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^{R x} PRESCRIPTION ONLY

AMK (Tablet)

(Amoxicillin and Clavulanic acid)

COMPOSITION

AMK 375: Each tablet contains 250 mg of amoxicillin and 125 mg of clavulanic acid.

AMK 625: Each tablet contains 500 mg of amoxicillin and 125 mg of clavulanic acid.

AMK 1000: Each tablet contains 875 mg of amoxicillin and 125 mg of clavulanic acid.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as clavulanate potassium.

Excipients: Crospovidone, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate, Hydroxypropyl methylcellulose, Polyethylene glycol (PEG 400), Titanium dioxide, Talcum, Isopropyl alcohol, Methylene chloride.

ACTION

AMK is a combination of amoxicillin and clavulanic acid. Amoxicillin, a penicillin antibiotic with a broad spectrum of bactericidal activity and clavulanic acid, an irreversible beta-lactamase inhibitor. With enzymes it produces stable nonactive complexes and protects amoxicillin from degradation.

ANTIBACTERIAL SPECTRUM

Gram-positive aerobes (S. pneumonia, S. pyogenes, S. viridans, S. bovis, S. aureus, S. epidimidis, Listeria spp., Enterococcus spp.).

Gram-negative aerobes ( H. influenzae, Moraxella catarrhalis, E.coli, Proteus spp., Kebsiella spp., N. gonorrhoeae, N. meningitides).

Anaerobes (Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp.).

PHARMACOKINETICS

Amoxicillin and Clavulanic acid are both well absorbed after oral administration and are stable in the presence of gastric acid. Food has no effect on the degree of absorption. Peak serum concentrations are achieved approximately 1-2.5 hours after ingestion. Amoxcillin and clavulanate potassium combination is eliminated primarily unchanged through the renal route. In patients with impaired renal function excretion of the drug from the body is delayed.

INDICATIONS

-           Upper respiratory tract infections eg. Sinusitis, otitis media, tonsillitis.

-           Lower respiratory tract infections eg. Acute and chronic bronchitis, pneumonia.

-           Urinary tract infections.

-           Gynecological infections

-           Skin and soft tissue infections

-           Bone and joint infections

-           Odontogenic infections

CONTRAINDICATIONS

Hypersensitivity to amoxicillin, clavulanic acid and penicillin group of antibiotics.

PRECAUTIONS

Should be used with caution in patients with a history of allergic reactions. In patients with severely impaired liver or renal function the dose should be adequately reduced or the dosing interval prolonged.

PREGNANCY AND LACTATION

There is no evidence of teratogenic effect to the fetus. AMK can be used during prenancy if clearly indicated. Both amoxicillin and clavulanic acid have been shown to be excreted in minor quantities in breast milk. It should be used with caution in nursing women.

SIDE EFFECTS

Adverse reactions are usually of a mild nature. The most frequently reported are digestive disorders (nausea, vomiting, diarrhea, abdominal discomfort, anorexia, flatulence and dyspepsia). These reactions can be minimized if the drug is taken with meals. Skin reactions may occur. A rise in hepatic enzymes may rarely occur. Cholestatic jaundice, hepatitis, interstitial nephritis. Leukopenia, thrombocytopenia, eozinophilia may occur.

DOSAGE AND ADMINISTRATION

In children: the exact doses are based on the body weight. Depending upon severity of infection, the daily dose in children under 40 kg body weight is 20-45 mg/ kg body weight (based on the amoxicillin component), divided every 8-12 hours.

Adults and children over 12 years:

Mild-Moderate infections: AMK 375 mg tablet three times a day or AMK 625 mg tablet two times a day.

Severe infections: AMK 1 g tablet two times a day.

In patients with severe renal insufficiency (creatinine clearance 10 to 30 mL/ min) the dose should be adequately adjusted or the dosing interval prolonged, in anuria to 48 hours or more (creatinine clearance less than 5 mL/ min).

OVERDOSAGE

Intoxication with AMK is unlikely to occur. However, ingestion of a large number of tablets may produce agitation, insomnia, dizziness, in some cases seizures. Treament is symptomatic. Amoxicillin can be removed by hemodialysis.

DRUG INTERACTION

Probenecid may increase amoxicillin levels. Increased effect of anticoagulants with amoxicillin. Efficacy of oral contraceptives may be reduced when taken with AMK.

STORAGE

Store in cool and dry place.

Keep the drug out of reach of children.

SHELF LIFE

24 months

Do not use the drug after the expiry date indicated on the package.

PRESENTATION

375 mg tablets (blister pack and aluminium strip foil) in boxes of 20’s and 100’s.

625 mg tablets (blister pack and aluminium strip foil) in boxes of 20’s and 100’s.

1000 mg tablets (blister pack) in boxes of 10’s

Manufactured by:   R.X. Manufacturing Co., Ltd.

76 Moo 10, Narapirom, Banglane, Nakornpathom, 73130, Thailand.

Tel: 66(0)-3429-8117-21   Fax: 66(0)-3429-8117-21, Ext: 214