MRP : 140/Vial
AGECLAV® 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® 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.
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.
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.
Precautions & Warnings
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.
Periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged AGECLAV® therapy. AGECLAV® 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® should be discontinued and/or appropriate therapy needs to be instituted. AGECLAV® must be co-administered with caution along with probenecid and allupurinol.
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.
AGECLAV® IV can cause sudden signs of allergy such as rash, itching or hives on the skin, swelling of face, lips, tongue or other parts of the body, hortness of breath, wheezing or troubled breathing. Rarely headache, dizziness and seizures can occur with AGECLAV® IV.
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.
Recommended Dosage & Administration
1.2 gm AGECLAV® IV tid, or as prescribed.
AGECLAV® IV is to be recommended as long as necessary to clear the infection. It is not advocated for more than 14 days.
<1 hour procedure: 1.2 gm AGECLAV® IV single dose, or as prescribed.
Longer operations: 1.2 gm AGECLAV® IV stat and repeat up to 4 times in 24 hours, or as prescribed.
AGECLAV® IV Injection: Vials of 1200 mg. With distilled water for injection.