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Amoxicillin Oral Suspension Sugar Free is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4 and 5.1) such as: • Acute bacterial sinusitis • Acute otitis media • Acute streptococcal tonsillitis and pharyngitis • Acute exacerbation of chronic bronchitis • Community acquired pneumonia • Acute cystitis • Asymptomatic bacteriuria in pregnancy • Acute pyelonephritis • Typhoid and paratyphoid fever • Dental abscess with spreading cellulitis • Prosthetic joint infections • Helicobacter pylori eradication • Lyme disease Amoxicillin Oral Suspension Sugar Free is also indicated for the prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. The dose of Amoxicillin Oral Suspension Sugar Free that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection • The age, weight and renal function of the patient; as shown below The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy). Children may be treated with Amoxicillin Capsules, dispersible tablets suspensions or sachets. Amoxicillin Paediatric Suspension is recommended for children under six months of age. Children weighing 40 kg or more should be prescribed the adult dosage. Take without regard to meals Mixing oral suspension: Tap bottle until all powder flows freely; add approximately one third of the total amount of water for reconstitution and shake vigorously to wet powder; add remainder of water and shake vigorously again After reconstitution, place required amount of suspension directly on child’s tongue for swallowing; if taste is unacceptable, required amount of suspension can be added to formula, milk, fruit juice, water, ginger ale, or other cold drinks; preparation must be taken immediately Shake suspension well before using; any unused portion must be discarded after 14 days Mucocutaneous candidiasis Gastrointestinal (eg, black hairy tongue and hemorrhagic/pseudomembranous colitis, which may occur during or after treatment) Hypersensitivity reactions (eg, anaphylaxis, serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, urticaria) Moderate increase in AST and/or ALT; hepatic dysfunction (eg, cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported) Renal (eg, crystalluria) Anemia (eg, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, agranulocytosis) CNS reactions (eg, reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, dizziness) Tooth discoloration (brown, yellow, or gray staining); may be reduced or eliminated with brushing or dental cleaning Anaphylaxis has been reported rarely but is more likely to occur following parenteral therapy with penicillins Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents; severity may range from mild diarrhea to fatal colitis; CDAD may occur over 2 months after discontinuation of therapy; if CDAD is suspected or confirmed, discontinue immediately and begin appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation Do not administer in patients with infectious mononucleosis because of risk of development of erythematous skin rash Do not administer to patients in the absence of a proven or suspected bacterial infection because of risk of development of drug-resistant bacteria Superinfections with bacterial or fungal pathogens may occur during therapy; if suspected, discontinue immediately and begin appropriate treatment Chewable tablets contain aspartame, which contains phenylalanine Use caution in patients with allergy to cephalosporins, carbapenems Endocarditis prophylaxis: use for only high-risk patients, as per recent AHA guidelines High doses may cause false urine glucose test by some methods Derivative of ampicillin and has similar antibacterial spectrum (certain gram-positive and gram-negative organisms); similar bactericidal action as penicillin; acts on susceptible bacteria during multiplication stage by inhibiting cell wall mucopeptide biosynthesis; superior bioavailability and stability to gastric acid and has broader spectrum of activity than penicillin; less active than penicillin against Streptococcus pneumococcus; penicillin-resistant strains also resistant to amoxicillin, but higher doses may be effective; more effective against gram-negative organisms (eg, N meningitidis, H influenzae) than penicillin The above information is provided for general informational and educational purposes only. 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