Indications

AUGBACTAM is indicated in the short term treatment of the following cases:
– Upper respiratory tract infections : tonsillitis, sinusitis, otitis media which had been treated unsuccessfully with other antibiotics.
– Lower respiratory tract infections caused by susceptible β– lactamase producing strains of H. influenzae and Branhamella catarrhalis: Acute and chronic pneumonia, bronchopneumonia.
– Severe genitourinary tract infections caused by susceptible β– lactamase producing strains of E.coli, Klebsiella and Enterobacter: Cystitis, urethritis, pyelonephritis (in women).
– Skin and soft tissue infections : pyodermas, abscesses, wound infections.
– Bone and joint infections: myelitis.
– Dental infections: periodontal abscesses.
– Others: Gyneco– obstetric, abdominal infections.

Present

Blister of 7 tablets. Box of 2 blisters.

Composition

Amoxicillin trihydrate equivalent to Amoxicillin …………………..875mg
Diluted potassium clavulanate equivalent to Clavulanic acid ….125mg
Excipients sq. for ……………………………………………………………..1 tablet

Pharmacology

AUGBACTAM is bactericidal to a wide range of organisms. The combination of Amoxicillin with Clavulanic acid as in AUGBACTAM renders Amoxicillin resistant to β– lactamase as well as enhancing the activity of Amoxicillin several species not generally considered sensitive and those that had been resistant to Amoxicillin and other Penicillins and Cephalosporins.

Pharmacokinetics

– Amoxicillin and Clavulanic acid is readily absorbed when given by mouth.
– About 55– 70% of an oral dose of Amoxicillin and about 30– 40% of that of Clavulanic acid is excreted unchanged in the urine.

Contra-Indications

– Hypersensitivity to Penicillins vaø Cephalosporins
– The 1st trimester of pregnancy.

Precaution

Use with cautions in patients with evidence of hepatic and renal dysfunction.

Interaction

– Administration of AUGBACTAM may result in prolonged hemorrhage and clotting time. Therefore use with cautions in patients who are on anticoagulant therapy.
– AUGBACTAM may reduce oral contraceptive efficacy hence those on the pills should be advised about this effect.
– Do not use Probenecid concomitantly with AUGBACTAM because of decrease of Amoxicillin elimination via renal tubular secretion. This concomitant use may lead to an increase and prolonged Amoxicillin level in blood but does not effect Clavulanic acid.
OVERDOSAGE:
When a overdose is given , it does not effect adverserly very much because it is well tolerable even at high doses. But generally speaking, the adverse reactions that follow an overdose will depend on patient predisposition toward the drug. The prominent risk is hyperkalemia because of Clavulanic acid in the drug is bound as salt of potassium. Hemodialysis can remove the active components of the drug from circulation.

Shelf life

– 36 months from the manufacturing date.
Never use after the expiry date clearly indicated on the outer packaging.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 25^oC. Protect from light.

Dosage

– Adults and children ≥ 12 years:
+ Mild– moderate infections: 1 film– coated tablet 625mg or 2 sachets of oral powder every 12 hrs.
+ Severe infections: 1 film– coated tablet 625mg or 2 sachets of oral powder every 8 hrs or 1 film– coated tablet 1g every 12 hrs.
– Children < 12 years (< 40kg body weight):
Dosage is based on Amoxicillin: 20– 45mg/kg body weight daily depending on severity of infection, divided into equal doses at interval of 8 – 12 hrs.
Usual dosage: Children: 6 yrs – < 12 yrs: 1 sachet every 8 hrs.
2 yrs – < 6 yrs: 1/2 sachet every 8 hrs.
9 mos – < 2 yrs: 1/4 sachet every 8 hrs.
It should be administration at the beginning of a meal to minimize adverseGI effects.
Treatment should not be extended beyond 14 days without review.