Otoxin 0.3%
Otoxin 0.3% Uses, Dosage, Side Effects, Food Interaction and all others data.
Otoxin 0.3% is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Otoxin 0.3% is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
Otoxin 0.3% is a quinolone/fluoroquinolone antibiotic. Otoxin 0.3% is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Otoxin 0.3% is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.
| Trade Name | Otoxin 0.3% |
| Availability | Prescription only |
| Generic | Ofloxacin |
| Ofloxacin Other Names | Ofloxacin, Ofloxacine, Ofloxacino, Ofloxacinum, OFLX |
| Related Drugs | amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin |
| Type | |
| Formula | C18H20FN3O4 |
| Weight | Average: 361.3675 Monoisotopic: 361.143784348 |
| Protein binding | 32% |
| Groups | Approved |
| Therapeutic Class | 4-Quinolone preparations, Ophthalmic antibacterial drugs |
| Manufacturer | |
| Available Country | Egypt |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Otoxin 0.3% Eye: It is used for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.
Otoxin 0.3% Ear: It is used for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).
Otoxin 0.3% Oral/Injection are used for the treatment of adults with mild to moderate infections caused by susceptible strains.
- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
- Gastrointestinal Tract: Enteric fever, shigellosis.
- Multi-drug-resistant Tuberculosis.
- Skin and skin structures: Uncomplicated skin and skin structure infections.
- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
Otoxin 0.3% is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute Otitis Media, Bacterial Infections, Cervicitis, Community Acquired Pneumonia (CAP), Complicated Urinary Tract Infection, Conjunctivitis, Epididymitis, Hansen's Disease, Nongonococcal urethritis, Otitis Externa, Prostatitis, Skin and Subcutaneous Tissue Bacterial Infections, Spontaneous Bacterial Peritonitis (SBP), Traveler's Diarrhea, Ulcerative keratitis, Acute Pelvic inflammatory disease, Acute, uncomplicated Gonorrhea, Chronic suppurative Otitis media, Uncomplicated Cystitis
How Otoxin 0.3% works
Otoxin 0.3% acts on DNA gyrase and toposiomerase IV, enzymes which, like human topoisomerase, prevents the excessive supercoiling of DNA during replication or transcription. By inhibiting their function, the drug thereby inhibits normal cell division.
Dosage
Otoxin 0.3% dosage
Otoxin 0.3% Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.
Otoxin 0.3% Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.
Otoxin 0.3% Intravenous (Adult):
- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Otoxin 0.3% Oral (Adult):
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Otoxin 0.3% tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.
- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
- Shigellosis: 400 mg single dose.
- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Children: Otoxin 0.3% is usually not indicated for use in children or growing adolescents.
Elderly: No adjustment of dosage is required in the elderly.
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
Side Effects
Otoxin 0.3% Eye: Transient ocular irritation, burning, stinging, redness, itching or photophobia have been reported.
Otoxin 0.3% Ear: Mild irritation or mild discomfort in the ear may occur. Symptoms of an allergic reaction include rash, itching, swelling or trouble breathing.
Otoxin 0.3% tablet or injection is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
Toxicity
LD50=5450 mg/kg (orally in mice)
Precaution
Patients being treated with Otoxin 0.3% should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.
Interaction
Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
Food Interaction
- Limit caffeine intake.
- Take with or without food. The absorption is unaffected by food.
Otoxin 0.3% multivitamins interaction
[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.
Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.
The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.
The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.
When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.
When coadministered with Suprep Bowel Prep (magnesium Please consult individual product labeling for specific recommendations.
Otoxin 0.3% Drug Interaction
Moderate: aspirin, aspirin, ginkgoMinor: sulfamethoxazole / trimethoprimUnknown: amoxicillin, amoxicillin / clavulanate, Allergy , ciprofloxacin, loratadine, acetaminophen, clopidogrel, acetaminophen, valproic acid, multivitamin, thiamine, cyanocobalamin, pyridoxine, ascorbic acid, cholecalciferol, phytonadione
Otoxin 0.3% Disease Interaction
Major: colitis, CNS disorders, myasthenia gravis, peripheral neuropathy, QT interval prolongation, tendonitisModerate: crystalluria, diabetes, hemodialysis, renal dysfunction
Elimination Route
Bioavailability of ofloxacin in the tablet formulation is approximately 98%
Half Life
9 hours
Elimination Route
Otoxin 0.3% is mainly eliminated by renal excretion, where between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via urine within 48 hours of dosing. About 4-8% of an ofloxacin dose is excreted in the feces and the drug is minimally subject to biliary excretion.
Pregnancy & Breastfeeding use
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Otoxin 0.3% is excreted in human milk. Cautions should be taken when Otoxin 0.3% eye & ear drops is administered during lactation.
Contraindication
It is contraindicated in patients who are hypersensitive to Otoxin 0.3% or any other component of Otoxin 0.3% (Eye/Ear Drops).
Otoxin 0.3% tablet injection should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Otoxin 0.3% is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
Special Warning
Renal Impairment:
- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily
Acute Overdose
Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
Storage Condition
Store between 15-30° C. Protect from light.
Innovators Monograph
You find simplified version here Otoxin 0.3%
Otoxin 0.3% contains Ofloxacin see full prescribing information from innovator Otoxin 0.3% Monograph, Otoxin 0.3% MSDS, Otoxin 0.3% FDA label
FAQ
What is Otoxin 0.3% used to treat?
Otoxin 0.3% is used to treat certain infections including pneumonia, and infections of the skin, bladder, reproductive organs, and prostate.
How safe is Otoxin 0.3%?
Otoxin 0.3% can cause serious side effects, including tendon problems, side effects on your nerves, serious mood or behavior changes , or low blood sugar.
How does Otoxin 0.3% work?
Otoxin 0.3% works by stopping the growth of bacteria.
What are the common side effects of Otoxin 0.3%?
Common side effects of Otoxin 0.3% are include:
- nausea
- diarrhea
- constipation
- gas
- vomiting
- stomach pain or cramps
- change in ability to taste food
- loss of appetite
- dry mouth
- excessive tiredness
- pale skin
- pain, swelling, or itching of the vagina
Is Otoxin 0.3% safe during pregnancy?
Otoxin 0.3% is avoide during pregnancy because of concerns about cartilage toxicity.
Is Otoxin 0.3% safe during breastfeeding?
Use of Otoxin 0.3% is acceptable in nursing mothers with monitoring of the infant for possible effects on the flora, such as diarrhea or candidiasis. Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to Otoxin 0.3% in breastmilk.
Can I drink alcohol with Otoxin 0.3%?
It is generally safe to drink alcohol in moderation while taking Otoxin 0.3%.
Can I drive after taking Otoxin 0.3%?
Taking Otoxin 0.3% may make you feel sleepy, dizzy or could affect your eyesight. Do not drive or use machines until you know how this medicine affects you. Drinking alcohol may make these symptoms worse.
How long does Otoxin 0.3% take to work?
Most people feel better within 48 to 72 hours and have minimal or no symptoms by 7 days
Can Otoxin 0.3% treat stomach pain?
Otoxin 0.3% is also sometimes used to treat other types of infection, including Legionnaires' disease, certain sexually transmitted diseases, infections of the bones and joints and of the stomach and intestines.
How long does Otoxin 0.3% stay in the body?
Administered oral dose of Otoxin 0.3% is excreted unchanged via the kidneys within 48 hours of dosing.
Who should not take Otoxin 0.3%?
Otoxin 0.3% may cause problems with bones, joints, and tissues around joints in children. Otoxin 0.3% should not be given to children younger than 18 years of age.
Can Otoxin 0.3% cause liver damage?
The severity of Otoxin 0.3% induced liver injury ranges from mild and transient serum enzyme elevations to self-limited jaundice to acute liver failure.
Can Otoxin 0.3% cause kidney problems?
Fluoroquinolone antibiotics have rarely been associated with renal failure.
Can Otoxin 0.3% raise blood sugar?
Medications like Otoxin 0.3% can sometimes affect blood glucose levels. Both hyperglycemia and, less frequently, hypoglycemia have been reported.
Can Otoxin 0.3% cause chest pain?
Otoxin 0.3% may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.
Does Otoxin 0.3% increase heart rate?
For patients with an abnormally slow heartbeat or low potassium levels in the blood, ofloxacin may increase your risk of having a fast, slow, or irregular heartbeat.
Is Otoxin 0.3% well tolerated?
Otoxin 0.3% in well tolerated, and in comparison with other available fluoroquinolones is less likely to cause clinically relevant drug interactions.
Does Otoxin 0.3% cause insomnia?
Brand can causes insomnia also eith other side effects.
Is Otoxin 0.3% an anti inflammatory?
Otoxin 0.3% is also used to treat pelvic inflammatory disease and Chlamydia or gonorrhea.
Does Otoxin 0.3% cause thrombocytopenia?
Fluoroquinolones are known to cause thrombocytopenia, Otoxin 0.3% induced thrombocytopenia cases are reported rarely.
Is it safe to take Otoxin 0.3% at night?
Otoxin 0.3% is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.
What happens if I miss a dose?
Take Otoxin 0.3% as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose of Otoxin 0.3%?
Otoxin 0.3% may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.
