Indications

Infections caused by susceptible strains of microorganisms such as:
– Infections of respiratory tract, digestive and hepatobiliary tract, genitourinary tract.
– Infections of skin.

Present

Sachet of 2.5g of oral powder. Box of 30 sachets.

Composition

Amoxicillin trihydrate equivalent to amoxicillin …….250mg
Excipients s.q. for ……………………………………………1 capsule
(Magnesium stearate).

Pharmacology

– Amoxicillin is bactericidal in action by binding to one or more of penicillin– binding proteins of the bacteria to inhibit biosynthesis of peptidoglycan, which is a vital component of the bacterial cell wall that result in killing of growing and dividing bacteria. Other mechanisms involved include bacterial lysis by the inactivation of endogenous inhibitors of bacteria autolysins.
– Amoxicillin, as for other aminopenicillins, is active in– vitro against most of 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. Aminopenicillins are inactive against Mycoplasma, Rickettsia, fungi, and viruses.
– Susceptible organisms: Gram– positive aerobic bacteria: S. aureus, S. epidermidis (non– penicillinase– producing), Streptococci group A, B, C and
G; Streptococcus pneumoniae, viridans streptococci and some strains of enterococci, Corynebacterium diphtheriae, Listeria monocytogenes, Bacillus anthracis, Erysipelothrix rhusiopathiae, some strains of Nocardia (although most of them are resistant to). Gram– negative aerobic bacteria: Neisseria meningitidis and N. gonorrhoeae (non– penicillinase– producing), Haemophilus influenzae and some strains of H. parainfluenzae and H. ducreyi, some strains of Enterobacteriaceae, Proteus mirabilis, Salmonella and Shigella, P. vulgaris, Enterobacter aerogenes, Citrobacter freundii, Vibrio cholerae, Helicobacter pylori, Bordetella pertussis, Actinobacillus, Pasteurella multocida, Gardnerella vaginalis (formerly Haemophilus vaginalis),
Moraxella catarrhalis (formerly Branhamella catarrhalis) (non– beta– lactamase– producing). Anaerobic bacteria: Actinomyces, Arachnia, Bifidobacterium, Clostridium tetani, C. perfringens, Eubacterium, Lactobacillus, Peptococcus, Peptostreptococcus and Propionibacterium, Fusobacterium. Spirochetes:
Treponema pallidum, Borrelia burgdorferi (Lyme disease pathogen). Moderate– susceptible organisms: Gram– positive bacteria Enterococcus faecium.
– Resistant organisms: Gram– positive aerobic bacteria: Staphylococcus aureus. Gram– negative aerobic bacteria: Acinetobacter alcaligenes, Moraxella catarrhalis (beta– lactamase– producing), Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter, Klebsiella oxytoca, Klebsiella pneumoniae, Legionella, Morganella morganii, Proteus rettgeri, Proteus vulgaris, Providencia, Pseudomonas, Serratia, Yersinia enterocolitica. Anaerobic bacteria: Bacteroides fragilis. Others: Mycobacterium, Mycoplasma, Rickettsia.

Pharmacokinetics

Amoxicillin is resistant to inactivation by gastric acid. The presence of foodin the stomach does not appear to diminish the total amount absorbed. It is widely distributed at varying concentrations in body tissues and fluids. About 60% of an oral dose of amoxicillin is excreted unchanged in the urine in 6 – 8 hours, a small amount may be excreted in the feces.

Contra-Indications

– Hypersensitivity to penicillins and cephalosporins.
– Infectious mononucleosis.

Side effect

– Common: skin rash, occurred about 7 days after initiation of the therapy.
– Uncommon: nausea, vomiting, diarrhea, erythema, maculopapular rash and urticaria, especially Stevens– Johnson syndrome.
– Rare: mild increase in serum ALT, hyperactivity, agitation, anxiety, insomnia, confusion, behaviour change and/or dizziness, anemia, purpura,
thrombocytopenia, eosinophilia, leucopenia, agranulocytosis.
– Inform your doctor about side– effects when using this medicine.

Precaution

– In patients with impaired kidney, adjust the dosage.
– Routine liver and renal function test should be carried out in long– term treatment.
– Whenever there are signs of allergic reactions, amoxicillin should be discontinued. Apply appropriate alternative therapies.
– In high– dose therapy, adequate water intake and output should be maintained to avoid amoxicillin crystalluria.
PREGNANCY & LACTATION:
This drug should be used during pregnancy or lactation only when clearly needed.
EFFECT OF THE DRUG TO DRIVER OR OPERATORS OF MACHINERY:
Caution should be exercised in drivers or operators of machinery.

Interaction

– Probenecid reduces renal tubular secretion of amoxicillin.
– Nifedipine increases absorption of amoxicillin.
– An increased frequency of skin rashes has been reported in patients receiving amoxicillin with allopurinol.
– Bacteriostatic antibiotics: chloramphenicol, erythromycin, sulfonamides, tetracyclines may affect the bactericidal effects of amoxicillin.
OVERDOSAGE & MANAGEMENT:
– Cases of overdosage with amoxicillin are usually asymptomatic. Pay special attention to electrolyte and water balance.
– Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

30 months from the manufacturing date.

Storage

Store in a dry place, protect from light, not exceeding 30^oC.

Dosage

– As prescribed by physician.
– Usual dosage:
+ Adults: 2 – 4 capsules, 2 – 3 times daily.
+ Children: 25 – 50mg/kg/day in 2 – 3 divided doses.
+ Patients with renal dysfunction: the dosage should be reduced according to creatinine clearance.
* 10 < Clcr < 30mL/min: 500mg every 12 hours.
* Clcr < 10mL/min: 500mg every 24 hours.
* Patients on hemodialysis should receive 500mg every 24 hours and an additional dose of the drug after each dialysis session.