Ofloxacin 0.3% Thephaco is an antibiotic that treats infections caused by bacteria.
Ofloxacin 0.3% Thephaco otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofloxacin 0.3% Thephaco otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).
Ofloxacin 0.3% Thephaco 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.
Ofloxacin 0.3% Thephaco may also be used for purposes not listed in this medication guide.
Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco tablets and other antibacterial drugs, Ofloxacin 0.3% Thephaco 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.
Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco, USP. Therapy with Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco?
Use Ofloxacin 0.3% Thephaco solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ofloxacin 0.3% Thephaco solution is only for the ear. Do not get it in your eyes, nose, or mouth.
Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for 5 minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
If you are using Ofloxacin 0.3% Thephaco solution for a middle ear infection, pump the flap over the ear 4 times after instilling the medicine in order to help it reach the middle ear.
Ofloxacin 0.3% Thephaco solution works best if used at the same time each day.
To clear up your infection completely, use Ofloxacin 0.3% Thephaco solution for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Ofloxacin 0.3% Thephaco solution, 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 Ofloxacin 0.3% Thephaco solution.
Uses of Ofloxacin 0.3% Thephaco 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.
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
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, Ofloxacin 0.3% Thephaco is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Ofloxacin 0.3% Thephaco 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.
Data from a limited number of patients in an open-label, parallel assessment study suggest that Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Ofloxacin 0.3% Thephaco for the treatment of paucibacillary leprosy.
Spontaneous bacterial peritonitis (treatment)
According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Ofloxacin 0.3% Thephaco 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.
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, Ofloxacin 0.3% Thephaco is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.
Ofloxacin 0.3% Thephaco description
Ofloxacin 0.3% Thephaco Solution also contains benzalkonium chloride as inactive ingredient.
Ofloxacin 0.3% Thephaco 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.
Ofloxacin 0.3% Thephaco has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Ofloxacin 0.3% Thephaco 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.
pH: 6-7. Osmotic pressure ratio (to physiological saline) 1-1.2.
Ofloxacin 0.3% Thephaco dosage
The usual dose of Ofloxacin 0.3% Thephaco® (Ofloxacin 0.3% Thephaco tablets) Tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients with Impaired Renal Function Subsection.
Acute Bacterial Exacerbation of Chronic Bronchitis
Comm. Acquired Pneumonia
Uncomplicated Skin and Skin Structure Infections
Acute, Uncomplicated Urethral and Cervical Gonorrhea
Nongonococcal Cervicitis/Urethritis due to C. trachomatis
Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrhoeae
Acute Pelvic Inflammatory Disease
Uncomplicated Cystitis due to E. coli or K. pneumoniae
Uncomplicated Cystitis due to other approved pathogens
Prostatitis due to E.Coli
† DUE TO THE DESIGNATED PATHOGENS
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx® (didanosine) should not be taken within the two-hour period before or within the two-hour period after taking Ofloxacin 0.3% Thephaco.
Patients with Impaired Renal Function: Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows:
the usual recommended unit dose
< 20 mL/min
½ the usual recommended unit dose
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
Creatinine Clearance (mL/min) =
(140 – age) x (actual body wt in kg)
72 x (serum creatinine)
Women: 0.85 x the value calculated for men
The serum creatinine should represent a steady-state of renal function.
Patients with Cirrhosis:
The excretion of Ofloxacin 0.3% Thephaco may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of Ofloxacin 0.3% Thephaco per day should therefore not be exceeded.
Ofloxacin 0.3% Thephaco® (Ofloxacin 0.3% Thephaco tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold oval, straight-edged, coated tablets. Each tablet is distinguished by an imprint of “Ofloxacin 0.3% Thephaco (Ofloxacin 0.3% Thephaco) ” and the appropriate strength. Ofloxacin 0.3% Thephaco® (Ofloxacin 0.3% Thephaco) Tablets are packaged in bottles in the following configurations:
Drugs Known to Prolong QT Interval: Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco 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, Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco should be discontinued.
Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco has not been reported.
Theophylline: Steady-state theophylline levels may increase when Ofloxacin 0.3% Thephaco and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco, 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.
In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacin 0.3% Thephaco otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.
An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both Ofloxacin 0.3% Thephaco and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.
In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.
In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.
Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes
In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with Ofloxacin 0.3% Thephaco otic solution:
Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.
Post-marketing Adverse Events
Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Ofloxacin 0.3% Thephaco otic solution 0.3% is unknown.
You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofloxacin 0.3% Thephaco or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ofloxacin 0.3% Thephaco, 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 Ofloxacin 0.3% Thephaco. These other medicines can make Ofloxacin 0.3% Thephaco much less effective when taken at the same time.
Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco 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 Ofloxacin 0.3% Thephaco:
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).
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