Gatilex 400

Uses

Gatilex 400 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.

Gatilex 400 is also used to associated treatment for these conditions: Bacterial Conjunctivitis, Ocular Infections, Irritations and Inflammations

How Gatilex 400 works

The bactericidal action of Gatilex 400 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

Gatilex 400 dosage

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

Gatilex 400 can be administered without regard to food.

Side Effects

Gatilex 400 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 .

Precaution

Gatilex 400 should be administered with caution in the presence of renal insufficiency.

Food Interaction

• Drink plenty of fluids.
• Take with or without food. The absorption is unaffected by food.

[Minor] Concurrent ingestion of calcium-fortified foods (i.e., cereal, orange juice) may alter the bioavailability of gatifloxacin.

The mechanism is chelation of calcium and the quinolone, resulting in decreased bioavailability.

In the case of orange juice, inhibition of intestinal transport mechanisms (P-glycoprotein or organic anion-transporting polypeptides) by flavones may also be involved.

Data have been conflicting: One study has reported no effect with milk coadministration.

Another study reported a modest decrease in gatifloxacin bioavailability (13.5% decrease in Cmax,12% decrease in AUC, 15% increase in total clearance) when taken with 12 ounces of calcium-fortified orange juice instead of water, which could be clinically significant if the infecting organisms have borderline susceptibilities.

The manufacturer states that gatifloxacin may be taken without regard to food, milk, or calcium.

Clinicians should be aware of the possibility of an interaction if subtherapeutic effects are observed.

Gatilex 400 multivitamins interaction

[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.

Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.

The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.

The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.

When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.

When coadministered with Suprep Bowel Prep (magnesium

Please consult individual product labeling for specific recommendations.

Gatilex 400 Drug Interaction

Major: dofetilide, dofetilideModerate: lactobacillus acidophilus, lactobacillus acidophilusMinor: sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprimUnknown: dapsone topical, dapsone topical, amphetamine, amphetamine, trifarotene topical, trifarotene topical, fexofenadine, fexofenadine, brimonidine ophthalmic, brimonidine ophthalmic, retapamulin topical, retapamulin topical, meperidine, meperidine

Gatilex 400 Disease Interaction

Major: colitis, dysglycemia, CNS disorders, myasthenia gravis, peripheral neuropathy, QT interval prolongation, tendonitisModerate: crystalluria, hemodialysis

Elimination Route

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

Half Life

7-14 hours

Pregnancy & Breastfeeding use

Pregnancy: Gatilex 400 should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether Gatilex 400 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

Gatilex 400 is contraindicated in patients with a history of hypersensitivity of Gatilex 400, quinolone antimicrobial agents, or any other components of this product.

Special Warning

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 Gatilex 400acin in pediatric populations (<18 years of age) have not been established.

Acute Overdose

Gatilex 400 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

You find simplified version here Gatilex 400