CP 50 ml. Suspension

CP 50 ml. susp

COMPOSITION

CP 200 tablet: Each film-coated tablet contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 200 mg.

CP powder for suspension: After reconstitution each 5 ml suspension contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 40 mg.

CP Paediatric Drops : After reconstitution each ml suspension contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 20 mg.

INDICATIONS

CP (Cefpodoxime Proxetil) is indicated in the following diseases: -

(1) Lower respiratory tract infections: Acute community-acquired pneumonia, Acute bacterial exacerbation of chronic bronchitis;

(2) Upper respiratory tract infections: Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsillitis;

(3) Sexually transmitted diseases: Acute uncomplicated urethral & cervical gonorrhea, Acute ano-rectal infection in woman caused by N. gonorrhoeae;

(4) Uncomplicated urinary tract infections: Cystitis;

(5) Skin & soft tissue infections: Furuncle, Cellulitis, Subcutaneous abscess, Infectious atheroma & Periproctal abscess.

(6) Childhood infections.

DOSAGE AND ADMINISTRATION

CP (Cefpodoxime Proxetil) tablet should be administered orally with food to enhance absorption.

CP (Cefpodoxime Proxetil) suspension may be given without regard to food. The recommended doses, durations of treatment, applicable patient populations are as below:

Child:

15 days -6 months: 4 mg / kg every 12 hours 6 months -2 years: 40 mg every 12 hours 3 -8 years: 80 mg every 12 hours Over 9 years: 100 mg every 12 hours

Patients with renal dysfunction: For patients with severe renal impairment (creatinine clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. Patients with liver cirrhosis: Cefpodoxime proxetil pharmacokinetics in cirrhotic patients are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

OR AS DIRECTED BY THE PHYSICIAN

SIDE-EFFECT

Cefpodoxime has very few side-effects. Possible side effects include gastrointestinal disorders (such as diarrhoea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

PRECAUTION

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other broad spectrum antibiotics, prolonged use of Cefpodoxime proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential.

CONTRAINDICATION

Cefpodoxime is contraindicated in patients with a known allergy to Penicillins, Cefpodoxime or other Cephalosporins group of antibiotics.

USE IN PREGNANCY AND LACTATION

Pregnancy category of Cefpodoxime is B. It was neither teratogenic nor embryocidal in animal trial. There are, however, no adequate and well-controlled studies of Cefpodoxime use in pregnant woman. The drug should be used during pregnancy only if clearly needed. Cefpodoxime is excreted in human milk. A decision should be made wheather to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mothers.

DRUG INTERACTIONS

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma level by 24% to 42% and the extent of absorption by 27% to 32%, respectively. Probenecid: Renal excretion of Cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC. Nephrotoxic drugs: Close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.

OVERDOSAGE

The symptoms following an overdose of Cefpodoxime antibiotic may include nausea, vomiting, epigastric distress and diarrhea.

DIRECTION FOR RECONSTITUTION OF SUSPENSION

First shake the bottle to loosen powder. Add 30 ml (by using the supplied measuring cup) boiled and cooled water to the bottle in two portions, shake well after each addition. Keep the bottle tightly closed. The reconstituted suspension should be kept in a cool and dry place, preferably in refrigerator. Unused portion should be discarded after 14 days.

DIRECTION FOR RECONSTITUTION OF PAEDIATRIC DROPS

Shake the bottle well before adding water to loosen the powder. Add 8 ml (2 spoonful of the supplied spoon) boiled and cooled water to the bottle in two portions. Shake well the bottle after each addition. The reconstituted drops should be kept in a cool and dry place, preferably in refrigerator. Unused portion should be discarded after 14 days.

SUPPLY

CP 200 tablet: Each box contains 2 x 4 tablets in Alu-Alu blister strips.

CP powder for suspension: Each bottle contains Cefpodoxime powder for 50 ml suspension. A 2.5 ml dropper and a 10 ml measuring cup is given.

CP Paediatric Drops : Each bottle contains Cefpodoxime powder for 15 ml Paediatric Drops. A dropper and a spoon is given.