

Indication
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.

Composition
- Each dispersible tablet of AUGMIT D ® 312 :
- Amoxicillin 250 mg (as Amoxicillin Trihydrate )
- Clavulanic acid 62.5 mg (as Potassium salt )

Dosage
Children and adult:
Patients aged 1 years and older-
: In mild to moderate infections
- 1-6 years: half tablet three times daily.
- 7-12 years: One tablet three times daily.
In sever infection:
- 1-6 years: One tablet three times daily.
- 7-12 years: Two tablet three times daily
* 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® is a broad spectrum combination of Amoxicillin and the β-lactamase inhibitor, Clavulanate potassium.
- AUGMIT® 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.
- AUGMIT® can be given without regard to meals.
- Each dispersible tablet of AUGMIT D ® 312 :
- Amoxicillin 250 mg (as Amoxicillin Trihydrate )
- Clavulanic acid 62.5 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 diarrhea, indigestion, nausea and vomiting, candidiasis, antibiotic-associated colitis have been reported rarely.
- Tooth discoloration 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 penicillin's 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 hemolytic anemia 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
Children and adult:
Patients aged 1 years and older-
: In mild to moderate infections
- 1-6 years: half tablet three times daily.
- 7-12 years: One tablet three times daily.
In sever infection:
- 1-6 years: One tablet three times daily.
- 7-12 years: Two tablet three times daily
* 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® 312 mg Tablets (Blister of 5 Dispersible tablets, pack of 4 blisters.)
- 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.