Gemicin320 mg

Gemicin 320 mg 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. ... Read moreGemicin 320 mg 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), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

4-Quinolone preparations

Gemicin 320 mg is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemicin 320 mg acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.Gemicin 320 mg is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that Gemicin 320 mg 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 Gemicin 320 mg, 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

Acute bacterial exacerbation of chronic bronchitis: 320 mg once daily for 5 days.Community-acquired pneumonia (Mild to moderate severity): Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection: One 320 mg tablet daily for 5 days. Due to known or suspected multi-drug resistant Streptococcus pneumoniae, K.pneumoniae, or M. catarrhalis infection: One 320 mg tablet daily for 7 days.

Acute bacterial exacerbation of chronic bronchitis: 320 mg once daily for 5 days.Community-acquired pneumonia (Mild to moderate severity): Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection: One 320 mg tablet daily for 5 days. Due to known or suspected multi-drug resistant Streptococcus pneumoniae, K.pneumoniae, or M. catarrhalis infection: One 320 mg tablet daily for 7 days.

Gemicin 320 mg absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Gemicin 320 mg should be taken at least 2 hours before or 3 hours after these agents. Gemicin 320 mg should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Gemicin 320 mg was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.

Known hypersensitivity to Gemicin 320 mg and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Gemicin 320 mg should not be used in children under 18 years of age.

The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.

Gemicin 320 mg should not be used in pregnant or lactating women. The safety and efficacy of Gemicin 320 mg in pregnant or lactating women have not been established.

For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Gemicin 320 mg should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Gemicin 320 mg 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 Gemicin 320 mg, but particularly in elderly patients or when corticosteroids are being co-administered. Gemicin 320 mg 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 Gemicin 320 mg a small mean increase in QTc interval was observed. Gemicin 320 mg 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. Gemicin 320 mg should be used with caution in patients with epilepsy.

No specific antidote is known. Dialysis does not remove Gemicin 320 mg 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.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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. The following table provides dosage guidelines for use in patients with renal impairment: Creatinine Clearance (>40 ml/min):  See usual dosage Creatinine Clearance (<40 ml/min): 160 mg once daily Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily. Hepatic impairment:  Gemicin 320 mg may be given to patients with hepatic impairment, with no requirement for dose adjustment.Elderly patients: Dose adjustment is not required.

4-Quinolone preparations

Gemicin 320 mg is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemicin 320 mg acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.Gemicin 320 mg is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that Gemicin 320 mg 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 Gemicin 320 mg, 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

Gemicin 320 mg should not be used in pregnant or lactating women. The safety and efficacy of Gemicin 320 mg in pregnant or lactating women have not been established.

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. The following table provides dosage guidelines for use in patients with renal impairment: Creatinine Clearance (>40 ml/min):  See usual dosage Creatinine Clearance (<40 ml/min): 160 mg once daily Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily. Hepatic impairment:  Gemicin 320 mg may be given to patients with hepatic impairment, with no requirement for dose adjustment.Elderly patients: Dose adjustment is not required.