COMPOSITION :
Each 5ml constituted suspension contains:
Amoxycillin Trihydrate IP equivalent to Amoxycillin 200mg
Potassium Clavulanate Diluted IP equivalent to Clavulanic Acid 28.5mg
Excipients q.s.
Description:
Amoxycillin is chemically designated as (6R) 6-a-D-(4 Hydroxyphenyl)-glycylamino penicillianic acid trihydrate. Its empirical formula is C16H19N3O5S.3H2O. Its molecular weight is 419.5. Potassium clavulanate is chemically designated as potassium (Z) –(2R.5R) – 3- (2- Hydroxyethylidene)- 7 axo- 4- axo-1 azabicyclo 3.2.0) heptane – 2 – carboxylate. Its empirical formula is C8H8NO5K& nbsp; and its molecular weight is 237.3.
Mechanism of Action:
Amoxicillin acts through inhibition of biosynthesis of the bacterial cell wall mucopeptide. It is bactericidal against many Gram-positive and Gram-negative organisms. However, it is susceptible to degradation by β-lactamase producing bacteria. Clavulanic acid inhibits a wide range of bacterial β-lactamase and protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many β-lactamase producing strains of bacteria.
Pharmacokinetics:
Amoxicillin and potassium clavulanate are well absorbed from the gastrointestinal tract after oral administration of curam. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin . while amoxicillin and potassium clavulanate can be given without regard to meals, absorption of potassium clavulanate when taken with food is greater relative to the fasted state. In 1 study, the relative bioavailability of clavulanate was reduced with amoxicillin and potassium clavulanate was dosed at 30 and 150 minutes after the start of a high-fat-breakfast. The safety and efficacy of amoxicillin and potassium clavulanate have been established in clinical trials where amoxicillin and potassium clavulanate was taken without regard to meals.
Amoxicillin serum concentrations achieved with amoxicillin and potassium clavulanate are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration amoxicillin and potassium clavulanate is 1.3 hours and that of clavulanic acid is 1.0 hour.
Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single 250mg or 500mg tablet of amoxicillin and potassium clavulanate.
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
Neither component in amoxicillin and potassium clavulanate is highly protein-bound, clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin is well distributed in body tissues.
Indications: Bacterial infections caused by gram-negative and gram-positive amoxicillin resistant organisms whose resistance is due to β-lactamase but which are sensitive to combination of amoxicillin and clavulanic acid.
Curam is suitable for treatment of the following indications:
Infections:
. of the upper and lower respiratory tract
. otitis media (inflammation of the middle ear)
. acute sinusitis
. acute exacerbation of chronic bronchitis
. pneumonia . of the kidneys and lower urinary tract.
Contraindications:
allergic reaction to specific β-lactamase antibiotics (e.g.penicillins, cephalosporins).
Contraindicated in patients with a previous history of cholestatic jaundice / hepatic dysfunction associated with amoxicillin and clavulanic acid.
Special warnings and precautions:
With prolonged therapy, kidney, liver and blood parameters should be regularly monitored. Patients with existing hepatic impairment should have their liver function closely monitored irrespective of the length of therapy.
Elderly patients (age 60 and over) should be treated with caution and their liver function monitored (see side effects ).
There are no special precautionary measures for children provided that the kidney and liver function are not impaired.
No adverse effects on the foetus or neonate have been observed in connection with amoxicillin when taken during pregnancy and lactation. By way of a precaution, however, curam should only be used during pregnancy and lactation if, in the physicians judgment, the potential benefits outweigh the possible risks.
Overdose and other misuses:
No specific measures are normally required in the case of overdose except for discontinuation of the drug. The symptoms of overdose are essentially the same as the side effects. With very high doses nausea, vomiting, abdominal pain and diarrhea can occur.
Other side effects:
All antibiotics can cause proliferation of bacteria that are insensitive to the drug being used. Attention should be paid to signs of follow-up infections through these organisms. Such infections should be treated accordingly.
Storage:
Suspension: store below 250c, protected from light and moisture.
Keep out of reach of children.
