Description : Natravox: Each 250 mg/125 mg and 500 mg/125 mg tablet contains amoxicillin 250 mg and 500 mg, respectively and clavulanic acid 125 mg.
Each 125 mg/31.25 mg, 250 mg/62.5 mg and 400 mg/57 mg oral suspension contains amoxicillin 125 mg, 250 mg and 400 mg, respectively and clavulanic acid 31.25 mg, 62.5 mg and 57 mg, respectively.
Indications / Uses : Upper Respiratory Tract Infections (including ENT): Sinusitis, otitis media, recurrent tonsillitis. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Lower Respiratory Tract Infections: Acute exacerbations of chronic bronchitis, bronchopneumonia, urinary-tract infections often caused by Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis.
Genitourinary Tract and Abdominal Infections: In particular cystitis (especially when recurrent or complicated, but not prostatitis), septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis. These infections are often caused by Enterobacteriaceae (mainly Escherichia coli), Staphylococcus saprophyticus, Enterococcus species.
Skin and Soft Tissue Infections: In particular cellulitis, animal bites and severe dental abscess with spreading cellulites caused by Staphylococcus aureus, Streptococcus pyogenes and Bacteroides species.
Administration : May be taken with or without food: May be given w/o regard to meals. Best taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications : Co-amoxiclav is contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of amoxicillin-potassium clavulanate-associated cholestatic jaundice/hepatic dysfunction.
Special Precautions : Changes in liver function tests have been observed in some patients receiving Co-amoxiclav. The clinical significance of these changes is uncertain but Co-amoxiclav should be used with caution in patients with evidence of hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for several weeks after treatment has ceased.
In patients with reduced urine output crystalluria has been observed very rarely, predominantly with parenteral therapy. During administration of high doses of amoxicillin it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of potency should be maintained.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity.
Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Natravox: Renal function should be monitored in patients with moderate to severe renal impairment and co-amoxiclav dosage should be adjusted.
Treatment with co-amoxiclav may give rise to a maculopapular rash during therapy or within a few days after completion. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth eg, vaginitis and thrush have been reported.
Treatment with co-amoxiclav can cause gastrointestinal symptoms eg, diarrhea, nausea and vomiting which are dose-related and can be minimized by administering the drug at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these gastrointestinal symptoms occur and a higher concentration of amoxicillin is required, consideration should be given to administering the additional amoxicillin separately.