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Hagimox 250 Caps (Grey - Ivory yellow)

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COMPOSITION:
Amoxicillin (as amoxicillin trihydrate)....................................... 250 mg
Excipients q.s ...................................................................... 1 capsule
(Aerosil, sodium lauryl sulfate, magnesium stearate).
DOSAGE FORM: Hard capsule (grey - ivory yellow).
PRESENTATION:  Box of 10 blisters x 10 capsules.
PHARMACODYNAMICS: Hagimox 250 Caps 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. The bactericidal effect of amoxicillin is by interfering with the biosynthesis of the bacterial cell wall mucopeptide. Amoxicillin is active against most of Gram-positive and Gram-negative microorganisms: Streptococci, non-penicillinase producing Staphylococci, H. influenzae, Diplococcus pneumoniae, N. gonorrheae, E. coli and Proteus mirabilis. Amoxicillin is inactive against penicillinase-producing bacteria, especially methicillin-resistant Staphylococci, all strains of Pseudomonas and most strains of Klebsiella and Enterobacter. Amoxicillin has been reported to be more active in vitro than ampicillin against Enterococcus faecalis and Salmonella spp. but less active against Shigella spp.. Concomitant use of sulbactam and clavulanic acid broadens the spectrum of activity of amoxicillin. Amoxicillin combined with clavulanic acid is reported to be resistant to E. coli (16.8%).
PHARMACOKINETICS: Amoxicillin is stable in the presence of gastric acid. The absorption is not affected by food, it is more rapidly and completely absorbed than ampicillin following the gastrointestinal tract. 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. The half-life of amoxicillin is 61.3 minutes and it may be longer in neonates and the elderly. In renal impairment patients, the half-life is approximately 7 - 20 hrs. About 60% of an oral dose of amoxicillin is excreted unchanged in the urine within 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.  
INDICATIONS: For the treatment of:
Upper respiratory tract infections.
Lower respiratory tract infections due to streptococci, pneumococci, nonpenicillinase-producing staphylococci and H. influenzae.
Uncomplicated urinary tract infections.
Gonorrhoea.
Biliary tract infections.
Skin and muscle infections due to streptococci, staphylococci, E. coli sensitive to amoxicillin.
CONTRAINDICATIONS:
A known history of hypersensitivity to any penicillins.
PRECAUTIONS: Renal and hepatic systems should be evaluated periodically during prolonged therapy with amoxicillin.
Serious hypersensitivity reactions have been reported in patients with a history of allergy to penicillins or other allergens. The history of allergies to penicillins, cephalosporins, and other allergens should be observed carefully before initiating therapy with amoxicillin.
In case allergic reactions e.g. erythema, Quincke’s oedema, anaphylactic shock, Stevens-Johnson syndrome occur, the therapy with amoxicillin should be stopped and first-aid treatment with adrenaline, breathing of oxygen, intravenous injection of corticosteroid, ventilation including intubation should be applied and never using penicillins or cephalosporins anymore.
PREGNANCY AND LACTATION: 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:
The effect of amoxicillin on the ability to drive vehicles and operate machinery is rarely reported.
INTERACTIONS: Nifedipine 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.
ADVERSE EFFECTS: Common: The skin rash (3 - 10%), when it occurs, generally appears 7 days after initiation of amoxicillin therapy.
Uncommon: nausea, vomiting, diarrhea. Erythema, maculopapular rash, urticaria, particularly Stevens-Johnson syndrome.
Rare: mildly elevated SGOT. Excitation, writhe, anxiety, insomnia, confusion, change in mood and/or dizziness. Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, hypoleukemia, granulocytopenia.
Inform a physician about any adverse effects occur during the treatment.
OVERDOSAGE: No documents have been reported.
DOSAGE & ADMINISTRATION:
The drug is administered orally without regard to meals.
Adults and children > 10 years of age: 500 mg (2 capsules) x 3 times daily.
Children aged from 5 - 10 years: 250 mg (1 capsule) x 3 times daily.
High dosage therapy, single dosage or short course therapy should be used in the following cases:
Dental abscess: two 3g doses with 8 hours between the doses. Uncomplicated urinary tract infections: two 3g doses with 10 - 12 hours between the doses.
For prophylaxis of endocarditis, a single dose of 3g is given 1 hour prior to the procedure, including tooth extraction.
High dosage therapy of 3g of amoxicillin twice daily is recommended in patients with severe or recurrent infections of the respiratory tract.
If needed, 750 mg twice a day for two days may be given in children aged 3 to 10 years with otitis media.
For patients suffered from renal impairment, the dosage should be as follows:
Creatinine clearances < 10 ml/ min: 500 mg/ 24 hrs.
Creatinine clearances > 10 ml/ min: 500 mg/ 12 hrs.
Or as directed by the physician.
Read the directions carefully before use.           
Consult the physician for more information.          
This drug is for prescriptions only.                           
Shelf-life: 36 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light. 
Specifications: Vietnamese Pharmacopoeia IV.

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