Augmen 457

Augmen 457
26 May

Augmen 457

Antibiotics & Antibacterial

- AUGMEN® is a broad spectrum combination of Amoxicillin and the β-lactamase inhibitor, Clavulanate potassium. 
- AUGMEN® exhibits bactericidal activity against many Gram-positive and Gram-negative organisms: Staphylococcus aureus (β-lactamase and non-β-lactamase producing), Streptococcus species, Enterobacter species, E. coli, Haemophilus influenzae, Klebsiella species, Moraxella catarrhalis and Clostridium species. 
- Amoxicillin and Clavulanate potassium are well absorbed from the gastrointestinal tract.  
- AUGMEN® can be given without regard to meals.

Indecation

 AUGMEN® is indicated in the following infections caused by susceptible organisms: 
- Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media. 
- Lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia. 
- Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
- Skin and soft tissue infections.  
- Other infections: bone and joint infections, dental infections and intra-abdominal sepsis.

Dosage & Administration

Adult and children over 12 years:
- In mild to moderate infection: one AUGMEN® 625 mg tablet twice daily or one 
  AUGMEN® 375 mg tablet three times daily.
- In severe infection and lower respiratory tract infection: one AUGMEN® 1000 mg tablet twice daily or one AUGMEN® 625 mg tablet three times daily.
- In dental infection: one AUGMEN® 625 mg tablet twice daily or one  AUGMEN®  375 mg tablet three times daily for 5 days.

Children:
- Children under 2 years should be dosed according to body weight.
- Patients aged 12 weeks (3months) and older: as shown in the tables below:
- In mild to moderate infections: upper respiratory tract infections (recurrent tonsillitis), lower respiratory tract infection, skin and soft tissue infections. 

- In sever infection of upper respiratory tract infection (otitis media and sinusitis), lower respiratory tract infections (bronchopneumonia) and urinary tract infection.

  - Treatment should not be extended beyond 14 days without review to the physician.
- Pediatric patients weighing 40 kg and more should be dosed according to the adult.
- Dosage in renal impairment should be reduced.

Infants: 
 Based on the Amoxicillin component, AUGMEN® should be used  in neonates and infants aged less than 12 weeks (3 months): 30 mg/kg/day divided into 2 doses or 20 mg/kg/day divid ed into 3 doses. In more serious infections the dosage may be  increased up to 50 mg/kg/day divided into 3 doses. 
- AUGMEN® Infant Drops should be administered using the supplied syringe doser. 
  The syringe doser has marking which correspond to the weight of the child. For example, for a child weighing 7 kg, the syringe piston should be withdrawn until the 7 kg marking is level with the top of the body of the syring and the dose is given to child through mouth and the dose repeated each 8 hours. 
- For information: each 0.13 ml of AUGMEN® infant Drops corresponds to 1 kg of body weight.

Over dose:-
 Cases of over dosage with AUGMEN® are usually symptomatic. If encountered, 
  gastrointestinal symptoms and disturbance of the fluid and electrolyte balances my be  evident. They may be treated symptomatically, with attention to the water/ electrolyte  balance. AUGMEN® may be removed from the circulation by hemodialysis.

- Each film coated tablet AUGMEN® 1000 contains:
    Amoxicillin 875 mg (as Amoxicillin Trihydrate)
    Clavulanic acid 125 mg (as Potassium salt )
- Each film coated tablet AUGMEN® 625 contains:
    Amoxicillin 500 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 125 mg (as Potassium salt )
- Each film coated tablet AUGMEN® 375 contains:
    Amoxicillin 250 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 125 mg (as Potassium salt )
- Each 5 ml of AUGMEN® 457 for oral suspension contains:
    Amoxicillin 400 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 57 mg (as Potassium salt )
- Each 5 ml of AUGMEN® 228 for oral suspension contains: 
    Amoxicillin 200 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 28.5 mg (as Potassium salt )
- Each 5 ml of AUGMEN® 312 for oral suspension contains:
    Amoxicillin 250 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 62.5 mg (as Potassium salt )
- Each 5 ml of AUGMEN® 156 for oral suspension contains: 
    Amoxicillin 125 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 31.25 mg (as Potassium salt )
- Each one ml of AUGMEN® Infant drops contains:
    Amoxicillin 50 mg (as Amoxicillin Trihydrate )
    Clavulanic acid 12.5 mg (as Potassium salt )

- AUGMEN® is contraindicated in patients with a history of allergic reactions to any penicillin.
It is also contraindicated in patients with a previous history of  AUGMEN® or penicillin-associated jaundice/hepatic dysfunction.

- AUGMEN® should be used with care in patients on anti-coagulation therapy. 
- It may reduce the efficacy of oral contraceptives.
- Concomitant use of probenecid with AUGMEN® may result in increased and prolonged blood levels of Amoxicillin but not Clavulanic acid.
- Concomitant use AUGMEN® with Allopurinol can increase the likelihood of allergic skin reactions, due to containing Amoxicillin.   

- AUGMEN® have shown no teratogenic effect. As with all medicines use should be avoided in pregnancy especially during the first trimester unless considered essential by the physician. 
- AUGMEN® may be administered during the period of lactation.

 Gastrointestinal reaction: Effects include diarrhoea, indigestion, nausea and vomiting. Candidiasis, antibiotic-associated colitis have been reported rarely.
- Tooth discolouration has been reported rarely, mostly with the suspension. It can usually be removed by brushing.
- Hepatic effects: 
  A moderate rise in AST and/or ALT has been noted in patients with semi-synthetic penicillins but the significance of these findings is unknown. Hepatitis and cholestatic jaundice have been reported rarely.
- Hypersensitivity reactions:
  Urticarial and erythematous rashes sometimes occur. Rarely erythema multiform, 
  Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis.
- Hematological effects:
  As with other ß-lactam reversible leucopenia (including neutropenia or  agranulocytosis) reversible thrombocytopenia and heamolytic anaemia have been reported rarely.
- CNS effects :
  CNS effects have been seen very rarely. These include reversible hyperactivity,   
  dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high dose. 

 AUGMEN® should be used with caution in patients with hepatic dysfunction and renal impairment.
- The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, the drug should be discontinued and
  appropriate therapy instituted.
- AUGMEN® 375 mg, 625 mg and 1000 mg tablets should not be recommended in children under 12 year.
- AUGMEN® 1000 mg tablets should only be used in patients with a glomerular filtration rate of  > 30 ml/min.

- AUGMEN® 1000 mg  Tablets (Blister of 5 tablets, pack of 2 blisters.)
- AUGMEN® 1000 mg  Tablets (Blister of 5 tablets, pack of 3 blisters.)
- AUGMEN® 1000 mg  Tablets (Blister of 5 tablets, pack of 2 blisters.)
- AUGMEN® 625 mg & 375 mg Tablets  (Blister of 5 tablets,  pack of 4 blisters.)
- AUGMEN® 457 mg & 228 mg  For Oral suspension (Bottle of 80 ml after reconstitution.) 
- AUGMEN®  312 mg &156 mg For Oral suspension (Bottle of 100 ml after reconstitution.)
- AUGMEN® Infant Drops: (Bottle of  20 ml after reconstitution.) 

- Store in a dry place at a temperature below 25° C. 
- AUGMEN® suspension, once reconstituted, must be stored in a refrigerator and used  within 7 days.