Amoxicillin (as amoxicillin trihydrate) ............................................ 500 mg
Excipients q.s............................................................................... 1 tablet
(Microcrystalline cellulose M112, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose 606, hypromellose 615, polyethylene glycol 6000, talc, titanium dioxide, quinoline color, ferric yellow oxide).
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 10 blisters x 10 tablets.    Box of 20 blisters x 10 tablets.    Bottle of 100 tablets.
PHARMACODYNAMICS: Hagimox 500 caplet contains the active ingredient amoxicillin which is a penicillin antibiotic. Amoxicillin is an aminopenicillin which is stable in acid medium, has a broader spectrum of activity than benzylpenicillin, particularly against Gram-negative bacilli. As with other penicillins, the bactericidal effect of amoxicillin is by binding to one or more bacterial penicillin-binding proteins (PBPs) to inhibit peptidoglycan biosynthesis, which is an important component of bacterial cell walls. Finally, the bacteria break down by the enzymes that destroy the bacterial cell wall (autolysin and murein hydrolase).
Amoxicillin is more active than ampicillin in vitro against Enterococcus faecalis, Helicobacter pylori and Salmonella spp., but less active against Shigella spp. and Enterobacter. Oral amoxicillin is preferred oral ampicillin, particularly in the treatment of respiratory tract infections due to a more complete in absorption from the gastrointestinal tract, higher concentrations in plasma, tissue and fluid, less frequency of administration, and less occurrence of undesirable effects (diarrhea).
Spectrum: Like other aminopenicillins, amoxicillin is active in vitro against most gram-positive and gram-negative aerobic cocci (except penicillinase-producing strains), some gram-positive aerobic and anaerobic bacilli, and some spirochetes. The drug is also active in vitro against some gram-negative aerobic and anaerobic bacilli. Amoxicillin is inactive against Mycoplasma, Rickettsia, fungi, and viruses.
Bacteria with amoxicillin MICs of 4 mcg/ml or less are considered susceptible and those with MICs of 16 mcg/ml or greater are resistant to amoxicillin. S. pneumoniae with amoxicillin MICs of 5 mcg/ml or less are considered susceptible and that with MICs of 2 mcg/ml or greater are resistant to amoxicillin. The rate of acquired resistance may vary depending on location and time; for some strains local, drug resistance rate reference is required, particularly in serious cases.
Susceptible bacteria:
Gram-positive aerobes: S. aureus, S. epidermidis (non-penicillinase producing), groups A, B, C and G streptococci; Streptococcus pneumoniae, viridans streptococci and some species of Enterococci, Corynebacterium diptheriae, Listeria monocytogenes, Bacillus anthracis, Erysipelothrix rhusiopathiae, some species of Nocardia (although most are resistant).
Gram-negative aerobes: Neisseria meningitidis and N. gonorrhoeae (nonpenicillinase-producing strains), Haemophilus influenzae and some species of H. parainfluenzae and H. ducreyi, some species of Enterobacteriaceae, Proteus mirabilus, Salmonella and Shigella, P. vulgaris, Enterobacter aerogenes, Citrobacter freundii, Vibrio cholerae, Helicobacter pylori, Bordetella pertussis, Actinobacillus, Pasteurella multocida, Gardnerella vaginalis, non-beta-lactamase producing Moraxella catarrhalis.
Anaerobes: Actinomyces, Aracchnia, Bifidobacterium, Clostridium tetani, C. perfringens, Eubacterium, Lactobacillus, Peptococcus, Peptostreptococcus and Propionibacterium, Fusobacterium.
Spirochetes: Treponema pallidum, Borelia burgdoferi which is causative organism of Lyme disease.
Moderately susceptible bacteria: Gram-positive aerobes: Enterococcus faecium.
Gram-positive aerobes: Staphylococci (Staphylococcus aureus).
Gram-negative aerobes: Beta-lactamase producing Acinetobacter alcaligenes, Moraxella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter, Klebsiella oxytoca, Klebsiella pneumoniae, Legionella, Morganella morganii, Proteus rettgeri, Proteus vulgaris, Providencia, Pseudomonas, Seratia, Yersinia enterocolitica.
Anaerobes: Bacteroides fragilis.
Others: Mycobacterium, Mycoplasma, Rickettsia.
Complete cross-resistance generally occurs between amoxicillin and ampicillin.
The mechanism of resistance is beta-lactamase producing bacteria, beta-lactam circle hydrolyzation to produce non-active derivatives or changes the permeability of bacterial cell membrane; disappears or alters the transpeptidases.
Absorption: Amoxicillin is stable in the presence of gastric acid. The absorption is not affected by food. Amoxixillin is more rapidly and completely absorbed from the GI tract than is ampicillin.
Orally administered doses of 500-mg amoxicillin result in average peak blood concentration 1 to 2 hours after administration in the range of 5.5 to 11 mcg/ml and lower or undetectable serum drug concentrations after 6 - 8 hours. Amoxicillin is widely distributed in body tissues and fluids, except for brain tissue and cerebrospinal fluid, but amoxicillin is readily diffused when meninges are inflamed. Amoxicillin has been shown to cross the placental barrier and to excrete into breast milk in small quantities. Amoxicillin is approximately 17 - 20% protein-bound. The half-life of amoxicillin is 1 - 1.5 hours and it may be longer in neonates (3.7 hours) and the elderly. In renal impairment patients with creatinine clearance < 10 ml/minute, the half-life is approximately 7 - 21 hrs.
Metabolism: Amoxicillin is partially metabolized to penicilloic acids which are microbiologically inactive.
Elimination: Serum clearance of amoxicillin is reported 283 ml/minute in adults with normal renal function. Approximately 43 - 80% of a single oral dose of amoxicillin is excreted unchanged in urine with 6 - 8 hours. Probenecid prolongs renal excretion of amoxicillin. High concentrations of amoxicillin have been reported in bile; some may be excreted in the faeces.
Amoxicillin is removed by hemodialysis. A 4- to 6-hour period of hemodialysis generally removes 30 - 40% of a single oral dose of the drug when the dose is given immediately prior to dialysis.
INDICATIONS: Amoxicillin is indicated in cases of infections caused by susceptible bacteria:
Upper respiratory tract infections.
Lower respiratory tract infections due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae.
Uncomplicated urinary tract infections.
Biliary tract infections.
Skin and muscle infections due to streptococci, staphylococci, E. coli sensitive to amoxicillin.
Combining with other drugs to treat H. pylori infection in patients with peptic ulcer.
CONTRAINDICATIONS: Hypersensitivity to any component of the drug.
A history of allergy to any penicillins.
Allergy to cephalosporins.
PRECAUTIONS: Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity and in atopic individuals.
Use with caution in patients with renal impairment; the dosage should be adjusted based on creatinine clearance.
Risk of diarrhea due to Clostridium dificile has been reported. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Safe use of amoxicillin during pregnancy has not been definitely established. Therefore, amoxicillin should be used during pregnancy only when clearly needed. However, harm of amoxicillin to the fetus has not been proven.
Amoxicillin has been shown to be excreted in human milk. Amoxicillin should be used with caution in nursing women.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Effects on the central nervous system have been very rarely reported. These adverse effects include transient hyperactivity, dizziness, headache and convulsions. The convulsions can occur in patients with renal impairment or in patients who receive high doses.
INTERACTIONS: Nifedipin increases the absorption of amoxicillin.
An increased incidence of rash reportedly occurs in patients who are receiving allopurinol and concomitant amoxicillin.
Oral probenecid administered simultaneously with amoxicillin slows the rate of renal tubular secretion of the amoxicillin and produces higher and prolonged serum concentrations of the drug.
Bacteriostatic substances, including chloramphenicol, tetracycline reportedly antagonized the bactericidal activity of amoxicillin.
Amoxicillin can cause a prolongation of bleeding and clotting; so caution should be taken in patients receiving treatment with anticoagulants (warfarin).
Methotrexate: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Common, ADR > 1/100:
Skin rash (1.4 - 10%), when it occurs, generally 7 days after initiation of amoxicillin therapy.
Gastrointestinal disorders: Nausea, vomiting, epigastric pain (2%), diarrhea (0.5 to 5%) in adults, a higher proportion in children and older patients (loose stools 42% in children younger than 8 months, 20% in children aged 8 - 16 months and 8.5% in children aged 24 - 36 months).
Uncommon, 1/1000 < ADR < 1/100:
Hypersensitive reactions: Rash, maculopapular rash, and urticaria, particularly Stevens-Johnson syndrome.
Rare, ADR < 1/1000:
Hepatic disorders: slight elevation of SGOT (AST).
CNS disorders: Agitation, anxiety, insomnia, confusion, behavioral changes and/or dizziness.
Gastrointestinal disorders: Pseudomembranous colitis caused by Clostridium difficile; enterocolitis accompanied with symptoms of abdominal pain and bloody diarrhea, not related to Clostridium difficile.
Blood disorders: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, agranulocytosis.
Inform your physician about any adverse effects occur during the treatment.
Treatment of ADRs:
The major adverse effects reported with amoxicillin are GI effects, blood effects that disappear on discontinuation of therapy. If severe pseudomembranous colitis occurs, supplement with fluid, electrolytes and protein and treatment with oral metronidazole and vancomycin are taken. Urticaria, other rashes and serum sickness-like reactions can be treated with antihistamines and, if necessary with systemic corticosteroid therapy. However when such reactions occur, amoxicillin therapy should be discontinued unless physician's advice is in special cases, dangerous to the life that only amoxicillin can solve.
If allergic reactions, including erythema, Quincke edema, anaphylaxis, Stevens-Johnson syndrome occur, the amoxicillin therapy should be discontinued. The following immediate measures include emergency treatment with adrenaline, oxygen breathing, intravenous corticoid therapy and ventilation, including intubation and never using penicillin or cephalosporin therapy anymore. 
OVERDOSE: Doses of 250 mg/kg cause no manifestations of overdose.
Crystalluria, in some cases leading to renal failure, has also been reported, adequate fluid intake and diuresis should be maintained.
High blood levels may occur more readily in patients with impaired renal function. Amoxicillin may be removed from circulation by hemodialysis.
The drug may be administered orally without regard to meals.
Children aged younger than 10 years or children < 40 kg: It is recommended to use appropriate dosage and dosage forms.
Dosing for respiratory tract, skin, urinary tract infections caused by susceptible organisms:
Dosing recommendations for adults and children aged older than 10 years or children ³ 40 kg with normal renal function:
Mild to moderate infections: 500 mg in divided doses every 12 hours.
Severe infections: 500 mg in divided doses every 8 hours.
Adults: 3 g as single oral doses.
Helicobacter pylori eradication:
Triple therapy: The recommended adult oral dose is 1 g amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily for 14 days.
Dual therapy: The recommended adult oral dose is 1 g amoxicillin and 30 mg lansoprazole, each given three times daily for 14 days.
Patients with impaired renal function, dosage is according to creatinine clearance ratio:
Patients with creatinine clearance less than 10 ml/minute should receive 250 - 500 mg every 24 hours, depending on severity of the infection.
Patients with creatinine clearance of 10 - 30 ml/minute should receive 250 - 500 mg every 12 hours, depending on severity of the infection.
Patients with creatinine clearance less than 30 ml/minute should receive the 875-mg tablet.
Hemodialysis patients should receive 250 - 500 mg every 24 hours, depending on severity of the infection. They should receive an additional dose during and at the end of dialysis.
There are currently no dosing recommendations for pediatric patients with impaired renal function.
Or as directed by the physician.
Read the directions carefully before use.
For more information, please consult a physician.
This drug is for prescription only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.


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