Brenz-100, 200

BRENZ- 200 (Cefixime 200 mg)

BRENZ- 100 DT (Cefixime 100 mg DT)

 (Seeking an oral therapy as effective as i.v.

A reliable step down therapy)

BRENZ is a semisynthetic, broad-spectrum cephalosporin antibiotic of third generation for oral administration. BRENZ is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. The walls are necessary to protect bacteria from their environment and to keep the contents of the bacterial cell together; bacteria cannot survive without a cell wall. BRENZ is active against a very wide spectrum of bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (the cause of strep throat) (Gram-positive), Hemophilus influenzae, E. coli, Klebsiella, Proteus mirabilis, (Gram-negative), Moraxella catarrhalis, Salmonella, Shigella, and Neisseria gonorrhoeae (beta-lactamase positive and negative). The FDA approved cefixime in April 1989.

BRENZ is highly stable in the presence of the beta-lactamase enzymes.

HIGHLIGHTS:

• Very low MIC against respiratory pathogens.

• High concentration in lung tissue and bronchial mucosa.

• Excellent beta-lactamase stability.

• Long half-life of about 3 hours after B. D. dosage. 

• In the treatment of uncomplicated gonorrhea, a single dose of BRENZ (400 or 800 mg) given orally appears to be as effective as the currently recommended regimen of Trecef-250 mg given intramuscularly.

• BRENZ is a suitable alternative to cefaclor or amoxycillin in acute otitis media and acute upper and lower respiratory tract infections, and to amoxycillin or co-trimoxazole in acute uncomplicated urinary tract infections.

• Ideal choice of antibiotic in MDR and non-MDR typhoid fever in children with 100 % clinical efficacy.

• More effective than Amoxycillin-clavulanate in UTIs.

• Unmatched spectrum (gram-positive and gram-negative bacteria).

• First choice therapy for acute lower respiratory tract infections with 96% cure rates.

INDICATIONS:

BRENZ is indicated in the treatment of the following infections:

• Typhoid fever
• Uncomplicated Urinary Tract Infections
• Otitis Media
• Pharyngitis and Tonsillitis,
• Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis (AECB)
• Uncomplicated gonorrhea (cervical/urethral)
• Pneumonia sinusitis
• Influenza
• Respiratory tract infections
• Skin and soft tissue infections
• Genital tract infections
• Gynaecological infections
• ENT infections 

DOSAGE AND ADMINISTRATION:

Adults: The recommended dose of BRENZ is 200-400 mg daily. This may be given as 400 mg once daily or as BRENZ-200 mg every 12 hours.

For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

In lower respiratory tract infections, 400 mg daily is recommended.

For upper respiratory tract infections and uncomplicated urinary tract infections, BRENZ-200 mg once daily is usually effective.

For sinusitis, the therapeutic dosage must be administered for 10-14 days.

CONTRAINDICATIONS:

BRENZ is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Treatment with broad-spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins).

UNDESIRABLE EFFECTS:

The following adverse reactions have been reported following the use of BRENZ. Incidence rates were less than 1 in 50 (less than 2%).

·        Diarrhea

·        loose stools

·        abdominal pain

·        dyspepsia

·        nausea and vomiting

·        Transient elevations in SGPT, SGOT, and alkaline phosphatase.

·        Renal: Transient elevations in BUN or creatinine.

·        Central Nervous System: Headaches or dizziness.

INTERACTIONS:

Carbamazepine: Elevated carbamazepine levels have been reported.

DRUG/LABORATORY TEST INTERACTIONS:

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside. The administration of BRENZ may result in a false-positive reaction for glucose in the urine using Benedict' solution, or Fehling's solution.
Usage in Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether BRENZ is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

WARNINGS:
Before therapy with BRENZ is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins. If an allergic reaction to BRENZ occurs, discontinue the use of drug, and appropriate measures should be taken.

The dose of BRENZ should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis(HD).

OVERDOSE:
Gastric lavage may be indicated; otherwise, no specific antidote exists. BRENZ is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.

M.R.P.:

Brenz-100: Rs. 7.69/- per tab.

Brenz-200: Rs. 11.25/- per tab.