Indications

AUMAKIN 1g 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 film– coated tablets. Box of 2 blisters.

Composition

Amoxicillin trihydrate equivalent to Amoxicillin ……………………875mg
Potassium clavulanate equivalent to Clavulanic acid ………………125mg
Excipients s.q. for ……………………………………………………………..1 tablet
(Microcrystalline cellulose, Crospovidone, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate, Methacrylic acid copolymer, Hypromellose, Talc, Titanium dioxide, Polyethylene glycol 6000, Polysorbate 80, Isopropanol, Ethanol 96%).

Pharmacology

AUMAKIN 1g is bactericidal to a wide range of organisms. The combination of Amoxicillin and Clavulanic acid as in AUMAKIN 1g renders Amoxicillin resistant to β– lactamase as well as enhancing the activity of Amoxicillin against 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. Peak plasma Amoxicillin and Clavulanic acid concentrations are attained about 1 to 2 hrs after oral doses. Bioavailability of Amoxicillin is about 90% and that of Clavulanic acid is about 75%. The half– life of Amoxicillin after the oral administration of AUMAKIN 1g is 1 – 2 hrs and that of Clavulanic acid is 1 hr. 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 and Cephalosporins.
– Patients with history of jaundice or with disorders of liver and/or gall– bladder function caused by Amoxicillin, Clavulanate or other Penicillins.

Precaution

Use with cautions in patients with evidence of hepatic and renal dysfunction.
PREGNANCY AND LACTATION:
– Avoid using AUMAKIN 1g during pregnancy, especially in the 1st trimester, unless prescribed to by the doctor.
– AUMAKIN 1g may be given to nursing mothers, but caution should be exercised when Amoxicillin is administered to nursing mothers because it is excreted into milk and pose a risk of hypersensitivity.

Interaction

– Administration of AUMAKIN 1g may result in prolonged hemorrhage and clotting time. Therefore use with cautions in patients who are on anticoagulant therapy.
– AUMAKIN 1g may reduce oral contraceptive efficacy hence those on the pills should be advised about this effect.
– Probenecid may prolong elimination time of Amoxicillin but do not affect the elimination time of 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

24 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

– Severe infections.
– Adults and children ≥ 12 years: 1 tablet, twice daily.
– It should be administration at the beginning of a meal to minimize adverse GI effects.
– Treatment should not be extended beyond 14 days without review.