Ornigat

Uses

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.

Ornidazole is used for Amoebiasis (Intestinal and hepatic), Giardiasis, Trichomoniasis, Bacterial vaginosis, Treatment of susceptible anaerobic infections

Ornigat is also used to associated treatment for these conditions: Bacterial Conjunctivitis, Ocular Infections, Irritations and InflammationsAmebiasis, Anaerobic Bacterial Infection, Chlamydial Infections, Gastrointestinal Infections caused by entamoeba histolytica, Giardiasis, Mixed Vaginal Infections, Surgical Site Infections, Trichomonal Vaginitis, Trichomoniasis

How Ornigat works

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

Ornigat 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

Amoebiasis:

• Adults: 500 mg twice a day for 5 days.
• Children: 10-25 mg per kg body weight in two divided doses.

Amoebic dysentery:

• Adults: 1.5 gm once a day for 3 days.
• Children: 40 mg per kg body weight, once a day for 3 days.

Giardiasis:

• Adults: 1.5 gm once daily for 1-2 days.
• Children: 40 mg per kg body weight for 2 days.

Trichomoniasis: 1.5 gm once or 500 mg twice a day for 5 days. Sexual partner should also be treated at the same time.

Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.

Gatifloxacin can be administered without regard to food.

Side Effects

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 .

Side effects of Ornidazole have been mainly limited to the gastrointestinal tract (nausea, vomiting, epigastric pain) and central nervous system (dizziness, headache, lassitude). Unlike other nitroimidazoles, Ornidazole does not interact with alcohol, although this requires further study.

Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.

Precaution

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

In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.

Interaction

Like other imidazoles, Ornidazole has a mild potential to cause disulfiramlike reactions. Concomitant administration of oral anticoagulants may increase the risk of haemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.

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: 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.

Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to fetus/neonate.

Contraindication

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

Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.

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 Gatifloxacinacin in pediatric populations (<18 years of age) have not been established.

Acute Overdose

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.

Renal Impairment Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic Impairment Severe: Double the interval between doses.

Storage Condition

Store at room temperature and protect from light and moisture.

Innovators Monograph

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