<p><strong>Indications</strong></p>

<p>AGECLAV Dry Syrup is indicated for the treatment of infections caused by amoxicillin-resistant organisms producing beta-lactamases sensitive to clavulanic acid: Upper Respiratory Tract Infections (UTI), such as sinusitis, recurrent otitis media, and tonsillitis; Lower Respiratory Tract Infections (RTI), such as bronchitis (caused by amoxicillin-resistant beta-lactamases producing Escherichia coli, Hemophilus influenzae and Hemophilus para-influenzae), and bronchopneumonia; Genitourinary Tract Infections (GTI), such as cystitis, urethritis, and pyelonephritis; Skin and soft tissue infections.</p>

<p>AGECLAV is also effective in the treatment of infections caused by amoxicillin-sensitive organisms at the appropriate amoxycillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect. AGECLAV I.V is additionally useful for surgical prophylaxis.</p>

<p><strong>Contraindications</strong></p>

<p>AGECLAV is not advocated for those with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. AGECLAV is also contraindicated in those with previous history of amoxicillin-clavulanic acid-associated jaundice / hepatic dysfunction.</p>

<p>AGECLAV should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin. AGECLAV should not be used in renal failure when glomerular filtration rate is less than 30 ml/minute.</p>

<p><strong>Precautions &amp; Warnings</strong></p>

<p>AGECLAV should be advocated with caution in presence of hepatic dysfunction or renal impairment. Prolonged use of AGECLAV Dry Syrup could result in overgrowth of non-susceptible organisms. Since AGECLAV contains amoxicillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if Amoxicillin is used.</p>

<p><strong>Adverse Reactions</strong></p>

<p>The most frequently reported adverse effects with Amoxicillin Clavulanic Acid (AGECLAV) are indigestion, diarrhea, nausea, vomiting, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, oral thrush, abnormal taste, headache, dizziness, tiredness and hot flushes. Other side effects attributable to amoxicillin (AGECLAV) include hypersensitivity reactions, other gastrointestinal reactions including superficial tooth discoloration, hepatitis, cholestatic jaundice, hematologic changes and central nervous system effects including convulsions.</p>

<p><strong>Drug Interaction</strong></p>

<p>Probenecid decreases the renal tubular secretion of amoxicillin, but does not affect Clavulanic Acid excretion. The combined administration of allopurinol and ampicillin substantially increases the incidence of skin rashes and AGECLAV must be cautiously co-administered with allupurinol.</p>

<p><strong>Dosage</strong></p>

<p>AGECLAV DRY SYRUP<br />
Children: (Children below 15 kg</p>

<p>To dose as per Amoxicillin and Clavulanic Acid recommendations of 25 mg/kg and 3.6/kg (respectively) per day in two divided doses, or as prescribed. Alternatively,</p>

<p>3-9 months: 1.25 ml (&frac14; tsf) AGECLAV Suspension twice daily.<br />
9 mths-2 yrs: 2.5 ml (&frac12; tsf) AGECLAV Suspension twice daily.<br />
2-6 yrs: 5 ml (1 tsf) AGECLAV Suspension twice daily.<br />
7-12 yrs: 10 ml (2 tsf) AGECLAV Suspension twice daily.</p>

<p><strong>Presentations</strong><br />
AGECLAV DRY SYRUP: 30 ml Bottle of Oral Suspension</p>
