An Overview of Fixed Dose Combination of B-Vitamins and Diclofenac

An Overview of Fixed Dose Combination of B-vitamins and Diclofenac
Dr Risa Anwar Medical Director PT Merck TbK
The Fixed Dose Combination
Dolofenac I RA I 2011
DOLOFENAC
Tiap tablet enteric coated DOLOFENAC mengandung :
Diclofenac sodium Thiamine mononitrate (vit B1) Pyridoxine HCl (vit B6) Cyanocobalamin (vit B12)
50 mg 50 mg 50 mg 1 mg
Pemakaian Klinis
Nyeri Back pain Neck pain Arm pain Radiculitis Carpal tunnel syndrome Fibromyalgia
Peripheral neuropathy karena berbagai sebab Alcoholic neuropathy Diabetic neuropathy
Neuralgia
Facial neuralgia Trigeminal neuralgia Intercostal neuralgia
Spondylitis
Herpetic neuralgia
Dosis & cara pemberian 3 x 1 tablet /hari setelah makan

4 Dolofenac I RA I 2011
Rationale Fixed Dose Combination Diclofenac & Neurotropik Vitamin ?
Dolofenac : DMAA Double Mechanism of Analgesic Action

Kombinasi 2 obat
yang bekerja pada reseptor berbeda dengan mekanisme berbeda akan : memperkuat efek analgesik mengurangi efek samping
Nyeri lebih cepat hilang Durasi terapi lebih singkat Efek samping minimal
Dolofenac & Mixed Pain Concept

( Baron & Binder,2004 dan Junker,2004)
Terdapat continuum antara
Nyeri akut
nyeri kronik
Nyeri nosiseptif
nyeri neuropatik
Mengapa Diclofenac ?
DICLOFENAC the preferential NSAIDs
Mengapa Neurotropik Vitamin Vitamin B1- B6 - B12 ?
10
Vitamin Neurotropik pada Penanganan Nyeri
Vitamin B1, B6, B12 :

efek anti-nosiseptif / anti-inflammasi
efek anti neuropatik melalui efek fisiologis vitamin B pada sistim saraf
11
Penelitian Preklinis Animal Models of Pain & Inflammation

Thermal Pain Mechanical Pain Chemical Pain
Paw & Tail Flick Test, Heat Coil Test Paw & Tail Pressure Test Writhing Test, Formalin Test, Capsaicin Test
Inflammatory Pain Neuropathic Pain

Formalin Test, Carrageenan Test Peripheral Nerve & Spinal Cord Injury, Streptozotocin Diabetes
Vitamin B complex attenuates hyperalgesia in neuropathic rats

Wang et al, Pain 114, 2005
Hyperalgesia Attenuation of hyperalgesia may be related to protection by B Vitamins from delayed apoptosis of nerve cells
Vitamin B12 downregulates sciatic TNF- in STZ diabetic rats

Figure 7: TNFa levels in rat sciatic nerve
350 Control 300 Diabetic
pg/mg protein
250 200 150 100 50 0 S+P groups
Diabetic + methylcobalamin 0.3 mg/kg 1 mg/kg Diabetic + methylcobalamin 1 mg/kg 3 mg/kg Diabetic + methylcobalamin 3 mg/kg Diabetic + C yanocobalamin 0.3 mg/kg mg/kg Diabetic1+ C yanocobalamin 1 mg/kg Diabetic + C yanocobalamin 3mg/kg
TNF- is upregulated in CSF of B12 deficient rats & humans

Scalabrino et al 2003
B Vitamins Reduced Tactile Allodynia in Streptozotocin-Induced Diabetic Rat

Test on Day 7 of Administration of B1, B6, and B12
16 14 Tactile Allodynia 50% Response Threshold mean + SEM [g] 12 10 8 6 4 2 0
Allodynia
non-diabetic control
diabetic control
B1 B6 B12
diabetic + 20 20 0.2
diabetic + 60 60 0.6
diabetic + 180 mg/kg 180 s.c. 1.8
15
Regenerasi Axons N. Saphenus

10 hari setelah kerusakan karena dingin %
Axons covered with myelin sheaths
70 60 50 40 30 20 10 0 Regenerating Degenerating not assigned
B Vitamins Control
16
Manfaat Vitamin Neurotropik pada Polineuropati Diabetes
17
Manfaat Vitamin Neurotropik pada Mixed Pain

Cervical and Lumbar Degenerative Disease
Open Randomized, 20 Hospitalized Patients (Destito et al., 1988)
Physical Ability No of Patients

12
Mean Score (0 = normal, 5 = impossible
16
Physical Disability
8 Impossible
Medium
Normal
0 before treatment after treatment
0 before day 3 day 6 day 10 treatment of treatment
1 daily i.m. Injection for 10 Days;

50 mg B1, 300 mg B6, 0.5 mg B12
Vitamin Neurotropik : Mencegah relaps pada acute pain
19
Vitamin Neurotropik : Mencegah relaps pada reccurent pain
20
s Dolofenac
Evidence Based
21
Dolofenac pada Mixed Pain- Nyeri Lebih Cepat Hilang
Lumbar Low back pain

Double Blind, 252 Patients (Vetter et al., 1988)
Hari ke 7 Sharpness Rhythm
0 -1
Akhir terapi Sharpness Rhythm
Mean Difference [Hoppe Pain Questionnaire]
-2 -3 -4
-5
-6 -7 -8 -9 -10
3x Diclofenac 50 mg/d
3x Diclofenac + B1 + B6 + B12 50 50 50 0.25 mg/d
22
Dolofenac pada Mixed Pain - Nyeri Lebih Cepat Hilang
Cervical & Lumbar Degenerative Disease

Double Blind, 190 Patients (Lettko, 1988)
Day 7 Sharpness
0 -2 -4 -6 -8 -10
Rhythm
End of Treatment Sharpness Rhythm
Mean Difference [Hoppe Pain Questionnaire]
* * *
-12
*
-14
3x Diclofenac + B1 + B6 + B12 50 100 100 1 mg/d
Dolofenac pada Mixed Pain - Nyeri Lebih Cepat Hilang
Lumbar Degenerative Disease

Double Blind, 122 Patients (Kuhlwein et al., 1990)
70
Mean Pain Score [mm on Visual Analogue Scale]
Pain at Day
Pain at Night
60
50
40 30 20 10 0
N=61 each
before
N=61 each
Day 3-4
N= 25 33
Day 7
N=61 each
before
N=61 each
Day 3-4
N= 25 33
Day 7
24
3x Diclofenac + B1 + B6 + B12 75 50 50 0.25 mg/d
Nyeri Lebih Cepat Hilang Terapi Lebih Singkat
25
Nyeri Lebih Cepat Hilang Lebih Cepat Kembali Bekerja
26
Nyeri Lebih Cepat HilangDosis Diclofenac lebih sedikit
Post-Operative Pain (Amygdalatomy)

Double Blind, 9 Patients (Medina et al., unpublished) Diclofenac on demand, Vitamins (100 mg B1+B6, 5 mg B12) i.v./12h
300 8
Diclofenac [mg/d] i.v.
Pain Perception [Visual Analog Scale]
200
*
100
0 Diclofenac Alone
0 Diclofenac + B Vitamins Initial 24 h 48 h
Keamanan
Pengalaman pasien dengan komponen Dolofenac : Neurobion telah dipakai lebih dari 5,4 juta pasien per tahun Lebih dari 18.000 pasien telah ikut dalam studi terkontrol dengan Diklofenak & lebih dari 85.000 dalam open studi
Pengalaman dengan Dolofenac 6649 pasien dengan penyakit rematik telah diobati dengan Dolofenac dalam open studi & lebih dari 450 pasien dalam studi terkontrol dibandingkan diklofenak
28
Efek Samping
Efek samping :
Nyeri lambung Sakit kepala, vertigo Insomnia Hipersensitivitas kulit
29
Kontra Indikasi
Hipersensitif terhadap salah satu kandungan Ulkus Gastroduodenal / peptikum Pasien dengan episode asma bronkial, urtikaria atau rinitis yang serangannya dicetuskan oleh asam asetil salisilat & turunannya Hamil & menyusui
30
Ringkasan
Fixed dose combination Vitamin Neurotropik + Diklofenak dalam 1 tablet 1. Double Mechanism of Analgesic Action :
efikasi analgesik meningkat

nyeri lebih cepat hilang dosis diklofenak lebih sedikit kejadian efek samping lebih minimal 2. Bermanfaat untuk nyeri nociseptif, neuropatik & mixed pain 3. Mudah dan nyaman untuk pasien
Terima Kasih atas Perhatiannya
32

An Overview of Fixed Dose Combination of B-Vitamins and Diclofenac

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Drepturi de autor:

Formate disponibile

An Overview of Fixed Dose Combination of B-vitamins and Diclofenac

Dr Risa Anwar Medical Director PT Merck TbK

The Fixed Dose Combination

Dosis & cara pemberian 3 x 1 tablet /hari setelah makan

Rationale Fixed Dose Combination Diclofenac & Neurotropik Vitamin ?

Dolofenac : DMAA Double Mechanism of Analgesic Action

Dolofenac & Mixed Pain Concept

Terdapat continuum antara

DICLOFENAC the preferential NSAIDs

Mengapa Neurotropik Vitamin Vitamin B1- B6 - B12 ?

Vitamin Neurotropik pada Penanganan Nyeri

Vitamin B1, B6, B12 :

Penelitian Preklinis Animal Models of Pain & Inflammation

Inflammatory Pain Neuropathic Pain

Vitamin B complex attenuates hyperalgesia in neuropathic rats

Vitamin B12 downregulates sciatic TNF- in STZ diabetic rats

250 200 150 100 50 0 S+P groups

TNF- is upregulated in CSF of B12 deficient rats & humans

B Vitamins Reduced Tactile Allodynia in Streptozotocin-Induced Diabetic Rat

diabetic + 180 mg/kg 180 s.c. 1.8

Regenerasi Axons N. Saphenus

Manfaat Vitamin Neurotropik pada Polineuropati Diabetes

Manfaat Vitamin Neurotropik pada Mixed Pain

Physical Ability No of Patients

Mean Score (0 = normal, 5 = impossible

0 before treatment after treatment

0 before day 3 day 6 day 10 treatment of treatment

1 daily i.m. Injection for 10 Days;

50 mg B1, 300 mg B6, 0.5 mg B12

Vitamin Neurotropik : Mencegah relaps pada acute pain

Vitamin Neurotropik : Mencegah relaps pada reccurent pain

Dolofenac pada Mixed Pain- Nyeri Lebih Cepat Hilang

Lumbar Low back pain

Akhir terapi Sharpness Rhythm

Mean Difference [Hoppe Pain Questionnaire]

3x Diclofenac + B1 + B6 + B12 50 50 50 0.25 mg/d

Dolofenac pada Mixed Pain - Nyeri Lebih Cepat Hilang

Cervical & Lumbar Degenerative Disease

End of Treatment Sharpness Rhythm

Mean Difference [Hoppe Pain Questionnaire]

3x Diclofenac + B1 + B6 + B12 50 100 100 1 mg/d

Dolofenac pada Mixed Pain - Nyeri Lebih Cepat Hilang

Lumbar Degenerative Disease

Mean Pain Score [mm on Visual Analogue Scale]

3x Diclofenac + B1 + B6 + B12 75 50 50 0.25 mg/d

Nyeri Lebih Cepat Hilang Terapi Lebih Singkat

Nyeri Lebih Cepat Hilang Lebih Cepat Kembali Bekerja

Nyeri Lebih Cepat HilangDosis Diclofenac lebih sedikit

Post-Operative Pain (Amygdalatomy)

Diclofenac [mg/d] i.v.

Pain Perception [Visual Analog Scale]

0 Diclofenac + B Vitamins Initial 24 h 48 h

efikasi analgesik meningkat

Terima Kasih atas Perhatiannya

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