Orasquin Tablet(Gemifloxacin)
Therapeutic Group: Anti Bacterial
Presentation
Orasquin Tablet: Each film coated tablet contains Gemifloxacin Mesylate INN 398.976 mg equivalent to Gemifloxacin 320 mg.
Description
Gemifloxacin is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of both DNA gyrase and topoisomerase IV (TOPO IV) which are essential for bacterial growth.
Gemifloxacin is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.
Following oral administration of Gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender.
Indications
Gemifloxacin is indicated for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-
Acute bacterial exacerbation of chronic bronchitis- caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity)- caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*; Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
Dosage & Administration
Gemifloxacin can be taken with or without food and should be swallowed with a liberal amount of liquid. The recommended dose of Gemifloxacin is 320 mg daily as described bellow-
• In acute bacterial exacerbation of chronic bronchitis Orasquin 320 mg tablet is given once daily for 5 days
• In community acquired pneumonia (of mild to moderate severity) Orasquin 320 mg tablet is given once daily for 5 days
• Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection Orasquin 320 mg tablet is given once daily for 5 days
• Due to known or suspected MDRSP*, K. pneumoniae or M. catarrhalis infection Orasquin 320 mg tablet is given once daily for 7 days
*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/ sulfamethoxazole.
Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction according to the following table-
Creatinine clearance: Dose
≥40 ml/min:Usual dose
<40 ml/min: 160 mg once daily
Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily.
Hepatic impairment: Gemifloxacin may be given to patients with hepatic impairment, with no requirement for dose adjustment.
Elderly patients: Dose adjustment is not required.
Side Effects
The general adverse events include abdominal pain, diarrhea, headache, nausea, vomiting and rash. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythematous skin rash.
Precautions
Adequate hydration of patients receiving Gemifloxacin should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Gemifloxacin may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination. Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Gemifloxacin, but particularly in elderly patients or when corticosteroids are being co-administered. Gemifloxacin should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Gemifloxacin a small mean increase in QTc interval was observed. Gemifloxacin should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Gemifloxacin should be used with caution in patients with epilepsy.
Use in Pregnancy & Lactation
The safety and efficacy of Gemifloxacin in pregnant or lactating women have not been established. Gemifloxacin should not be used in pregnant or lactating women.
Drug Interaction
Gemifloxacin absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Gemifloxacin should be taken at least 2 hours before or 3 hours after these agents. Gemifloxacin should be taken at least 2 hours before sucralfate administration.
Over Dose
No specific antidote is known. Dialysis does not remove Gemifloxacin sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.
Storage
Do not store above 30°C. Keep out of the reach of children.
Commercial Pack
Orasquin Tablet: Each box contains 8 tablets in Alu-Alu blister strips.