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Sporidex

Ranbaxy Nigeria Limited
24, Abimbola street, Abimbola House, Isolo, Lagos.
Tel: 234-1-7932744, 7913002
Fax: 234 1 7913003, 4526371

Brand Name

Sporidex

Manufacturer

Lab. Ltd, Industrial Area-3 Dewas 455001, India.

Therapeutic Class

Antibacterial, Cefalosporins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Capsule (NRN: 04-1430): Cephalexin BP equivalent to anhydrous Cephalexin 250 mg, 500 mg.

 

Pack Size: Blister strip of 10’s, 24 x 10’s, 20’s & 24 x 20’s.

 

  Sporidex 500

 

Suspension (NRN: 04-1356): Cephalexin USP equivalent to anhydrous Cephalexin 125 mg per 5 mL, 250 mg per 5 mL.

 

Pack: Bottle of 60 mL & 100 mL.

 

Sporidex 125   Sporidex 250

Pharmacology

Mechanism of Action:

Cephalexin inhibits bacterial cell wall synthesis, probably by acylation of membrane bound transpeptidase enzymes. This prevents cross linkage of peptidoglycan chains which is necessary for bacterial cell was strength and rigidity. The cell division and growth are also inhibited.

Pharmacokinetics:

Cephalexin is most completely absorbed from the gastro-intestinal tract with a bioavailability of about 95%. One hour after an oral dose of cephalexin 250 mg, the mean peak serum concentrations is about 9 mcg/mL.

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 plasma elimination half-life is about one hour.

Indications

Respiratory tract infections including pneumonia and otitis media;

Skin and soft tissue infections including burn and wound infections;

Urinary tract infections;

Bone and Joint infections;

Septicaemia.

Contra-indications

History of hyper-sensitivity to penicillins, penicillin derivatives, penicillamine or cephalosporins.

Precautions/Warnings

General:

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on beta-lactam therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral beta- lactams. These reactions are more likely to occur in individuals with a history of beta-lactams hypersensitivity and/or a history of sensitivity to multiple allergens; careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

If allergic reactions occur, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, IV steroids and airway management, including intubation, should also be administered as indicated. Pseudo-membranous colitis has been reported with nearly all antibacterial agents, and has ranged in severity from mild to life threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents. In severe cases, hepatic or renal function impairment, the potential risks and benefit should be carefully considered. Dosage reduction is recommended in patients with renal or hepatic function impairment.

Warnings:

Patients hypersensitive to one cephalosporin may be hypersensitive to other cephalosporins as well. Caution is recommended when cephalosporins are administered to patients with a history of beta-lactam antibiotic.

Pregnancy/Reproduction:

Studies in animals have not shown any evidence of adverse effect on the foetus. Safety of cephalexin during pregnancy in humans has not been established.

Breast feeding:

Cephalosporins are secreted in low concentration into breast milk. Caution should be exercised when cephalexin is administered to nursing women.

Paediatrics:

Lower metabolic and/or renal clearance of cephalosporins with prolonged half-life has been reported in newborn infants.

Geriatrics:

No geriatric specific problems have been documented to date. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment of dosage.

Oral:

Long term therapy with cephalosporins may result in oral candidiasis.

Interactions

Oral contraceptives: Cephalexin has been reported to decrease the efficacy of oestrogen containing oral contraceptives.

Vitamin K: Cephalosporins has been reported to inhibit vitamin K synthesis by suppressing gut flora.

Loop diuretics: Cephalosporins when used with loop diuretics may increase nephrotoxicity.

Probenecid: Probenecid slows the tubular secretion of cephalexin.

Laboratory value alterations: Urine Glucose: cephalexin may produce false positive or falsely elevated test results with Benedict’s, Fehling’s, or Clinitest tablets tests. Glucose enzymatic tests such as Tes-Tape are not affected.

Coomb’s tests: Haemolysis has been reported to occurs rarely, and a test positive Coomb’s reaction reported in patients taking cephalosporins.

SGOT, SGPT, LDH, BUN: Values may be increased in patients taking cephalosporins.

Complete blood count or platelet count: Transient leucopenia, neutropenia, thrombocytopenia, eosinophilia and lymphocytosis have been reported.

Adverse Effects

GI System:

Nausea, vomiting, abdominal cramps, diarrhoea, oral candidiasis, pseudomembranous colitis.

Hypersensitivity/Allergic reactions:

Fever, skin rash, itching, redness, swelling, anaphylaxis, erythema multiforme or Stevens Johnson Syndrome.

Haematological:

Hypoprothrombinaemia, haemolytic anaemia.

CNS:

Seizures can occur at high doses of in infants with impaired renal function.

Dosage & Administration

Usual adult dose: 250 mg every six hours.

Streptococcal, pharyngitis, skin and soft tissue infections and uncomplicated cystitis: 500 mg every twelve hours. The maximum daily dose is 4 gm.

Usual paediatric dose: 25 to 50 mg per kg body weight every six hours.

Streptococcal pharyngitis: 25 to 50 mg per kg body weight every six hours.

Overdosage and Administration

Treatment of overdosage is required when more than 5 times the normal dose is ingested. The treatment is symptomatic and supportive. Patients may develop antibiotic associated pseudo-membranous colitis and may require fluid, electrolyte and protein replacement.

Absorption of drug from the GIT may be decreased by activated charcoal. Some patients may require metronidazole, bacitracin, cholestyramine or vancomycin.

 

Storage/Handling Recommendations

Sporidex capsules: Store below 25oC, protected from moisture.

Sporidex suspension: Dry powder - Store below 25oC, protected from moisture.

After constitution - Store below 2 - 8oC, and use within seven days.

Review Date

2016-07-01 04:12:59