Sialexin

SIALEXIN CAPSULE (250 MG): Each capsule contains Cephalexin monohydrate (INN: Cefalexin (as monohydrate)) equivalent to Cephalexin 250 mg.
SIALEXIN CAPSULE (500 MG): Each capsule contains Cephalexin monohydrate (INN: Cefalexin (as monohydrate)) equivalent to Cephalexin 500 mg.
SIALEXIN SUSPENSION: Each 5 mL (after reconstitution) contains Cephalexin monohydrate (INN: Cefalexin (as monohydrate)) equivalent to Cephalexin 125 mg.

Pharmacology: Pharmacodynamics: SIALEXIN is a first generation of cephalosporins antibiotic SIALEXIN inhibits cell wall synthesis by binding the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacteria cell walls.
In vitro Cephalexin is susceptible to gram positive and gram negative bacteria.
Gram-positive aerobic bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes (Group A β-hemolytic Streptococci), Streptococcus agalactiae (Group A β-Streptococci) and Streptococcus pneumoniae.
Gram negative aerobic bacteria: Escherichia coli, Haemophilus influenzae, Neisseria catarrhalis, Klebsiella pneumoniae, Proteus mirabilis and Shigella sp.
Pharmacokinetics: Cephalexin is rapidly and completely absorbed from GI tract. Absorption of Cephalexin is delayed in young children and may be decreased up to 50% in neonate. Peak serum concentrations of the drug have been reported to occur within 3 hours in infants younger than 6 months of age, within 2 hours in children 9-12 months of age, and within 1 hour in older children and adults. When Cephalexin is administered with food, peak serum concentration is minimally decreased and time to reach peak serum concentration is delayed.
However extent of absorption is unchanged. Cephalexin is widely distributed into body tissue and fluids i.e. liver, kidney and bone but it is poorly distributed to synovial fluids and cerebrospinal fluid. The drug can distribute across placenta, and enters breast milk. Protein binding of Cephalexin is 6%-15%, Cephalexin is mainly excreted in urine as uncharged. The serum half-life of Cephalexin is 0.5-1.2 hours in adults with normal renal function and longer in patient with renal impairment.

SIALEXIN is used in the treatment of bacterial infection caused by susceptible bacteria: Respiratory tract infection: Chronic and acute bronchitis, pneumonia, pleurisy; Ear, nose, throat and soft tissue infections: Otitis media, sinusitis, pharyngitis; Genitourinary tract infections: Cystitis, pyelonephritis; Bone, joint and skin infections: Osteomyelitis, infected wound, dermatitis with abscesses.

Dosage recommendation: SIALEXIN CAPSULE: Adult dosage: The usual adult dosage of Cephalexin ranges from 1-4 g daily given in divided dose. Dosage usually is 250 mg every 6 hours or 500 mg every 12 hours. For severe infections higher dosage (up to 4 g daily) may be needed.
Children dosage: The usual dosage of Cephalexin for children is 25-50 mg/kg daily in divided doses 3-4 times a day or as doctor directed.
Dose in elderly: In the elderly with impaired renal function, dose adjustment according to renal function may be needed.
Dose in patients with renal impairment: In renal impairment patients, dose adjustment with creatinine clearance is necessary. Patients should be closely monitored. (See table.)

Click on icon to see table/diagram/image

SIALEXIN SUSPENSION (Powder before reconstituted): Disperse the powder and add water to the labeled mark. Shake until completely wet and uniformly distributed with no mass, and then adjust volume with water to the mark; finally, SIALEXIN SUSPENSION 125 mg in 5 mL will be obtained as directed in the label.
Shake well before use.
Dosages adjust followed severity of infection or followed to doctor recommended but highest dose not more than 4 g/day.
Children: Starts with Cephalexin 25-100 mg/kg daily or Children weight 10 kg take 2.5-10 mL 4 times a day; Children weight 20 kg take 5-20 mL 4 times a day; Children weight 30 kg take 7.5-30 mL 4 times a day.
Stability: SIALEXIN SUSPENSION: Before reconstituted store below 30°C.
After reconstituted store at refrigerator (2-8°C) and used within 7 days.

Symptoms of overdose include diarrhea, hematuria, nausea and vomiting.
Hemodialysis may be helpful to aid in drug removal from blood, otherwise, treatment is supportive and symptom-directed.

It is contraindicated in patients who are hypersensitivity to Cephalexin, any component of the formulation, or other cephalosporins should be avoided.

1. This drug is contraindicated in patients with known hypersensitivity to this drug.
2. Using this drug in patients with hypersensitivity to penicillins can cause severe to fatal allergic reaction.
3. Stop using this drug and immediately consult the doctor when manifesting any signs and symptoms such as fever, skin rash, blisters, detachment of skin and epithelial lining in oral cavity, throat, nose, genital organ and conjunctivitis after taking the drug.

Prolonged use of drug may cause colitis from Clostridium difficile called pseudomembranous colitis which has severity ranging from mild to life-threatening. For mild case, colitis may disappear with drug discontinuation. In severe case, fluid, electrolytes and protein supplement should be administered and patients should be treated with suitable antibiotics.
Use with caution in patients with impaired renal function. Dose adjustment is needed and if prolonged use, monitoring of renal and hepatic function is required.
Prolonged use of broad spectrum antibiotics may result in resistant bacterial and fungal growth.
Administration of high dose cephalosporins with nephrotoxic drugs such as aminoglycosides, or strong diuretics such as furosemide may increase nephrotoxicity, the drug should be used with caution.

Pregnancy category: B. Safety for use during pregnancy is not established. Use only when potential benefits outweighs potential hazards to the fetus.
Nursing women: Cephalosporins are distributed into milk, the drugs should be used with caution in nursing women.

Central nervous system: Agitation, confusion, dizziness, fatigue, hallucinations, headache.
Dermatologic: Angioedema, erythema multiforme, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, gastritis, nausea, pseudomembranous colitis, vomiting.
Genitourinary: Genital pruritus, genital moniliasis, vaginitis, vaginal discharge.
Hematologic: Eosinophilia, neutropenia, thrombocytopenia.
Hepatic: AST/ALT increased, cholestatic jaundice, transient hepatitis.
Neuromuscular & skeletal: Arthritis, joint disorder.
Renal: Intestinal nephritis.

Concurrent use Cephalexin with nephrotoxic agents such as aminoglycosides, colistin, polymyxin B or vancomycin may increase the risk of nephrotoxicity. Hence, concomitant use of such drugs should be avoided.
Concomitant administration of Cephalexin with oral probenecid may increase Cephalexin serum concentration because probenecid inhibits tubular secretion resulting in less drug secretion and prolong drug serum concentration.

SIALEXIN CAPSULE: Store below 30°C.
SIALEXIN SUSPENSION: Before reconstitution store below 30°C.
After reconstitution, store at refrigerator 2-8°C. Reconstituted suspension should be discarded if not used within 7 days.

Cephalosporins

J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.

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