FDA label 442d176a-ece1-010f-e054-00144ff8d46c

WARNING Fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS). Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ofloxacin in patients with known history of myasthenia gravis (see WARNINGS).

Central Nervous System Effects: Convulsions, increased intracranial pressure, (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including 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, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with ofloxacin than some other products in the quinolone class. As with all quinolones, 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 PRECAUTIONS , General , Information for Patients , Drug Interactions and ADVERSE REACTIONS .)

ADVERSE REACTIONS The following is a compilation of the data for 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 due to adverse experiences. In clinical trials, the following events were considered likely to be drug-related in patients receiving multiple doses of 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: Body as a Whole: asthenia, chills, malaise, extremity pain, pain, epistaxis Cardiovascular System: cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation Gastrointestinal System: dyspepsia Genital/Reproductive System: burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia Musculoskeletal System: arthralgia, myalgia Nervous System: seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion Nutritional/Metabolic: thirst, weight loss Respiratory System: respiratory arrest, cough, rhinorrhea Skin/Hypersensitivity: angioedema, diaphoresis, urticaria, vasculitis Special Senses: decreased hearing acuity, tinnitus, photophobia Urinary System: dysuria, urinary frequency, urinary retention The following laboratory abnormalities appeared in ≥ 1% of patients receiving multiple doses of ofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated. Hematopoietic: anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated ESR Hepatic: elevated: alkaline phosphatase, AST (SGOT), ALT (SGPT) Serum Chemistry: hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN Urinary: glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria Postmarketing Adverse Events Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including ofloxacin: Clinical Cardiovascular System: cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, torsade de pointes Endocrine/Metabolic: hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents (see PRECAUTIONS , General and Drug Interactions ). Gastrointestinal System: hepatic dysfunction including: hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; intestinal perforation; hepatic failure (including fatal cases); pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment), GI hemorrhage; hiccough, painful oral mucosa, pyrosis (see WARNINGS ). Genital/Reproductive System: vaginal candidiasis Hematopoietic: anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising (see WARNINGS ). Musculoskeletal: tendinitis/rupture; weakness; rhabdomyolysis (see WARNINGS ). Nervous System: nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy that may be irreversible, ataxia, incoordination; exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness (see WARNINGS and PRECAUTIONS ). Respiratory System: dyspnea, bronchospasm, allergic pneumonitis, stridor (see WARNINGS ). Skin/Hypersensitivity: anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption (see WARNINGS and PRECAUTIONS ). Special Senses: diplopia, nystagmus, blurred vision, disturbances of: taste, smell, hearing and equilibrium, usually reversible following discontinuation Urinary System: anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria (see WARNINGS and PRECAUTIONS ). Laboratory Hematopoietic: prolongation of prothrombin time Serum Chemistry: acidosis, elevation of: serum triglycerides, serum cholesterol, serum potassium, liver function tests including: GGTP, LDH, bilirubin Urinary: albuminuria, candiduria In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established. CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with other quinolones.

<table border="1" width="421.000" ID="id_8ebd4afb-c80e-42c9-8b2e-0649e9bb62b2"> <col width="30.4%"/> <col width="69.6%"/> <tbody> <tr ID="id_da254ed4-1378-494a-8f98-7a2f78818283"> <td align="left" styleCode="Toprule Botrule Lrule" valign="top">Body as a Whole:</td> <td align="left" styleCode="Botrule Rrule" valign="top">asthenia, chills, malaise, extremity pain, pain, epistaxis</td> </tr> <tr ID="id_4e3ba7e6-7774-4367-a23b-dc6a9e61f34e"> <td align="left" styleCode="Lrule Botrule" valign="top">Cardiovascular System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation</td> </tr> <tr ID="id_6073b27f-12d7-46f0-86a2-9ce80dc1711d"> <td align="left" styleCode="Lrule Botrule" valign="top">Gastrointestinal System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">dyspepsia</td> </tr> <tr ID="id_01b62370-d5b7-439e-ab95-c032bac6adef"> <td align="left" styleCode="Lrule Botrule" valign="top">Genital/Reproductive System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia</td> </tr> <tr ID="id_a19048b3-b93d-4318-9181-02f40b72455d"> <td align="left" styleCode="Lrule Botrule" valign="top">Musculoskeletal System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">arthralgia, myalgia</td> </tr> <tr ID="id_e8c07548-e5e7-4259-8a93-7d867346e9a2"> <td align="left" styleCode="Lrule Botrule" valign="top">Nervous System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion</td> </tr> <tr ID="id_7af6e1ed-f329-4233-a425-475d6391dfcf"> <td align="left" styleCode="Lrule Botrule" valign="top">Nutritional/Metabolic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">thirst, weight loss</td> </tr> <tr ID="id_f9ee4f26-e066-4345-a707-8dc8e17fc016"> <td align="left" styleCode="Lrule Botrule" valign="top">Respiratory System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">respiratory arrest, cough, rhinorrhea</td> </tr> <tr ID="id_54486418-ca5b-470a-b29b-d72e5a064a90"> <td align="left" styleCode="Lrule Botrule" valign="top">Skin/Hypersensitivity:</td> <td align="left" styleCode="Botrule Rrule" valign="top">angioedema, diaphoresis, urticaria, vasculitis</td> </tr> <tr ID="id_a94ac1aa-a6c9-4329-937a-ba6d3f6d76b8"> <td align="left" styleCode="Lrule Botrule" valign="top">Special Senses:</td> <td align="left" styleCode="Botrule Rrule" valign="top">decreased hearing acuity, tinnitus, photophobia</td> </tr> <tr ID="id_d78ac97c-0889-4196-bba3-3094f8235eed"> <td align="left" styleCode="Lrule Botrule" valign="top">Urinary System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">dysuria, urinary frequency, urinary retention</td> </tr> </tbody> </table>

<table border="1" width="420.000" ID="id_933942ab-bb9d-449a-85e1-0f597c54afa7"> <col width="30.2%"/> <col width="69.8%"/> <tbody> <tr ID="id_bbc63c37-5633-4b2d-ad40-8e865ba8c7a4"> <td align="left" styleCode="Toprule Botrule Lrule" valign="top">Hematopoietic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated ESR</td> </tr> <tr ID="id_72eb9267-b67e-4864-b945-36c493c66463"> <td align="left" styleCode="Lrule Botrule" valign="top">Hepatic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">elevated: alkaline phosphatase, AST (SGOT), ALT (SGPT)</td> </tr> <tr ID="id_6c27da01-bba5-4122-9562-ae10176a4782"> <td align="left" styleCode="Lrule Botrule" valign="top">Serum Chemistry:</td> <td align="left" styleCode="Botrule Rrule" valign="top">hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN</td> </tr> <tr ID="id_82b65ee8-c8d6-45ec-9c1c-78dc89a6e04e"> <td align="left" styleCode="Lrule Botrule" valign="top">Urinary:</td> <td align="left" styleCode="Botrule Rrule" valign="top">glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria</td> </tr> </tbody> </table>

<table border="1" width="419.000" ID="id_66c5f9db-f778-4e07-8227-4041748b0cf6"> <col width="32.2%"/> <col width="67.8%"/> <tbody> <tr ID="id_6a93a619-5950-4cde-a9d0-122c877efa40"> <td align="left" styleCode="Toprule Botrule Lrule" valign="top">Cardiovascular System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, torsade de pointes</td> </tr> <tr ID="id_df9fbc0d-c2e9-40fb-bd1a-60545a01db08"> <td align="left" styleCode="Lrule Botrule" valign="top">Endocrine/Metabolic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents (see <content styleCode="bold">PRECAUTIONS</content>, <content styleCode="bold"> General </content>and <content styleCode="bold">Drug Interactions</content>). </td> </tr> <tr ID="id_184ae67f-4a6b-4243-829b-ecd0044fcf8e"> <td align="left" styleCode="Lrule Botrule" valign="top">Gastrointestinal System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">hepatic dysfunction including: hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; intestinal perforation; hepatic failure (including fatal cases); pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment), GI hemorrhage; hiccough, painful oral mucosa, pyrosis (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr ID="id_834f9160-98e6-4b3a-b14b-724bdd1aa005"> <td align="left" styleCode="Lrule Botrule" valign="top">Genital/Reproductive System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">vaginal candidiasis</td> </tr> <tr ID="id_9353dcbc-3ca2-4170-9817-f070afabe36c"> <td align="left" styleCode="Lrule Botrule" valign="top">Hematopoietic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr ID="id_b939a0da-bcc1-40c8-8301-9777836a431f"> <td align="left" styleCode="Lrule Botrule" valign="top">Musculoskeletal:</td> <td align="left" styleCode="Botrule Rrule" valign="top">tendinitis/rupture; weakness; rhabdomyolysis (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr ID="id_e43b9b09-7503-4111-a198-4073045ce60c"> <td align="left" styleCode="Lrule Botrule" valign="top">Nervous System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy that may be irreversible, ataxia, incoordination; exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness (see <content styleCode="bold">WARNINGS</content> and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> <tr ID="id_86858707-fcd8-4a1b-8004-6eb86443aa12"> <td align="left" styleCode="Lrule Botrule" valign="top">Respiratory System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">dyspnea, bronchospasm, allergic pneumonitis, stridor (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr ID="id_7bc8f7fe-233d-44a5-ae9a-044f61e00ca2"> <td align="left" styleCode="Lrule Botrule" valign="top">Skin/Hypersensitivity:</td> <td align="left" styleCode="Botrule Rrule" valign="top">anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption (see <content styleCode="bold">WARNINGS </content>and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> <tr ID="id_c87e3df9-579f-4cfd-a11a-e0ac24c7a0fe"> <td align="left" styleCode="Lrule Botrule" valign="top">Special Senses:</td> <td align="left" styleCode="Botrule Rrule" valign="top">diplopia, nystagmus, blurred vision, disturbances of: taste, smell, hearing and equilibrium, usually reversible following discontinuation</td> </tr> <tr ID="id_fb7ad7ad-4f0b-424f-9ab7-f5ccd3c7d0fd"> <td align="left" styleCode="Lrule Botrule" valign="top">Urinary System:</td> <td align="left" styleCode="Botrule Rrule" valign="top">anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria (see <content styleCode="bold">WARNINGS </content>and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> </tbody> </table>