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What is Ofialin?
Ofialin is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Ofialin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Ofialin belongs to the class of drugs known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, Ofialin will not work for colds, flu, or other virus infections.
Ofialin is available only with your doctor's prescription.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofialin tablets and other antibacterial drugs, Ofialin 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.
Ofialin 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 Ofialin, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Ofialin 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 Ofialin, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Ofialin 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 Ofialin, USP. Therapy with Ofialin, 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 Ofialin, 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 Ofialin?
Use Ofialin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ofialin 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 Ofialin 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.
- Ofialin solution works best if used at the same time each day.
- To clear up your infection completely, use Ofialin 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 Ofialin 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 Ofialin solution.
Uses of Ofialin in details
This medication is used to treat eye infections. Ofialin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria.
This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
How to use Ofialin ophthalmic
To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.
Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer's directions and check with your doctor before using them.
Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over the eye and place one drop into the eye. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed, and if your dose is for more than 1 drop.
Do not rinse the dropper. Replace the dropper cap after each use.
If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.
Use this medication regularly in order to get the most benefit from it. Continue using it for the full time 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 relapse of the infection.
Inform your doctor if your condition persists or worsens.
Ofialin Solution also contains benzalkonium chloride as inactive ingredient.
Ofialin 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.
Ofialin has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Ofialin 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.
Adults: Given orally in a usual daily dose of 300-600 mg of Ofialin (3-6 tabs) divided into 2-3 doses. If used for leprosy, it is recommended to give a total of 400-600 of Ofialin per day divided into 2-3 doses. In general, the dosage should be adjusted according to the causative organism and the severity of the symptoms. For leprosy, Ofialin should as a rule be co-administered with other antileprosy drugs.
Urinary Tract Infections: 1 x 100 mg up to 2 x 100 mg (or 1 x 200 mg).
Kidney and Reproductive Organ Infections: 2 x 100 mg up to 2 x 200 mg.
Respiratory Tract and Ear, Nose and Throat: 2 x 200 mg.
Skin and Soft Tissue Infections: 2 x 200 mg.
Bones and Joint Infections: 2 x 200 mg.
Abdominal Infections: 2 x 200 mg.
Septicaemia: 2 x 200 mg.
It is important that the individual doses be given at approximately equal intervals.
Depending on the severity of the infection and on the presence of complicating factors or pathogens of moderate susceptibility, it may be necessary to increase the dose to up 2 x 400 mg daily.
Patients with Impaired Renal Function: The initial dose is the same as for patients with normal renal function, whereas the maintenance dose should be reduced as follows: Creatinine clearance: 50-20 mL/min: 100-200 mg every 24 hrs; <20 mL/min: 100 mg every 24 hrs; haemodialysis or Peritoneal dialysis:
Peritoneal dialysis:100 mg every 24 hrs. In individual instances, it may be necessary to increase the dosage.
Patients with Impaired Liver Function: The excretion of Ofialin may be reduced in patients with severe impairment of liver function (eg, cirrhosis with ascites). A maximum daily dose of 400 mg of Ofialin should therefore not be exceeded.
Duration of Treatment: The duration of treatment depends on the response of the causative organism and on the clinical picture. In most cases of acute infection, a course of treatment lasting 7-10 days is sufficient. In salmonelloses, the duration of treatment is usually 7-8 days, in shigelloses 3-5 days and in intestinal infections caused by E. coli 3 days.
For uncomplicated infections of the lower urinary tract, 3-day treatment is usually sufficient.
In case of infections with β-haemolytic streptococci (eg, purulent tonsillitis or erysipelas), treatment must be continued for at least 10 days in order to prevent late complications eg, rheumatic fever or inflammation of the renal glomeruli (glomerulonephritis). However, since β-haemolytic streptococci are of varying susceptibility to Ofialin, treatment of such infections requires individual proof of susceptibility.
Until further experience is available, the duration of treatment should not exceed 2 months.
Drugs Known to Prolong QT Interval: Ofialin, 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 Ofialin 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, Ofialin 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 Ofialin should be discontinued.
Ofialin 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 Ofialin and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofialin, 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 Ofialin has not been reported.
Theophylline: Steady-state theophylline levels may increase when Ofialin and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofialin 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 Ofialin 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 Ofialin 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 Ofialin, 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.
Ofialin side effects
Subjects with Otitis Externa
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 Ofialin 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 Ofialin 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 Ofialin 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 Ofialin otic solution 0.3% is unknown.
Hypersensitivity to 4-quinolone antibacterials, Ofialin or to any of the excipients of Ofialin.
Patients with past history of tendonitis and epilepsy or with a lowered seizure threshold; since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.
Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Use in pregnancy & lactation: The safety of Ofialin for use in human pregnancy has not been established. Reproduction studies performed in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and postnatal development. However, as with other quinolones, Ofialin has been shown to cause arthropathy in immature animals and therefore, its use during pregnancy is not recommended. Studies in rats have indicated that Ofialin is secreted in milk. It should therefore not be used during lactation.
Use in children: Ofialin is not indicated for use in children or growing adolescents.
Active ingredient matches for Ofialin:
Ofloxacin in Vietnam.
|Unit description / dosage (Manufacturer)||Price, USD|
|Ofialin 200 mg x 1 Box|
List of Ofialin substitutes (brand and generic names):
|Ofia OZ 200+500 Tablet (Biosync Pharmaceuticals Pvt Ltd)||$ 0.12|
|Ofics 200 mg Tablet (Inargo Medichem)||$ 0.07|
|Ofics TZ 200+600 Tablet (Inargo Medichem)||$ 0.08|
|Ofikel 200mg TAB / 10 (Kelvin Pharmaceuticals Labs. Pvt. Ltd.)||$ 0.87|
|Ofikel 200 mg Tablet (Kelvin Pharmaceuticals Labs. Pvt. Ltd.)||$ 0.09|
|Ofil TZ 200+600 Tablet (Vostok & Wilcure Remedies)||$ 0.10|
|Ofin 200mg TAB / 10 (Oscar Remedies Pvt. Ltd.)||$ 10.95|
|Ofin 200 mg Tablet (Oscar Remedies Pvt. Ltd.)||$ 0.11|
|Ofin Eye 5 ml Drop (Oscar Remedies Pvt. Ltd.)||$ 0.36|
|Ofin D Eye 5 ml Drop (Oscar Remedies Pvt. Ltd.)||$ 0.41|
|Ofin T 200+600 Tablet (Oscar Remedies Pvt. Ltd.)||$ 0.13|
|Ofin Z 200+500 Tablet (Oscar Remedies Pvt. Ltd.)||$ 0.13|
|Ofina 30 ml Suspension (Anikem Laboratories)||$ 0.08|
|Ofina 200 mg Tablet (Anikem Laboratories)||$ 0.08|
|Ofina 400 mg Tablet (Anikem Laboratories)||$ 0.14|
|ofina 60 ml Suspension (Anikem Laboratories)||$ 0.06|
|Ofina OZ 200+500 Tablet (Anikem Laboratories)||$ 0.12|
|Ofina OZ 30 ml Suspension (Anikem Laboratories)||$ 0.09|
|OFIOR 50MG SUSPENSION 1 bottle / 60 ML suspension each (Bio Warriors Pharmaceuticals Pvt Ltd)||$ 0.67|
|Ofist 200mg TAB / 10x10 (Thiest Biotec)||$ 8.25|
|Ofist 200 mg Tablet (Thiest Biotec)||$ 0.08|
|Ofist OZ 200+500 Tablet (Thiest Biotec)||$ 0.11|
|Ofit 200 mg Tablet (National Chemical & Pharmaceuticals Works (P) Ltd.)||$ 0.10|
|Ofit TZ 200+600 Tablet (National Chemical & Pharmaceuticals Works (P) Ltd.)||$ 0.12|
|Ofix 100mg TAB / 10 (Nexus Biotech)||$ 0.46|
|Ofix 200mg TAB / 10 (Nexus Biotech)||$ 0.62|
|Ofix 400mg TAB / 10 (Nexus Biotech)||$ 1.24|
|Ofix 50mg/5ml SUSP / 30ml (Nexus Biotech)||$ 0.41|
|Ofix 100 mg Tablet (Nexus Biotech)||$ 0.05|
|Ofix 200 mg Tablet (Nexus Biotech)||$ 0.08|
|Ofix 400 mg Tablet (Nexus Biotech)||$ 0.12|
|Ofix 30 ml Suspension (Nexus Biotech)||$ 0.13|
|OFIX 200MG TABLET 1 strip / 10 tablets each (Nexus Biotech)||$ 0.85|
|Ofix 200mg Tablet (Nexus Biotech)||$ 0.09|
|Ofix OZ 30 ml Suspension (Nexus Biotech)||$ 0.09|
|Ofix OZ 200+500 Tablet (Nexus Biotech)||$ 0.13|
|Ofizen 200mg TAB / 10x10|
|Ofka 200mg TAB / 10 (Aishika Pharma (P) Ltd)|
|Ofka 200 mg Tablet (Aishika Pharma (P) Ltd)||$ 0.06|
|Ofka 400 mg Tablet (Aishika Pharma (P) Ltd)||$ 0.10|
|Ofka OZ 200+500 Tablet (Aishika Pharma (P) Ltd)||$ 0.12|
|200 mg x 100's (Lancer Pharmaceuticals (P) Ltd.)||$ 7.78|
- 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).
ReviewsThe results of a survey conducted on ndrugs.com for Ofialin 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 Ofialin. 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.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
1 consumer reported time for resultsTo what extent do I have to use Ofialin before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 3 days and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Ofialin. To get the time effectiveness of using Ofialin drug by other patients, please click here.
Consumer reported ageNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology