Clinical Pharmacology Details


GATIFLOXACIN


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Indications & Dose:

Acute bacterial exacerbation of chronic bronchitis, acute sinusitis, and community-acquired pneumonia; uncomplicated skin and skin structure infections: cystitis, pyelonephritis, and complicated urinary tract infections caused by susceptible organisms; and. uncomplicated urethral or cervical gonorrhea, and acute, uncomplicated rectal gonorrhea in women


 


DOSAGE



Adult


• Acute bacterial exacerbation of chronic bronchitis PO 400 mg ad for 5 days


• Acute sinusitis PO 400 mg qd for 10 days


• Community-acquired pneumonia PO 400 mg qd for 7-14 days


• Cystitis PO 400 mg single dose or PO 200 mg qd for 3 days • Complicated urinary tract infections PO 400 mg qd for 7- 10 days


• Acute pyelonephritis PO 400 nip qd for 7- 10 days 


• Gonorrhea: uncomplicated urethral PO 400 mg single dose; endocervical or rectal in women PO 400 mg singledose


• Dose adjustment for renal insufficiency: CrCl <40 ml/min initial dose PO 400 mg, Subsequent doses PO 200 mg every day; hemodialysis or peritoneal dialysis patients, initial dose PO 400 mg, subsequent doses PO 200 mg every day 

Contraindications:

Side Effects:

CNS: Anxiety, asthenia, confusion, dizziness (3%), depersonalization, headache (3%), incoordination, insomnia, somnolence, tremor, vertigo


CV: Bradycardia, edema, hypertension, hypotension, palpitation tachycardia, vasodilatation


EENT: Taste perversion, tinnitus


GI: Abdominal pain (2%), diarrhea (4%), dyspepsia (1%), nausea (8%), vomiting (2%), abnormal liver function test (1%), increased amylase, pseudomembranous colitis


GU: Moniliasis, vaginitis, increase in BUN, creatinine


HEME: Leukopenia, prothrombin time decrease, prothrombin time increase, thrombocythemia, thrombocytopenia


METAB: Hyperglycemia, hypoglycemia (if taking hypoglycemic agents)


MS: Arthralgia, myalgia, tendon inflammation, tendon rupture


RESP: Asthma, cough ‘Increased, dyspnea


SKIN: Urticaria, rash, pruritus, sweating

Cautions:

Precautions:

Children < 18 yr; renal insufficiency (CrCl < 40 ml/min); diabetes (may affect glucose control); may prolong, the QT interval, avoid in patients with known prolongation of the QT interval, hypokalemia, and patients receiving class Ia (e.g., quinidine, procaina-mide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents, or cisapride, erythromycin, antipsychotics, and tricyclic antidepressants; bradycardia; acute myocardial infarction; known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold 

Interaction:

Drugs


• Aluminum: Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Aminodarone: Additive cardiac toxicity


• Antacids (containing aluminum or magnesium): Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Antipsychotics: Additive cardiac toxicity


• Didanosine (buffered formulation); Markedly reduced absorption of gatifloxacin; take ggatifloxacin 2 hr before didanosine


• Erythromycin: Coadministration may increase risk of cardiac toxicity due to gatifloxacin


• Foscarnet: Coadministration increase seizure risk


• Iron: Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Magnesium: Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Probenecid: Inhibits excretion of gatifloxacin


• Procainamide: Additive cardiac toxicity


• Quinidine: Additive cardiac toxicity


• Sodium bicarbonate: Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Sotalol: Additive cardiac toxicity


• Sucralfate: Reduced absorption of gatifloxacin; do not take within 4 hr of dose


• Tricyclic antidepressants: Additive cardiac toxicity


• Zinc: Reduced absorption of gatifloxacin., do not take within 4 hr of dose

Warnings:

Adverse Effects:

Lactations:

 Pregnancy category C; breast milk excretion unknown 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: