S O M A T E C

About Us

SOMATEC PHARMACEUTICALS LTD. is a fast growing pharmaceutical company in Bangladesh.

Contact Info

28/B, Segun Bagicha, Dhaka-1000, Bangladesh.

+880-02-9337667

+880-02-9357827

+880-02-8391480

info@somatecpharmabd.com

Cefurim CV

Cefurim CV 250 Tablet: Each film coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil USP and Clavulanic Acid 62.50 mg as diluted Potassium Clavulanate BP.
Cefurim CV 500 Tablet: Each film coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil USP and Clavulanic Acid 125 mg as diluted Potassium Clavulanate BP.
Cefurim CV Powder for suspension: Each 5 ml contains Cefuroxime 125 mg as Cefuroxime Axetil USP  & Clavulanic Acid 31.25 mg as Potassium Clavulanate BP.

Brand Name

: Cefurim CV

Therapeutic Class

: Antibiotics

Strength

:
250mg 500mg 70ml

Indications

< Pharyngitis/tonsillitis caused by Streptococcus pyogenes
<Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes
<Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only)
<Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, E. coli
<Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus penumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains)
<Skin and skin-structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, E. coli, Klebsiella spp. and Enterobacter spp.
<Urinary tract infections caused by E. coli or Klebsiella pneumoniae
<Bone and Joint Infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
<Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains) in both males and females
< Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi
<Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, E. coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
<Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin resistant strains), Neisseria meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
<Switch therapy (injectable to oral) after surgery when patient’s condition is improved.

Pharmacology

Cefuroxime is one of the bactericidal second generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. It is indicated for the treatment of infections caused by sensitive bacteria. Clavulanic acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. The presence of clavulanic acid in Cefurim CV formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

Dosage

DOSAGE AND ADMINISTRATION
Cefurim CV tablets can be given without regard to meal.

Adolescents & adults 
Bacterial Infections     Dosage    Duration
Pharyngitis/Tonsillitis      250 mg twice daily    5-10 days
Acute bacterial maxillary sinusitis     250 mg twice daily    10 days
Acute bacterial exacerbation of chronic bronchitis   250-500 mg twice daily    10 days
Secondary bacterial infections of acute bronchitis   250-500 mg twice daily    5-10 days
Community Acquired Pneumonia  250-500 mg twice daily 5-10 days 
Uncomplicated skin & skin-structure infections    250-500 mg twice daily    10 days
MDR Typhoid fever  500 mg twice daily 10-14 days Uncomplicated urinary tract infection    250 mg twice daily    7-10 days
Uncomplicated gonorrhoea     1000 mg single dose    ---
Early Lyme disease 500 mg twice daily   20 days

Pediatric Patients (who can swallow tablets whole)
Acute otitis media 250 mg twice daily     10 days
Acute bacterial maxillary sinusitis 250 mg twice daily     10 days

Pediatric Patients (3 months to 12 years)
Pharyngitis/Tonsilitis      20 mg/kg/day in two divided doses   5-10 days
Acute otitis media       30 mg/kg/day in two divided doses   10 days
Acute bacterial maxillary sinusitis     30 mg/kg/day in two divided doses   10 days
Community Acquired Pneumonia  30 mg/kg/day in two divided doses  5-10 days    
MDR Typhoid fever  30 mg/kg/day in two divided doses  10-14 days    
Uncomplicated skin and skin-structure infections  30 mg/kg/day in two divided doses   10 days
Uncomplicated urinary tract infections  20 mg/kg/day in two divided doses  7-10 days

Interaction

Concomitant administration of probenecid with Cefurim CV increases the area under the serum concentration versus time curve by 50%. Drugs that reduce gastric acidity may result in a lower bilavailability of Cefurim CV compared with that of fasting state and tend to cancel the effect of postprandial absorption. In common with other antibiotics, Cefurim CV may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone.
 

Contraindications

Patients with known hypersensitivity to cephalosporins and pseudomembranous colitis are contraindicated.
 

Side Effects

In generally Cefuroxime Axetil/Clavulanic Acid preparation is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, loose motions, abdominal discomfort or pain, flatulence, headache, thirst, anorexia  may occur. As with other broad spectrum antibiotics, long term use of Cefuroxime Axetil/Clavulanic Acid preparation may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal desfunction, angioedema, anaphylaxis, pruritis, rash and urticarea may appear.

Pregnancy & Lactation

During pregnancy: Both Cefuroxime Axetil & Clavulanic Acid are USFDA approved pregnancy category B drug. While all antibiotics should be avoided in the first trimester if possible. However, Cefurim CV can be safely used in later pregnancy to treat urinary and other infections.
During lactation: Cefurim CV excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind

Precautions & Warnings

Cefurim CV should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function and who have history of colitis.

Storage Conditions

· Store in cool & dry place below 250C temperature,
  preferably in a refrigerator  but do not freeze.   
· Keep out of the reach of children.

Indications

< Pharyngitis/tonsillitis caused by Streptococcus pyogenes
<Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes
<Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only)
<Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, E. coli
<Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus penumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains)
<Skin and skin-structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, E. coli, Klebsiella spp. and Enterobacter spp.
<Urinary tract infections caused by E. coli or Klebsiella pneumoniae
<Bone and Joint Infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
<Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase producing strains) in both males and females
< Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi
<Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, E. coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
<Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin resistant strains), Neisseria meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
<Switch therapy (injectable to oral) after surgery when patient’s condition is improved.

Pharmacology

Cefuroxime is one of the bactericidal second generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. It is indicated for the treatment of infections caused by sensitive bacteria. Clavulanic acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. The presence of clavulanic acid in Cefurim CV formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

Dosage

DOSAGE AND ADMINISTRATION
Cefurim CV tablets can be given without regard to meal.

Adolescents & adults 
Bacterial Infections     Dosage    Duration
Pharyngitis/Tonsillitis      250 mg twice daily    5-10 days
Acute bacterial maxillary sinusitis     250 mg twice daily    10 days
Acute bacterial exacerbation of chronic bronchitis   250-500 mg twice daily    10 days
Secondary bacterial infections of acute bronchitis   250-500 mg twice daily    5-10 days
Community Acquired Pneumonia  250-500 mg twice daily 5-10 days 
Uncomplicated skin & skin-structure infections    250-500 mg twice daily    10 days
MDR Typhoid fever  500 mg twice daily 10-14 days Uncomplicated urinary tract infection    250 mg twice daily    7-10 days
Uncomplicated gonorrhoea     1000 mg single dose    ---
Early Lyme disease 500 mg twice daily   20 days

Pediatric Patients (who can swallow tablets whole)
Acute otitis media 250 mg twice daily     10 days
Acute bacterial maxillary sinusitis 250 mg twice daily     10 days

Pediatric Patients (3 months to 12 years)
Pharyngitis/Tonsilitis      20 mg/kg/day in two divided doses   5-10 days
Acute otitis media       30 mg/kg/day in two divided doses   10 days
Acute bacterial maxillary sinusitis     30 mg/kg/day in two divided doses   10 days
Community Acquired Pneumonia  30 mg/kg/day in two divided doses  5-10 days    
MDR Typhoid fever  30 mg/kg/day in two divided doses  10-14 days    
Uncomplicated skin and skin-structure infections  30 mg/kg/day in two divided doses   10 days
Uncomplicated urinary tract infections  20 mg/kg/day in two divided doses  7-10 days

Interaction

Concomitant administration of probenecid with Cefurim CV increases the area under the serum concentration versus time curve by 50%. Drugs that reduce gastric acidity may result in a lower bilavailability of Cefurim CV compared with that of fasting state and tend to cancel the effect of postprandial absorption. In common with other antibiotics, Cefurim CV may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone.
 

Contraindications

Patients with known hypersensitivity to cephalosporins and pseudomembranous colitis are contraindicated.
 

Side Effects

In generally Cefuroxime Axetil/Clavulanic Acid preparation is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, loose motions, abdominal discomfort or pain, flatulence, headache, thirst, anorexia  may occur. As with other broad spectrum antibiotics, long term use of Cefuroxime Axetil/Clavulanic Acid preparation may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal desfunction, angioedema, anaphylaxis, pruritis, rash and urticarea may appear.

Pregnancy & Lactation

During pregnancy: Both Cefuroxime Axetil & Clavulanic Acid are USFDA approved pregnancy category B drug. While all antibiotics should be avoided in the first trimester if possible. However, Cefurim CV can be safely used in later pregnancy to treat urinary and other infections.
During lactation: Cefurim CV excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind

Precautions & Warnings

Cefurim CV should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function and who have history of colitis.

Storage Conditions

· Store in cool & dry place below 250C temperature,
  preferably in a refrigerator  but do not freeze.   
· Keep out of the reach of children.

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