding from the ear
- fast heartbeat
- fever
- headache
- ringing in the ear
- runny or stuffy nose
- sore throat
Minor Side Effects
Some of the side effects that can occur with Ofloxacine Aguettant otic 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:
- Change in taste
- earache
- numbness or tingling
Ofloxacine Aguettant contraindications
See also:
What is the most important information I should know about Ofloxacine Aguettant?
You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofloxacine Aguettant or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ofloxacine Aguettant, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take Ofloxacine Aguettant. These other medicines can make Ofloxacine Aguettant much less effective when taken at the same time.
Ofloxacine Aguettant may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Ofloxacine Aguettant and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.
Do not share this medication with another person (especially a child), even if they have the same symptoms you have.
Active ingredient matches for Ofloxacine Aguettant:
Ofloxacin in France.
List of Ofloxacine Aguettant substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Ofloxacine-Sandoz (Belgium, France, Luxembourg, Netherlands) | |
| Ofloxacino (Brazil, Peru) | |
| Ofloxacino Combix (Spain) | |
| Ofloxacino G.E.S. (Spain) | |
| Ofloxacino Gen.Germed (Brazil) | |
| Ofloxacino Genfarma (Spain) | |
| Ofloxacino Ges (Spain) | |
| Ofloxacino Ranbaxy (Spain) | |
| Ofloxacino Teva (Spain) | |
| Ofloxain | |
| Ofloxain 400 mg Tablet (Sain Medicaments Pvt. Ltd.) | $ 0.12 |
| Ofloxain 200 mg Tablet (Sain Medicaments Pvt. Ltd.) | $ 0.07 |
| Ofloxal (Peru) | |
| Ofloxamac | |
| Ofloxamac 200 mg Tablet (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.05 |
| OFLOXAMAC 200MG SUSPENSION 1 bottle / 30 ML suspension each (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.36 |
| OFLOXAMAC 200MG TABLET 1 strip / 10 tablets each (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.72 |
| OFLOXAMAC EYE/EAR DROPS 1 packet / 10 ML eye/ear drops each (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.10 |
| Ofloxamac 200mg Suspension (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.36 |
| Ofloxamac 200mg Tablet (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.07 |
| Ofloxamac NA Eye/Ear Drops (Torque Pharmaceuticals Pvt. Ltd.) | $ 0.10 |
| Ofloxamarksans (Vietnam) | |
| Ofloxamarksans 200 mg x 10 Blister x 10 Tablet | |
| Ofloxamed (Poland) | |
| Ofloxan (Brazil) | |
| Ofloxat (Japan) | |
| Ofloxat 0.3% (Japan) | |
| Ofloxavis (Spain) | |
| Ofloxbeta (Germany) | |
| Tablet, Film-Coated; Oral; Ofloxacin 200 mg (Betapharm) | |
| Tablets, Film-Coated; Oral; Ofloxacin 200 mg (Betapharm) | |
| Ofloxbeta Uro | |
| Tablet, Film-Coated; Oral; Ofloxacin 100 mg | |
| Tablets, Film-Coated; Oral; Ofloxacin 100 mg | |
| Ofloxcin (Thailand) | |
| OFLOXEL (India) | |
| OFLOXEL tab 200 mg x 10's (Jaiwik) | $ 0.65 |
| OFLOXEL tab 400 mg x 10's (Jaiwik) | $ 0.95 |
| OFLOXIBACT | |
| OFLOXIBACT 200MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd) | $ 0.41 |
| OFLOXIBACT OZ | |
| OFLOXIBACT OZ 100MG TABLET 1 strip / 10 tablets each (Unireach Healthcare Pvt Ltd) | $ 0.66 |
| Ofloxin (Bulgaria, Czech Republic, Estonia, Japan, Latvia, Lithuania, Romania, Russian Federation, Slovakia, Thailand) | |
| Injectable; Injection; Ofloxacin 2 mg / ml (Siam Bheasach) | |
| Tablet, Film-Coated; Oral; Ofloxacin 200 mg (Siam Bheasach) | |
| Tablet, Film-Coated; Oral; Ofloxacin 400 mg (Siam Bheasach) | |
| Ofloxin 400mg - 10 Tablets (Siam Bheasach) | $ 16.60 |
| Ofloxin 200mg - 10 Tablets (Siam Bheasach) | $ 10.40 |
| Ofloxin 100 mg x 10 x 10's (Siam Bheasach) | |
| Ofloxin 200 mg x 10 x 10's (Siam Bheasach) | |
| Tablets, Film-Coated; Oral; Ofloxacin 200 mg (Siam Bheasach) | |
See 9094 substitutes for Ofloxacine Aguettant | |
References
- DailyMed. "OFLOXACIN: 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).
- PubChem. "ofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ofloxacin". http://www.drugbank.ca/drugs/DB01165 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
