Amoxicillin/Clavulanate is an effective medicine to treat acute sinusitis. For treatment measures, the medical doses may vary from high dose (875 mg) to standard dose (125 mg) of amoxicillin/clavulanate prescribed for 7 days. To vary the above scenario, amoxicillin clav manufacturers in India studied the clinical analysis of acute sinusitis treatment in more detail. The trial was carried out by the government to identify the level of doses.

Clinical Study

When an adult patients visits a healthcare centre and is diagnosed by an acute bacterial sinusitis there are two types of prescription given as per their health history and other factors –

  • Standard dose: Amoxicillin/clavulanate 875 mg/125mg & lactase ( a dietary supplement) – twice a day x 7 days.

Treatment: Lactase can work in place of additional amoxicillin

  • High dose: Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg – twice a day x 7 days

Treatment: Doubling the dose of amoxil (amoxicillin/clavulanate) by adding 875 mg to the standard dose

The standard dose (SD) provides immediate release (IR) of amoxicillin clav 875/125 mg that can include a single dose sachet of amoxiclav for children. High dose (HD) contains 1750 mg of IR of antibiotic, amoxicillin in combination with 125 mg clavulanate. High dose case of IR amoxicillin was compared to extended release (ER) amoxicillin to see if there was any major difference.

The combination was mainly carried out in a series of adults (315) to study clinical outcomes. The objective was to assess improvement from no symptoms to feeling better in adult individuals. Studying major improvement helped in analysis of treatment measures. 

Criteria

  • Trials were conducted on adults having an age 18 years and above
  • Suffering from acute bacterial sinusitis showing symptoms for 10 or more days, severe bacterial sinusitis with symptoms for at least 3 days and double sickening patients

The above exclude patients that has either of:

  • Penicillin allergic
  • Hypersensitive to beta lactam
  • Signs showing elevated risk from amoxicillin resistance bacteria
  • Chronic or recurrent sinus infections with around 8 weeks or more episodes of antibiotic treatment
  • Immunocompromised
  • Cognitive impairment
  • Pregnancy
  • Lactating mothers
  • Chronic Kidney or liver disorders
  • History of antibiotic associated colitis

Results

Primary outcomes

Improvement within day 3: A major improvement was seen in around 38.8% of patients that were prescribed extended release (ER) HD compared to a 37.9 of patients recommended with SD. On the other hand, improvement in 52.4% of IR high dose prescribed patients was observed against 34.4% of patients consuming SD.

Side Effects

At day 3, around 7.4% of ER HD and 5.7 of SD patients suffered from severe diarrhea. On the other hand, 15.8% of IR HD and 4.8 of SD patients suffered severe diarrhea.

Conclusion

The more likely treatment for acute bacterial sinusitis is immediate release high dose instead of standard dose for rapid improvement. Although, extended release high dose isn’t recommended with a standard dose is prescribed. This may cause patients to undergo severe diarrhea, more likely within 3 days itself.

In conclusion to the above study, pharma manufacturers in India state the usage of single dose sachet of co amoxiclav, or tablets or other form as per regulatory norms prescribed by government.

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