What happens if I overdose Levofloxacin 0.5.% Ohara?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Levofloxacin 0.5.% Ohara tablets:
Store Levofloxacin 0.5.% Ohara tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Levofloxacin 0.5.% Ohara tablets out of the reach of children and away from pets.
Overdose of Levofloxacin 0.5.% Ohara in details
Levofloxacin 0.5.% Ohara exhibits a low potential for acute toxicity.
Symptoms: Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of Levofloxacin 0.5.% Ohara: Ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.
Treatment: In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin 0.5.% Ohara is not efficiently removed by hemodialysis or peritoneal dialysis.
What should I avoid while taking Levofloxacin 0.5.% Ohara?
You may be taking certain other medicines that should not be taken at the same time as Levofloxacin 0.5.% Ohara. Avoid taking the following medicines within 2 hours before or after you take Levofloxacin 0.5.% Ohara. These other medicines can make Levofloxacin 0.5.% Ohara much less effective when taken at the same time:
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antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);
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didanosine (Videx) powder or chewable tablets; or
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vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.
Avoid exposure to sunlight or tanning beds. Levofloxacin 0.5.% Ohara 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.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
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 Levofloxacin 0.5.% Ohara and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Levofloxacin 0.5.% Ohara warnings
Tendinopathy and Tendon Rupture
Fluoroquinolones, including Levofloxacin 0.5.% Ohara, 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 tendon sites 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. Levofloxacin 0.5.% Ohara 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..
Exacerbation of Myasthenia Gravis
Fluoroquinolones, including Levofloxacin 0.5.% Ohara, 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 Levofloxacin 0.5.% Ohara in patients with a known history of myasthenia gravis.
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including Levofloxacin 0.5.% Ohara. 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. Levofloxacin 0.5.% Ohara 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 Reactions
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 fluoroquinolones, including Levofloxacin 0.5.% Ohara. 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;
- allergic pneumonitis;
- 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.
Hepatotoxicity
Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with Levofloxacin 0.5.% Ohara. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin 0.5.% Ohara should be discontinued immediately if the patient develops signs and symptoms of hepatitis.
Central Nervous System Effects
Convulsions, toxic psychoses, increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including Levofloxacin 0.5.% Ohara. Fluoroquinolones may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Levofloxacin 0.5.% Ohara, the drug should be discontinued and appropriate measures instituted. As with other fluoroquinolones, Levofloxacin 0.5.% Ohara should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction)..
Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Levofloxacin 0.5.% Ohara, 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.
Peripheral Neuropathy
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 fluoroquinolones, including Levofloxacin 0.5.% Ohara. Symptoms may occur soon after initiation of Levofloxacin 0.5.% Ohara and may be irreversible. Levofloxacin 0.5.% Ohara should be discontinued immediately 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.
Prolongation of the QT Interval
Some fluoroquinolones, including Levofloxacin 0.5.% Ohara, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including Levofloxacin 0.5.% Ohara. Levofloxacin 0.5.% Ohara should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals
Levofloxacin 0.5.% Ohara is indicated in pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving Levofloxacin 0.5.% Ohara.
In immature rats and dogs, the oral and intravenous administration of Levofloxacin 0.5.% Ohara resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with Levofloxacin 0.5.% Ohara revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.
Blood Glucose Disturbances
As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with Levofloxacin 0.5.% Ohara, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with Levofloxacin 0.5.% Ohara, Levofloxacin 0.5.% Ohara should be discontinued and appropriate therapy should be initiated immediately.
Photosensitivity/Phototoxicity
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs.
Development of Drug Resistant Bacteria
Prescribing Levofloxacin 0.5.% Ohara in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
What should I discuss with my healthcare provider before taking Levofloxacin 0.5.% Ohara?
You should not use this medication if you are allergic to Levofloxacin 0.5.% Ohara or other fluoroquinolones (ciprofloxacin, gemifloxacin, moxifloxacin, ofloxacin, norfloxacin, and others).
You may not be able to use Levofloxacin 0.5.% Ohara if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis.
To make sure Levofloxacin 0.5.% Ohara is safe for you, tell your doctor if you have:
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a heart rhythm disorder, especially if you take medication to treat it;
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a personal or family history of Long QT syndrome;
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tendon problems, arthritis or other joint problems (especially in children);
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a muscle or nerve disorder;
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bone problems;
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liver or kidney disease;
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seizures or epilepsy;
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a history of head injury or brain tumor;
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a history of allergic reaction to an antibiotic;
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diabetes (especially if you use insulin or take oral diabetes medication);
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low levels of potassium in your blood (hypokalemia); or
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if you use a blood thinner (warfarin, Coumadin) and have "INR" or prothrombin time tests.
Levofloxacin 0.5.% Ohara 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. This can happen during treatment or up to several months after you stop taking Levofloxacin 0.5.% Ohara. Tendon problems 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.
FDA pregnancy category C. It is not known whether Levofloxacin 0.5.% Ohara will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether Levofloxacin 0.5.% Ohara passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Levofloxacin 0.5.% Ohara precautions
Photosensitivity reactions have been observed in patients, exposure to sunlight or UV should be avoided.
As with other quinolones, Levofloxacin 0.5.% Ohara should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose to CNS stimulation (eg, dizziness, lightheadedness), although it rarely happens.
Careful monitoring of blood glucose is recommended in patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin.
For long-term therapy, periodic assessment of renal, hepatic and hematopoetic function is necessary.
Levofloxacin 0.5.% Ohara should be discontinued if the patient experiences pain, inflammation or rupture of a tendon.
Serious and occasionally fatal hypersensitivity often occur following the 1st dose, hence, Levofloxacin 0.5.% Ohara should be discontinued immediately at the 1st appearance of a skin rash or any other sign of hypersensitivity.
It is important to consider the diagnosis of pseudomembranous colitis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.
Quinolones, including Levofloxacin 0.5.% Ohara, cause arthropathy and osteochondrosis in juvenile animals of several species.
Effects on the Ability to Drive or Operate Machinery: Levofloxacin 0.5.% Ohara may cause dizziness. Veloca should be used with caution in patients who perform activities requiring mental alertness and cordination eg, operating an automobile or machinery.
Use in pregnancy & lactation: Levofloxacin 0.5.% Ohara can be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Based upon the data from ofloxacin, it can be presumed that Levofloxacin 0.5.% Ohara will be excreted in human milk. Because of the potential for serious adverse reactions from Levofloxacin 0.5.% Ohara in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Levofloxacin 0.5.% Ohara, taking into account the importance of Levofloxacin 0.5.% Ohara to the mother.
Use in children: The safety and efficacy of Levofloxacin 0.5.% Ohara in pediatric patients and adolescents <18 years have not been established.
What happens if I miss a dose of Levofloxacin 0.5.% Ohara?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "LEVOFLOXACIN: 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).
- DrugBank. "LEVOFLOXACIN". http://www.drugbank.ca/drugs/DB01137 (accessed September 17, 2018).
- MeSH. "Cytochrome P-450 CYP1A2 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
