Sekarang ati ati kalo mengkonsumsi obat emplu (baca : flu),
Ini ada berita baru bahwa obat flu yg mengandung Phenylpropanolamine
(spt Decolgen, Stop Cold,dsb) harus ditarik dari peredaran karena bisa
menyebabkan stroke.
Di singapore akan ditarik dan di Amerika sudah ditarik. Jadi hati-hati kalau
mengkonsumsi obat flu yang mengandung bahan tsb.
Daftarnya ada dibawah
semoga bermanfaat...
NATIONAL PHARMACEUTICAL ADMINISTRATION
Ministry of Health
2 Jalan Bukit Merah Singapore 169547
http://www.gov.sg/moh/npa/index.html
HEALTHCARE PROFESSIONAL CIRCULAR NO.1/2000
14 November 2000
Dear Health Care Professional
WITHDRAWAL OF PHENYLPROPANOLAMINE (PPA) PRODUCTS
The Ministry of Health has asked all pharmaceutical companies marketing
products containing phenylpropanolamine (PPA) to voluntarily withdraw and discontinue
the distribution of these products in Singapore.
This is a precautionary measure in line with the recent call by the US Food and Drug
Administration (FDA) for voluntary discontinuation of marketing of such products in
the USA.
Phenylpropanolamine (PPA) is a sympathomimetic agent, commonly found in
cough, cold and allergy medications. It is classified as a Pharmacy Medicine in
Singapore.
In the United States, PPA is popular as an over-the-counter cough and cold medicine as
well as a slimming agent.
Case reports have linked exposure to PPA to the occurrence of haemorrhagic stroke.
Many of the affected patients have been young women using PPA as an
appetite suppressant, often after a first dose.
To further examine the association between PPA and haemorrhagic stroke, the Yale
University Medical School designed a case-control study involving men and women ages
18 to 49 years who were hospitalised with a subarachnoid haemorrhage (SAH) or
intracerebral haemorrhage (ICH). Eligible case subjects had no prior history of stroke
and were able to participate in an interview within 30 days of their event.
Case subjects were recruited from hospitals in 4 geographic regions of the United
States.
The final study cohort comprised 702 case subjects who were matched by
demographic characteristics with 1,367 controls who had not had strokes.
Age matching was successful for 1,367 controls (99%) and ethnicity matching was
achieved for 1,321 controls (96%). For the association between haemorrhagic stroke and
any use of PPA within 3 days, the adjusted odds ratio was 1.49 (lower limit of the
one-sided 95% confidence interval (LCL) = 0.93, p =0.084).
For the association between haemorrhagic stroke and PPA use in
cough/cold remedies within the 3-day exposure window, the adjusted odds
ratio was 1.23 (LCL = 0.75, p = 0.245).
For the association between haemorrhagic stroke and PPA use in appetite suppressants
within the 3-day exposure window, the adjusted odds ratio was 15.92 (LCL = 2.04, p =
0.013).
For the association between PPA in appetite suppressants and risk for
haemorrhagic stroke among women, the adjusted odds ratio was 16.58
(LCL = 2.22, p = 0.011).
For first dose PPA uses among women, the adjusted odds ratio was 3.13 (LCL = 1.05, p =
0.042).
All first dose PPA use involved cough/cold remedies.
In conclusion, the results of the HSP suggest that PPA increases the risk for
haemorrhagic stroke.
The HSP is a case control study and there are limitations for definitive conclusions.
However, the overall assessment was that the study was well-designed and executed. All
reasonable steps were taken to minimise bias and confounding.
The Ministry has also considered the HSP report in the context of the spontaneous
reports of haemorrhagic stroke received by the US FDA during the period 1991 - 2000.
Although the risk of haemorrhagic stroke is very low, the Ministry has significant
concerns because of the seriousness of this adverse event (the irreversible outcome)
and the inability to predict who is at risk. The Ministry does not consider the
conditions for which PPA is used as justifying the risk of this serious event as
alternative cough and cold medications which do not contain PPA are available for use.
All doctors and pharmacists are advised not to prescribe or sell
PPA-containing medications to patients. Please also reassure your patients that there
is no risk of adverse effects once PPA-containing products are no longer being taken.
Patients who have previously taken PPA-containing products also do not have to be
worried about their health as there are no long term adverse effects from
PPA-containing products.
The list of PPA-containing cough and cold remedies available in Singapore is enclosed
at Annex.
If you need further clarification, please contact Ms Chan Cheng Leng, Head ation &
Research) Unit, National Pharmaceutical Administration, at
telephone 3255610
Yours sincerely
DR JOHN LIM
DIRECTOR
NATIONAL PHARMACEUTICAL ADMINISTRATION
MINISTRY OF HEALTH
cc:
President, SMA
President, PSS
Master, Academy of Me
Annex
Combination Products Containing PPA in Singapore
S/No. Name of Product Active Ingredients Strength
1 ACCOL TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 4 mg
PHENYLPROPANOLAMINE HCl 25 mg
2 ALLERIN EXPECTORANT DIPHENHYDRAMINE HCl 12.5 mg/5 ml
GUAIPHENESIN 50 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
SODIUM CITRATE 180 mg/5 ml
3 ANTIKOF SYRUP TRIMEPRAZINE TARTRATE 2.5 mg/5 ml
PHENYLPROPANOLAMINE HCl 10 mg/5 ml
GUAIPHENESIN 25 mg/5 ml
IPECACUANHA TINCTURE 0.015 ml/5 ml
4 BEACOGEN TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
DEXCHLORPHENIRAMINE MALEATE 1 mg
5 BEAFLU TABLETS PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 2 mg
PHENYLPROPANOLAMINE HCl 25 mg
6 BROMANATE ELIXIR BROMPHENIRAMINE MALEATE 2 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
7 COLD SPECIAL SYRUP BROMPHENIRAMINE MALEATE 2 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
8 COLDACHE TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 15 mg
CHLORPHENIRAMINE MALEATE 2 mg
9 CONTAC 400 CAPSULE PHENYLPROPANOLAMINE HCl 50 mg
CHLORPHENIRAMINE MALEATE 4 mg
10 CORITAB TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 25 mg
CHLORPHENIRAMINE MALEATE 2 mg
11 CORITUSSAL SYRUP DEXTROMETHORPHAN 120 mg/100 g
PHENYLPROPANOLAMINE 300 mg/100 g
CARBINOXAMINE 24 mg/100 g
12 COUGH SPECIAL SYRUP TRIPROLIDINE HCl 1.25 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
CODEINE PHOSPHATE 10 mg/5 ml
S/No. Name of Product Active Ingredients Strength
13 CTP COUGH FORMULA TRIPROLIDINE HCl 1.25 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
CODEINE PHOSPHATE 10 mg/5 ml
14 DE- COLD ELIXIR BROMPHENIRAMINE MALEATE 4 mg/10ml
PHENYLPROPANOLAMINE HCL 25 mg/10ml
15 DECOLDIN TABLET PARACETAMOL 480 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
CHLORPHENIRAMINE MALEATE 2 mg
16 DECOLGEN FORTE TABLET ACETAMINOPHEN 500 mg
PHENYLPROPANOLAMINE HCl 25 mg
CHLORPHENIRAMINE MALEATE 2 mg
17 DECOLGEN LIQUID ACETAMINOPHEN 300 mg/15 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/15 ml
CHLORPHENIRAMINE MALEATE 1 mg/15 ml
18 DECOLGEN TABLET ACETAMINOPHEN 300 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
CHLORPHENIRAMINE MALEATE 1 mg
ASCORBIC ACID 25 mg
19 DELIX PAEDIATRIC LINCTUS PHENYLPROPANOLAMINE HCl 10 mg/5 ml
PROMETHAZINE HCl 1.5 mg/5 ml
PHOLCODINE CITRATE 1.5 mg/5 ml
20 DEXEDYL LINCTUS DEXTROMETHORPHAN HBr 15 mg/10 ml
PHENYLPROPANOLAMINE HCl 15 mg/10 ml
CHLORPHENIRAMINE MALEATE 2 mg/10 ml
21 DHAFLU TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 3 mg
PHENYLPROPANOLAMINE HCl 20 mg
CAFFEINE ANHYDROUS 30 mg
22 DIMETAPP ELIXIR PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
BROMPHENIRAMINE MALEATE 2 mg/5 ml
23 DIMETAPP EXTENTABS BROMPHENIRAMINE MALEATE 12 mg
PHENYLPROPANOLAMINE HCl 75 mg
24 DYNACOLIN TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 25 mg
CHLORPHENIRAMINE MALEATE 4 mg
25 EAZKOFF COUGH AND COLD LINCTUS PHENYLPROPANOLAMINE HCl 10 mg/5 ml
TRIMEPRAZINE TARTRATE 2.5 mg/5 ml
GUAIPHENESIN 25 mg/5 ml
S/No. Name of Product Active Ingredients Strength
26 FEBRICOL ELIXIR PARACETAMOL 162.5 mg/5 ml
CHLORPHENIRAMINE MALEATE 1 mg/5 ml
PHENYLPROPANOLAMINE HCl 6.25 mg/5 ml
27 FEBRICOL TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 15 mg
CHLORPHENIRAMINE MALEATE 2 mg
28 FLU FORTE SYRUP CHLORPHENIRAMINE MALEATE 4 mg/5 ml
PHENYLPROPANOLAMINE HCl 25 mg/5 ml
29 FLUTAMIN COLD FORMULA CHLORPHENIRAMINE MALEATE 4 mg/5 ml
PHENYLPROPANOLAMINE HCl 25 mg/5 ml
30 GUARDIAN COUGH & COLD SYRUP GUAIFENESIN 50 mg/5 ml
PHENYLPROPANOLAMINE HCl 6.25 mg/5 ml
31 MEHISDIN SYRUP CHLORPHENIRAMINE MALEATE 2 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
SODIUM CITRATE 40 mg/5 ml
32 MENDICOF SYRUP DEXCHLORPHENIRAMINE MALEATE 2 mg/5 ml
DEXTROMETHORPHAN HBr 15 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
33 MILIDON-CO TABLET CHLORPHENIRAMINE MALEATE 2 mg
PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
34 NASATAB TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 4 mg
PHENYLPROPANOLAMINE HCl 25 mg
35 NOBIS TABLET BROMPHENIRAMINE MALEATE 4 mg
PHENYLPROPANOLAMINE HCl 25 mg
36 P3 COUGH SYRUP PHOLCODINE 3 mg/5 ml
PROMETHAZINE HCl 3 mg/5 ml
PHENYLPROPANOLAMINE HCl 6 mg/5 ml
37 PAEDICOF SYRUP DEXCHLORPHENIRAMINE MALEATE 0.5 mg/5 ml
DEXTROMETHORPHAN HBr 5 mg/5 ml
PHENYLPROPANOLAMINE HCl 6.25 mg/5 ml
38 PANAFLU PLUS TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 2 mg
PHENYLPROPANOLAMINE HCl 25 mg
CAFFEINE ANHYDROUS 15 mg
39 PANAFLU TABLET PARACETAMOL 300 mg
CHLORPHENIRAMINE MALEATE 2 mg
PHENYLPROPANOLAMINE HCl 25 mg
S/No. Name of Product Active Ingredients Strength
40 PARAMINE TABLET PARACETAMOL 500 mg
PHENYLPROPANOLAMINE HCl 15 mg
CHLORPHENIRAMINE MALEATE 2 mg
41 PARCLORPHEN TABLET PARACETAMOL 300 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
CHLORPHENIRAMINE MALEATE 2 mg
42 PEDILIX COUGH LINCTUS PROMETHAZINE HCl 1.5 mg/5 ml
PHOLCODINE 1.5 mg/5 ml
PHENYLPROPANOLAMINE HCl 10 mg/5 ml
43 PROFLU TABLET PARACETAMOL 300 mg
CHLORPHENIRAMINE MALEATE 1 mg
PHENYLPROPANOLAMINE Hcl 12.5 mg
ASCORBIC ACID 25 mg
44 RHINOPRONT SYRUP PHENYLPROPANOLAMINE 300 mg/90 ml
CARBINOXAMINE 24 mg/90 ml
45 ROBITUSSIN-CF SYRUP GUAIPHENESIN 100 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/ 5ml
DEXTROMETHORPHAN HBr 10 mg/5 ml
46 SINUZIN-D TABLETS PARACETAMOL 325 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
CHLORPHENIRAMINE MALEATE 2 mg
47 SYNCOLDTAB-M TABLET PHENYLPROPANOLAMINE HCl 25 mg
CHLORPHENIRAMINE MALEATE 2 mg
48 TEMPRO SUSPENSION PARACETAMOL 250 mg/5 ml
PHENYLPROPANOLAMINE HCl 10 mg/5 ml
CHLORPHENIRAMINE MALEATE 2 mg/5 ml
49 TRIPRO SYRUP TRIPROLIDINE HCl 1.25 mg/5 ml
PHENYLPROPANOLAMINE HCl 12.5 mg/5 ml
50 UNIRHINOL FORTE TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 4 mg
PHENYLPROPANOLAMINE HCl 25 mg
51 UNIRHINOL TABLET PARACETAMOL 500 mg
CHLORPHENIRAMINE MALEATE 2 mg
PHENYLPROPANOLAMINE HCl 25 mg
52 UPHAMIN CAPSULE PARACETAMOL 250 mg
CHLORPHENIRAMINE MALEATE 2 mg
PHENYLPROPANOLAMINE HCl 12.5 mg
53 WALEKOF SYRUP TRIMEPRAZINE TARTRATE 2.5 mg/5 ml
PHENYLPROPANOLAMINE HCl 10 mg/5 ml
GUAIPHENESIN 25 mg/5 ml
Thanks
Doddy Mulyadi
Supply Chain Dept
Philips Ralin Electronics
Jl. Berbek Industri I kav. 5 - 19
Sidoarjo 61256
Phone 62-031-8491674 ext. 234
Fax 62-031-8437561
E-mail : [EMAIL PROTECTED]
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