Acefra 500 mg (Capsule)

Indications

• Treatment of upper respiratory tract infections
• Treatment of lower respiratory tract infections
• Treatment of urinary tract infections
• Treatment of skin and soft tissue infections
• Effective against Staphylococci (both penicillin sensitive and resistant strains)
• Effective against Streptococci and Streptococcus pyogenes (beta haemolytic)
• Effective against Gram-negative bacteria such as Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp, Neisseria spp
• Effective against E.coli and Staphylococcus aureus that produce the enzyme penicillinase
• Susceptible microorganisms
• Bactericidal antibiotic
• Cell wall inhibition
• Broad spectrum
• Semisynthetic
• Gram-positive and Gram-negative bacteria
• Peptidoglycan inhibition

Pharmacology

• Cell wall inhibition
• Bactericidal antibiotic
• Active against gram-positive and gram-negative microorganisms
• Inhibition of cross-linking process in cell wall

Dosage & Administration

• Oral administration for adults and children
• Recommended dosage for urinary tract infections, respiratory tract infections, skin and soft tissue infections
• Dosage adjustments for elderly, renal, or hepatic impairment
• Injectable administration for adults and children
• Prophylaxis dosage
• Maximum daily dosage

Interaction

• Nephrotoxic drug interaction
• Enhanced renal toxicity with diuretics and probenecid

Contraindications

• Hypersensitivity to cephalosporins

Side Effects

• Gastro-intestinal disturbances
• Hypersensitivity phenomena
• Skin reactions
• Glossitis
• Heartburn
• Dizziness
• Nausea
• Vomiting
• Diarrhoea
• Abdominal pain
• Vaginitis
• Candida overgrowth
• Blood disorders
• Immune system disorders
• Psychiatric disorders
• Nervous system disorders
• Hepatobiliary disorders
• Renal and urinary disorders
• Elevation of blood urea nitrogen
• Elevation of serum creatinine
• Elevation of liver enzymes

Pregnancy & Lactation

• Animal studies on teratogenicity
• Excretion in breast milk
• Caution in lactating mothers
• Safety in pregnancy not established
• Caution for operating hazardous machinery

Precautions & Warnings

• Prolonged use may result in superinfection
• Careful administration to patients hypersensitive to penicillins
• Cephalosporin antibiotics may cause a positive result in Coombs’ testing
• False positive urine glucose result
• Dosage adjustment in renal impairment
• Contains lactose
• Avoid in patients with hereditary problems of galactose intolerance
• Bacteriological and clinical monitoring for chronic urinary tract infections
• Transfer from intramuscular/intravenous to oral treatment

Use in Special Populations

• Dosing recommendations for patients not on haemodialysis
• Dosing recommendations for patients on chronic, intermittent haemodialysis
• Higher doses may be required for chronic or severe infections
• Treatment duration for rheumatic fever or glomerulonephritis prevention
• Regular bacteriological and clinical monitoring for chronic urinary tract infections
• Paediatric dosage restrictions

Overdose Effects

• Non-specific symptoms
• Supportive treatment
• Nausea
• Vomiting
• Diarrhoea
• Gastric upsets
• Gastric lavage for large ingestions

Therapeutic Class

• First generation Cephalosporins

Storage Conditions

• Freshly prepared suspension
• Reconstituted Suspension shelf life
• Injection solutions shelf life
• Effect of storage temperature on potency
• Variability in color of reconstituted solutions
• Medicine expiry date
• Keep out of the reach of children
• Dispensing under physician's prescription

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