HAPENXIN CAPSULES (HT) CHAI

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COMPOSITION:
Cephalexin monohydrate ........................... equivalent to 500 mg of cephalexin
Excipients q.s..................................................................................1 capsule
(Aerosil, sodium starch glycolate, magnesium stearate, talc)
DOSAGE FORM: Hard capsule (pink - white).
PRESENTATION: Box of 10 blisters x 10 capsules. Bottle of 100 capsules.
Bottle of 200 capsules.  Bottle of 500 capsules.
PHARMACODYNAMICS:
Hapenxin with the main active ingredient cephalexin, a first-generation cephalosporin antibiotic, is bactericidal by inhibiting bacterial cell-wall synthesis. Cephalexin is stable to penicillinase of Staphylococcus; therefore, it is active against strains of penicillin- (or ampicillin-) resistant penicilinase-producing Staphylococci aureus. Cephalexin has been shown to be active against most strains of the following microorganisms in vitro: hemolytic beta Streptococci, Staphylococci, including coagulase (+), coagulase (-) producing strains and penicillinase; Streptococcus pneumoniae; some Escherichia coli, Proteus mirabilis; some Klebsiella spp., Branhamella catarrhalis; Shigella. Haemophilus influenzae often reduces the susceptibility. Cephalexin is also active against most ampicillin-resistant E.coli.
Most strains of Enterococci (Enterococcus faecalis) and some Staphylococci are resistant to cephalexin.  Indol-positive Proteus, some Enterobacter spp., Pseudomonas aeruginosa, Bacteroides spp. also have also showed to be resistant to cephalexin. Staphylococci express a cross-resistance ability between cephalexin and methicillin antibiotics in vitro.
Currently, there are many strains resistant to cephalexin; therefore, local resistance should be paid attention when using cephalexin.
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 placenta and small quantities are found in the milk of nursing mothers. About 80% of a dose is excreted unchanged in the urine; so it is used for prophylaxis of recurrent urinary infections.
INDICATIONS: Cephalexin is indicated for the treatment of infections caused by susceptible 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 (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.
CONTRAINDICATIONS: Hypersensitivity to cephalosporins. 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 administration 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 influences assay for creatinine by alkaline 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.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effect of cephalexin on the ability to drive and use machines is rarely reported.
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 with cephalexin in the gastrointestinal tract to prevent its absorption. Probenecid may increase the plasma concentration and 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 in patients concomitantly taking cephalexin and metformin.
ADVERSE EFFECTS: Frequent: diarrhea, nausea.
Less frequent: eosinophilia; rash, urticaria, pruritus; recoverably elevated liver transaminase.
Rare: headache, dizziness, anaphylactic reaction, fatigue; neutrophilopenia, thrombocytopenia; gastrointestinal disorders, pseudomembranous colitis; Stevens - Johnson syndrome, multiform erythema, Lyell's syndrome, Quincke's 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, particularly in patients with renal impairment.
Treatment of overdose: 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.
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 capsule) x 4 times/ day, depending on the level of infections. The dose can be increased to 1 g (2 capsules) four times daily (4g/ day).
Children aged from 7 - 12 years: 1 - 2 capsules twice daily.
In treatment of gonorrhea, a usual single dose of 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, maximum maintenance dose of 1g, 4 times for 24 hours.
If creatinine clearance 49 - 20 ml/ minute, plasma creatinine 133 - 295 micromol/ l, maximum maintenance dose of 1g, 3 times for 24 hours.
If creatinine clearance 19 - 10 ml/ minute, plasma creatinine 296 - 470 micromol/ l, maximum maintenance dose of 500 mg, 3 times for 24 hours.
If creatinine clearance ≤ 10 ml/ minute, plasma creatinine ≥ 471 micromol/ l, maximum maintenance dose of 250 mg, twice for 24 hours.
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: 24 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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