SANCEPH – 250 CAP (Cephalexin)

SANCEPH – 250 CAP (Cephalexin)

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SANCEPH – 250 CAP (Cephalexin)

Cephalexin monohydrate is an orally effective, semi synthetic,, broad spectrum antibiotic. It is a first generation cephalosporin. SANCEPH – 250 CAP is green/white coloured hard gelatin capsule of size ‘2’ containing white to off granular powder.

Mechanism of action

Cephalexin is bactericidal because of its ability to inhibit cell wall synthesis of bacteria.

Spectrum of antibacterial activity

Gram-positive Aerobes:

  • Staphylococcus aureus (including penicillinase producing strains)
  • Streptococcus pneumoniae (penicillin-susceptible strains)
  • Streptococcus pyogenes

Gram-negative Aerobes

  • Escherichia coli
  • Klebsiella pneumoniae
  • Moraxella (Branhamella) catarrhalis
  • Proteus mirabilis

Note: Mithicillin-resistant staphylococci and most strains of enterococci (Enterococcus faecalis) formerly Streptococcus faecalisa are resistant to cephalosporins, including Cephalexin. It is not active against most strains of Enterobacter spp…, Morganella morganii and Proteus vulgaris. It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus. Penicillin resistant Streptococcus pneumoniae is usually cross-resistant to betalactam antibiotics.

Pharmacokinetics

Cephalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250mg and 500mg, average peak serum levels of approximately 9 and 18μg/ml respectively are obtained at 1 hour. Measurable levels are present 6 hours after administration. The plasma half life is normally 1 hour, but is increased in case of reduced renal function. It crosses the placenta and is present in small amounts in the milk of nursing mothers. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies show that over 90% of the drug is excreted unchanged in the urine within 8 hours. About 15% is present bound to plasma proteins. The peak urine concentrations following the 250mg, 500mg and 1g doses will be approximately 1000, 2000 and 5000μg/ml respectively.

Indications

CEPHALEXIN CAPSULES USP 250 mg can be used for the relief of following conditions when caused by susceptible strains

  • Bacterial sinusitis
  • Respiratory tract infections
  • Otitis media
  • Skin and skin structure infections
  • Bone infections
  • Genitourinary tract infections
  • Dental infections

Contraindications

Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Stomach upset, headache, fatigue, dizziness, or diarrhea may occur. In case of symptoms like mental/mood changes, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, new signs of infection (e.g., persistent sore throat or fever), easy bruising/bleeding or change in the amount of urine, advice should be sought from a doctor. This medication may rarely cause pseudomembranous colitis due to resistant bacteria, while receiving therapy or even weeks after treatment has stopped.

Do not use anti-diarrheal or narcotic pain medications if symptoms like persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in stool are present because they may worsen the condition. Use of this medication for prolonged or repeated periods may result in oral thrush or a vaginal yeast infection.

Warning

Before therapy with Cephalexin is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to Cephalexin, Cephalosporins, penicillins or other drugs. If cephalexin capsule is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cephalexin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous antihistamines, corticosteroids, presser amines and airway management, as clinically indicated.

Precautions

Prescribing Cephalexin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to cephalexin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines or corticosteroids).

Prolonged use of cephalexin may result in the overgrowth of non-susceptible organisms. If super infection occurs during therapy, appropriate measures should be taken.

Positive direct Coomb’s tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin test 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.

Cephalexin should be administered with caution in the presence of markedly impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

Broad spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Dosage and administration

Cephalexin is administered orally.

Adults: the adult dosage ranges from 1 to 4g daily in divided doses. The usual adult dose is 250mg every 6 hours. For streptococcal pharyngitis, skin and skin structure infections and uncomplicated cystitis, a dosage of 250mg may be administered every 12 hours in patients over 15 years of age.

Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric patients: the usual recommended daily dosage for pediatric patients is 25 to 50mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 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 100mg/kg/day in 4 divided doses is required.

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

Overdosage

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea and hematuria. If other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication.

In case of over dosage, undertake necessary treatment depending on the situation. Unless 5 to 10 times the normal dose of cephalexin capsule has been ingested, gastrointestinal decontamination should be necessary.

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