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Product
Anti-infective Products (Gatiquin)
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Anti-infective Products (Gatiquin)
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Gatiquin 200
Gatiquin 400
COMPOSITION
Gatiquin 200
Each film-coated tablet contains ....
Gatifloxacin 200 mg
Colour: Titanium Dioxide
Gatiquin 400
Each film-coated tablet contains ....
Gatifloxacin 400 mg
Colour: Titanium Dioxide
Description
Gatifloxacin is a synthetic broad spectrum 8-methoxyfluoroquinolone antibacterial agent. Gatifloxacin has in vitro activity against a wide range of gram negative and gram positive organisms. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. Gatifloxacin has been shown to be active against most strains of the following micro-organism, both in vitro and in clinical infections as described in the indications: |
Aerobic gram-positive micro-organisms:
Staphylococcus aureus (methicillin-susceptible strains only)
Streptococcus pneumoniae (penicillin susceptible strains)
Streptococcus pyogenes
Aerobic gram-negative micro-organisms:
E.coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus mirabilis
Other organims:
Chlamydia pneumoniae
Legionella pneumophila
Mycoplasma pneumoniae
Anaerobic micro-organisms:
Peptococcus spp.
Indications
Gatifloxacin is indicated for the treatment of infections due to susceptible strains of the designated micro-organisms 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 pneumoniae due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae or Legionella pneumophila.
Uncomplicated urinary tract infections (cystitis) due to E.coli, Klebsiella pneumoniae or Proteus mirabilis.
Complicated urinary tract infections due to E.coli, Klebsiella pneumoniae or Proteus mirabilis.
Pyelonephritis due to E.coli
Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae.
Dosage and Administration
The recommended dosage for gatifloxacin tablets or injection is described below. Doses of Gatiquin are administered once every 24 hours. These recommendations apply to all patients with a creatinine clearance > 40 ml/min. For patients with a creatinine clearance < 40 ml/min, see the impaired renal function subsection.
Acute Bacterial Exacerbation of Chronic Bronchitis
400 mg once daily for 7-10 days
Acute Sinusitis
400 mg once daily for 10 days
Community acquired pneumonia
400 mg once daily for 7-14 days
Uncomplicated urinary tract infections
(Cystitis)
400 mg stat dose or 200 mg once daily for 3 days
Acute pyelonephritis
400 mg once daily for 7-10 days
Uncomplicated Urethral Gonorrhea in Men; Endocervical and Rectal Gonorrhea in women.
400 mg as a single dose
Intravenous administration
When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Gatiquin injection may be switched to Gatiquin tablets when clinically indicated at the discretion of the physician.
Gatifloxacin injection should be administered by intravenous infusion only.
It is not intended for intramuscular, intrathecal, intraperitoneal or subcutaneous administration.
Gatifloxacin injection should be administered by intravenous infusion over a period of 60 minutes.
Caution: Rapid or bolus intravenous infusion should be avoided.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Since only limited data are available on the compatability of gatifloxacin intravenous injection with other intravenous substances, additives or medications should not be added to Gatiquin injection in infusion bottle/containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of different drugs, the line should be flushed before and after infusion of Gatiquin injection with an infusion solution compatible with Gatiquin injection and with any other drug(s) administered via this common line.
Impaired Renal Function
Since gatifloxacin is eliminated primarily by renal excretion, a dosage modification of gatifloxacin is recommended for patients with creatinine clearance < 40 mL/min, including patients on hemodialysis and on CAPD.
The recommended dosage of Gatiquin is:
| Creatinine
clearance |
Initial
Dose |
Subsequent
Dosea |
| > 40 mL/min |
400 mg 4 |
00 mg
every day |
| < 40 mL/min |
400 mg |
200 mg
every day |
| Hemodialysis |
400 mg |
200 mg
every day |
| Continuous peritoneal
dialysis |
400 mg |
200 mg
every day |
*Start subsequent dose on day 2 of dosing
Single 400 mg dose gatifloxacin regimen (for the treatment of uncomplicated urinary tract infections and gonorrhea) and 200 mg once daily for 3 days gatifloxacin regimen (for the treatment of uncomplicated urinary tract infections) require no dosage adjustment in patients with impaired renal function.
The following formula may be used to estimate creatinine clearance:
Men: Creatinine Clearance (mL/min) = Weight (kg) X (140-age)
72 X serum creatinine (mg/dL)
Women: 0.85 X the value calculated for men.
Contraindications
Gatiquin is contraindicated in persons with a history of hypersensitivity to gatifloxacin or any member of the quinolone class of antimicrobial agents.
Warnings and Precautions
The safety and effectiveness of Gatifloxacin in pediatric patients, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established.
Gatifloxacin may have the potential to prolong the QTc interval of the electrocardiogram in some patients. Due to the lack of clinical experience, gatifloxacin should be avoided in patients with known prolongation of the QTc interval, patients with uncorrected hypokalemia, and patients receiving class IA (eg. Quinidine, Procainamide) or class III (Eg. Amiodarone, Sotalol) antiarrythmic agents.
Pharmacokinetic studies between gatifloxacin and drugs that prolong the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. Gatifloxacin should be used with caution when given concurrently with these drugs, as well as in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia.
As with other members of the quinolone class, gatifloxacin has caused arthropathy and/or chondrodysplasia in immature dogs. The relevance of these findings to the clinical use of gatifloxacin is unknown.
Convulsions, increased intracranial pressure, and psychosis have been reported in patients receiving quinolones. Quinolones may also cause central nervous system (CNS) stimulation, which may lead to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares and insomnia. These reactions may occur following the first dose. If these reactions occur in patients receiving gatifloxacin, the drug should be discontinued and appropriate measures instituted.
As with other quinolones, Gatifloxacin should be used with caution in patients with known or suspected CNS disorder, such as severe cerebral atherosclerosis, epilepsy, and other factors that predispose to seizures.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions may occur following the first dose.
Gatifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Pseudomembranes colitis has been reported with nearly all antibacterial agents, including gatifloxacin and may range in severity from mild to life-threatening. It is important, therefore, to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.
Precautions
GENERAL
Quinolones may cause central nervous system (CNS) events including nervousness, agitation, insomnia, anxiety, nightmares, or paranoia.
Administer gatifloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of gatifloxacin may be reduced. In patients with impaired renal function (creatinine clearance < 40 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of gatifloxacin due to decreased clearance.
As with other quinolones, disturbances of blood glucose, including symptomatic hyper and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (eg., glyburide) or with insulin. In these patients, the monitoring of blood glucose is recommended.
DRUG INTERACTIONS
Gatifloxacin can be taken 4 hours before ferrous sulfate, dietary supplements containing zinc, magnesium, or iron (such as multivitamins), or aluminium/magnesium-containing antacids without any significant pharmacokinetic interactions.
Milk, calcium carbonate, cimetidine, theophylline, warfarin, glyburide, or midazolam: No significant interactions have been observed when administered concomitantly with Gatifloxacin. No dosage adjustments are necessary when these drugs are 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. Patients taking digoxin should therefore be monitored for signs and/or symptoms of toxicity.
Probenecid: The systemic exposure of Gatifloxacin 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 nonsteriodal anti-inflammatory drugs with a quinolone may increase the risks of CNS stimulation and convulsions.
PREGNANCY
There are no adequate and well-controlled studies in pregnant women, gatifloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
NURSING MOTHERS
Gatifloxacin is excreted in the breast milk of rats. It is known whether this drug 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.
PAEDIATRIC USE
As with other drugs of this class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Hence ciprofloxacin is usually not recommended for use in children.
PAEDIATRIC USE
The safety and effectiveness of gatifloxacin in pediatric populations (< 18 years of age) have not been established. Quinolones, including gatifloxacin, cause arthropathy and osteochondrotoxicity in juvenile animals (rats and dogs).
Side Effects
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 2.9% of patients.
In patients who were treated with either intravenous gatifloxacin or with intravenous followed by oral therapy, the incidence of side effects was similar to those who received oral therapy alone. Local injection site reactions (redness at injection site) were noted in 5% of patients.
Overdosage
Gatifloxacin exhibits a low potential for acute toxicity in animal studies. The minimum lethal oral doses in rats and dogs were greater than
2000 mg/kg and 1000 mg/kg, respectively. The minimum lethal intravenous dose was 144 mg/kg in rats and greater than 45 mg/kg in dogs. Clinical signs observed included decreased activity and respiratory rate, vomiting, tremors, and convulsions.
In the event of acute oral overdose, the stomach should be emptied by inducing vomiting or by gastric lavage.
Presentation
Gatiquin-200 Strip pack of 5 tablets
Gatiquin-400 Strip pack of 5 tablets
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