HAPENXIN 250 CAPS

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COMPOSITION:

Cephalexin monohydrate...................equivalent to 250 mg of cephalexin

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

(Sodium lauryl sulfate, magnesium stearate, talc, aerosil)

DOSAGE FORM: Hard capsule.

PRESENTATION: Box of 10 blisters x 10 capsules.

                               Bottle of 100 capsules.

PHARMACODYNAMICS: Hapenxin 250 Caps with the 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 penicillinase-producing Staphylococcus aureus. Cephalexin has been shown to be active against most strains of the following microorganisms in vitro: hemolytic beta Streptococcus, Staphylococcus, including coagulase (+), coagulase (-) producing strains and penicillinase (excluding strain of methicillin-resistant Staphylococcus aureus); Streptococcus pneumoniae; some Escherichia coli, Proteus mirabilis; some Klebsiella spp., Branhamella catarrhalis; Shigella. Haemophilus influenzae is less susceptible. Cephalexin is also active against most ampicillin-resistant E.coli.

PHARMACOKINETICS: Cephalexin is almost completely absorbed from the gastrointestinal tract and produces a peak plasma concentration of about 9 mcg per ml one hour after a 250 mg oral dose. Up to 15% of a dose is bound to plasma proteins. The serum half-life of cephalexin is about 0.5 to 1.2 hours. The serum half-life of the drug is reported to be longer in neonates (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 (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. A 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, some can suffer from cross allergy.

Prolonged administration 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 broad-spectrum antibiotics. The diagnosis of pseudomembranous colitis should be cautious in patients who develop severe diabetes in association with the use of antibiotics. The dosage of cephalexin should be reduced in the presence of markedly impaired renal function. Cephalexin may result in false positive test for glucose in the urine by Benedict’s, Fehling’s solutions or Clinitest tablets and in positive Coombs test 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 it is considered to discontinue breast-feeding during the cephalexin therapy.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug may cause dizziness, headache; it should be used with caution in drivers and machine users.

INTERACTIONS: Concurrent use of high-dose 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 their 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 in patients concomitantly taking cephalexin and metformin

ADVERSE EFFECTS:

Frequent: Diarrhea, nausea.

Less frequent: Eosinophilia. Rash, urticaria, pruritus. Reversible elevated liver transaminase.

Rare: Headache, dizziness, anaphylactic reactions, fatigue. Neutropenia, thrombocytopenia. Gastrointestinal disorders, abdominal pain, pseudomembranous colitis. Stevens - Johnson syndrome, multiform erythema, Lyell’s syndrome, Quincke oedema. Hepatitis, obstructive jaundice. Genital pruritus, vaginitis, reversible interstitial nephritis.

Central nervous system symptoms including dizziness, confusion, agitation and hallucinations have been reported; however, these symptoms have not been completely proven to have a relationship with cephalexin.

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: Unless 5 - 10 times the normal total daily dose has been ingested, gastric lavage will not be necessary.

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 usual adult oral dose is 250 mg every 6 hours or 500 mg every 12 hours, depending on the severity of infections. The dose may be up to 4 g/day. If a higher dose is required, cephalosporin injection should be considered.

- Pharyngitis and tonsillitis: Oral dose of 500 mg every 12 hours for at least 10 days.

- Bone infections: Oral dose of 250 mg every 6 hours.

- Respiratory tract infections: Oral dose of 250 mg every 6 hours.

- Skin and soft tissue infections: Oral dose of 500 mg every 12 hours.

- Urinary tract infections: Oral dose of 500 mg every 12 hours for 7 - 14 days.

- Prevention of bacterial endocarditis: Adult patients should receive a single 2-g dose administered 1 hour prior to the procedure. Cephalexin should not be used for such prophylaxis in individuals with a history of hypersensitivity to penicillin (e.g., urticaria, angioedema, anaphylaxis).

Children aged less than 15 years should not take this dosage form.

With gonorrhea, a single dose of 3 g with 1 g probenecid for male or 2 g with 0.5 g probenecid for female should be taken.

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 dose is 1 g 4 times for 24 hours.

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

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

If creatinine clearance ≤ 10 ml/minute, plasma creatinine ≥ 471 micromol/l, the maximum dose is 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 a dry place, not exceeding 30oC, protect from light.   

Specifications: Vietnamese Pharmacopoeia IV.

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