Generic Keflex, Cephalexin Tablet Patient Information Sheet

For the use only of registered medical practitioners or a hospital or a laboratory

Cephalexin Long Acting Tablets 375 mg / 750 mg

Phexin® BD

Tablets

COMPOSITION Phexin BD 375

Each long acting film-coated tablet contains: Cephalexin IP equivalent to anhydrous Cephalexin 375mg Colours: Feme Oxide USPNF (Red) and Titanium Dioxide IP

Phexin BD 750

Each long acting film-coated tablet contains: Cephalexin IP equivalent to anhydrous Cephalexin 750mg Colours: Ferric Oxide USPNF (Red) and Titanium Dioxide IP

DESCRIPTION

Phexin BD is an extended release oral formulation of cephalexin designed to be effective on twice daily dosing.

PHARMACOKINETICS

Cephalexin is almost completely absorbed from the gastrointestinal tract with a bioavailability of about 95%. Cephalexin is widely distributed in the body but does not enter the cerebrospinal fluid in significant quantities. The plasma protein binding is about 15%. Over 90% of an administered dose is excreted unchanged by glomerular filtration and tubular secretion within 8 hours.

The pharmacokinetics of phexin BD 750 mg have been studied in comparison with conventional cephalexin capsules 500 mg in human volunteers \ The results of a single dose study under fed conditions are shown below

i

The pharmacokinetic determinant of therapeutic outcome, i.e. . the duration for which plasma cephalexin concentration exceeds the MIC90 of cephalexin for pathogens (>8 mcg/ml) determined from a multiple dose study in human volunteers was 5.82 hours over a 24 hours period during which 2 doses of Phexin BD 750 mg were administered 12 hours apart: in the same study, the duration MIC with 3 doses of conventional cephalexin capsules 500 mg given 8 hours apart was 5.01 hours,

INDICATIONS

Phexin BD is indicated in the treatment of following infections caused by suspceptible pathogens.

• Respiratory tract infections

■ Skin and soft tissue infections

• Bone infections

• Otitis media

• Genitourinary tract infections, including prostatitis

• Dental infections

DOSAGE AND ADMINISTRATION:

Usual adult dose is 750 mg twice daily. For skin and soft tissue infections, streptococcal pharyngitis and mild uncomplicated urinary tract infection the dose is 375 mg twice daily. For children 5 years and over the dose is 375 mg twice daily. The dose may be doubled in severe infections. The tablet should not be divided, crushed, powdered or chewed but should be swallowed whole with a glass of water, after meals.

Renal impairment

Cephalexin has not been shown to have a toxic effect on the kidney, but as with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is below about half of normal. Clinical practice indicates that in view of the wide therapeutic window of cephalexin, the standard recommended doses should be halved only in those patients with severe renal impairment (creatinine clearance less than 10ml/min).

The maximum recommended dosages should be reduced by 50% in mild, 75% in moderate and 87.5% in severe renal failure.

Adult patients receiving intermittent dialysis should be given an additional 500 mg cephalexin after each dialysis. Children should

receive an additional 8 mg/kg. •

CONTRA-INDICATIONS

Hypersensitivity to any ingredient of the preparation.

Patients with known hypersensitivity to cephalosporin -intiniotirs

FE 0926/03RNB

WARNINGS AND PRECAUTIONS

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams. As with other broad-spectrum antibiotics, prqlpngeo' use rnav result, in the overgrowth of non-susceptible organisms (e.g. Candida, enterococci. Clostridium difficile), which may require interruption of treatment.

Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics.therefore, it is important to consider its diagnosis in patients who develop severe diarrhoea during or after antibiotic use.

Cephalexin can interfere with the determination of the alkaline Pic/at e assay for creatinine, giving a false high reading, although this is unlikely to be of clinical importance.

In patients receiving cephalexin, a false-positive reaction for glucose in the urine may be given, with Benedict's or Fehlinq's solution or with Chnitest tablets, but notwfthanzvrno baafj tests.

As with other antibiotics that are excreted mainly by the kidneys , when renal function is poor, dosage of cephalexin should be suitably reduced[see Dosage and Administration).

INTERACTIONS

Concurrent treatment with high doses of cephalos po rin s. jand nephrotoxic drugs such as aminoglycosides or potent diuretics (e.g. fnjsemide. ethacrynic acid and piretanide) may adversely affect renal function. Clinical experience has shown that this is not likely to be a problem with cephalexin at the recommended dosage levels.

In common with other antibiotics, cephalexin may affect the gut flora, leading to lower oestrogen renbsorption and reduced efficacy of combined oral contraceptives

PREGNANCY AND LACTATION

There is no experimental or clinical evidence of teratogenic effects attributable to cephalexin, but it should be administered with cautj on during the early months of pregnancy.

Cephalexin is excreted in human milk in low concentrations and should be used with caution in nursing mothers.

ADVERSE REACTIONS

Data from large clinical studies were used to determine the frequency of very common to rare undesirable reactions. The frequencies assigned to all other undesirable reactions (i.e. those occurring at < 1/10,000) were mainly determined using post- marketing data and refer to a reporting rate rather than a true frequency. The following convention has been used for the classification of frequency:

Very common > 1/10 Common > 1/100 and < 1/10 Uncommon > 1/1000 and < 1/100 Rare > 1/10.000 and < 1/1000 Very rare< 1/10,000 Infections and infestations

Common: Prolonged use can result in the overgrowth of Candida causing vulvovaginitis. Blood and lymphatic system disorders

Common: Positive Coombs test. Rare: Reversible neutropenia. Very rare: Haemolytic anaemia.

Cephalosporins as a class tend to be adsorbed onto the surface of red cell membranes If antibodies directed against the drug are also present, this may result in reports of positive Coombs' test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia. Immune system disorders

Hypersensitivity reactions including: Rare: Anaphylaxis. Very rare: Angioedema Gastrointestinal disorders

Common: Gastrointestinal symptoms including nausea, diarrhoea. Uncommon: Vomiting. Very rare: Pseudomembranous colitis. Skin and subcutaneous tissue disorders

Common: Drug rashes, both urticarial and maculopapular. Very rare: Severe skin reactions including toxic epidermal necrolysis fexanthematic necrolysis). Stevens Johnson syndrome.

Renal and urinary disorders

Very rare: Reversible interstitial nephritis.

OVERDOSE Treatment

Serum levels of cephalexin can be reduced by haemodialysis or by peritoneal dialysis. STORAGE

Store below 25°C. protected from moisture

PHARMACEUTICAL PRECAUTIONS

Keep in a cool dry place.

KEEP OUT OF REACH OF CHILDREN.

PRESENTATION:

Phexin BD 375: Strip of 10's, Box of 10 X 10s Phexin BD 750: Strip of 10's. Box of 10 X 10s

REFERENCES:

1. Martindale - The Extra Pharmacopoeia 1996; 31 st ed.: 130 -168; 199.

2. Drug Information for the Health Care Professional - USP Dl (Vol. 1) 1996; 16th ed.: 766 - 792. g Data on file g

3. Mosby'sGenRx8thed.1998;ppll411-ll413. . £ Manufactured by: to Ranbaxy Laboratories Limited En Industrial Area-3. Dewas-455 001.

Marketed by:

GlaxoSmithKline Pharmaceuticals Limited

Dr. Annie Besant Road , Mumbai 400 030.

® Registered Trade Mark FE 0926/03RNB

GlaxoSmithKline® Versjon 01/|ND m