Each 5 ml of AUGMIT® 156 for Oral suspension contains:

• Amoxicillin 125 mg (as Amoxicillin Trihydrate)
• Clavulanic acid 31.25 mg (as Potassium salt)
   

AUGMIT® 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.

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

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

• AUGMIT® 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. 
• AUGMIT® 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. 

Over dose:-

• Cases of over dosage with AUGMIT® 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. AUGMIT® may be removed from the circulation by hemodialysis.

1) Children:

Patients aged 1 years and older-
:In mild to moderate infections

•    1-6 years: 5 ml three times daily.
•    7-12 years:10 ml three times daily.

In sever infection: 

•    1-6 years:10 ml three times daily.

2) Infants:

 Augmit should be used in neonates and infants aged less than 12 weeks  (3 months ) as :-             

• 30mg/kg/day divided into 2 doses.    
• 20mg/kg/day divided into 3 doses.

 In more serious infections ,the dosage may be increased up to 50 mg/kg/day divided into 3 doses

* 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.

• AUGMIT® 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.
• AUGMIT® 375 mg, 625 mg and 1000 mg tablets should not be recommended in children under 12 year.
• AUGMIT® 1000 mg tablet should only be used in patients with a glomerular filtration rate of > 30 ml/min.

• AUGMIT®156mg  for Oral suspension: Bottle of 100 ml after reconstitution.

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