Cephalexin monohydrate............................ equivalent to 500 mg of cephalexin
Excipients q.s.................................................................................. 1 capsule
(Aerosil, sodium starch glycolate, magnesium stearate, talc).
DOSAGE FORM: Hard capsule (blue - purple).
PRESENTATION: Box of 10 blisters x 10 capsules.  
Box of 100 capsules.  Box of 200 capsules.   Box of 500 capsules.
PHARMACODYNAMICS: Hapenxin with the main active ingredient cephalexin, a first-generation cephalosporin, 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 Staphylococcus 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 penicilinase; 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 (Streptococcus faecalis) and some cephalexin-resistant Staphylococci.  Positive Indol Proteus, some Enterobacter spp., Pseudomonas aeruginosa, Bacteroides spp., also have also showed to be resistant to cephalexin. Staphylococci express a cross-resistance 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; it is reported to be longer in neonate (5 hours) and higher in impaired renal patients. 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. It is also 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 and syphilis (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 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 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 influences assay for creatinine by alkaline picrate.
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.
The effect of cephalexin on the ability to drive vehicles and operate machinery is rarely reported.
Concurrent use of high doses of cephalosporins and aminoglycoside or potent diuretics may be reported to damage renal function. Probenecid may increase and prolong the plasma cephalosporin concentration and toxicity.
ADVERSE 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 oedema; hepatitis, obstructive jaundice; genital pruritus, vaginitis, reversible interstitial nephritis.
Inform your physician about any adverse effects occur during the treatment.
Treatment of ADRs: Cephalexin therapy should be discontinued. If allergies or severe hypersensitivity reactions occur, supportive treatment should be conducted (ensuring ventilation and use of epinephrine, oxygen, intravenous steroid injection should be recommended).
Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken, such as use of fluids and electrolytes, protein supplementation, and antibiotic therapy which acts to treat C. difficile-induced colitis.
OVERDOSAGE: Symptoms of oral overdose may include nausea, vomiting, diarrhoea, possibility of neuromuscular hypersensitivity, and seizures, particularly in patients with renal impairment.
Treatment of overdose: protect the patient's airway and support ventilation and perfusion. Give repeated doses of activated carbon or supplement gastric lavage. Safeguard the patient's airway while employing gastric lavage or activated carbon.
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 level of infection. The dose can be increased to 1 g (2 capsules) four times daily (4 g/ day).
Children aged from 7 - 12 years: 1 - 2 capsules twice daily.
Doses of cephalexin may need to be adjusted in patients with renal impairment.
If creatinine clearances ≥ 50 ml/ minute, plasma creatinine ≤ 132 micromol/ l, maximum dose should be 1g, 4 times for 24 hours.
If creatinine clearances of 49 - 20 ml/ minute, plasma creatinine of 133 - 295 micromol/ l, maximum dose should be 1g, 3 times for 24 hours.
If creatinine clearances of 19 - 10 ml/ minute, plasma creatinine of 296 - 470 micromol/ l, maximum dose should be 500 mg, 3 times for 24 hours.
If creatinine clearances ≤ 10 ml/ minute, plasma creatinine ≥ 471 micromol/ l, maximum dose should be 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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