Ofloxacin (Page 7 of 10)

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.

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