Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Ofloxa-Vision 3mg/ml solution may be harmful if swallowed.
Proper storage of Ofloxa-Vision 3mg/ml solution:
Store Ofloxa-Vision 3mg/ml solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ofloxa-Vision 3mg/ml solution out of the reach of children and away from pets.
Overdose of Ofloxa-Vision 3mg/ml in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Information on overdosage with Ofloxa-Vision 3mg/ml is limited. One incident of accidental overdosage has been reported. In this case, an adult female received 3 grams of Ofloxa-Vision 3mg/ml intravenously over 45 minutes. A blood sample obtained 15 minutes after the completion of the infusion revealed an Ofloxa-Vision 3mg/ml level of 39.3 μg/mL. In 7 h, the level had fallen to 16.2 μg/mL, and by 24 h to 2.7 μg/mL. During the infusion, the patient developed drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation. All complaints except the dizziness subsided within 1 h after discontinuation of the infusion. The dizziness, most bothersome while standing, resolved in approximately 9 h. Laboratory testing reportedly revealed no clinically significant changes in routine parameters in this patient.
In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Ofloxa-Vision 3mg/ml is not efficiently removed by hemodialysis or peritoneal dialysis.
What should I avoid while taking Ofloxa-Vision 3mg/ml?
You may be taking certain other medicines that should not be taken at the same time as Ofloxa-Vision 3mg/ml. Avoid taking the following medicines within 2 hours before or after you take Ofloxa-Vision 3mg/ml. These other medicines can make Ofloxa-Vision 3mg/ml much less effective when taken at the same time:
antacids that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate);
didanosine (Videx) powder or chewable tablets;
vitamin or mineral supplements that contain aluminum, calcium, iron, magnesium, or zinc.
Avoid exposure to sunlight or tanning beds. Ofloxa-Vision 3mg/ml can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Ofloxa-Vision 3mg/ml and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Ofloxa-Vision 3mg/ml may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Ofloxa-Vision 3mg/ml warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Tendinopathy and Tendon Rupture
Fluoroquinolones, including Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml), are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml) should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
THE SAFETY AND EFFICACY OF Ofloxa-Vision 3mg/ml IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.
In the immature rat, the oral administration of Ofloxa-Vision 3mg/ml at 5 to 16 times the recommended maximum human dose based on mg/kg or 1-3 times based on mg/m² increased the incidence and severity of osteochondrosis. The lesions did not regress after 13 weeks of drug withdrawal. Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.
Exacerbation of Myasthenia Gravis
Fluoroquinolones, including Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml), have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml) in patients with a known history of myasthenia gravis.
Central Nervous System Effects
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including Ofloxa-Vision 3mg/ml. Quinolones, including Ofloxa-Vision 3mg/ml, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Ofloxa-Vision 3mg/ml, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with Ofloxa-Vision 3mg/ml than some other products in the quinolone class. As with all quinolones, Ofloxa-Vision 3mg/ml should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including Ofloxa-Vision 3mg/ml. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. This drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Ofloxa-Vision 3mg/ml. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
vasculitis; arthralgia; myalgia; serum sickness;
interstitial nephritis; acute renal insufficiency or failure;
hepatitis; jaundice; acute hepatic necrosis or failure;
anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including Ofloxa-Vision 3mg/ml. Ofloxa-Vision 3mg/ml should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ofloxa-Vision 3mg/ml® (Ofloxa-Vision 3mg/ml), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Ofloxa-Vision 3mg/ml has not been shown to be effective in the treatment of syphilis.
Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with Ofloxa-Vision 3mg/ml for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted.
What should I discuss with my healthcare provider before taking Ofloxa-Vision 3mg/ml?
Some medical conditions may interact with Ofloxa-Vision 3mg/ml. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have diabetes, liver problems, or a recent heart attack
if you or a family member have heart problems (eg, angina), irregular heartbeat (eg, QT prolongation), fast or slow heartbeat, or low potassium levels
if you have Alzheimer disease, hardening in the arteries in the brain, seizures, increased pressure on the brain, or another central nervous system disorder
if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant
if your skin is sensitive to sunlight
Some MEDICINES MAY INTERACT with Ofloxa-Vision 3mg/ml. Tell your health care provider if you are taking any other medicines, especially any of the following:
Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, quinidine, sotalol), cisapride, diuretics (eg, furosemide, hydrochlorothiazide), macrolide or ketolide antibiotics (eg, erythromycin, telithromycin), medicines for mental or mood disorders, medicines that may affect your heartbeat, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of serious side effects, including irregular heartbeat and other heart problems, may be increased. Check with your doctor or pharmacist if you are unsure if any of your medicines may affect your heartbeat
Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased
Foscarnet, NSAIDs (eg, ibuprofen), or tramadol because the risk of seizures may be increased
Insulin or other medicines for diabetes (eg, glipizide) because the risk of low blood sugar may be increased
Anticoagulants (eg, warfarin), procainamide, or theophylline because the risk of their side effects may be increased by Ofloxa-Vision 3mg/ml
Live typhoid vaccine because its effectiveness may be decreased by Ofloxa-Vision 3mg/ml
Aluminum salts (eg, aluminum hydroxide), iron salts (oral) (eg, ferrous sulfate), or magnesium salts (eg, magnesium hydroxide) because they may decrease Ofloxa-Vision 3mg/ml's effectiveness. Take Ofloxa-Vision 3mg/ml 2 hours before or 2 hours after these medicines to offset this effect
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ofloxa-Vision 3mg/ml may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ofloxa-Vision 3mg/ml precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
General: As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
The systemic administration of quinolones, including Ofloxa-Vision 3mg/ml at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.
Young growing guinea pigs dosed in the middle ear with 0.3% Ofloxa-Vision 3mg/ml otic solution showed no systemic effects, lesions or erosions of the cartilage in weightbearing joints, or other signs of arthropathy. No drug-related structural or functional changes of the cochlea and no lesions in the ossicles were noted in the guinea pig following otic administration of 0.3% Ofloxa-Vision 3mg/ml for one month.
No signs of local irritation were found when 0.3% Ofloxa-Vision 3mg/ml was applied topically in the rabbit eye. Ofloxa-Vision 3mg/ml was also shown to lack dermal sensitizing potential in the guinea pig maximization study.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to determine the carcinogenic potential of Ofloxa-Vision 3mg/ml have not been conducted. Ofloxa-Vision 3mg/ml was not mutagenic in the Ames test, the sister chromatid exchange assay (Chinese hamster and human cell lines), the unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or the mouse micro-nucleus assay. Ofloxa-Vision 3mg/ml was positive in the rat hepatocyte UDS assay, and in the mouse lymphoma assay. In rats, Ofloxa-Vision 3mg/ml did not affect male or female reproductive performance at oral doses up to 360 mg/kg/day. This would be over 1000 times the maximum recommended clinical dose, based upon body surface area, assuming total absorption of Ofloxa-Vision 3mg/ml from the ear of a patient treated with Ofloxa-Vision 3mg/ml® Otic (Ofloxa-Vision 3mg/ml otic solution) twice per day.
Teratogenic effects: Pregnancy Category C.
Ofloxa-Vision 3mg/ml has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day.
These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxa-Vision 3mg/ml has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.
Ofloxa-Vision 3mg/ml has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of Ofloxa-Vision 3mg/ml that will be delivered ototopically at the recommended clinical doses.
Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxa-Vision 3mg/ml® Otic (Ofloxa-Vision 3mg/ml otic solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of Ofloxa-Vision 3mg/ml in milk which were similar to those found in plasma. It is not
known whether Ofloxa-Vision 3mg/ml is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from Ofloxa-Vision 3mg/ml in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed
six months and older: otitis externa with intact tympanic membranes
one year and older: acute otitis media with tympanostomy tubes
twelve years and older: chronic suppurative otitis media with perforated tympanic membranes
Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product.
No changes in hearing function occurred in 30 pediatric subjects treated with Ofloxa-Vision 3mg/ml otic and tested for audiometric parameters. Although quinolones, including Ofloxa-Vision 3mg/ml, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% Ofloxa-Vision 3mg/ml otic solution for one month showed no systemic effects, quinoloneinduced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.
What happens if I miss a dose of Ofloxa-Vision 3mg/ml?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of Ofloxa-Vision 3mg/ml otic unless otherwise directed by your doctor.
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).