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Home Page > Products by Alphabet > AMOXICILLIN 500 mg BARAKAT
   
 
 
  Brand name: AMOXICILLIN 500 mg BARAKAT  
  Formula: Capsules    
  Categories: Antibiotics  
  Code: 13-27  
  Composition:

Each capsule contains:
Amoxicillin  500mg (As Amoxicillin Trihydrate)

 
 
  Detailed Information:

INDICATIONS AND USAGE:
AMOXICILLIN is indicated in the treatment of infections due to susceptible (ONLY (beta)-lactamase-negative) strains of the designated microorganisms in the conditions listed below:
Infections of the ear, nose, and throat: due to Streptococcus spp. ((alpha) - and (beta)-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract: due to E. coli, P. mirabilis, or E. faecalis .
Infections of the skin and skin structure: due to Streptococcus spp. ((alpha) - and (beta)-hemolytic strains only), Staphylococcus spp., or E. coli.
Infections of the lower respiratory tract: due to Streptococcus spp. ((alpha)- and (beta)-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections): due to N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
CONTRAINDICATIONS:
A history of allergic reaction to any of the penicillins is a contraindication.
ADVERSE REACTIONS:
As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:
Gastrointestinal:    Nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions:    Serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.
NOTE:    These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.
Liver:   Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Renal:    Crystalluria has also been reported.
Hemic and Lymphatic Systems:    Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System:    Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.
Miscellaneous:    Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases. 
DOSAGE AND ADMINISTRATION:
AMOXICILLIN may be given without regard to meals.
Neonates and Infants Aged Pediatric Patients > 3 Months:
Ear/Nose/Throat (Mild/Moderate): 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours.
Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours.
Lower Respiratory Tract (Mild/Moderate or Severe): 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours.
Skin/Skin Structure (Mild/Moderate): 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours.
Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours.
Genitourinary Tract (Mild/Moderate): 25 mg/kg/day in divided doses every 12 hours or
20 mg/kg/day in divided doses every 8 hours.
Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours.
Adults:
Ear/Nose/Throat (Mild/Moderate): 500 mg every 12 hours or 250 mg every 8 hours.
Severe: 500 mg every 8 hours.
Lower Respiratory Tract (Mild/Moderate or Severe): 500 mg every 8 hours.
Skin/Skin Structure (Mild/Moderate): 500 mg every 12 hours or 250 mg every 8 hours.
Severe: 500 mg every 8 hours.
Genitourinary Tract (Mild/Moderate): 500 mg every 12 hours or 250 mg every 8 hours.
Severe: 500 mg every 8 hours.
Gonorrhea Acute, uncomplicated ano-genital, and urethral infections in males and females:
3 grams as single oral dose.
All patients with gonorrhea should be evaluated for syphilis.
Larger doses may be required for stubborn or severe infections.
General:    It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
Dosing Recommendations for Adults with Impaired Renal Function:    Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
There are currently no dosing recommendations for pediatric patients with impaired renal function.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.
HOW SUPPLIED:
Boxes of 20 capsules.

 
   
 
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