CEFPODOXIME LUPIN Powder for oral suspension Ref.[8385] Active ingredients: Cefpodoxime

Product name and form

Cefpodoxime-Lupin 40 mg/5 mL powder for oral suspension.

Pharmaceutical Form

Powder for oral suspension.

Almost white to pale yellow coloured powder.

Qualitative and quantitative composition

After reconstitution 5 mL oral suspension contains 40 mg cefpodoxime (as cefpodoxime proxetil).

After reconstitution 1 mL oral suspension contains 8 mg cefpodoxime (as cefpodoxime proxetil).

Excipients with known effect:

Sucrose 2.5 g/5 mL

Aspartame (E951) 20 mg/5 mL

Sodium benzoate (E211) 10 mg/5 mL

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefpodoxime

Like other beta-lactam drugs, cefpodoxime exerts antibacterial activity by binding to and inhibiting the action of certain bacterial cell wall synthetic enzymes, namely the penicillin binding proteins.

List of Excipients

Microcrystalline cellulose and carboxymethyl cellulose sodium (15%), with viscosity of 102.6 cps
Silica, colloidal anhydrous
Maize starch
Hydroxypropyl cellulose 7.39 mPas
Sodium benzoate (E211)
Anhydrous citric acid
Aspartame (E951)
Artificial banana flavour spray dry
Iron oxide, yellow (E172)
Sucrose

Pack sizes and marketing

The powder for oral suspension is packed in 75 cc HDPE heavy weight bottle for 50 mL and 150 cc HDPE heavy weight bottle for 100 mL with child resistant polypropylene closure and heat induction foil innerseal.

Cardboard box contains one (1) bottle, 12.5 mL oral syringe, graduated in kg, 10 mL oral syringe graduated in mL, graduated measuring cup for preparation of suspension and an instruction leaflet. Each bottle of 50 mL contains 32.40 g powder for the reconstitution of 54.0 mL of oral suspension and each bottle of 100 mL contains 64.8 g powder for the reconstitution of 108 mL oral suspension.

Also available in a combined pack size of 2 × 100ml bottles (200 ml).

Not all pack sizes may be marketed.

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