Chapter 1: Catafly PKN

Key learning objectives

On ompletion of this Chapter, you should be able to:

Understand Catafly pharmacokinetics & pharmacodynamics Define Catafly Dosage & Indications Explore the role of Catafly as antipyretic, analgesic &antiinflammatory

Explore Catafly competitors

Catafly Pharmacokinetics & Pharmacodynamics

Catafly Pharmacokinetics
Mean peak plasma

2.7 mol/L reached in 30 min.

AUC
Protein binding

Half that of injection

99.7%

T1/2

1-2 hours

Site of inflammation

8 hours 60% Kidney 40% Liver

Excretion

Catafly Pharmacodynamics
Inhibits prostaglandin (PG) biosynthesis. Which largely contribute to causation of inflammation, pain and fever. A non-steroidal compound with pronounced anti-inflammatory, analgesic and antipyretic properties.

Catafly Dosage & Indications

Catafly Composition
Each 1 ml of

Contains 1.8 mg Diclofenac Free Acid equivalent to 2 mg of Diclofenac K .

Dosage:
Chlidern one year and over. Dividing the body weight by 4 (2-3 times/daily) Body weight 10 Kg 20 Kg 30 Kg 40 Kg Dose (2-3 times/daily) 2.5 ml 5 ml 7.5 ml 10 ml

Catafly indications:
As an adjuvant in severe painful infections of the ear, nose or throat, e.g. pharyngotonsilitis, otitis, in keeping with general therapeutic principles, the underlying disease should be treated with basic therapy. (fever alone is not an indication.)

Catafly offers for URTI control the fever 2hrs

control the inflammation 2days control the pain 30min

Catafly as antipyretic,analgesic&anti-iflammatory
Antipyretic effect of Catafly 1. Controlling fever in 2 hours

Analgesic effect of Catafly

2. Rapid analgesic within 30 min

Anti-inflammatory effect of Catafly 3. Relief inflammatory symptoms in 2 days

Potent anti-inflammatory that improves nd symptoms by the 2 day

Catafly Clinical Trials

Efficacy of Catafly in AOM
Objective: To assess efficacy of Catafly in acute otitis media. Design: 51 patients with acute otitis media (25 pts receiving Diclofenac t.i.d, 26 pts receiving placebo t.i.d) over 7 days All patients were also treated with amoxicillin 30mg/Kg/d 59% of children were males Efficacy & Safety assessed before treatment, at day 2&at day 7

Results: On day 2 Fever

84% of patients in the diclofenac group were free of fever at day 2, compared to only 23% of patients on placebo. (p<0.01)
% of Fever Free Patients at Day 2
90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

84%

23%

Catafly

Placebo

 Ear pain
After 2 days, ear pain had disappeared in 40% of patients on diclofenac but in

none of the patients on placebo (p<0.01).

% of pain Free Patients at Day 2
45% 40% 35% 30% 25% 20% 15% 10% 5% 0%

40%

0%
Catafly Placebo

on day 7 pain
After 7 days 76% of patients were pain-free on diclofenac compared to 36% on placebo (p<0.01).
% of pain Free Patients at Day 7
80% 70% 60% 50% 40% 30% 20% 10% 0%

76%

36%

Catafly

Placebo

 Efficacy assessment
The overall assessment of efficacy at day 7 showed excellent or good results in 96% of Diclofenac treated patients compared to 32% in placebo (p0.001)
120% 100%

96%

% of Patients

80% 60% 40% 20% 0%

32%

Catafly

Placebo

Conclusion
Diclofenac showed a statistically significant better outcome at day 2 and/or day 7 for all efficacy parameters, except for discharge (the latter still showing trends in favor of diclofenac). Side effects were reported in 4 patients on diclofenac (diarrhoea, epigastric pain, vomiting) and in 5 patients on placebo (diarrhoea, hypothermia, vomiting).

Cooperative study
Objective:
Investigation of using Diclofenac in treatment of inflammatory disorders in children.

Design: Pediatric multicenter study.

4,423 children were suffering from acute ENT disorders, mostly tonsillitis (40%), otitis (22%) or pharyngitis (12%).

The children were treated with Diclofenac for five days. Results:
Pain, fever, and dysphagia rapidly disappeared in over 95% of patients. Side effects were reported in 7.8% of patients, the majority related to gastrointestinal tolerability (> 70%) and of mild or moderate intensity (95.5%). Overall tolerability at the end of the study was rated as excellent or good in 96% of patients.

Catafly: Fastest Fever Reduction

Objective:
Comparing the rapid onset in body temperature reduction & efficacy of Diclofenac& Ibuprofen in children 1 to 6 years of age.

Design:
300 patients with body temperatures up to 39.5 C. Oral syrup forms were used as follows: Diclofenac: 1.8 mg/ml. Ibuprofen: 5-10 mg/Kg. Body Temperature was measured at 20, 30, 45, 60, 90 &120 Mins.

Results: Rectal Temperature after 20 minutes of drug adminstration

Ibuprofen
0.00 Average Reduction in Rectal Temperature -0.10 -0.20 -0.30 -0.40 -0.50 -0.60

Catafly

-0.36

P value = 0.0015

-0.58

Efficacy Assessment by Patient & Physician

Parents assessment
(p < 0.01 for Diclofenac vs. Ibuprofen).

Doctors assessment

About 90% of parents and physicians assessed Catafly as effective treatment in reducing fever.

Catafly Competitors Brufen Syrup (Ibuprofen)

Efficacy: Catafly is superior to Brufen as o Antipyretic o Analgesic o Anti-inflammatory Safety: Catafly is superior to Brufen

Efficacy Antipyretic effect:

Catafly is faster in fever reduction than ibuprofen. (Catafly reduces body temperature by 0.58,while Ibuprofen reduces by 0.36 in 20 minutes)

Anti-inflammatory effect:

Catafly improves inflammatory symptoms within 2 days. Ibuprofen is a Weak Anti-inflammatory.

 Analgesic effect
T max of Brufen Syrup is 1.6 h. (Slow onset of action)

Safety
Ibuprofen is 79% is eliminated through the urine. Has a Longer plasma half-life: 4-5 hours.

Cetal (Paracetamol)

o Its not an anti-inflammatory o Its just analgesic & antipyretic o Not effective for more than 38.5 C , Catafly Up to 39.5 C o Cetal has a very bad taste (not suitable for children)