Ofm Uses

• Ofm indications
• Uses of Ofm in details
• Ofm description
• Ofm dosage
• Ofm interactions
• Ofm side effects
• Ofm contraindications

What is Ofm?

Ofm is an antibiotic that treats infections caused by bacteria.

Ofm otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofm otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).

Ofm 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.

Ofm may also be used for purposes not listed in this medication guide.

Ofm indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofm tablets and other antibacterial drugs, Ofm 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.

Ofm 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 Ofm, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Ofm 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 Ofm, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Ofm 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 Ofm, USP. Therapy with Ofm, 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 Ofm, 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 Ofm?

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

• To use Ofm 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 Ofm drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Ofm drops works best if used at the same time each day.
• To clear up your infection completely, use Ofm 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 Ofm 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 Ofm drops.

Uses of Ofm 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, Ofm is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Ofm 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 Ofm, 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 Ofm regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Ofm for the treatment of paucibacillary leprosy.

Spontaneous bacterial peritonitis (treatment)

According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Ofm 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, Ofm is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.

Ofm description

Ofm Solution also contains benzalkonium chloride as inactive ingredient.

Ofm 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.

Ofm has a molecular formula of C₁₈H₂₀FN₃O₄, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Ofm 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.

Ofm 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

Ofm® Otic (Ofm otic) solution 0.3% is supplied in plastic dropper bottles containing 5 mL and 10 mL.

NDC 63395-101-05 Ofm® Otic (Ofm otic solution) 5 mL

NDC 63395-101-10 Ofm® Otic (Ofm 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

Ofm interactions

See also:
What other drugs will affect Ofm?

Drugs Known to Prolong QT Interval: Ofm, 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 Ofm 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, Ofm 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 Ofm should be discontinued.

Ofm 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 t_½ and AUC of some quinolones. The potential for interaction between Ofm and cimetidine has not been reported.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Ofm, 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 Ofm has not been reported.

Theophylline: Steady-state theophylline levels may increase when Ofm and theophylline are administered concurrently. As with other quinolones, concomitant administration of Ofm may prolong the t_½ 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 Ofm 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 Ofm 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 t_½ 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 Ofm, 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.

Ofm side effects

See also:
What are the possible side effects of Ofm?

Applies to Ofm otic: otic solution

In addition to its needed effects, some unwanted effects may be caused by Ofm otic (the active ingredient contained in Ofm). 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 Ofm 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 Ofm 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 Ofm 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

Ofm contraindications

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

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Ofm or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking Ofm, 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 Ofm. These other medicines can make Ofm much less effective when taken at the same time.

Ofm 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 Ofm 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 Ofm:

Ofloxacin

Metronidazole

References

1. DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: 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. 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).
3. PubChem. "ofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology