Gate Df

Uses

Difluprednate is used for the treatment of inflammation and pain associated with ocular surgery. It is also used for the treatment of uveitis, ocular surface diseases, e.g. blepharitis & corneal inflammation.

Gatifloxacin is used for the following infections:

• 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, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila.
• Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus or Streptococcus pyogenes.
• Uncomplicated urinary tract infections 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.

Gate Df is also used to associated treatment for these conditions: Anterior Uveitis (AU), Endogenous Anterior Uveitis, Eye Pain, Ocular Inflammation, Pain of the eyeBacterial Conjunctivitis, Ocular Infections, Irritations and Inflammations

How Gate Df works

Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

The bactericidal action of Gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Dosage

Gate Df dosage

For the treatment of inflammation and pain associated with ocular surgery: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period, followed by 2 times daily for a week and then a taper based on the response.

For the treatment of endogenous anterior uveitis: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

For blepharitis: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily for 1 week & then once daily for 1 week.

For pseudophakic cystoid macular edema: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily.

Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg 5 days

Acute Sinusitis: 400 mg 10 days

Community-acquired Pneumonia: 400 mg 7-14 days

Uncomplicated Skin and Skin Structure Infections: 400 mg 7-10 days

Uncomplicated Urinary Tract Infections: 400 mg Single Dose or 200 mg 3 days

Complicated Urinary Tract Infections: 400 mg 7-10 days

Acute Pyelonephritis: 400 mg 7-10 days

Uncomplicated Urethral Gonnorrhea in Men: 400 mg Single dose

Gatifloxacin can be administered without regard to food.

Side Effects

Glaucoma with optic nerve damage, visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Gatifloxacin is generally well tolerated. The most common side effects that can occur while taking this drug are usually mild and include nausea, vomiting, stomach pain, diarrhea, dizziness,and headache .

Toxicity

Preclinical pharmacokinetic and toxicity studies have established that difluprednate ophthalmic emulsion 0.05% given 4 times a day is not toxic to the eye.

Precaution

• For ophthalmic use only.
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity & visual field, and in posterior subcapsular cataract formation.
• Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Gatifloxacin should be administered with caution in the presence of renal insufficiency.

Interaction

Specific drug interaction studies have not been conducted with Difluprednate 0.05% ophthalmic emulsion.

Elimination Route

Difluprednate penetrates the corneal epithelium rapidly and effectively. Low systemic absorption.

Well absorbed from the gastrointestinal tract after oral administration with absolute bioavailability of gatifloxacin is 96%

Half Life

7-14 hours

Elimination Route

78.5% of radioactivity was excreted aftert 24 hours, and 99.5% by 7 days after a single dose of labeled difluprednate instilled in the right eyes of pigmented rabbits.

Pregnancy & Breastfeeding use

Use in pregnancy: Use of difluprednate in pregnancy has not been evaluated. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether difluprednate passes into breast milk. Caution should be exercised when it is administered to a nursing mother.

Pregnancy: Gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether Gatifloxacin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.

Contraindication

Difluprednate is contraindicated in most viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.

Gatifloxacin is contraindicated in patients with a history of hypersensitivity of Gatifloxacin, quinolone antimicrobial agents, or any other components of this product.

Special Warning

Use in children: Safety and effectiveness in pediatric patients have not been established.

Renal Impaired patient:

• Creatinine Clearance 40 mL/min: 400 mg every day.
• Creatinine Clearance < 40 mL/min: 400 mg 200 mg every day.

Dialysis patients:

• Hemodialysis: 400 mg 200 mg every day.
• Continuous peritoneal dialysis: 400 mg 200 mg every day.

Pediatric use: The safety and effectiveness of Gatifloxacinacin in pediatric populations (<18 years of age) have not been established.

Acute Overdose

Over dosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Gatifloxacin exhibits a low potential for acute toxicity in animal studies. In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed (including ECG monitoring) and given symptomatic and supportive treatment. Adequate hydration should be maintained.

Innovators Monograph

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