HAGIMOX CAPSULES (HỒNG ĐẬM - HỒNG NHẠT) CHAI

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HAGIMOX CAPSULES (dark pink – light pink)

COMPOSITION:

Amoxicillin trihydrate ........................... equivalent to 500 mg of amoxicillin

Excipients q.s ............................................................................ 1 capsule

(Aerosil, sodium starch glycolate, magnesium stearate).

DOSAGE FORM: Hard capsule (dark pink - light pink).

PRESENTATION: Box of 10 blisters x 10 capsules. Bottle of 100 capsules. Bottle of 200 capsules. Bottle of 500 capsules.

PHARMACODYNAMICS: Hagimox contains the active ingredient amoxicillin which is a penicillin antibiotic. Amoxicillin is an aminopenicillin, stable in gastric acid, 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 not active against penicillinase-producing bacteria, especially to methicillin-resistant Staphylococci, all strains of Pseudomonas and most of Klebsiella and Enterobacter strains. Amoxicillin has been reported to be more active in vitro than ampicillin against Enterococcus faecalis and Salmonella spp. but less active against Shigella spp.. The spectrum of activity of amoxicillin may be extended by concomitant use of sulbactam and clavulanic acid. Amoxicillin combined with clavulanic acid (16.8%) is reported to be resistant to E. coli.

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 when given by mouth. 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 retards renal excretion of amoxicillin. High concentrations of amoxicillin have been reported in bile; some may be excreted in the faeces.

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.

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 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 penicillin or other allergens, so their history of allergy should be observed carefully before initiating therapy with amoxicillin.

In case the 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 penicillin or cephalosporin any more.

Prolonged use of the drug may result in risk of nonsusceptible fungal/bacterial infections.

Risk of diarrhoea and colitis has been reported because Clostridium difficile produces clostridial toxins which may cause a resistance.

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

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effect of amoxicillin on the ability to drive and use machines is rarely reported.

INTERACTIONS: Nifedipin increases the absorption of amoxicillin. Allopurinol has been reported to 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.

Methotrexate: Amoxicillin may reduce the excretion of methotrexate causing a potential increase in toxicity on gastrointestinal tract and hematopoietic system.

Amoxicillin has been reported to affect tests for the presence of glucose in urine using copper sulfate method (Clinitest), but not affecting tests using glucose oxidase method (Clinistix).

ADVERSE EFFECTS:

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

Uncommon: nausea, vomiting, diarrhea. Erythema, lumps, 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, granulocytosis.

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

OVERDOSAGE: Dose of 250 mg/ kg causes no manifestations of overdose.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. In case of overdosage, fluid infusion and diuresis should be reasonably applied.

Drug concentrations may be increased in patients with renal insufficiency. Amoxicillin may be removed from circulation by hemodialysis.

DOSAGE & ADMINISTRATION:

The drug can be taken before or after meals.

Adults and children > 10 years of age: 500 mg (1 capsule) x 3 times daily.

Gonorrhea: Adults and children weighed > 40 kg: use a single dose of 3 g only.

For patients suffered from renal impairment, the dose is as follows:

CrCl < 10 ml/ min: 500 mg/ 24 hrs.

CrCl > 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 prescription 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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