Ofloxacin Information
Ofloxacin (Ofloxacin)
Ofloxacin (Ofloxacin) Description
Ofloxacin (Ofloxacin) tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, Ofloxacin (Ofloxacin) , a fluorinated carboxyquinolone, is the racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7-pyrido[1,2,3-]-1,4-benzoxazine-6-carboxylic acid. The chemical structure is:
CHFNO M.W. 361.4
Ofloxacin (Ofloxacin) is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of Ofloxacin (Ofloxacin) at room temperature, as defined by USP nomenclature, indicate that Ofloxacin (Ofloxacin) is considered to be in aqueous solutions with pH between 2 and 5. It is to in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and in aqueous solutions with pH above 9. Ofloxacin (Ofloxacin) has the potential to form stable coordination compounds with many metal ions. This chelation potential has the following formation order: Fe> Al> Cu> Ni> Pb> Zn> Mg> Ca> Ba.
Ofloxacin (Ofloxacin) tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol 400, polysorbate 80, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg tablets contain iron oxide yellow and the 400 mg tablets contain iron oxide yellow and iron oxide red.
Ofloxacin (Ofloxacin) Clinical Pharmacology
Following oral administration, the bioavailability of Ofloxacin (Ofloxacin) in the tablet formulation is approximately 98%. Maximum serum concentrations are achieved one to two hours after an oral dose. Absorption of Ofloxacin (Ofloxacin) after single or multiple doses of 200 to 400 mg is predictable, and the amount of drug absorbed increases proportionately with the dose. Ofloxacin (Ofloxacin) has biphasic elimination. Following multiple oral doses at steady-state administration, the half-lives are approximately 4 to 5 hours and 20 to 25 hours. However, the longer half-life represents less than 5% of the total AUC. Accumulation at steady-state can be estimated using a half-life of 9 hours. The total clearance and volume of distribution are approximately similar after single or multiple doses. Elimination is mainly by renal excretion. The following are mean peak serum concentrations in healthy 70 to 80 kg male volunteers after single oral doses of 200, 300, or 400 mg of Ofloxacin (Ofloxacin) or after multiple oral doses of 400 mg.
Steady-state concentrations were attained after four oral doses, and the area under the curve (AUC) was approximately 40% higher than the AUC after single doses. Therefore, after multiple-dose administration of 200 mg and 300 mg doses, peak serum levels of 2.2 mcg/mL and 3.6 mcg/mL, respectively, are predicted at steady-state.
The single dose and steady-state plasma profiles of Ofloxacin (Ofloxacin) injection were comparable in extent of exposure (AUC) to those of Ofloxacin (Ofloxacin) tablets when the injectable and tablet formulations of Ofloxacin (Ofloxacin) were administered in equal doses (mg/mg) to the same group of subjects. The mean steady-state AUC attained after the intravenous administration of 400 mg over 60 min was 43.5 mcg•h/mL; the mean steady-state AUC attained after the oral administration of 400 mg was 41.2 mcg•h/mL (two one-sided t-test, 90% confidence interval was 103 to 109) (see following chart).
Between 0 and 6 h following the administration of a single 200 mg oral dose of Ofloxacin (Ofloxacin) to 12 healthy volunteers, the average urine Ofloxacin (Ofloxacin) concentration was approximately 220 mcg/mL. Between 12 and 24 hours after administration, the average urine Ofloxacin (Ofloxacin) level was approximately 34 mcg/mL.
Following oral administration of recommended therapeutic doses, Ofloxacin (Ofloxacin) has been detected in blister fluid, cervix, lung tissue, ovary, prostatic fluid, prostatic tissue, skin, and sputum. The mean concentration of Ofloxacin (Ofloxacin) in each of these various body fluids and tissues after one or more doses was 0.8 to 1.5 times the concurrent plasma level. Inadequate data are presently available on the distribution or levels of Ofloxacin (Ofloxacin) in the cerebrospinal fluid or brain tissue.
Ofloxacin (Ofloxacin) has a pyridobenzoxazine ring that appears to decrease the extent of parent compound metabolism. Between 65% and 80% of an administered oral dose of Ofloxacin (Ofloxacin) is excreted unchanged via the kidneys within 48 hours of dosing. Studies indicate that less than 5% of an administered dose is recovered in the urine as the desmethyl or N-oxide metabolites. Four to eight percent of an Ofloxacin (Ofloxacin) dose is excreted in the feces. This indicates a small degree of biliary excretion of Ofloxacin (Ofloxacin) .
The administration of Ofloxacin (Ofloxacin) tablets with food does not affect the C and AUC of the drug, but T is prolonged.
Clearance of Ofloxacin (Ofloxacin) is reduced in patients with impaired renal function (creatinine clearance rate ≤ 50 mL/min), and dosage adjustment is necessary (see , and ).
Following oral administration to healthy elderly subjects (65 to 81 years of age), maximum plasma concentrations are usually achieved one to two hours after single and multiple twice-daily doses, indicating that the rate of oral absorption is unaffected by age or gender. Mean peak plasma concentrations in elderly subjects were 9 to 21% higher than those observed in younger subjects. Gender differences in the pharmacokinetic properties of elderly subjects have been observed. Peak plasma concentrations were 114% and 54% higher in elderly females compared to elderly males following single and multiple twice-daily doses. [This interpretation was based on study results collected from two separate studies.] Plasma concentrations increase dose-dependently with the increase in doses after single oral dose and at steady state. No differences were observed in the volume of distribution values between elderly and younger subjects. As in younger subjects, elimination is mainly by renal excretion as unchanged drug in elderly subjects, although less drug is recovered from renal excretion in elderly subjects. Consistent with younger subjects, less than 5% of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites in the elderly. A longer plasma half-life of approximately 6.4 to 7.4 hours was observed in elderly subjects, compared with 4 to 5 hours for young subjects. Slower elimination of Ofloxacin (Ofloxacin) is observed in elderly subjects as compared with younger subjects which may be attributable to the reduced renal function and renal clearance observed in the elderly subjects. Because Ofloxacin (Ofloxacin) is known to be substantially excreted by the kidney, and elderly patients are more likely to have decreased renal function, dosage adjustment is necessary for elderly patients with impaired renal function as recommended for all patients (see , and ).
Ofloxacin (Ofloxacin) Indications And Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ofloxacin (Ofloxacin) tablets and other antibacterial drugs, Ofloxacin (Ofloxacin) 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.
Ofloxacin (Ofloxacin) 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 for specific recommendations.
NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.
* = 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 Ofloxacin (Ofloxacin) . Therapy with Ofloxacin (Ofloxacin) 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 may develop resistance fairly rapidly during treatment with Ofloxacin (Ofloxacin) . 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.
Ofloxacin (Ofloxacin) Contraindications
Ofloxacin (Ofloxacin) tablets are contraindicated in persons with a history of hypersensitivity associated with the use of Ofloxacin (Ofloxacin) or any member of the quinolone group of antimicrobial agents.
Ofloxacin (Ofloxacin) Warnings
Fluoroquinolones, including Ofloxacin (Ofloxacin) , 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 also occurred 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. Ofloxacin (Ofloxacin) 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.
In the immature rat, the oral administration of Ofloxacin (Ofloxacin) at 5 to 16 times the recommended maximum human dose based on mg/kg or 1 to 3 times based on mg/m 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 (see ).
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including Ofloxacin (Ofloxacin) . Quinolones, including Ofloxacin (Ofloxacin) , 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 Ofloxacin (Ofloxacin) , the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with Ofloxacin (Ofloxacin) than some other products in the quinolone class. As with all quinolones, Ofloxacin (Ofloxacin) 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) (see , , , and ).
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including Ofloxacin (Ofloxacin) . 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 (see and ).
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 Ofloxacin (Ofloxacin) . These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (see , and ).
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 Ofloxacin (Ofloxacin) . Ofloxacin (Ofloxacin) 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.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated (see ).
Ofloxacin (Ofloxacin) 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 Ofloxacin (Ofloxacin) 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.
Ofloxacin (Ofloxacin) Precautions
Prescribing Ofloxacin (Ofloxacin) tablets 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.
Adequate hydration of patients receiving Ofloxacin (Ofloxacin) should be maintained to prevent the formation of a highly concentrated urine.
Administer Ofloxacin (Ofloxacin) with caution in the presence of renal or hepatic insufficiency/impairment. In patients with known or suspected renal or hepatic insufficiency/impairment, careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of Ofloxacin (Ofloxacin) may be reduced. In patients with impaired renal function (creatinine clearance ≤ 50 mg/mL), alteration of the dosage regimen is necessary (see and ).
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 quinolones 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 (see , ).
As with other quinolones, Ofloxacin (Ofloxacin) should be used with caution in any patient 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) (see and ).
A possible interaction between oral hypoglycemic drugs (e.g., glyburide/glibenclamide) or with insulin and fluoroquinolone antimicrobial agents have been reported resulting in a potentiation of the hypoglycemic action of these drugs. The mechanism for this interaction is not known. If a hypoglycemic reaction occurs in a patient being treated with Ofloxacin (Ofloxacin) , discontinue Ofloxacin (Ofloxacin) immediately and consult a physician (see and ).
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy (see and ).
Long-term studies to determine the carcinogenic potential of Ofloxacin (Ofloxacin) have not been conducted.
Ofloxacin (Ofloxacin) was not mutagenic in the Ames bacterial test, and cytogenetic assay, sister chromatid exchange (Chinese Hamster and Human Cell Lines), unscheduled DNA Repair (UDS) using human fibroblasts, dominant lethal assays, or mouse micronucleus assay. Ofloxacin (Ofloxacin) was positive in the UDS test using rat hepatocytes and Mouse Lymphoma Assay.
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ofloxacin (Ofloxacin) . This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Ofloxacin (Ofloxacin) to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Ofloxacin (Ofloxacin) and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur (see ; ; and , ).
In phase 2/3 clinical trials with Ofloxacin (Ofloxacin) , 688 patients (14.2%) were ≥ 65 years of age. Of these, 436 patients (9.0%) were between the ages of 65 and 74 and 252 patients (5.2%) were 75 years or older. There was no apparent difference in the frequency or severity of adverse reactions in elderly adults compared with younger adults. The pharmacokinetic properties of Ofloxacin (Ofloxacin) in elderly subjects are similar to those in younger subjects. Drug absorption appears to be unaffected by age. Dosage adjustment is necessary for elderly patients with impaired renal function (creatinine clearance rate ≤ 50 mL/min) due to reduced clearance of Ofloxacin (Ofloxacin) . In comparative studies, the frequency and severity of most drug-related nervous system events in patients ≥ 65 years of age were comparable for Ofloxacin (Ofloxacin) and control drugs. The only differences identified were an increase in reports of insomnia (3.9% vs 1.5%) and headache (4.7% vs 1.8%) with Ofloxacin (Ofloxacin) . It is important to note that these geriatric safety data are extracted from 44 comparative studies where the adverse reaction information from 20 different controls (other antibiotics or placebo) were pooled for comparison with Ofloxacin (Ofloxacin) . The clinical significance of such a comparison is not clear (see and ).
Elderly patients may be more sensitive to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Ofloxacin (Ofloxacin) with concomitant drugs that can result in prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmics) or in patients with risk factors for Torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia) (see , , ).
Ofloxacin (Ofloxacin) Adverse Reactions
The following is a compilation of the data for Ofloxacin (Ofloxacin) based on clinical experience with both the oral and intravenous formulations. The incidence of drug-related adverse reactions in patients during Phase 2 and 3 clinical trials was 11%. Among patients receiving multiple-dose therapy, 4% discontinued Ofloxacin (Ofloxacin) due to adverse experiences.
In clinical trials, the following events were considered likely to be drug-related in patients receiving multiple doses of Ofloxacin (Ofloxacin) :
nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1%, dysgeusia 1%.
In clinical trials, the most frequently reported adverse events, regardless of relationship to drug, were:
nausea 10%, headache 9%, insomnia 7%, external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%, vomiting 4%.
In clinical trials, the following events, regardless of relationship to drug, occurred in 1 to 3% of patients:
abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.
Additional events, occurring in clinical trials at a rate of less than 1%, regardless of relationship to drug, were:
The following laboratory abnormalities appeared in ≥ 1.0% of patients receiving multiple doses of Ofloxacin (Ofloxacin) . It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated.
Ofloxacin (Ofloxacin) Overdosage
Information on overdosage with Ofloxacin (Ofloxacin) is limited. One incident of accidental overdosage has been reported. In this case, an adult female received 3 grams of Ofloxacin (Ofloxacin) intravenously over 45 minutes. A blood sample obtained 15 minutes after the completion of the infusion revealed an Ofloxacin (Ofloxacin) level of 39.3 mcg/mL. In 7 h, the level had fallen to 16.2 mcg/mL, and by 24 h to 2.7 mcg/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. Ofloxacin (Ofloxacin) is not efficiently removed by hemodialysis or peritoneal dialysis.
Ofloxacin (Ofloxacin) Dosage And Administration
The usual dose of Ofloxacin (Ofloxacin) tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance ≤ 50 mL/min), see the subsection.
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or didanosine, chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking Ofloxacin (Ofloxacin) (see ).
Ofloxacin (Ofloxacin) How Supplied
Ofloxacin (Ofloxacin) tablets, 200 mg are available as light-yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7180” on the other. They are available in bottles of 100 tablets.
Ofloxacin (Ofloxacin) tablets, 300 mg are available as white to off-white, film-coated, oval-shaped tablets, debossed with “93” on one side and “7181” on the other. They are available in bottles of 100 tablets.
Ofloxacin (Ofloxacin) tablets, 400 mg are available as pale-gold, film-coated, oval-shaped tablets, debossed with “93” on one side and “7182” on the other. They are available in bottles of 100 tablets.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Ofloxacin (Ofloxacin) Animal Pharmacology
Ofloxacin (Ofloxacin) , as well as other drugs of the quinolone class, has been shown to cause arthropathies (arthrosis) in immature dogs and rats. In addition, these drugs are associated with an increased incidence of osteochondrosis in rats as compared to the incidence observed in vehicle-treated rats (see ). There is no evidence of arthropathies in fully mature dogs at intravenous doses up to 3 times the recommended maximum human dose (on a mg/m basis or 5 times based on mg/kg basis), for a one-week exposure period.
Long-term, high-dose systemic use of other quinolones in experimental animals has caused lenticular opacities; however, this finding was not observed in any animal studies with Ofloxacin (Ofloxacin) .
Reduced serum globulin and protein levels were observed in animals treated with other quinolones. In one Ofloxacin (Ofloxacin) study, minor decreases in serum globulin and protein levels were noted in female cynomolgus monkeys dosed orally with 40 mg/kg Ofloxacin (Ofloxacin) daily for one year. These changes, however, were considered to be within normal limits for monkeys.
Crystalluria and ocular toxicity were not observed in any animals treated with Ofloxacin (Ofloxacin) .
Ofloxacin (Ofloxacin) References
Manufactured In Israel By:
Jerusalem, 91010, Israel
Manufactured For:
Sellersville, PA 18960
Rev. J 2/2011
Ofloxacin (Ofloxacin) Medication Guide
Read the Medication Guide that comes with Ofloxacin (Ofloxacin) tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Ofloxacin (Ofloxacin) tablets belong to a class of antibiotics called fluoroquinolones. Ofloxacin (Ofloxacin) tablets can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Ofloxacin (Ofloxacin) tablets.
See the section “” for more information about side effects.
Ofloxacin (Ofloxacin) tablets are a fluoroquinolone antibiotic medicine used in adults to treat certain infections caused by certain germs called bacteria. It is not known if Ofloxacin (Ofloxacin) tablets are safe and work in people under 18 years of age. Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking Ofloxacin (Ofloxacin) tablets.
Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics including Ofloxacin (Ofloxacin) tablets do not kill viruses.
Call your healthcare provider if you think your condition is not getting better while you are taking Ofloxacin (Ofloxacin) tablets.
Do not take Ofloxacin (Ofloxacin) tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in Ofloxacin (Ofloxacin) tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in Ofloxacin (Ofloxacin) tablets at the end of this Medication Guide.
See “ ”.
Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. Ofloxacin (Ofloxacin) tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if any of your medicines are listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
Ofloxacin (Ofloxacin) tablets can cause side effects that may be serious or even cause death. See “ ”.
Other serious side effects of Ofloxacin (Ofloxacin) tablets include:
● : Seizures have been reported in people who take fluoroquinolone antibiotics including Ofloxacin (Ofloxacin) tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Ofloxacin (Ofloxacin) tablets will change your risk of having a seizure.
Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of Ofloxacin (Ofloxacin) tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
● : Allergic reactions can happen in people taking fluoroquinolones, including Ofloxacin (Ofloxacin) tablets, even after only one dose. Stop taking Ofloxacin (Ofloxacin) tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
● : Skin rash may happen in people taking Ofloxacin (Ofloxacin) tablets, even after only one dose. Stop taking Ofloxacin (Ofloxacin) tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be sign of a more serious reaction to Ofloxacin (Ofloxacin) tablets.
● (Pseudomembranous colitis): Pseudomembranous colitis can happen with most antibiotics, including Ofloxacin (Ofloxacin) tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may also have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.
● (Peripheral Neuropathy): Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Ofloxacin (Ofloxacin) tablets. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
Ofloxacin (Ofloxacin) tablets may need to be stopped to prevent permanent nerve damage.
● (QT prolongation and torsade de pointes): Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ofloxacin (Ofloxacin) tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
● (photosensitivity): See “”.
● (hypoglycemia). People taking Ofloxacin (Ofloxacin) tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking Ofloxacin (Ofloxacin) tablets, stop taking Ofloxacin (Ofloxacin) tablets right away and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
The most common side effects of Ofloxacin (Ofloxacin) tablets include:
Ofloxacin (Ofloxacin) tablets may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.
These are not all the possible side effects of Ofloxacin (Ofloxacin) tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ofloxacin (Ofloxacin) tablets for a condition for which they are not prescribed. Do not give Ofloxacin (Ofloxacin) tablets to other people, even if they have the same symptoms that you have. They may harm them.
This Medication Guide summarizes the most important information about Ofloxacin (Ofloxacin) tablets. If you would like more information about Ofloxacin (Ofloxacin) tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ofloxacin (Ofloxacin) tablets that is written for healthcare professionals. For more information call 1-888-838-2872, MEDICAL AFFAIRS.
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured In Israel By:
Jerusalem, 91010, Israel
Manufactured For:
Sellersville, PA 18960
Rev. B 2/2011
Ofloxacin (Ofloxacin)
Ofloxacin (Ofloxacin)
Ofloxacin (Ofloxacin)
