MAXXVENPREX 500 

COMPOSITION: Each hard capsule contains:

Cephalexin (as Cephalexin monohydrate)                              500 mg

Excipients: Lactose, Talc, Magnesium stearate, Aerosil and Sodium starch glycolate q.s. one capsule.

Pharmacotherapeutic group

Cephalexin is an antibiotic belonging to the group known as first generation cephalosporins.

INDICATIONS

MAXXVENPREX 500 is indicated for treatment of following infections due to susceptible strains of the designated microorganisms, but not for severe infections:

• Respiratory Tract Infections: Acute and chronic bronchitis and superinfected bronchiectasis.
• Ear, nose and throat infections: Otitis media, mastoiditis, sinusitis, follicular tonsilltitis and pharyngitis.
• Urinary tract infections: Cystitis and prostatitis. Prophylaxis of recurrent urinary tract infections.
• Gynaecological and obstetric infections.
• Skin and soft tissue, and bone infections.
• Gonorrhoea (when penicillin is unsuitable)
• Dental infections. As prophylaxis treatment for patients with heart diseases undergoing dental treatment as an alternative to penicillin.

DOSAGE AND ADMINISTRATION

The dosage and duration of treatment for infections for individuals are prescribed by the doctor. The usual dosage is as follows:

• The usual duration of treatment is from 7 to 14 days.
• Adults and Adolescents (Age 12 years and Older): 500 mg x 3 times/day.
• Children: Common dosage is 25-60 mg/kg daily in 2-3 divided doses.
• Usual prescribing limits: Up to 6 g daily for adults, 4 g daily for children. However, if high doses are required the use of a parenteral cephalosporin should be considered.
• Gonorrhoea: a single dose of 3 g with 0.5 g probenecid for female is usually effective.
• Note: when renal function is below about half of normal, the maximum recommended dosages should be reduced proportionally in these patients. In elderly patients, the possibility of renal impairment should be considered.

Dose adjustment in renal impairment:

• If creatinine clearance ≥ 50 ml/min, serum creatinine ≤ 132 micromols/l, maximum maintenance dose is 1 g, 4 times daily.
• If creatinine clearance: 49 – 20 ml/min, serum creatinine: 133 – 295 micromols/l, maximum maintenance dose is 1 g, 3 times daily.
• If creatinine clearance: 19 – 10 ml/min, serum creatinine: 296 – 470 micromols/l, maximum maintenance dose is 500 mg, 3 times daily.
• If creatinine clearance ≤ 10 ml/ min, serum creatinine ≥ 471 micromols/l, maximum maintenance dose is 250 mg, 2 times daily.

Method of Administration

The capsules should be swallowed whole with water.

CONTRAINDICATIONS

MAXXVENPREX 500 is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

Patients have been report to have had penicillin anaphylaxis or other severe IgE-mediated reactions should not receive cephalosporins.

PRECAUTIONS

MAXXVENPREX 500 is usually well tolerated even by patients allergic to penicillin, but cross-reaction has been encountered rarely.

As with other broad-spectrum antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococus, Clostridium difficile) which may require interruption of treatment. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics.

As with other antibiotics that are excreted mainly by the kidneys, when the renal function is poor, dosage of cephalexin should be suitably reduced. Laboratory experiments and clinical experience show no evidence of teratogenicity, but it would be wise to proceed with caution during the early months of pregnancy, as with all drugs.

In patients receiving cephalexin, a false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions, or with “Clinitest” tablets, but not with enzyme based tests.

There are reports of positive Coomb’s test.

Cephalexin can interfere with the alkaline picrate assay for creatinine, giving a falsely high reading, but the degree of elevation is unlikely to be of clinical importance.

Pregnancy

Laboratory experiments and clinical experiences show no evidence of toxicity for the foetus, and teratogenicity but it should be administered during pregnancy only if clearly needed.

Nursing mothers

Cephalexin is excreted into breast milk in low concentrations. However, a decision should be considered to discontinue nursing temporarily during therapy with cephalexin.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

There are no effects on ability to drive or to operate machinery.

PRESENTATION: Blisters of 10 hard capsules, Box of 10 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured  by: US PHARMA USA Co. Ltd.,        

Lot B1-10, D2 Street, Tay Bac Cu Chi Industrial Zone, Hochiminh city

For more information, please contact: Tel: 028 37908860 – 028 37908861, Fax: 028 37908856

Distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province.

Tel: 02513 566 202    -     Fax: 02513 566 203