HAGIMOX 250

Description

HAGIMOX 250

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COMPOSITION:

Amoxicillin trihydrate ... equivalent to tướng 250 mg of amoxicillin

Excipients q.s...................................................................... 1 sachet

(Aspartame, strawberry-flavored powder, sorbitol P60W).

DOSAGE FORM: Powder for oral suspension.

PRESENTATION: Box of 24 sachets x 1.5 g.

PHARMACODYNAMICS:

Hagimox contains the active ingredient amoxicillin which is a penicillin antibiotic. Amoxicillin is an aminopenicillin which is stable in gastric acid, has a broader spectrum of activity kêu ca 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 Gram-positive and Gram-negative microorganisms: Streptococci, non-penicillinase producing Staphylococci, H. influenzae, Diplococcus pneumoniae, N. gonorrheae, E. coli and Proteus mirabilis. Amoxicillin is not active against penicillinase-producing strains, especially to tướng methicillin-resistant Staphylococci, all strains of Pseudomonas and most of Klebsiella and Enterobacter strains. Amoxicillin has been reported to tướng be more active in vitro kêu ca ampicillin against Enterococcus faecalis and Salmonella spp. but less active against Shigella spp. The spectrum of activity of amoxicillin may be extended by the concomitant use of sulbactam and clavulanic acid. Amoxicillin combined with clavulanic acid is reported to tướng be resistant to tướng E. coli (16.8%).

According to tướng the Notice No. 2 and No. 3 in 2000 of the National Monitoring Program on Antibiotic Susceptibility Test Surveillance (ASTS), ampicillin resistant level against E. coli is 66.7%, respectively Salmonella typhi 50%, Shigella 57.7%, Acinetobacter spp. 70.7%, other intestinal bacteria (Citrobacter, Enterobacter, Klebsiella, Morganella, Proteus, Serratia, etc.) 84.1%, Streptococcus spp. 15.4%, Enterococcus spp. 13.1% and other strains of Gram-negative bacilli (Achromobacter, Chriseomonas, Flavobacterium, Pasteurella, etc.) 66.7%.

PHARMACOKINETICS: Amoxicillin is stable in the presence of gastric acid. The absorption is not affected by food; it is more rapidly and completely absorbed kêu ca ampicillin when given by mouth. Amoxicillin is widely distributed in body toàn thân 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 - trăng tròn hrs. About 60% of an oral dose of amoxicillin is excreted unchanged in urine within 6 - 8 hours. Probenecid retards renal excretion. High concentrations 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 tướng streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae.

Uncomplicated urinary tract infections.

Gonorrhoea.

Biliary tract infections.

Skin and muscle infections due to tướng streptococci, staphylococci, E. coli sensitive to tướng amoxicillin.

CONTRAINDICATIONS:

A known history of hypersensitivity to tướng any penicillins.

PRECAUTIONS: Renal and hepatic functions should be periodically observed in case of long-term administration. A severe hypersensitive reaction may occur in patients with a history of allergy to tướng penicillins or other allergens; ví their history of allergy to tướng penicillin, cephalosporins, and other allergens should be observed carefully before initiating therapy.

In case the allergic reactions e.g., erythema, Quincke's oedema, anaphylactic shock, Stevens-Johnson syndrome occur, the therapy with amoxicillin should be discontinued 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 any more.

USE IN PREGNANCY AND LACTATION:

The safety of amoxicillin in pregnant period has not been determined; therefore, just use in really required cases. However, harms of amoxicillin in foetus have not been proven.

Amoxicillin have been shown to tướng be excreted in human milk. Caution should be exercised when amoxicillin is administered to tướng a nursing woman.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The effect of amoxicillin on the ability to tướng drive and use machinery is rarely reported.

INTERACTIONS:

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Nifedipine increases the absorption of amoxicillin.

Allopurinol has been reported to tướng enhance risks of allergic reactions of amoxicillin

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased blood levels of amoxicillin.

There is an antagonism between amoxicillin and bacteriostatic substances such as chloramphenicol, tetracyclines.

ADVERSE EFFECTS:

Common: skin rash (3 - 10%), which slowly appears after 7 days of treatment.

Uncommon: nausea, vomiting, diarrhea. Erythema, maculopapular rash, urticaria, particularly Stevens-Johnson syndrome.

Rare: mildly elevated SGOT. Excitation, writhe, anxiety, insomnia, confusion, and change in mood and/or dizziness. Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, hypoleukemia, agranulocytosis.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: No documents have been reported.

DOSAGE & ADMINISTRATION:

Dissolve the drug with sufficient water (about 5 - 10 ml for 1 sachet), stir well before use.

The drug can be taken before or after meals.

Adults and children aged > 10 years: 500 mg (2 sachets) x 3 times daily.

Children aged to tướng 10 years: 125 - 250 mg x 3 times/day.

Children weighed less kêu ca trăng tròn kg: trăng tròn - 40 mg/kg of body-weight, in 2 - 3 divided doses daily. In details as follows:

- Children aged less kêu ca 1 year: As indicated by the doctor.

- Children aged from 1 to tướng 5 years: 1 sachet twice daily.

- Children aged from 5 to tướng 10 years: 1 sachet 3 times daily.

For patients suffered from renal impairment: