Indications

AGECLAV-625 (Amoxyciline 500 mg & Clavulanic acid 125 mg) Tablet 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.

AGECLAV-625 (Amoxyciline 500 mg & Clavulanic acid 125 mg) Tablet 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.

Contraindications

AGECLAV-625 (Amoxyciline 500 mg & Clavulanic acid 125 mg) Tablet is not advocated for those with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. AGECLAV-625 is also contraindicated in those with previous history of amoxicillin-clavulanic acid-associated jaundice / hepatic dysfunction.

AGECLAV-625 (Amoxyciline 500 mg & Clavulanic acid 125 mg) Tablet 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-625 Tablet should not be used in renal failure when glomerular filtration rate is less than 30 ml/minute.

Precautions & Warnings

AGECLAV-625 should be advocated with caution in presence of hepatic dysfunction or renal impairment. Since AGECLAV-625 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.

Periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged AGECLAV therapy. AGECLAV-625 (Amoxyciline 500 mg & Clavulanic acid 125 mg) Tablet is not ideally meant for pregnant lady or lactating mother; however, it could be advocated only if strictly necessary. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida spp), AGECLAV-625 should be discontinued and/or appropriate therapy needs to be instituted. AGECLAV-625 must be co-administered with caution along with probenecid and allupurinol.

Adverse Reactions

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.

Drug Interaction

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-625 must be cautiously co-administered with allupurinol.

Dosage & Administration

Adults:
Mild-to-Moderate Infections: 1 AGECLAV 625 Tablet bid, or as prescribed.       
Severe Infections: 1 AGECLAV 625 tid or as prescribed.

Renal Impairment:
Glomerular filtration rate of 10-30 ml/min: 1 AGECLAV 375 / 625 BID depending upon the severity of infection.

Hemodialysis: 1 AGECLAV 375 / 625 OD depending upon the severity of infection. Or as prescribed.

Presentations
AGECLAV-625 Tablets: ALU ALU of 10s