Starcef
F.e. Tablets· Capsules – Powder Pro-suspension
Generic name :
Cefalexin
Composition :
Starcef 1 g. Film Coated Tablets Each tablet contains:
Active ingredient:
Cefalexin monohydrate 1051.8 mg equivalent to 19. Cefalexin.
Inactive ingredients:
sodium starch glycolate, pregelatinized starch , maize starch , P.V.P , Magnesium stearate, Aerosil 200, Methocel, PEG 6000, Titanium
Stareef 500 mg Hard Gelatin Capsules Each capsule contains:
Active ingredient:
Cefalexin monohydrate 525.9 mg equivalent to 500 mg Cefalexin.
Inactive ingredients:
Lactose, Sodium starch glycolate, Aerosil 200, Magnesium stearate and Sodium lauryl sulphate.
Starcef 250 mg/ 5 rnl Powder for Oral Suspension
Each 5 rnl reconstituted suspension contains:
Active ingredient:
Cefalexin 250 mg
Inactive ingredients: povidone , xanthan gum , Avicel, Aerosil200, Sodium chloride, Sodium benzoate, tween 80, Citric acid, Sorbitol powder, Orange
powder, Quinoline yellow color and Sucrose.
Pharmaceutical form :
Film Coated Tablets
Hard Gelatin Capsules
Powder for Oral Suspension (Powder Pro-suspension)
Pharmacological action :
Cefalexin is a bactericidal antibiotic of the Cephalosporin group which is active against a wide range of Gram-Positive and Gram-
negative organisms.
Gram-positive organisms
Cefalexin is stable to staphylococcal penicillinase, and so is active against pencillin-resistant Staphylococcus aureus and other
staphylococcal species induding coagulase- positive, coagulase-negative, and penicillinase-producing strains (exduding methicillin-
resistant isolates), Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus agalactiae (Group B),other beta -haemolytic streptocd and most viridans group streptocci are also highly susceptible to Cefalexin.
Gram-negative organisms
Cefalexin has in vitro activity against E. coli, Klebsiella species, Proteus mirabilis, Corynebacterium diphtheriae, Salmonella and
Shigella species, Neisseria qonorrhoeae. N. meningitides, Haemophilus influenzae and BranhamelJa catarrbahs are also susceptible.
Pharmacokinetics :
Absorption
Oral Cefalexin is almost completely absorbed in the upper portions of the gastrointestinal tract Following oral administration, absorption
is rapid and peak serum levels (9 micrograms I ml for 250 mg dose, 18 micrograms I ml for 500 mg dose and 32 microgramslml for
a 1000 mg dose) are usually reached at 1 hour and therapeutic levels are maintained for 6-8 hours. Absorption is delayed when Cefalexin is giving with or shortJy after food, but the total amount absorbed is not altered, absorption of Starcef is not adversely affected by cellae disease, partial gastrectomy, achlorhydria, jaundice or diverticulosis (duodenal or jejunal).
Distribution
The drug- protein binding is weak and reversible varying from 0 to 30 % according to the method of determination. Cefalexin is widely
distributed in body tissues and high concentrations are found in all organs, particularty the liver and kidneys. (Cefalexin reaches
therapeutic levels in the blood, urine, bile, synovial fluid, pus, tonsillar tissue, amniotic fluid, cord blood and foetal blood.
Metabolism
Cefalexin is not metabolized in the body.
Elimination
The serum half-life is normally about 1 hour, but is longer in the newborn. Cefalexin is eliminated by glomerular filtration and tubular secretion reaching the urine in an active and unchanged form. Urinary recovery after 6 hour is about 60 % of the administered dose. No accumulation is seen with dosages above the therapeutic maximum
Indications :
Starcef is a bactericidal antibiotic which is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for treatment of the following conditions when caused by susceptible bacteria : respiratory tract infections acute and chronic bronchitis and infected bronchiectasis
Ear, nose and throat infections: otits media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis. Urinary tract infections: acute and chronic pyelonephritis, cystitis and prostatitis. Prophylaxis of recurrent urinary tract infection.
Gynaecological and obstetric infections.
Skin, soft-tissue and bone infections.
Gonorrhoea (when penicillin is unsuitable).
Dental procedures: treatment of dental infections. As prophylaxis treatment for patients with heart disease undergoing dental treatment as an alternative to penicillin.
Dosage and administration :
– Adults
The adult dosage ranges from 1-4g daily in divided doses.
Many infections in adults will respond to oral dosage of 1 g to 2 g per day in divided dosage; however, for most infections, the simple
scheme of 500 mg three times daily will be found satisfactory.
To aid compliance, especially in ambulatory patients, the daily dosage may be given in two equal doses; e.g. 1 g twice daily in adults
with urinary tract infections.
For severe or deep-seated infections, especially when less sensitive organisms are involved, the dosage should be increased to 1 g
three times daily. If daily doses of Cefalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be
considered.
– Children
Ideally, dosage should be calculated on a body-weight basis, particularly in infants.
The usual recommended daily dosage for children is 25-50 mglkg 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:
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100mg/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.
– Elderly
In elderly patients. the possibility of renal impairment should be considered.
– Renal impairment
Cefalexin should be administered with caution in the presence of markedly impaired renal function. Careful dinical and laboratory
studies should be made because safe dosage may be lower than that usually recommended. Clinical practice indicates that in view
of the wide therapeutic window of Starcef. the standard recommended doses should be halved only in those patients with severe renal impairment (creatinine clearance less than 10 mUmin).
Duration of treatment :
For most acute infections, treatment should continue for at least two days after signs have returned to normal and symptoms have
subsided, but in chronic. recurrent or complicated urinary tract infections, treatment for two weeks (giving 500 mg four times daily) is recommended for gonorrhoea asingle dose of 3 g with 1 g probenacid for males or 2 g with 0.5 g probenecid for females is usually effective
Contraindications :
– Hypersensitivity to any ingredient of the preparation.
– Patients with known hypersensitivity to cephalosporin antibiotics.
Side effects :
Common side effects induding: Gastrointestinal symptoms, such as nausea, vomiting and diarrhea. Symptoms of pseudomembranous
colitis may appear either during or after antibiotic treatment dyspepsia and abdominal pain have also occurred.
Eosinophilia, neutropenia. thrombocytopenia, and haemolytic anaemia have been reported.
Other side effects includes: dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder.
Drug interactions :
– Concurrent treatment with high doses of Cephalosporins and nephrotoxic drugs such as aminoglycoside or potent diuretics (e.g.
furosemide, ethacrynic acid and piretanide) may adversely affect renal function. Clinical experience has shown that this is not likely
to be a problem with Starcef at the recommended dosage levels.
– In common with other antibiotics, Cefalexin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy
of combined oral contraceptives.
– As with other beta-Iactam drugs, renal excretion of CefakJxin is inhibited by probenecid.
Pregnancy and Lactation :
Pregnancy: There is no experimental or clinical evidence of teratogenic effects attributable to Cefalex!n, but Starcef shouki be
administered with caution during the early months of pregnancy.
Lactation: Cefalexin is excreted in human milk in low concentrations and should be used with caution in nursing mothers.
Precautions and warnings :
– Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-Iactams.
– As with other broad-spectrum antibiotics, prolonged use may 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 diarrhea durin~ or after antibiotics use.
– Starcef can interfere with the determination of the alkaline picrate assay for creatinine, giving a false high reading, although this is
unlikely to be of clinical importance.
– In patients receiving Starcef, a false-positive reaction for glucose in the urine may be given, with Benedict’s or Fehling’s solution or
with’ Clinltest’ tablets, but not with enzyme-based tests.
– Positive direct Coombs test have been reported during treatment with the cephalosporin antibiotics. Also Coombs testing of newboms
whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coornbs test may
be due to the drug.
– Starcef suspension contains Sorbitol powder, so it should be used with caution in cases of diabetic patients.
Patient Instructions :
– Starcef suspension is prepared by adding water to the powders in two portions, shaking after each addition to give suspension
containing 250 mg Starcef in each 5rn!. Shake the bottle well before use.
– Keep out of reach of children.
Package and Storage :
Stareef 1 g. Film Coated Tablets
A carton box containing 1 (AU PVC) blister of 12 film coated tablets + insert leaflet
Stareef 500 mg Hard Gelatin Capsules
A carton box containing 1. 2 or 3 (AU PVC) blisters. each of 10 hard gelatin capsules + insert leaflet
Store in a dry place at temperature not exceeding 3O”C.
Stareef 250 mgl 5 rnl Powder for Oral Suspension
A carton box containing an amber glass bottle of powder to form 60 ml of suspension, and a graduated measuring cup + insert leaflet
Store at temperature not exceeding 30″C.
Reconstituted Starcef suspension retains its potency for 10 days when kept in a refrigerator (2-S”C).
Produced by:
Sigma-Tec Pharmaceutical Industries. Egypt. S.A.E.
