AUGMEX Tablet

Susceptible organisms:

* Staphylococcus aureus, *Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, viridans group Streptococcus, Enterococcus faecalis, Corynebacterium species, Bacillus anthracis, Listeria monocytogenes, Clostridium species, Peptococcus species, Peptostreptococcus species, *Escherichia coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella species, *Salmonella species, *Shigella species, Bordetella pertussis, *Yersinia enterocolitica, Gardnerella vaginalis, Brucella species, Neisseria meningitides, *Neisseria gonorrhoeae, *Moraxella catarrhalirococcus, *Haemophilus influenzae, *Haemophilus ducreyi, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, *Bacteroides species

*: Including beta-lactamase producing organisms which are resistant to ampicillin and amoxicillin.

- Acute and chronic bronchitis, lobar- and broncho- pneumonia, empyema, lung abscess, tonsillitis, sinusitis, otitis media.

- Cystitis, urethritis, nephropyelitis.

- Septic abortion, puerperal septicemia, pelvic cellulitis, chancroid, gonorrhea.

- Furuncle and abscess, cellulitis, wound infection, intra-abdominal sepsis.

- Peritonitis.

- Osteomyelitis.

- Septicemia.

- Post-operative infection.

Dosage and Administration

Adults

The usual adult oral dose is 1 tablet every 8 hours.

Dosage may be adjusted according to the patient’s age or symptoms.

Patients with hypersensitivity to penicillins.

Patients with contagious mononucleosis.

Patients with a history of penicillin-associated jaundice/hepatic dysfunction.

See the package insert about the details below:

Hypersensitivity

Gastrointestinal effects: Diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting, stomatitis and candidiasis may occur.

Skin effects: Rarely multiform of erythematous eruption, Stevens-Johnson Syndrome (mucocutaneous - ocular syndrome), Lyell’s syndrome (toxic epidermal necrosis), vessel edema and rarely dermatitis may occur.

Hepatic effects: Occasionally increases in AST, ALT, AL-P may occur. Hepatitis and cholangietic jaundice may occur rarely. Liver dysfunctions are usually reversible but they may be severe and, very rarely, deaths have been reported.

Hematological effects: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, leukemia, granulosus have been reported during therapy.

Renal effects: rarely severe real impairment such as acute renal failure and interstitial nephritis may occur.

See the package insert about the details below:

- Probenecid

- Allopurinol

- Disulfiram

- Patients on anticoagulation therapy

- Oral contraceptives

Drug/laboratory test interactions: See the package insert about the details.

Pregnancy

The drug should not be used in pregnant or possibly pregnant women unless clearly needed.

The drug, in particular, should not be used in the first 3 months of pregnancy. (see the package insert about the details.)

Lactation

Small amount of the drug may be distributed into breast milk.

Patients with severe hepatic impairment.

Patients with moderate to severe renal impairment (frequency of administration should be modified because of prolonged half-life of the drug).

Patients with a history of hypersensitivity to penicillins or cephems.

Patients whose family are susceptible to cause the allergy symptoms such as bronchial asthma, eruption and urticaria, etc.

Patients who cannot ingest orally, patients receiving parenteral nutrition, elderly patients and patients in systemic bad (poor) condition (because avitaminosis K occur, they should be sufficiently observed).

General precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and vessel edema may occur in patients receiving penicillin. These reactions are more likely to occur in individuals with a history of hypersensitivity to penicillin and/or a history sensitivity to multiple allergens. These reactions are more likely to occur in individuals with parenteral administration than oral, but oral penicillin-associated reactions have also been reported.

- Long term administration occasionally results in super infection of unsusceptible strains. Therefore, patients should be carefully observed for signs and symptoms when the therapy is longer than 14 days.

- Signs and symptoms of adverse reactions are reported to occur within 6 weeks after discontinuation of the drug as well as during the therapy.