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Home Page > Products by Alphabet > CLAVENEN 625
   
 
 
  Brand name: CLAVENEN 625  
  Formula: Coated Tablets    
  Categories: Antibiotics  
  Code: 13-7  
  Composition:

Each film coated tablet contains:
- Amoxicillin       500 mg (as Amoxicillin trihydrate)
- Clavulanic Acid 125 mg (As Clavulanate Potassium)

 
 
  Detailed Information:

INDICATIONS AND USAGE:
CLAVENEN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
- Lower Respiratory Tract Infections -caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.
- Otitis Media-caused by β-lactamase -producing strains of H. influenzae and M. catarrhalis.
Sinusitis- caused by (beta)-lactamase-producing strains of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections-caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp.
Urinary Tract Infections-caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp.
While CLAVENEN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with CLAVENEN due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to CLAVENEN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and CLAVENEN.

CONTRAINDICATIONS:
CLAVENEN is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with CLAVENEN.

ADVERSE REACTIONS:
The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.
In pediatric patients (aged 2 months to 12 years): diarrhea, skin rashes/urticaria, and diaper area rashes.

DOSAGE AND ADMINISTRATION:
Dosage:
Pediatric Patients: Based on the amoxicillin component, CLAVENEN should be dosed as follows:
Neonates and infants aged <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of CLAVENEN is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group.

Patients aged 12 weeks (3 months) and older:

1- Otitis media sinusitis,lower respiratory tract infections,and more severe infections:

DOSING REGIMEN:                   CLAVENEN 457                  CLAVENEN 156.25  or CLAVENEN 312.5 
                                                  45 mg/kg/dayq12h                         40 mg/kg/day q8h  

2- Less severe infections:

DOSING REGIMEN:                  CLAVENEN 457                  CLAVENEN 156.25  or CLAVENEN 312.5 
                                                  25 mg/kg/day q12h                      20 mg/kg/dayq8h                           

Pediatric Pat  ients Weighing 40 kg and More: Should be dosed according to the following adult recommendations: The usual adult dose is one tablet of CLAVENEN-625 every 12 hours or one tablet of CLAVENEN-375 every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one tablet of CLAVENEN-1000 every 12 hours or one tablet of CLAVENEN-625 every 8 hours. Among adults treated with CLAVENEN-1000 every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with CLAVENEN-625 every 8 hours.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Adults: Adults who have difficulty swallowing may be given the CLAVENEN-156.25 or CLAVENEN-312.5 suspension in place of the CLAVENEN-625 tablet. The CLAVENEN 457 suspension may be used in place of the CLAVENEN-1000 tablet.
Directions for Mixing Oral Suspension: Tap bottle until all the powder flows freely. Add approximately ⅔ of the total amount of water for reconstitution and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Note: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

Administration: CLAVENEN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when CLAVENEN is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, CLAVENEN should be taken at the start of a meal.

HOW SUPPLIED:
CLAVENEN 625: Box of 6 or 10 or 15 tablets.

 
   
 
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