Welcome To Pediatro

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 &anti-inflammatory

Explore Catafly competitors

Catafly Pharmacokinetics

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.

2.7 µmol/L reached in 30 min.

Half that of injection

99.7%

1-2 hours

8 hours

60% Kidney40% Liver

Mean peak plasma

AUC

Protein binding

T1/2

Site of inflammation

Excretion

Catafly Pharmacokinetics & Pharmacodynamics

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 Dose (2-3 times/daily)10 Kg 2.5 ml20 Kg 5 ml30 Kg 7.5 ml40 Kg 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 Dosage & Indications

Antipyretic effect of Catafly

1. Controlling fever in 2 hours

Analgesic effect of Catafly

2. Rapid analgesic within 30 min

Catafly as antipyretic,analgesic&anti-iflammatory

F

Anti-inflammatory effect of Catafly

3. Relief inflammatory symptoms in 2 days

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

Efficacy of Catafly in AOMObjective: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)

Catafly Placebo0%

10%

20%

30%

40%

50%

60%

70%

80%

90% 84%

23%

% of Fever Free

Patients at

Catafly Clinical Trials

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

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

Catafly Placebo0%5%

10%15%20%25%30%35%40%45% 40%

0%

on day 7

pain

After 7 days 76% of patients were pain-free on diclofenac compared to 36% on placebo (p<0.01).

Catafly Placebo

0%

10%

20%

30%

40%

50%

60%

70%

80% 76%

36%

% of pain Free

Patients at

% of pain Free

Patients at

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 (p˂0.001)

Catafly Placebo0%

20%

40%

60%

80%

100%

120%

96%

32%

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).

% of Patients

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 Catafly

-0.60

-0.50

-0.40

-0.30

-0.20

-0.10

0.00

-0.36

-0.58

Ave

rage

Red

ucti

on in

Rec

tal T

empe

ratu

re

P value = 0.0015

Efficacy Assessment by Patient & Physician

(p < 0.01 for Diclofenac vs. Ibuprofen).

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

Parent’s assessment Doctor’s assessment

Brufen Syrup (Ibuprofen)

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.

Catafly Competitors

Efficacy: Catafly is superior to Brufen as o Antipyretico Analgesico Anti-inflammatory

Safety: Catafly is superior to Brufen

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 It’s not an anti-inflammatory

o It’s 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)