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

Posology

Adults and older people

Not applicable for this product.

Paediatric population

The recommended mean dosage for children is 8 mg/kg/day administered in two divided doses at a 12 hour interval. With the exception of patients with renal insufficiency (see below).

Note that:

• 5 mL of suspension contains the equivalent of 40 mg cefpodoxime.
• 1 mL of suspension contains the equivalent of 8 mg cefpodoxime.

The 10 mL oral syringe is graduated in mL (from 1 mL to 10 mL with 0.5 mL graduations indicated on the syringe).

The 12.5 mL oral syringe is graduated in kg (from 5 to 25 kg, with 1 kg graduations indicated, between 5 and 25 kg, on the syringe) making it possible directly to measure the individual dose of the medicine (one dose of medicine administration) depending on the child’s body weight. The individual dose is provided by reading the body weight marks directly from the syringe.

It is necessary to take two separate doses per day, e.g.: For the 12.5 mL oral syringe, graduation number 12 corresponds to the individual single dose for a child of 12 kg to be administered at 12 hour intervals.

As a guideline, the following information applies for patients with normal renal function:

Infants 4 weeks–3 months: 20 mg (2.5 mL) at 12 hour intervals.

Children 3 months–2 years: 40 mg (5 mL) at 12 hour intervals.

Children 2 years–6 years: 60 mg (7.5 mL) at 12 hour intervals.

Children 6 years–12 years: 80 mg (10 mL) at 12 hour intervals.

In children over 25 kg body weight, using 200 mg/day, the 100 mg film-coated tablets may be used.

Cefpodoxime-Lupin 40 mg/5 mL oral suspension should not be used in infants less than 4 weeks old or from 4 weeks to 3 months with renal insufficiency, as no experience yet exists in this age group.

Hepatic Impairment

The dosage does not require modification in cases of impairment.

Renal Impairment

The dosage of cefpodoxime does not require modification if creatinine clearance exceeds 40 mL/min/1.73m².

Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately.

Duration

The duration of therapy depends on the patient, the indication and the causative pathogen(s). The treatment period is usually 5–10 days.

Method of administration

For oral administration.

This product should be taken during meals for optimal absorption.

For instructions on reconstitution of the product before administration, see section 6.6.

In the event of overdose with Cefpodoxime-Lupin 40 mg/5 mL oral suspension, supportive and symptomatic therapy is indicated.

In cases of overdose, particularly in patients with renal insufficiency, encephalopathy may occur. The encephalopathy is usually reversible once cefpodoxime plasma levels have fallen.

Unreconstituted product: 2 years.

Reconstituted suspension: 10 days stored in a refrigerator (2-8°C).

Unreconstituted product should be stored below 25°C in the original package in order to protect from light/moisture.

For storage conditions after reconstitution, see section 6.3.

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.

The suspension is for oral administration only.

Warning:

• A plastic graduated measuring cup is provided, this serves only to measure the amount of water needed to prepare the suspension.
• After preparing the suspension, the plastic measuring cup should be discarded.
• The graduated plastic measuring cup should never be used to give medicine to the child.

Preparation of suspension:

1. The bottle is vigorously shaken to separate the powder from the bottom of the bottle.
2. The child-resistant cap is opened by exerting pressure on the cap and turning at the same time.
3. The protective foil is removed and the graduated plastic measuring cup filled with water to the mark 27 mL for the 50 mL product and 54 mL for the 100 mL product.
4. The water from the measuring cup is added to the bottle and shaken vigorously so that there is no remaining powder adhering to the walls of the bottle.
5. The graduated plastic measuring cup is filled again with water to the mark 27 mL for the 50 mL product and 54 mL for the 100 mL product and the water added to the bottle.
6. The bottle is shaken vigorously to get an almost white to light yellow homogenous suspension with a distinctive fruity taste.
7. The graduated plastic measuring cup is disposed of.

Shake well before each use.

Close the bottle carefully after each use.

Keep the prepared suspension in the refrigerator (2-8°C), up to 10 days.

The reconstituted suspension is administered by the graduated oral syringe provided. A 10 mL oral syringe, graduated in mL (from 1 mL to 10 mL, with 0.5 mL graduations indicated on the syringe), 12.5 mL oral syringe, gradualted in kg (from 5 to 25 kg, with 1 kg graduations indicated, between 5 and 25 kg, on the syringe) is provided with the Cefpodoxime-Lupin 40 mg/5 mL oral suspension.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.