COMPOSITIONS :
Cefabiotic® Capsule 500 mg, each capsule contains : Cefalexin monohydrate equivalent to Cefalexin 500 mg.
DESCRIPTIONS :
Cefabiotic® containing Cefalexin monohydrate (equivalent to Cefalexin) is available in capsule 500 mg and dry syrup 125 mg/5 ml.
INDICATIONS :
- Urogenital tract infections, including acute prostatitis, respiratory tract, skin and soft tissue and otorhinolaryngs infections caused by cephalosporin susceptible organisms.
- For continuing the previous therapy with parenteral cephalosporin, susceptibility test must be conducted, if possible before usage.
- For the treatment of the following infections when caused by susceptible strains of the designated microorganisms :
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- Bacterial sinusitis caused by Streptococci, pneumoniae and Staphylococcus aureus (Methicillin-sensitive only).
- Respiratory tract infections caused by pneumoniae and S. pyogenes (penicillin is the usual medicine of choice in the treatment and prevention of Streptococcal infections, including the prophylaxis of rheumatic fever – Cefalexin monohydrate is generally effective in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cefalexin monohydrate in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present).
- Otitis media due to pneumoniae, H. influenzae, Staphylococci, Streptococci and M. catarrhalis.
- Skin and skin-structure infections caused by Staphylococci and/or Streptococci.
- Bone infections caused by Staphylococci and/or mirabilis.
- Genitourinary tract infections, including acute prostatitis, caused by coli, P. mirabilis and Klebsiella pneumoniae.
- Dental infections caused by Staphylococci and/or Streptococci.
DOSAGE AND ADMINISTRATIONS :
Adults :
Daily dose in infection cases caused by very susceptible organisms (gram positive) is 1 – 2 g in divided dose.
Daily dose in infection cases caused by less susceptible organisms (gram negative) is 2 – 4 g in divided dose.
Daily dose should not less than 1 g.
Children :
25 – 50 up to 100 mg/kgBW, given in 3 – 4 divided dose daily.
Unless as instructed by doctor, recommended dose is as follows :
| Age | Body weight | Cefalexin monohydrate average dose 500 mg/capsule |
| 10 – 14 years | 33 – 49 kg | 4 x 1 |
| Adults | 4 x 1 |
Infants and children < 6 years should not exceed 100 mg/kgBW/day.
Adolescents and adults : Daily dose should not exceed 4 g.
To prevent complications, the therapy must be conducted at least 10 days for infection cases caused by Streptococcus.
Dose in patients with renal insufficiency : Dose above must be reduced in patients with renal insufficiency.
OVERDOSAGE :
In the event of severe overdosage, general supportive care is recommended including close clinical and laboratory monitoring of haematological, renal, 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 monohydrate; however, it would be extremely unlikely that one of these procedures would be indicated.
CONTRAINDICATION :
Cefalexin monohydrate is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or previous experience of a major allergy to penicillin.
WARNINGS AND PRECAUTIONS :
- Cefalexin monohydrate therapy should be discontinued if a hypersensitivity reaction occurs, particularly anaphylactic shock and appropriate therapy instituted.
- A cross-resistance exists between cephalosporin and isoxazolyl penicillin in Staphylococcal infections.
- This drug should be used during pregnancy only if clearly needed.
- According to the literature, should be kept in mind that cross allergy between penicillin and cephalosporin in hypersensitivity cases to penicillin is at 5 up to 10% of the cases.
- Secondary infection can be occurs.
- Beware in administrations to patients with renal insufficiency, patients with gastrointestinal disease, particularly colitis and in lactating women.
- Cefalexin monohydrate should not ordinarily be given to those allergic to cephalosporins or to penicillins, especially where an allergic or urticarial reaction has occurred.
- Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics.
- Patients should be followed carefully so that any side effects or unusual manifestations of medicine idiosyncrasy may be detected. If an allergic reaction to Cefalexin monohydrate occurs, the medicine should be discontinued and the patient treated with the usual agents (e.g. Adrenaline or Epinephrine or other pressor amines, antihistamines or corticosteroids).
- Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
- Use in pregnancy : Cefalexin monohydrate should be used during pregnancy only if clearly needed.
- Use in lactation : Caution should be exercised when Cefalexin monohydrate is administered to a nursing woman.
- Effects on ability to drive and use machines : This medicine is presumed to be safe or unlikely to produce an effect.
PRESENTATIONS :
Cefabiotic® Capsule 500 mg Box, 10 strips @ 10 capsules Reg. No. DKL8802313501B1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
