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Drugs Hapenxin 500 have composition cephalexin monohydrat 500mg. Cephalexin is indicated for the treatment of the infections: Respiratory tract, ear-nose-throat infections, Skin, soft tissue, and bone infections …

Celormed 500 treatment of susceptible infections including, Low Upper respiratory-tract infections

Scanax 500mg Treatment of infections including anthrax, biliary-track infections, bone infections

COMPOSITION:

Cephalexin monohydrate  equivalent to 500mg of cephalexin

Excipients q.s                1 tablet

(Avicel 112, sodium lauryl sulfate, aerosil. magnesium stearate, talc, HPMC 606, HPMC 615, kollidon VA64, PEG 6000. titanium dioxide, orange El 10 color, red ferric oxide).

Hapenxin 500 - Cephalexin monohydrate 500mg

DOSAGE FORM: Film coated tablets.

PRESENTATION:

Box of 10 blisters x 10 tablets.

Bottle of 100 tablets.

PHARMACODYNAMICS:

Hapenxin 500 with the active ingredient cephalexin, a first-generation cephalosporin antibiotic, is bactericidal because of its inhibition of cell-wait synthesis Cephalexin is stable to penicillinase of Staphylococcus, therefore, it is active against strains of penicillin- (or ampicillin-) resistant pemcilinase-producing Staphylococcus aureus. Cephalexin has been shown to be active against most strains of the following microorganisms in vitro: hemolytic beta Streptococcus, Staphylococcus, including positive coagulase-, negative coagulase-producing strains and penicilinase; Streptococcus pneumoniae, some Escherichia coh, Proteus mirabilis: some Klebsiella spp. Branhamella catarrhalis; Shigella. Haemophilus influenzae often reduces the susceptibility. Cephalexin is also active against most ampicillimresistant E.coli.

PHARMACOKINETICS:

Cephalexin is almost completely absorbed from the gastrointestinal tract and produces a peak plasma concentration of about 18 mcg per ml one hour after a 500-mg oral dose. Up to 15% of a dose is bound to plasma proteins. The plasma half-life is about 0.5 to 1.2 hours, but may be more prolonged in neonate (5 hours), it increases in reduced renal function. Cephalexin crosses the placeta and small quantities are found in the milk of nursing mothers. About 80% of a dose is excreted unchanged in the urine. It is also used for prophylaxis of recurrent urinary infections.

INDICATIONS:

Cephalexin is indicated for the treatment of the infections when caused by susceptible strains of the microorganisms, not for the treatment of severe infections:

– Respiratory tract, ear-nose-throat infections including sinusitis, tonsillitis, otitis media, dental infections, particularly rhinopharyngeal infections caused by Streptococci.

– Skin, soft tissue, and bone infections.

– Genitourinary tract infections including cystitis, gonorrhoea and syphilis (in cases where penicillin is unsuitable).

– Prophylaxis of recurrent urinary tract infections. Replacement of penicillin in prophylactic treatments for patients with cardiopathy, who are undergoing dental treatment.

CONTRAINDICATIONS:

Hypersensitivity to cephalosporin. History of anaphylactic shock caused by penicillin or other severe reactions through IgE.

PRECAUTIONS:

Cephalexin is well absorbed even in patients who are allergic to penicillin; however, few can suffer from cross allergy.

Prolonged administration ot cephalexin may lead to an excessive development of non-susceptible microorganisms (e.g Candida, Enterococcus, Clostridium difficile). In this case, the administration of cephalexin should be discontinued. Pseudomembranous colitis has been reported when administration of broad-spectmm antibiotics. The diagnosis of pseudomembranous colitis should be cautious in patients with severe diabetes during or after taking antibiotics. The dosage of cephalexin should be reduced in the presence of markedly impaired renal function.

Cephalexin may result in false-positive test for glucosuria by Benedict, Fehling solution or Clinitest pills; in positive Coombs tests and influences assay for creatinine by alkali picrate.

PREGNANCY AND LACTATION:

No sign of foetus toxicity or monster has been reported. However, cephalexin should be used during pregnancy if really necessary. The excretion of cephalexin in human milk is very low; but caution should be exercised when cephalexin is administered to a nursing woman.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

The effect of Cephalexin on the ability to drive vehicles and operate machinery is rarely reported.

INTERACTIONS:

Concurrent use of high-dose cephalosporin and aminoglycoside or potent diuretics may be reported to damage renal function. Probenecid may increase and prolong the plasma cephalexin concentration and toxicity.

ADVERSE EFFECTS:

Frequent: diarrhea, nausea.

Less frequent: eosinophilia; rash, urticaria, itching; recoverable hepatic hyper-transaminase.

Rare: headache, dizziness, anaphylactic reaction, fatigue. Neutrophilopenia, thrombocytopenia. Gastrointestinal disorders, pseudomembranous colitis. Stevens – Jonhnson syndrome, multiform erythema, Lyell syndrome, Quincke oedema. Hepatitis, obstructive jaundice. Genital itching, vaginitis, recoverable interstitial nephritis. Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Symptoms of oral overdose may include nausea, vomiting, diarrhoea, possibility of neuromuscular hypersensitivity, and seizure, particiiarly in patients with renal impairment.

Trealment of overdose: protect the patient’s airway and support ventilation and perfusion. Give repeated doses ot activated charcoal or supplement gastric lavage. Safeguard the patient’s airway while employing gastric lavage or activated charcoal.

DOSAGE & ADMINISTRATION:

Hapenxin 500 should be taken before meals.

Hapenxin 500 should be pursued. The therapy should be at least 7 to 10 days.

Adults and children aged > 12 years: 500 mg (1 tablet) x 4 times/day, depending on level ot infection. The dose can be increased to 1 g (2 tablets) lour times daily (4 g/day).

Children aged trom 6-12 years: 1 – 2 tablets x 2 times/ day.

Doses of cephalexin may need to be adjusted in patients with renal impairment.

If creatinine clearance >=50 ml/ minute, plasma creatinine <=132 micromol/l, maximum dose: 1 g, 4 times for 24 hours.

If creatinine clearance 49 – 20 ml/ minute, plasma creatinine 133 – 295 micromol/l, maximum dose: 1g, 3 times for 24 hours.

It creatinine clearance 19-10 ml/ minute, plasma creatinine 296 – 470 micromol/l, maximum dose: 500 mg, 3 times for 24 hours.

If creatinine clearance s10 ml/ minute, plasma creatinine £471 micromol/l, maximum dose: 250 mg, twice for 24 hours.

Or as directed by the physician.

Read the directions carefully before use.

Shelf-life: 24 months from the manufacturing date.

Consult the physician for more information.

Storage conditions: Store in dry places, not exceeding 300C; protect from light.

Hapenxin 500 is for prescription only.

Specifications: Vietnamese Pharmacopoeia IV.

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