Gatifloxacin/Loteprednol

Gatifloxacin (gatifloxacin) is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.

Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.

Community-acquired pneumonia due to Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP])*, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.

Uncomplicated skin and skin structure infections (ie, simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.

NOTE: An insufficient number of patients with the diagnosis of impetiginous lesions were available for evaluation.

Uncomplicated urinary tract infections (cystitis) due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Pyelonephritis due to Escherichia coli.

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gatifloxacin (gatifloxacin (removed from us market - may 2006)) and other antibacterial drugs, Gatifloxacin (gatifloxacin (removed from us market - may 2006)) 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.

*Multidrug-resistant Streptococcus pneumoniae (MDRSP) includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC 2 µg/mL), 2 generation cephalosporins (eg, cefuroxime), macrolides, tetracyclines, and trimethoprim/ sulfamethoxazole.

Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.

Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with Loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with Loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication.

Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery.

Gatifloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Gatifloxacin fights bacteria in the body.

Gatifloxacin ophthalmic (for the eyes) is used to treat eye infections caused by bacteria.

Gatifloxacin ophthalmic may also be used for purposes not listed in this medication guide.

Loteprednol is used to treat eye pain, redness, and swelling caused by certain eye problems or eye surgery. It is also used to temporarily treat itching of the eye caused by a condition known as seasonal allergic conjunctivitis. loteprednol belongs to the group of medicines known as corticosteroids (steroids or cortisone-like medicines).

loteprednol is available only with your doctor's prescription.

Applies to the following strengths: 200 mg; 400 mg; 10 mg/mL; 5%-200 mg/100 mL

Usual Adult Dose for:

• Inhalation Bacillus anthracis
• Anthrax Prophylaxis
• Bronchitis
• Cystitis
• Gonococcal Infection - Uncomplicated
• Pneumonia
• Pyelonephritis
• Urinary Tract Infection
• Sinusitis
• Skin or Soft Tissue Infection
• Tuberculosis - Active

Usual Pediatric Dose for:

• Otitis Media

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Inhalation Bacillus anthracis

Mass casualty treatment or prophylaxis of inhalational anthrax: 400 mg orally once daily for 60 days

The Working Group on Civilian Biodefense has suggested that, based on in vitro studies, gatifloxacin could be used for postexposure prophylaxis or treatment of inhalational anthrax if ciprofloxacin and doxycycline are not available. This use is not approved by the FDA.

Usual Adult Dose for Anthrax Prophylaxis

Mass casualty treatment or prophylaxis of inhalational anthrax: 400 mg orally once daily for 60 days

The Working Group on Civilian Biodefense has suggested that, based on in vitro studies, gatifloxacin could be used for postexposure prophylaxis or treatment of inhalational anthrax if ciprofloxacin and doxycycline are not available. This use is not approved by the FDA.

Usual Adult Dose for Bronchitis

Acute bacterial exacerbation of chronic bronchitis: 400 mg orally or IV once a day for 5 days depending on the nature and severity of the infection

Usual Adult Dose for Cystitis

400 mg orally or IV once, or 200 mg once a day for 3 days

Usual Adult Dose for Gonococcal Infection - Uncomplicated

Urethral gonorrhea in men and endocervical or rectal gonorrhea in women: 400 mg orally or IV as a single-dose treatment

Usual Adult Dose for Pneumonia

Community-acquired: 400 mg orally or IV once a day for 7 to 14 days

Usual Adult Dose for Pyelonephritis

Pyelonephritis or complicated UTI: 400 mg orally or IV once a day for 7 to 10 days, depending on the nature and severity of the infection

Usual Adult Dose for Urinary Tract Infection

Pyelonephritis or complicated UTI: 400 mg orally or IV once a day for 7 to 10 days, depending on the nature and severity of the infection

Usual Adult Dose for Sinusitis

400 mg orally or IV once a day for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection

Uncomplicated infection: 400 mg orally or IV once a day for 7 to 10 days

Usual Adult Dose for Tuberculosis - Active

400 mg IV or orally once a day

May be given in combination with at least 3 other active drugs for treatment of multi-drug resistant TB, or when the patient is intolerant of first-line agents. AFB smear and culture should be monitored monthly.

Duration: Treatment for TB should generally continue for 18 to 24 months, or for 12 to 18 months after culture results are negative.

Usual Pediatric Dose for Otitis Media

Recurrent or nonresponsive otitis media (studies, n=128, n = 254):

6 months or older: 10 mg/kg orally once daily (maximum 600 mg)

Renal Dose Adjustments

CrCl 39 mL/min or less: 400 mg orally or IV once, followed by 200 mg orally or IV once a day

Liver Dose Adjustments

No adjustment recommended in patients with moderate hepatic impairment (Child-Pugh B). Data not available for severe hepatic impairment.

Precautions

Recommended doses should not be exceeded due to increased risk of QT interval prolongation. Discontinue use and initiate appropriate therapy if signs of QT interval prolongation, seizures, hypoglycemia, hyperglycemia, neuropathy, or hypersensitivity occur.

Patients should avoid direct or indirect exposure to sunlight and artificial UV light during and for several days after treatment. The drug should be discontinued if signs of phototoxicity occur (e.g., sunburn, redness, burning, itching, rash, blistering).

Patients should be advised to discontinue the drug, rest, and avoid exercise if they experience pain, inflammation, or rupture of a tendon.

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following quinolone therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.

The patient should be well hydrated or instructed to drink plenty of water to avoid crystalluria.

Renal, hepatic, and hematopoietic function should be monitored periodically during prolonged therapy.

Dosage adjustments are recommended for renally impaired patients. Caution and monitoring is recommended for elderly patients, who may be at a greater risk of adverse reactions due to declining renal function.

Gatifloxacin may cause dizziness or lightheadedness. Patients should be advised to avoid driving or engaging in other tasks requiring mental alertness and coordination until they know how the drug affects them.

The safety and effectiveness of gatifloxacin in pediatric patients less than 18 years have not been established. Cartilage erosion and arthropathy have been reported in studies with juvenile animals.

Dialysis

400 mg orally or IV as an initial dose, followed by 200 mg orally or IV once a day to be administered following hemodialysis or continuous ambulatory peritoneal dialysis

Other Comments

Gatifloxacin may be taken without regard to meals. Patients should be advised to drink plenty of fluids.

Oral doses should be administered at least 4 hours before or 8 hours after iron-, zinc-, aluminum-, or magnesium-containing compounds (e.g., antacids, sucralfate, mineral supplements, buffered didanosine).

Intravenous doses of gatifloxacin must be administered over a minimum of 60 minutes.

Water for injection should not be used as a diluent for concentrated gatifloxacin for injection because it results in a hypotonic solution.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about gatifloxacin

• Gatifloxacin Side Effects
• During Pregnancy or Breastfeeding
• Drug Interactions
• Support Group
• 1 Review
• Drug class: quinolones

Consumer resources

Other brands: Gatifloxacin

Professional resources

• Gatifloxacin (Wolters Kluwer)

Related treatment guides

• Bladder Infection
• Bronchitis
• Anthrax
• Anthrax Prophylaxis
• ... +8 more

Usual Adult Dose for Seasonal Allergic Conjunctivitis

0.2% suspension: 1 drop instilled into the affected eye(s) four times per day

Comments:

-Shake well before using.

Use: Temporary relief of the signs and symptoms of seasonal allergic conjunctivitis

Usual Adult Dose for Acne Rosacea

0.5% suspension:1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day

Comments:

-Shake well before using.

-During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if needed.

-Care should be taken not to discontinue therapy prematurely.

-If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Use: Treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation

Usual Adult Dose for Iritis

0.5% suspension:1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day

Comments:

-Shake well before using.

-During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if needed.

-Care should be taken not to discontinue therapy prematurely.

-If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Use: Treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation

Usual Adult Dose for Keratitis

0.5% suspension:1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day

Comments:

-Shake well before using.

-During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if needed.

-Care should be taken not to discontinue therapy prematurely.

-If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Use: Treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation

Usual Adult Dose for Conjunctivitis

0.5% suspension:1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day

Comments:

-Shake well before using.

-During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if needed.

-Care should be taken not to discontinue therapy prematurely.

-If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Use: Treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation

Usual Adult Dose for Cyclitis

0.5% suspension:1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day

Comments:

-Shake well before using.

-During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if needed.

-Care should be taken not to discontinue therapy prematurely.

-If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

Use: Treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation

Usual Adult Dose for Postoperative Ocular Inflammation

0.5% ointment: A small amount (approximately 0.5 inch ribbon) should be applied into the conjunctival sac(s) four times per day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period

0.5% gel/0.5% suspension: 1 to 2 drops should be applied into the conjunctival sac of the affected eye four times per day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period

Comments:

-0.5% gel: Invert closed bottle and shake once to fill tip before instilling drops.

-0.5% suspension: Shake well before using.

Use: Treatment of post-operative inflammation following ocular surgery

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

-Do not freeze

-Store the container in an upright position

See also:
What is the most important information I should know about Gatifloxacin?

You should not use this medication if you allergic to gatifloxacin ophthalmic.

Before using this medication, tell your doctor if you have ever had an allergic reaction to gatifloxacin (Gatifloxacin) or similar medications such as levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Avoid wearing contact lenses while you still have active symptoms of the eye infection you are treating. Do not use other eye drops or medications during treatment unless otherwise directed by your doctor.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Call your doctor at once if you have a serious side effect such as severe swelling, burning, redness, or discomfort, eye pain or vision changes, signs of new eye infection (drainage, crusting, or oozing), or the first sign of any skin rash, no matter how mild.

See also:
What is the most important information I should know about Loteprednol?

Loteprednol etabonate, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Use Gatifloxacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gatifloxacin is only for the eye. Do not get it in your nose or mouth.
• To use Gatifloxacin in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• If you are using other kinds of eye drops, wait at least 5 minutes before applying the other medicines.
• Do not wear contact lenses while you are using Gatifloxacin. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Gatifloxacin works best if it is used at the same time each day.
• To clear up your infection completely, use Gatifloxacin for the full course of treatment. Keep using it even if you feel better in a few days.
• Discard the medicine if it changes color, turns cloudy, or if it contains particles.
• If you miss a dose of Gatifloxacin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Gatifloxacin.

Use Loteprednol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Loteprednol is only for the eye. Do not get it in your nose or mouth.
• Wash your hands before using Loteprednol.
• To use Loteprednol in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Loteprednol, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
• Do not wear contact lenses while you are using Loteprednol. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• If you miss a dose of Loteprednol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Loteprednol.

Use: Labeled Indications

Conjunctivitis: Treatment of bacterial conjunctivitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Haemophilus influenzae.

Off Label Uses

Bacterial keratitis

Data from a limited number of patients in two small randomized trials support the use of gatifloxacin in the treatment of bacterial keratitis. Additional data may be necessary to further define the role of gatifloxacin for this condition.

Based on the American Academy of Ophthalmology Preferred Practice Pattern Guidelines for Bacterial Keratitis, gatifloxacin is an effective and recommended agent in the management of bacterial keratitis.

Loteprednol is used in the treatment of inflammatory and allergic conditions of the superficial layers of the eye, such as allergic conjunctivitis (allergic itching and redness of the whites of the eye, with tearing), conjunctivitis that occurs as part of acne rosacea (persistent redness over the areas of the face and nose), superficial punctate keratitis (inflammation of cornea), iritis (Inflammation of the interior eye structures), cyclitis (inflammation of cilliary body of the eye). It is also used in the treatment of postoperative inflammation of the eye after the eye surgery.

See also:
What other drugs will affect Gatifloxacin?

Gatifloxacin (gatifloxacin) can be taken 4 hours before ferrous sulfate, dietary supplements containing zinc, magnesium, or iron (such as multivitamins), or aluminum/magnesium-containing antacids without any significant pharmacokinetic interactions.

Milk, calcium carbonate, cimetidine, theophylline, warfarin, or midazolam

No significant interactions have been observed when administered concomitantly with Gatifloxacin (gatifloxacin (removed from us market - may 2006)). No dosage adjustments are necessary when these drugs are administered concomitantly with Gatifloxacin.

Antidiabetic Agents

Pharmacodynamic changes in glucose homeostasis have been seen with concomitant glyburide use. However, no significant pharmacokinetic interactions have been observed when glyburide was administered concomitantly with Gatifloxacin.

Digoxin

Concomitant administration of Gatifloxacin and digoxin did not produce significant alteration of the pharmacokinetics of gatifloxacin; however, an increase in digoxin concentrations was observed for 3 of 11 subjects. Patients taking digoxin should therefore be monitored for signs and/or symptoms of toxicity. In patients who display signs and/or symptoms of digoxin intoxication, serum digoxin concentrations should be determined, and digoxin dosage should be adjusted as appropriate.

Probenecid

The systemic exposure of Gatifloxacin (gatifloxacin (removed from us market - may 2006)) is significantly increased following the concomitant administration of Gatifloxacin and probenecid.

Warfarin

In subjects receiving warfarin, no significant change in clotting time was observed when gatifloxacin was coadministered. However, because some quinolones have been reported to enhance the effects of warfarin or its derivatives, prothrombin time or other suitable anticoagulation test should be monitored closely if a quinolone antimicrobial is administered with warfarin or its derivatives.

Nonsteroidal anti-inflammatory drugs (NSAIDS)

Although not observed with gatifloxacin in preclinical and clinical trials, the concomitant administration of nonsteroidal anti-inflammatory drugs with a quinolone may increase the risks of CNS stimulation and convulsions.

Laboratory Test Interactions

There are no reported laboratory test interactions.

See also:
What are the possible side effects of Gatifloxacin?

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 Gatifloxacin (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 Gatifloxacin (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.

See also:
What are the possible side effects of Loteprednol?

Applies to loteprednol ophthalmic: ophthalmic gel/jelly, ophthalmic ointment, ophthalmic suspension

In addition to its needed effects, some unwanted effects may be caused by loteprednol ophthalmic. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking loteprednol ophthalmic:

More common:

• Blurred vision or other change in vision
• redness or swelling of the eye
• sensitivity of the eyes to light
• swelling of the membrane covering the white part of the eye

• Discharge from the eye
• eye discomfort, irritation, or pain
• redness of the eyelid or inner lining of the eyelid
• tiny bumps on the inner lining of the eyelid

• Blindness
• delayed wound healing
• loss of vision
• nausea or vomiting

Minor Side Effects

Some of the side effects that can occur with loteprednol ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Burning when medicine is applied
• dry eyes
• feeling of something in the eye
• headache
• itching
• runny nose
• sore throat
• tearing or watery eye

Each mL of sterile ophthalmic solution contains gatifloxacin 3 mg. It also contains benzalkonium chloride 0.005% as preservative, disodium edetate, purified water, sodium chloride and hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6.

Gatifloxacin is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use. Its chemical name is (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid sesquihydrate.

Gatifloxacin is a sterile, clear, pale yellow colored isotonic unbuffered solution. It has an osmolality of 260-330 mOsm/kg.

Loteprednol (as Loteprednol Etabonate) is a topical corticoid antiinflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides. As a nasal spray, is used for the treatment and management of seasonal allergic rhinitis.