Gatifloxacin

Last updated on RxList: 8/9/2019
Gatifloxacin Side Effects Center

Last reviewed on RxList 8/9/2019

Gatifloxacin Ophthalmic Solution, 0.5% is a fluoroquinolone antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia, and Haemophilus influenza. Gatifloxacin ophthalmic solution is available in generic form. Common side effects of gatifloxacin ophthalmic solution include:

  • worsening of the conjunctivitis,
  • eye irritation,
  • changes in taste,
  • eye pain,
  • eye inflammation,
  • burst blood vessels in the eye,
  • dry eye,
  • eye discharge,
  • eyelid swelling,
  • headache,
  • increased tearing, and
  • reduced vision.

The dosage of gatifloxacin ophthalmic solution for patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. Gatifloxacin ophthalmic solution may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using gatifloxacin ophthalmic solution; it is unknown if it will affect a fetus. It is unknown if gatifloxacin ophthalmic solution passes into breast milk. Consult your doctor before breastfeeding.

Our Gatifloxacin Ophthalmic Solution, 0.5% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Gatifloxacin Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • blisters or small white/yellow patches on the surface of your eye;
  • pain behind your eyes; or
  • signs of eye infection--swelling, redness, severe discomfort, crusting or drainage.

Common side effects may include:

  • mild eye irritation after using the medicine;
  • blurred vision;
  • eye redness;
  • red, puffy, or droopy eyelids;
  • dry or watery eyes;
  • feeling like something is in your eye;
  • headache; or
  • skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gatifloxacin (gatifloxacin)

SLIDESHOW

Pink Eye (Conjunctivitis) Symptoms, Causes, Treatments See Slideshow
Gatifloxacin Professional Information

SIDE EFFECTS

Over 5000 patients have been treated with gatifloxacin in single- and multiple-dose clinical efficacy trials worldwide.

In gatifloxacin studies, the majority of adverse reactions were described as mild in nature. Gatifloxacin was discontinued for adverse events thought related to drug in 2.7% of patients.

Drug-related adverse events classified as possibly, probably, or definitely related with a frequency of ³3% in patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows: nausea 8%, vaginitis 6%, diarrhea 4%, headache 3%, dizziness 3%.

In patients who were treated with either intravenous gatifloxacin or with intravenous followed by oral therapy, the incidence of adverse events was similar to those who received oral therapy alone. Local injection site reactions (redness at injection site) were noted in 5% of patients.

Additional drug-related adverse events (possibly, probably, or definitely related) considered clinically relevant that occurred in ³0.1% to <3% of patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows:

Body as a Whole: allergic reaction, asthenia, back pain, chest pain, chills, face edema, fever

Cardiovascular System: hypertension, palpitation

Digestive System: abdominal pain, anorexia, constipation, dyspepsia, flatulence, gastritis, glossitis, mouth ulcer, oral moniliasis, stomatitis, vomiting

Metabolic/Nutritional System: hyperglycemia, peripheral edema, thirst

Musculoskeletal System: arthralgia, leg cramp

Nervous System: abnormal dream, agitation, anxiety, confusion, insomnia, nervousness, paresthesia, somnolence, tremor, vasodilatation, vertigo

Respiratory System: dyspnea, pharyngitis

Skin/Appendages: dry skin, pruritus, rash, sweating

Special Senses: abnormal vision, taste perversion, tinnitus

Urogenital System: dysuria

Additional drug-related adverse events considered clinically relevant that occurred in <0.1% (rare adverse events) of patients receiving gatifloxacin in single- and multiple-dose clinical trials are as follows: abnormal thinking, alcohol intolerance, arthritis, asthma (bronchospasm), ataxia, bone pain, bradycardia, breast pain, cheilitis, colitis, convulsion, cyanosis, depersonalization, depression, diabetes mellitus, dysphagia, ear pain, ecchymosis, edema, epistaxis, euphoria, eye pain, eye photosensitivity, gastrointestinal hemorrhage, generalized edema, gingivitis, halitosis, hallucination, hematemesis, hematuria, hostility, hyperesthesia, hypertonia, hyperventilation, hypoglycemia, lymphadenopathy, maculopapular rash, metrorrhagia, migraine, mouth edema, myalgia, myasthenia, neck pain, panic attack, paranoia, parosmia, photophobia, pseudomembranous colitis, psychosis, ptosis, rectal hemorrhage, stress, substernal chest pain, tachycardia, taste loss, tongue edema, vesiculobullous rash.

Laboratory Changes

Clinically relevant changes in laboratory parameters, without regard to drug relationship, occurred in fewer than 1% of TEQUIN (gatifloxacin (removed from us market - may 2006)) -treated patients. These included the following: neutropenia, increased ALT or AST levels, alkaline phosphatase, bilirubin, serum amylase, and electrolytes abnormalities. It is not known whether these abnormalities were caused by the drug or the underlying condition being treated.

Postmarketing Adverse Event Reports

The following events have been reported during postapproval use of TEQUIN (gatifloxacin (removed from us market - may 2006)) . Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Abnormal renal function (including acute renal failure), acute allergic reaction including anaphylactic reaction and angioneurotic edema, hepatitis, hypotension, increased International Normalized Ratio (INR)/prothrombin time, pancreatitis, severe hyperglycemia (including hyperosmolar nonketotic hyperglycemia), severe hypoglycemia (including hypoglycemic coma), Stevens-Johnson syndrome, syncope, tendon rupture, thrombocytopenia, and torsades de pointes.

Read the entire FDA prescribing information for Gatifloxacin (gatifloxacin)

© Gatifloxacin Patient Information is supplied by Cerner Multum, Inc. and Gatifloxacin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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