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CEFALEXIN CAPSULES BP 250MG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Cefalexin Capsules BP 250 mg

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QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Cefalexin monohydrate Ph. Eur. equivalent to anhydrous Cefalexin 250 mg. Excipients with known effect: Lactose monohydrate and sunset yellow (E110) For a full list of excipients, see section 6.1

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PHARMACEUTICAL FORM
Capsules Dark green/White, self locked hard gelatine capsules of size 2 Imprinted with RX656 in black edible ink containing white to off white granular powder/pellets.

4 4.1.

CLINICAL PARTICULARS Therapeutic Indications Cefalexin is indicated in the treatment of the following infections caused by susceptible micro-organisms: Respiratory tract infection; otitis media; skin and soft tissue infections; bone and joint infections; genito-urinary tract infections including acute prostatitis; dental infections

4.2.

Posology and Method of Administration Cefalexin is administered by oral route. Adults: The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. A dose of 250 mg every 6 hours, or 500 mg every 12 hours can be given for the treatment of skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections. For more severe infections or those caused by less

susceptible organisms, larger doses may be needed. Parenteral cephalosporin might be required if a dose of >4g is required daily. The elderly and patients with impaired renal function: As for adults. Dosage may need to be reduced in patients with markedly impaired renal function. (See Precautions) Children: The usual recommended daily dosage for children is 25-50 mg/kg (10 - 20 mg/lb) in divided doses. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours. For most infections the following schedule is suggested: Children 5 years and over: 250 mg every 8 hours. In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. In the treatment of B-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days. Children under 5 years: this medication cannot be given to children under 5 years as the usual dose is 125 mg every 8 hours.

4.3

Contraindications Cefalexin is contraindicated in patients with known hypersensitivity to penicillins, cephalosporins group of antibiotics, penicillin derivatives or penicillamine and patients with porphyria. Cefalexin is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe systemic infections, which require parenteral cephalosporin treatment, should not be treated orally during the acute stage.

4.4

Special warnings and precautions for use

Any patient who has a relative with porphyria should be screened and advised about the potential for cephalosporins to induce acute porphyric crises. Cefalexin should be given cautiously to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins. Patients have had severe reactions (including

anaphylaxis) to both drugs. If the patient experiences an allergic reaction cefalexin should be discontinued and treatment with the appropriate agents initiated. Cefalexin should be administered with caution in the presence of markedly impaired renal function as it is excreted mainly by the kidneys. Careful clinical and laboratory studies should be made because safe dosage may be lower than that usually recommended. Positive direct Coombs tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies, or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs testing of newborns whose mothers have received cephalosporin antibiotics before parturition it should be recognized that positive Coombs test may be due to the drug. A false positive reaction for glucose in the urine may occur with Benedicts or Fehlings solutions or with copper sulphate test tablets. Tests based on glucose oxidation reactions may be safely used.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

As cephalosporins like cefalexin are only active against proliferating microorganisms, they should not be combined with bacteriostatic antibiotics. Concomitant use of uricosuric drugs (e.g. probenicid) suppresses renal drug elimination. As a result, cefalexin plasma levels are increased and sustained for longer periods. If associated with highly potent diuretics (ethacrynic acid, furosemide) or other potentially nephrotoxic antibiotics (aminoglycosides, polymyxin, colistin), cephalosprins may show higher nephrotoxicity. Combined use of cephalosporins and oral anticoagulants may prolong prothrombin time. Cefalexin may reduce the effects of oral contraceptives. A potential interaction between cefalexin and metformin may result in an accumulation of metformin and could result in fatal lactic acidosis.

4.6.

Pregnancy and Lactation

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient. Small quantities of Cefalexin appears in human breast milk. Therefore, caution should be exercised while administering Cefalexin to a nursing woman.

4.7

Effects on ability to drive and use machines

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

4.8

Undesirable effects

Infections and infestations: As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida (Genital candidiasis). This may present a vulvo-vaginitis. Blood and lymphatic system disorders Eosinophilia, neutropenia, thrombocytopenia. Immune system disorders Allergic reactions have been observed in the form of rash, urticaria, angioedema and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions usually subsided upon discontinuation of the drug, although in some cases supportive therapy may be necessary. Anaphylaxis has also been reported. Nervous and psychiatric system disorders Dizziness, fatigue, headache, agitation, confusion, hallucinations. Gastrointestinal disorders: Nausea, vomiting diarrhoea and abdominal discomfort have been reported. The most frequent side effect has been diarrhoea. It was rarely severe enough to warrant cessation of therapy. Dyspepsia and abdominal pain have also occurred. There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea while taking cefalexin. It may range in severity from mild to life threatening with mild case usually responding to cessation of therapy. Appropriate measures should be taken with moderate to severe cases. Hepato-biliary disorders As with some penicillin and some other cephalosporins, transient hepatitis and cholastatic jaundice have been reported rarely.

Musculoskeletal, connective tissue and bone disorders Arthralgia, arthritis and joint disorder. Renal and urinary disorders Reversible interstitial nephritis has been reported rarely. Reproductive system and breast disorders Genital and anal pruritis, vaginal discharge. Investigations Slight elevations in AST and ALT have been reported.

4.9.

Overdose Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhoea and haematuria. In the event of severe overdosage, general supportive care is recommended, including close clinical and laboratory monitoring of haematological, renal and hepatic functions, and coagulation status until the patient is stable. Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of Cefalexin. It would be extremely unlikely that one of these procedures would be indicated. Unless 5 to 10 times the normal total daily dose has been ingested, gastrointestinal decontamination should not be necessary. There have been reports of haematuria without impairment of renal function in children accidentally ingesting more than 3.5g of Cefalexin in a day. Treatment has been supportive (fluids) and no sequelae have been reported.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

Cefalexin is an oral broad-spectrum antibiotic belonging to the group known as cephalosporins. In adequate concentrations it is bactericidal for sensitive proliferating microorganisms by inhibiting the biosynthesis of the cell wall. It is active against the following pathogens: Gram Positive Staphylococci (coagulase positive as well as penicillinase-producing strains), Streptococci, pneumococci, Corynebacterium diphtheriae, Baccillus anthracis,

Clostridia, Listeria monocytogenes, Bacillus subtilis and Bacteroides melaninogenicus. Gram Negative Escherichia coli, Salmonellae, Shigellae, Neisseria, Proteus mirabilis, Haemophilus influenzae (some strains), Brucellae, Klebsiella species, Treponema pallidum and actinomycetes.

5.2.

Pharmacokinetic Properties Cefalexin is almost completely absorbed from the gastro-intestinal tract and produces a peak plasma concentration of about 18 g/ml one hour after a 500 mg oral dose; doubling the dose doubles the peak concentration. If Cefalexin is taken with food, absorption may be delayed, but the total amount absorbed is not appreciably altered. Up to 15% of a dose is bound to plasma proteins. The plasma half-life is about 1 hour; it increases with reduced renal function. Cefalexin is widely distributed in the body but does not enter the cerebrospinal fluid in significant quantities. It crosses the placenta and small quantities are found in the milk of nursing mothers. Cefalexin is not metabolised. About 80% or more of a dose is excreted unchanged in the urine in the first 6 hours by glomerular filtration and tubular secretion. Probenecid delays urinary excretion. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route.

5.3.

Pre-clinical Safety Data The safety of Cefalexin is well established as it has been used on the market for 20 years.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Lactose monohydrate Magnesium Stearate Capsule Shell Gelatin Iron oxide yellow (E172) Titanium dioxide (E171) FD & C Blue 1 (E133) FD & C yellow 6 (E110)

Water Printing Ink Shellac Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene glycol Stong ammonia solution Black iron oxide (E172) Potassium hydroxide Purified water

6.2

Incompatibilities

No incompatibilities have been reported with Cefalexin.

6.3.

Shelf Life Shelf life: Two years

6.4.

Special Precautions for Storage Store in well closed containers, at a temperature not exceeding 25C, protected from moisture.

6.5

Nature and contents of container
* HDPE Bottle pack comprise of white opaque high-density polyethylene with neck and screw cap with induction seal liner containing 100 capsules. Strip pack containing 20, 21 or 28 capsules.

*

6.6.

Instructions for Use, Handling and Disposal None.

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MARKETING AUTHORISATION HOLDER

Ranbaxy (UK) Limited

Building 4, Chiswick Park, 566 Chiswick high road, London, United Kingdom. W4 5YE 8. MARKETING AUTHORISATION NUMBER(S) PL 14894 /0010

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/02/2009

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DATE OF REVISION OF THE TEXT
14/10/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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