Monocef is indicated for the treatment of respiratory tract infections (RTI's), urinary tract infections (UTI's), skin and soft tissue infections, otitis media and other infections due to sensitive organisms.

(See Section 5.2 Pharmacokinetic properties-Special patient population)

Monocef 250 and 500 mg capsules are for oral use. Each capsule should be swallowed whole with water.

•  Adults

The dosage is 1 to 4 g daily in divided doses. Most infections will respond to 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild uncomplicated UTI's, the usual dosage is 250 mg every 6 hours or 500 mg every 12 hours. For more severe infections or those caused by less susceptible organisms, larger dosages may be needed.

•  Elderly

The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.

• Children

The usual recommended daily dosage for children is 25 to 50 mg/kg 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 under 5 years          125 mg every 8 hours
- 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 beta-haemolytic streptococcal infections, a therapeutic dose should be administered for at least 10 days.

Any patient who has a relative with porphyria should be screened and advised about the potential for cephalosporins to induce acute porphyric crises.

Cephalexin 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 Cephalexin should be discontinued and treatment with the appropriate agents initiated.

Cephalexin 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 the safe dosage may be lower than that usually recommended.

Positive direct Coombs' tests have been reported during treatment with cephalosporin antibiotics. For 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 a positive Coombs' test may be due to the drug.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets. Tests based on glucose oxidation reactions may be safely used.

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.

•  Pregnancy: Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient.
•  Nursing mothers: Small quantities are found in the milk of nursing mothers.

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

Blood and lymphatic disorders
Eosinophilia, neutropenia, thrombocytopenia.

Hypersensitivity
Allergic reactions have been reported such as rash, urticaria, angioedema and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis).

Nervous system disorders
Dizziness, fatigue, headache, agitation, confusion, hallucinations.

Gastrointestinal disorders
Nausea, vomiting and abdominal discomfort. The most frequent side effect has been diarrhea, but this is rarely severe enough to warrant cessation of therapy. There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhea while taking Cephalexin. 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
Transient hepatitis and cholestatic jaundice have been reported rarely. Slight elevations in AST and ALT have been reported.

Musculo-skeletal, connective tissue and bone disorders
Arthralgia, arthritis, and joint disorder.

Renal and urinary disorders
As with other cephalosporins interstitial nephritis has rarely been reported.

Infections and infestations
As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.

Reproductive system and breast disorders
Genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge.

Symptoms of oral overdose include nausea, vomiting, epigastric distress, diarrhoea and haematuria.

General management consists of close clinical and laboratory monitoring of haematological, renal and hepatic functions and coagulation status until the patient is stable.

Serum levels of cefalexin can be reduced by haemodialysis or peritoneal dialysis

•  Pharmacological group: Cephalosporin antibacterial agent. ATC Code: J01DB01.
•  Cephalexin 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.

Cephalexin is almost completely absorbed from the gastrointestinal tract and produces peak plasma concentrations about 1 hour after administration.

A dose of 500 mg produces a peak plasma concentration of about 18 μg / ml; doubling the dose doubles the peak concentration. Cephalexin readily diffuses into tissues, including bone, joints and the pericardial as well as pleural cavities. Only 10 to 15% of the dose is bound to plasma proteins. Elimination is mainly renal with 80% of the dose, recovered from the urine, therapeutically active, in the first 6 hours.

Cephalexin does not enter cerebrospinal fluid in significant quantities. Cephalexin crosses the placenta and small quantities are found in the milk of nursing mothers. Therapeutically effective concentrations may be found in the bile and some may be excreted by this route.

The half life has been reported to range from 0.5 to 2 hours and this increases with reduced renal function.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

- Colloidal starch glycolate;
- Colloidal silicon dioxide;
- Magnesium sterate.

Not applicable

Do not store above 30° C.

Blisters of 20 capsules per pack.

No special requirements.