HAPENXIN 500 CAPLET BOTTLE

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COMPOSITION:
Cephalexin (as cephalexin monohydrate) ............................................................... 500 mg
Excipients q.s ....................................................................................................... 1 tablet
(Microcrystalline cellulose M112, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, talc, HPMC 606, HPMC 615, kollidon VA64, PEG 6000, titanium dioxide, orange E110, red ferric oxide).
PHARMACEUTICAL FORM: Film coated tablet.
PHARMACODYNAMIC PROPERTIES:
ATC code: J01DB01
Hapenxin 500 Caplet with the main active ingredient cephalexin, a first-generation cephalosporin, is bactericidal by inhibiting bacterial cell-wall synthesis.
Cephalexin has been shown to be active in vitro against gram-positive aerobic cocci, but has limited activity against gram-negative bacteria.
Spectrum:
Susceptible organism: Gram-positive aerobes: Corynebacterium diphtheria, Propionibacterium acnes, methicillin-susceptible Staphylococcus, Staphylococcus, Streptococcus pneumoniae. Gram-negative aerobes: Branhamella catarrhalis, Citrobacter koseri, Escherichia coli, Klebsiella, Neisseria gonorrhoeae, Pasteurella. Anaerobes: Fusobacterium, Prevotella.
Moderately susceptible organisms (also called intermediately susceptible organisms on the antibiogramme): Gram-negative aerobes:  Proteus mirabilis, Haemophilus influenzae. Anaerobes: Clostridium perfringens, Peptostreptococcus.
Resistance:
Gram-positive aerobes: Enterococcus (Streptococcus faecalis), Listeria monocytogenes, methicillin-resistant Staphylococcus.
Gram-negative aerobes: Acinetobacter, Citrobacter freundii, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, Serratia.
Anaerobes: Bacteroides, Clostridium difficile.
When tested in vitro, Staphylococcus demonstrated a cross-resistance between cephalexin and methicillin antibiotics.
Penicillin-resistant penicillinase producing Staphylococci can be viewed as cephalexin resistance although in vitro results on susceptible tests showed that bacteria are susceptible to the drug.
In Vietnam, some domestic studies also showed cephalexin is more or less resistant to Staphylococcus aureus, Salmonella, E. coli, Proteus, Enterobacter, Pseudomonas aeruginosa.
PHARMACOKINETIC PROPERTIES:
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. Absorption is likely delayed when cephalexin is administered with food, although the total amount of drug absorbed is unchanged. Up to 15% of a dose is bound to plasma proteins. The serum half-life of cephalexin is 0.5 to 1.2 hours. The serum half-life of the drug is reported to be longer in neonate (5 hours) and higher in impaired renal patients.
Cephalexin is widely distributed throughout the body; CSF penetration is poor. Cephalexin crosses the placenta and small quantities are found in the milk of nursing mothers.
Cephalexin is not metabolized. The volume of distribution of cephalexin is 18 liters/1.78 m2 body area. About 80% of a dose excreted in urine as unchanged in the first 6 hours by glomerular filtration and tubular secretion. Probenecid slows the excretion of cephalexin in urine. Cephalexin, at therapeutic concentrations can be found in bile and a small amount of cephalexin is excreted in this route. Cephalexin is excreted by hemodialysis and peritoneal dialysis (20-50%).
PRESENTATIONS:
Box of 10 blisters x 10 tablets. Box of 20 blisters x 10 tablets. Bottle of 100 tablets.
THERAPEUTIC INDICATIONS: Cephalexin is indicated for the treatment of infections caused by susceptible microorganisms, not for the treatment of severe infections.
- Respiratory tract, ENT 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 (in cases where penicillin is unsuitable).
Prophylaxis of recurrent urinary tract infections. Replacement of penicillin in prophylactic treatment for patients with cardiopathy, who are undergoing dental treatment.
DOSAGE & ADMINISTRATION:
The drug should be taken before meals.
The dosage 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 the severity of infections. The dose can be increased to 1 g (2 tablets) four times daily           (4 g/day).
Children aged from 7 - 12 years: 1 - 2 tablets twice daily.
For the treatment of gonorrhea, a single dose is 3 g cephalexin and 1 g probenecid for male or 2 g cephalexin and 0.5 g probenecid for female.
Doses of cephalexin may need to be adjusted in patients with renal impairment.
If creatinine clearance ≥50 ml/minute, plasma creatinine ≤132 micromol/l, the maximum maintenance dose is 1 g 4 times for 24 hours.
If creatinine clearance 49 - 20 ml/minute, plasma creatinine 133 - 295 micromol/l, the maximum maintenance dose is 1 g 3 times for 24 hours.
If creatinine clearance 19 - 10 ml/minute, plasma creatinine 296 - 470 micromol/l, the maximum maintenance dose is 500 mg 3 times for 24 hours.
If creatinine clearance ≤10 ml/minute, plasma creatinine ≥471 micromol/l, the maximum maintenance dose is 250 mg twice for 24 hours.
Or as directed by the physician.
CONTRAINDICATIONS:
Hypersensitivity to cephalosporins or any component of the drug.
History of anaphylactic shock caused by penicillins or other severe reactions through IgE.
PRECAUTIONS:
Cephalexin is well absorbed even in patients who are allergic to penicillins; however, some can suffer from cross allergy.
Prolonged use of cephalexin may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococcus, Clostridium difficile). In this case, the therapy of cephalexin should be discontinued. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics. It is important, therefore, to consider its diagnosis in patients who develop severe diarrhoea in association with the use of antibiotics. The dosage of cephalexin should be reduced in the presence of markedly impaired renal function. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with Clinitest tablets. Positive direct Coombs' tests have been reported and influence assay for creatinine by alkaline picrate.
Pregnancy and lactation:
No signs of foetus toxicity or monster have been reported. However, cephalexin should be used during pregnancy if really necessary.
The excretion of cephalexin in human milk is very low; but discontinuation of breast-feeding should be considered during cephalexin therapy.
Effects on works:
Cephalexin should be used with caution in drivers, machinery operators, workers at height, and other cases because it can cause headache, dizziness.
INTERACTIONS:
Concurrent use of high doses of cephalosporins and aminoglycosides or potent diuretics may be reported to damage renal function.
Cephalexin reduces the effects of estrogen. Cholestyramine binds to cephalexin in the gastrointestinal tract to reduce its absorption. Probenecid may increase the plasma concentration and the half-life of cephalexin.
Combined use of cephalosporins and oral anticoagulants may prolong prothrombin time. Adverse effects could potentially arise from co-administration of cephalexin and metformin; so, careful patient monitoring and dose adjustment of metformin is recommended.
Cephalexin may decrease the effectiveness of typhoid vaccines.
UNDESIRABLE EFFECTS:
Frequent: diarrhea, nausea.
Less frequent: eosinophilia; rash, urticaria, pruritus; reversibly elevated liver transaminase.
Rare: headache, dizziness, anaphylactic reaction, fatigue; neutropenia, thrombocytopenia; gastrointestinal disorders, pseudomembranous colitis; Stevens - Johnson syndrome, multiform erythema, Lyell's syndrome, Quincke's oedema; hepatitis, obstructive jaundice; genital itching, vaginitis, reversible interstitial nephritis.
OVERDOSE:
Symptoms of oral overdose may include nausea, vomiting, diarrhoea, possibility of neuromuscular hypersensitivity, and seizure, particularly in patients with renal impairment.
Treatment: Protect the patient's airway and support ventilation and perfusion. Give repeated doses of activated charcoal or supplement gastric lavage. Protect the patient's airway while employing gastric lavage or activated charcoal.
Read the directions carefully before use.
Please consult a physician for more information.
The drug is for prescription only.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: April 16, 2018

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