Zifam Gemz

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ZIFAM GEMZ

Gemifloxacin Mesylate Tablets

 

Composition:

Each film coated tablets contains:

Gemifloxacin Mesylate Equivalent to Gemifloxacin…….320mg

Colours: Yellow Oxide of Iron & Titanium Dioxide BP

 

Indications:

Zifam Gemz is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Acute bacterial exacerbation of chronic bronchitis caused by S.pneumonia, Haemophilus influnzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Community-acquired pneumonia(of mild to moderate severity) caused by S.pneumoniae (including multi-drug resistant strains, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

 

Dosage and Administration:

ZIFAM GEMZ TABLETS can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of ZIFAM GEMZ TABLETS is 320mg daily, according to the following table.

 

Recommended Dosage Regimen of ZIFAM GEMZ TABLETS

The clinical decision regarding the use of a 5 day or 7 day regimen should be guided by results of the initial sputum culture.

 

INDICATION DOSE/DURATION
Acute bacterial exacerbation of chronic bronchitis One tablet daily for 5 days
Community-acquired pneumonia (of mild to moderate severity)
Due to known or suspectedS.Pneumoniae,

H.influenzae,

M.pneumoniae, or

C.pneumoniae infection

One tablet daily for 5 days
Due to known or suspected MDRSP*,K.pneumoniae, or M.catarrhalis infection One   tablet daily for 7 days
*MDRSP: multi-drug resistant Streptococcus pneumoniae, include isolates 

Previously known as PRSP (Penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin(MIC=2g/ml), 2nd generation Cephalosporins(e.g., cefuroxime), Macrolides, Tetracyclines and Trimethoprim/Sulfamethoxazole.

 

 

The recommended dose and duration of ZIFAM GEMZ TABLETS should not be exceeded as per the table below

 

Rash Incidence in ZIFAM GEMZ TABLETS Treated Patients from the Clinical Studies Population* by Gender, Age, and Duration of Therapy

 

Gender & Age(yr)Category Duration of ZIFAM GEMZ TABLETS Therapy
5 days 7days 10days 14days
Female<40 10/399 (2.5%) 49/407(12.0%) 20/131(15.3%) 7/31(22.6%)
Female³40 30/1438(2.1%) 34/887(12.0%) 19/308(6.2%) 10/126(7.9%)
Male<40 6/356 (2.5%) 26/453(12.0%) 7/74(9.5%) 3/39(7.7%)
Male³40 10/1503(2.5%) 26/984(12.0%) 9/345(2.6%) 3/116(2.6%)
Totals 56/3696(2.5%) 135/2732(12.0%) 55/858(6.4%) 23/312(7.4%)

 

*Includes patients from studies of community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, and other indications

**exceeds the recommended duration of therapy

 

Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance > 40ml/min is not required. Modification of the dosage is recommended for patients with creatinine clearance= 40ml/min. Table 5 provides dosage guidelines for use in patients with renal impairment.

 

Recommended Doses for Patients with Renal Impairment

 

Creatinine Clearance (ml/min) Dose
>40 See Usual Dosage
£ 40 160mg every 24 hours

 

Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160mg every 24 hours.

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

 

 

Men Creatinine Clearance Weight (kg) x (140-age)72 x serum creatinine(mg/dL)
Women: 0.85 x the value calculated for men

 

Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with wild (Child-Pugh Class A), moderate (Child-Pugh Class B) or servere (Child-Pugh Class C) hepatic impairment.

Use in Elderly: No dosage adjustment is recommended.

 

SIDE EFFECTS

In clinical studies, 8119 patients received daily or doses of 320 mg ZIFAM GEMZ TABLETS. In addition, 1797 healthy volunteers and 81 patients with renal or hepatic impairment received single or repeat doses of gemifloxacin in clinical pharmocology studies. The majority of adverse reactions experienced by patients in clinical trials were considered to be of mild to moderate severity.

ZIFAM GEMZ TABLETS was discontinued because of an adverse event (determined by the investigator to be possibly or probably related to drug) in 2.0% of patients, primarily due to rash (0.8%), nausea(0.3%), diarrhaea(0.3%), urticaria (0.2%) and vomiting (0.2%). Comparator antibiotics were discontinued because of an adverse event of an overall comparable rae of 2.1%, primarily due to diarrhea(0.5%), nausea (0.4%), vomiting (0.3%), rash(0.3%), abdominal pain(0.2%) and vertigo (0.2%).

The most commonly reported adaverse events with a frequency of ³2%for patients receiving 320mg ZIFAM GEMZ TABLETS versus comparator drug (Beta-Lactam Antibiotics, Macrolides or other Fluoroquinolones) are as follows: diarrhea 5.0%   vs. 6.2%; rash 3.5%vs. 1.1%; nausea 3.7% vs.4.5%; headache 4.2% vs. 5.2%; abdominal pain 2.2%; vomiting 1.6 % vs. 2.0%; and dizziness 1.7% vs.2.6%.

 

CONTRAINDICATIONS:

ZIFAM GEMZ TABLETS is contraindicated in patients with a history of hypersensitivity to Gemifloxacin, Fluoroquinolone antibiotic agents, or any of the product components.

 

STORAGE:

Store in cool dry place. Protect from Light.

 

Presentation:

10x1x5 Tablets

Myanmar Reg. No: 1703AA 3845

 

Manufactured by:

Galpha Laboratories Limited

Village- Thana, Baddi,

Himachal Pradesh – 173 205. INDIA

 

Product of

Zifam Pinnacle Pty Ltd.

The Healthcare Group