Suprax 100 mg/5 ml Granules for oral suspension 60 ml

Suprax 100 mg/5 ml Granules for oral suspension 60 ml

Composition:
Each 5 ml of reconstituted suspension contains:
Active ingredient:
Cefixime trihydrate 111.9 mg (equivalent to 100 mg cefixime).
Inactive ingredients:
Xanthan gum, Sodium benzoate, Strawberry flavour, Sucrose.
Description:
Suprax is an orally active cephalosporin antibiotic with marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
It is highly stable in the presence of beta-lactamases.
Used for the treatment of acute infections caused by susceptible microorganisms.
Indications for Use:
Indicated for the treatment of the following acute infections caused by susceptible microorganisms:
- Upper Respiratory Tract Infections (URTI): otitis media and other URTI when resistance to commonly used antibiotics is known or suspected, or where treatment failure may carry significant risk.
- Lower Respiratory Tract Infections: bronchitis.
- Urinary Tract Infections: cystitis, cystourethritis, uncomplicated pyelonephritis.
- Clinical efficacy has been demonstrated in infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative), and Enterobacter species.
Dosage and Method of Administration:
Food does not significantly modify absorption.
Usual duration - 7 days; may be prolonged to 14 days if required.
Children (Oral Suspension):
Recommended dose - 8 mg/kg/day as a single dose or in two divided doses.
Suggested daily volumes:
- 6 months-1 year: 3.75 ml
- 1-4 years: 5 ml
- 5-10 years: 10 ml
- >10 years or >50 kg: adult dose (200-400 mg daily)
Renal impairment:
- CrCl ≥20 ml/min: normal dose
- CrCl <20 ml/min: do not exceed 200 mg once daily
- Dialysis patients: same recommendations as CrCl <20 ml/min.
Contraindications
- Hypersensitivity to cefixime, other cephalosporins, or any excipient.
- Previous immediate and/or severe hypersensitivity to penicillins or other beta-lactam antibiotics.
Precautions:
- Severe cutaneous reactions may occur: toxic epidermal necrolysis, Stevens–Johnson syndrome, DRESS. Discontinue immediately if they occur.
- Caution in patients with hypersensitivity to penicillins (cross-allergenicity possible).
- Risk of anaphylaxis.
- Acute renal failure including tubulointerstitial nephritis reported.
- Use with caution in marked renal impairment.
- Safety not established in premature or newborn infants.
- Broad-spectrum antibiotics may cause C. difficile–associated diarrhoea, including pseudomembranous colitis.
- If severe diarrhoea occurs - discontinue and treat appropriately.
Side Effects:
Blood and lymphatic system: Eosinophilia, hypereosinophilia, agranulocytosis, leucopenia, neutropenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, thrombocytosis.
Gastrointestinal: Abdominal pain, diarrhoea*, dyspepsia, nausea, vomiting, flatulence.
Hepatobiliary: Jaundice.
Infections: Pseudomembranous colitis.
Investigations: Increased AST, ALT, blood bilirubin, urea, creatinine.
Nervous system: Dizziness, headache.
Respiratory: Dyspnoea.
Renal and urinary: Acute renal failure including tubulointerstitial nephritis.
Immune and skin disorders: Anaphylactic reaction, serum sickness-like reaction, DRESS, pruritus, rash, drug fever, arthralgia, erythema multiforme, Stevens–Johnson syndrome, toxic epidermal necrolysis, angioedema, urticaria, pyrexia, face oedema, genital pruritus, vaginitis.
Pregnancy and Breastfeeding:
No adequate data in pregnant women.
High-dose studies in rabbits caused abortion and maternal death.
Use only if considered essential by the physician.
Storage Conditions:
Store below 30°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing bottle with granules to prepare 60 ml oral suspension after reconstitution, and a leaflet.