Ministry ofHealth Malaysia - Kementerian Kesihatan Malaysia

KEMENTERIAN
KESIHATAN
MALAYSIA
Ministry of Health Malaysia
BAHAGIAN
PERKmDMATAN
Pharmaceutical
FARMASI
Services Division
Lot 36, Jalan Universiti, 46350 Petaling Jaya, Selangor, Malaysia
Your Ref/ Ruj. Tuan:
Our Ref/ Ruj. Kami : KKM-55/BPF/103io01/09
Date / Tarikh
.:14 September 2010
Semua Ahli Panel Kajisemula Senarai Ubat-ubatan,
Kementerian Kesihatan Malaysia
Semua Pengerusi JKK Ubat-ubatan KKM
Pengarah,
Biro Pengawalan Farmaseutikal Kebanqsaan
Kementerian Kesihatan Malaysia
Semua Timbalan Pengarah Kesihatan Negeri (Farmasi)
Ketua Pegawai Farmasi,
Hospital Kuala Lumpur.
Y.Bhg. Tan Sri/ Puan Sri/ Datuk/ Dato'/ Datin/ Tuan/ Puan,
PindaanlTambahan Kepada:
1) Formulari Ubat Kementerian Kesihatan Malaysia - Bil 212010
2) Senarai Ubat Klinik 1Malaysia - Bil1/2010
Adalah saya diarahmerujuk perkara di atas dan sukacita memaklumkan bahawa Panel
Kajisemula Senarai Ubat Kementerian Kesihatan Malaysia telah pun menimbangkan
permohonan-permohonan yang diterima untuk pindaan/tambahan kepada
Formulari
Ubat
KKM
dan
Senarai
Ubat
Klinik
1Malaysia. Keputusan-keputusan
pindaan/tambahan adalah seperti yang dilampirkan.
2.
Penggunaanut>at-ubatan yang baru perlu dipantau ciengan rapi dan sebarang
kesan advers dilapQrJ<~nk~pada· MAORAC(Jawatankuasa
Penasihat Kesan Advers
Ubat Kebanqsaanldi 8iroP~ngawalan Farmaseutikal Kebangsaan, Petaling Jaya dan
satu salinan dihantar ke Bahagia.n ini:<'
3.
Penggunaan butiran-butiran yang telah dibatalkan seperti mana terdapat di
lampiran boleh diteruskan sehingga stoknya habis di hospital/institusi masing-masing
atau sehingga stok baru (bagi yang melibatkan ubat gantian) diperolehi.
4.
Harga-harga yanq terdapat di dalam senarai di lampiran adalah harga yang
diberikan ke Bahagian ini untuk menyenaraikan ubat berkenaan ke dalam Formulari
Ubat KKM. Sebarang kelainan harga yang ditawarkan di peringkat hospital/institusi KKM
hendaklah dilaporkan ke Sahagian ini beserta bukti dengan kadar segera supaya
tindakan selanjutnya dapat diambil.
Alamat Surat Menyurat / Correspondence Address
Sea Berkunci No. 924. Peiabat Pos Jalan Sultan. 46790 Petalinq Java. Selanoor. Malavsia.
Jld.11(1.:l.)
5.
Sukacita dapat Y.Shg. Tan Sril Puan Sril Datukl Dato'l Datinl Tuanl Puan
mengambil maklum terhadap ubat-ubatan yang terlibat dan syarat-syarat terhadap
penggunaannya dalam hospital/institusi Kementerian Kesihatan. Kerjasama Y.Shg. Tan
Sril Puan Sril Datukl Dato'l Datinl Tuanl Puan adalah juga diminta untuk memastikan
bahawa maklumat-maklumat mengenai pindaan/tambahan tersebut diedarkan kepada
hospital! institusil klinik kesihatan di negeri masing-masing.
Sekian, terima kasih.
'BERKHIDMAT UNTUK NEGARA'
sa;;~n~ut
perintah,
(~
~INTI A.RAHMAN)
Pengarah Kanan Perkhidmatan Farmasi,
Kementen
.
n Mala sia.
s.k.
1.
Ketua Setiausaha,
Kementerian Kesihatan Malaysia
2.
Pengarah
Sahagian Perkembangan Perubatan
Aras 5-7, Siok E1, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
3.
Pengarah Kawalan Penyakit
Kementerian Kesihatan Malaysia
Aras 3, Siok E10, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putraiaya
4.
Setlausaha Bahaglan (Perolehan & Penswastaan)
Kementerlan Kesihatan Malaysla
Aras 7, Siok fZ7,lDarcell;
Pr~$int 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putraiaya
(u.p Pegawai Farmasi)-
5.
Pengarah,
Pusat Perubatan Universiti Malaya
Petaling Jaya
(u.p Ketua Pegawai Farmasi)
6.
Pengarah,
Hospital Universiti Kebangsaan Malaysia,
Sandar Tun Razak, Kuala Lumpur
(u.p Ketua Pegawai Farmasi)
7.
Pengarah,
Hospital Universiti Sains Malaysia,
Kubang Kerian, Kelantan
(u.p Ketua Pegawai Farmasi)
8.
Pengarah Farmasi,
Sahagian Perkhidmatan Kesihatan
Kementerian Pertahanan Malaysia
Jalan Padang Tembak
50634 Kuala Lumpur
9.
Pegawai Farmasi
Sahagian Pembangunan Kesihatan Keluarga
Aras 5, Siok E6, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
10.
Pengarah
Pusat Darah Negara
Jalan Tun Razak
50400 Kuala Lumpur
(u.p Pegawai Farmasi)
11.
Unit Teknikal Santuan Perubatan
Pejabat Timbalan Ketua Pengarah Kesihatan (Perubatan)
Aras 7, Siok E1, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
12.
Pegawai Farmasi
Sahagian Kesihatan dan Perubatan,
Jabatan Hal Ehwal Orang Asli
KM.24, Jalan Pahang
53100 Gombak, Selangor
13.
Penolonq Pegawai Perpustakaan
Aras 4, Siok E7, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
14.
Penolong Pegawai Perpustakaan
Institut Pengurusan Kesihatan
Kementerian Kesihatan Malaysia
Jalan Sangsar
Kuala Lumpur
15.
Semua Ketua Unit
Sahagian Perkhidmatan Farmasi
anis/azuwana/masitah
TERHAD - Edaran dalaman sahaja
PINDAAN BIL. 2 TAHUN 2010 KEPADA FORMULARI UBAT KKM
1.
BUTIRAN-BUTIRAN YANG DIMANSUHKAN DARI FORMULARI UBAT KKM
No
MDC
Generic Name
Trade Name,
Category,
Dosage
Remarks
1
A05C000920P3001XX
Glucometamine 150 mg
Injection
As in the MOH
formulary
2
A05C000920C1001XX
Glucometamine Capsule
As in the MOH
formulary
Supplier unable to continue with
supply due to ceased production by
manufacturer.
Replacements suggested by
supplier (Hepavite Capsule and
Rawachol Capsule) were not
accepted as they are only
nutraceutics with no evidences of
therapeutic efficacies.
3
M05BB03972T1001XX
Alendronate Sodium
70mg and
Cholecalciferol 2800 IU
Tablet
As in the MOH
formulary
Deletion effective after tender
expires on 2/3/2011.
Reasons:
 Higher dose of cholecalciferol in
line with CPG
 Cost remain the same
2. UBAT–UBAT BARU YANG DILULUSKAN MASUK KE DALAM FORMULARI UBAT KKM
No
MDC
1
A10AB04000
P5001XX
Generic Name
Brand name
Price quoted
Insulin Lispro 100 IU/ml
Injection in Prefilled
syringe/cartridge
(Humalog® 3ml
Cartridge)
Cost
RM110 per box of 5
cartridges
RM22 per 3 ml cartridge
Prescriber
Category
A*
Details
Indication
i) As initial therapy in children with Type 1
diabetes
ii) Type 1 diabetes patients on basal bolus
regimen, not controlled or experience
hypoglycaemia with conventional insulin, to
be used in combination with long-acting
insulin
iii) Type 2 diabetes patients on basal bolus or
premixed regimen, not controlled or
experience hypoglycaemia with
conventional insulin, to be used in
combination with intermediate-acting
insulin or long-acting insulin
iv) Patients with diabetes in pregnancy with
poor postprandial control or experience
hypoglycaemia with conventional shortacting insulin
Dose
Dose to be individualized. The average daily
insulin requirement is between 0.5 to 1.0
units/kg body weight, given within 15 minutes
before meal.
Precaution
Illness or emotional disturbance that increases
insulin requirements, renal or hepatic failure,
activity or diet changes, hypoglycaemia,
transferring from other insulin, children under 12
years old.
PFUKKM
September 2010 -
2/10
1/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Contraindication
In patients with hypersensitivity to insulin lispro
or its excipients and in patients having
episodes of hypoglycaemia
Interaction
Corticosteroids, diuretics, oral contraceptives,
thyroxine may increase insulin requirement.
Oral hypoglycemics, salicylates, sulfa
antibiotics, MAOIs, ACE inhibitors, angiotensin
II receptor blockers (ARB) may intensify
hypoglycemic effect of insulin.
Adverse effect
Injection site reaction (e.g. lipodystrophy,
pruritus, rash), localized allergy (redness,
swelling or itching), generalized allergic
reactions (less common but may be lifethreatening), hypoglycaemia, hypokalaemia.
Rapid changes in serum glucose levels may
induce symptoms of hypoglycemia in persons
with diabetes, regardless of the glucose value.
2
A10AD04000
P5001XX
Insulin Lispro 25% &
Insulin Lispro Protamine
75% 100 IU/ml Injection
in Prefilled
syringe/cartridge
(Humalog Mix25 ® 3ml
Cartridge)
Cost
RM110 per box of 5
cartridges
RM22 per 3 ml cartridge
A*
Indication
Patients with Type 2 diabetes whom
experience hypoglycemia with the use of
human premixed insulin.
Dose
Dose to be individualized. The average daily
insulin requirement is between 0.5 to 1.0
units/kg body weight
Precaution
Transferring from other insulins, emotional
distress, renal or hepatic failure,
hypoglycaemia, diet and activity changes,
children under 12 years.
Contraindication
In patients with hypersensitivity to insulin lispro
Mix or its excipients and in patients having
episodes of hypoglycaemia.
Not for IV administration.
Interaction
Insulin requirements may be increased by oral
contraceptives, corticosteroid or thyroid
replacement therapy. Requirement may be
reduced by oral hypoglycemic agent, salicylate,
sulfa antibiotic & certain antidepressant
(MAOIs), ACE inhibitors, angiotensin II
receptor blockers (ARB) and alcohol.
Adverse effect
Injection site reactions (lipodystrophy, pruritus,
rash), localized allergy (redness, swelling or
itching), generalized allergic reactions (less
common but may be life-threatening),
hypoglycaemia, hypokalaemia. Rapid changes
PFUKKM
September 2010 -
2/10
2/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
in serum glucose levels may induce symptoms
of hypoglycemia in persons with diabetes,
regardless of the glucose value.
3
A10AE05000
P5001XX
Insulin Detemir 100 IU/ml
Injection in Prefilled
syringe/cartridge
A*
(Levemir Flexpen® 3ml)
Cost
RM203.75 per box of 5
pre-filled pens or
RM40.75 per pen or
0.1358 per IU.
Indication
i) Type 1 Diabetes patients on basal bolus
regimen, whom experience hypoglycemia
with conventional insulin, to be used in
combination with rapid or short-acting
insulin.
ii) Type 2 Diabetes patients on oral antidiabetics and basal insulin regimen or
basal bolus insulin regimen whom
experience hypoglycemia with conventional
basal insulin.
Dose
Adult and child over 6 years: Individualised
dose, once or twice daily.
For twice daily dosing, the evening dose can
be administered either with the evening meal,
at bedtime, or 12 hours after the morning dose.
Precaution
Monitor glucose levels in elderly and patients with
renal or hepatic impairment. Transferring from
other insulin types should be done under strict
medical supervision. Concomitant illness
especially infection usually increase insulin
requirement. Do not administer intravenously.
Risk of hyper/hypoglycemia during therapy.
Pregnancy and lactation, children.
Contraindication
Hypersensitivity to insulin detemir or any of its
excipients, hypoglycemia
Interaction
Oral antidiabetics, MAOIs, nonselective βblockers, ACE inhibitors, salicylates, alcohol,
thiazides, glucocorticoids, β-sympathomimetics,
thyroid & growth hormones, danazol,
octreotide/lanreotide.
Adverse effect
Hypoglycaemia, allergic reactions, lipodystrophy,
pruritus, rash, mild injection site reactions,
oedema, weight gain.
4
J01DH04000
P4001XX
Doripenem Monohydrate
500 mg Injection
(Doribax®)
Cost
RM95.50 per vial of
500mg
PFUKKM
A*
Indication
Ventilator-associated
pneumonia
(VAP)
patients at risk or involving multidrug resistant
pathogens
especially
Pseudomonas
aeruginosa infections
Dose
500mg every 8 hours as a one hour infusion for 5
to 14 days according to severity, site of infection
and the patient’s clinical response.
Use in children below 18 years old not
recommended.
September 2010 -
2/10
3/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Precaution
Severe renal impairment, dialysis patients,
consider pseudomembranous colitis (in
patients with diarrhoea while on doripenem).
Avoid prolonged use. Pregnancy & lactation.
Contraindication
Hypersensitivity to other carbapenems, other βlactams (e.g. penicillins or cephalosporins).
Interaction
Valproic acid, probenecid.
Adverse effect
Diarrhoea, headache disorder, nausea,
phlebitis, skin rash, anaemia, pruritus of skin,
vulvovaginal candidiasis, abnormal hepatic
function tests, anaphylaxis, interstitial
pneumonitis, leukopenia, neutropenia,
pseudomembranous enterocolitis, renal
disease, seizure disorder, Stevens-Johnson
syndrome, toxic epidermal necrolysis
5
B01AB10520
P5001XX
Tinzaparin sodium 10,000
anti-Factor Xa IU/ml
Injection in Prefilled
syringe/cartridge
A*
(Innohep ® prefilled
syringe)
Dose
i) Treatment of DVT and PE, in conjunction
with warfarin: 175 anti-Factor Xa IU/kg SC
once daily for at least 6 days
Cost
RM8.43 (0.35ml syringe)
RM11.70 (0.45ml syringe)
6
B01AB10520
P5002XX
Tinzaparin sodium 20,000
anti-Factor Xa IU/ml
Injection in Prefilled
syringe/cartridge
Indication
i) Treatment of deep vein thrombosis (DVT)
and pulmonary embolism (PE), not
amounting to hemodynamic instability.
ii) Prevention of post-operative DVT in
patients undergoing general and
orthopaedic surgery.
A*
ii) Thromboprophylaxis in patients with:
Moderate risk of thrombosis (general
surgery):3,500 anti-Factor Xa IU SC 2 hrs
before surgery and postoperatively, 3,500
anti-Factor Xa IU once daily for 7-10 days.
(Innohep prefilled
syringe®)
High risk of thrombosis (eg. total hip
replacement):4,500 anti-Factor Xa IU SC or
50 anti-Factor Xa IU/kg body weight SC 2 hrs
before surgery and then once daily until the
patients has been mobilized.
Cost
RM27.43 (0.5ml syringe)
RM44.92 (0.7ml syringe)
Precaution
Renal or hepatic impairment, recent cerebral
haemorrhage, trauma, recent surgery to the
central nervous system, concurrent spinal or
epidural anaesthesia, bleeding disorders,
severe thrombocytopenia. Do not administer IM
(risk of haematoma).
Contraindication
Hypersensitivity to sodium bisulfite, treatment
of DVT in patient 90 years old and older with
PFUKKM
September 2010 -
2/10
4/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
renal insufficiency, generalized or local
haemorrhagic tendency, uncontrolled severe
hypertension, acute cerebral insults, septic
endocarditis.
Interaction
Salicylates, NSAIDs, vitamin K antagonists,
dextran.
Adverse effect
Skin necrosis, erythema, increased liver
function test, local pain, major bleeding,
granulocytopenic disorder (rare), hematoma,
neurological injury with concurrent use of spinal
or epidural anaesthesia, pancytopenia,
thrombocytopenia anaphylaxis, priapism and
death.
7
N06DX01110
T1001XX
Memantine HCI 10 mg
Tablet
(Ebixa®)
Cost
RM320 per box of 56s or
5.714 per tab
A*
Indication
As monotherapy or as adjunctive therapy with
cholinesterase inhibitors for the symptomatic
treatment of patients with moderate to severe
Alzheimer’s disease.
Dose
Adult Initially 5 mg/day on the 1st week, 5mg
twice a day on the 2nd week, then 15 mg/day
(10mg in the morning and 5mg in the evening)
on the 3rd week. From the 4th week on,
continue treatment with maintenance dose of
20 mg/day (10mg twice a day). Max: 20
mg/day.
Precaution
Severe renal impairment, epilepsy, coadministration with N-methyl-D-aspartate
(NMDA) antagonists (eg amantadine, ketamine
or dextromethorphan), patients with factors that
may raise urine pH, recent myocardial infarct,
uncompensated congestive heart failure,
uncontrolled hypertension, pregnancy and
lactation, children. May impair ability to drive or
operate machinery.
Contraindication
Hypersensitivuty to either memantine
hydrochloride or any components of the tablet,
renal impairment (CrCl <50 mL/min), current or
history of seizures.
Interaction
L-dopa, dopaminergic agonists,
anticholinergics, barbiturates, neuroleptics,
antispasmodic agents (dantrolene or baclofen),
phenytoin, cimetidine, ranitidine, procainamide,
quinidine, quinine, nicotine,
hydrochlorothiazide. Avoid administration with
amantadine, ketamine & dextromethorphan.
PFUKKM
September 2010 -
2/10
5/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Adverse effect
Hypertension, constipation, dizziness,
somnolence, headache, pain, StevensJohnson syndrome, deep venous thrombosis,
hepatitis, liver failure, cerebral infarction,
cerebrovascular accident, grand mal seizure,
intracranial hemorrhage, seizure, transient
ischemic attack, acute renal failure, neuroleptic
malignant syndrome
8
N07BA01000
M7004XX
Nicotine 5 mg/ 16 hour
Transdermal Patch
A/KK
Indication
For the treatment of tobacco dependence by
relieving nicotine withdrawal symptoms,
thereby facilitating smoking cessation in
smokers motivated to quit.
A/KK
Dose:
Adult over 18 years old:15 mg patch on waking
(usually in the morning) and remove 16 hours
later (usually at bedtime) for 8 weeks, then 10
mg patch daily for 2 weeks followed by one 5
mg patch daily for another 2 weeks. Apply to
dry non-hairy skin site.
(Nicorette Patch®)
9
N07BA01000
M7005XX
Nicotine 10 mg/ 16 hour
Transdermal Patch
(Nicorette Patch®)
10
N07BA01000
M7006XX
Nicotine 15 mg/16 hour
Transdermal Patch
A/KK
Application limited to 16 hours in a 24-hr period
in each case. Review at 3 months.
(Nicorette Patch®)
Precaution
Patients with chronic generalised
dermatological disorders eg, psoriasis, chronic
dermatitis or urticaria should not use the patch.
Patients with severe cardiovascular disease
(eg, occlusive peripheral arterial disease,
cerebrovascular disease, stable angina
pectoris and heart failure), vasospasms,
uncontrolled hypertension, severe hepatic
and/or renal impairment, active duodenal and
gastric ulcer. Patients with diabetes mellitus,
hyperthyroidism or pheochromocytoma, since
nicotine causes the release of catecholamines
from the adrenal medulla
Contraindication
Hypersensitivity to nicotine or any other
product component. Patients with recent
myocardial infarct; unstable or worsening
angina pectoris; Prinzmetal’s angina; severe
cardiac arrhythmias; acute stroke. Pregnancy
and lactation. Children below 18 years old.
Interaction
Paracetamol, caffeine, imipramine, oxazepam,
pentazocine, propranolol, theophylline,
warfarin, oestrogens, lignocaine, phenacetin;
may require a decrease in dose at cessation of
smoking due to the de-induction of hepatic
enzymes on smoking cessation. Subcutaneous
insulin absorption may increase with smoking
cessation. Adrenergic antagonists (eg.
prazosin, labetalol); decrease in circulating
PFUKKM
September 2010 -
2/10
6/12
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
catecholamines with smoking cessation.
Adrenergic agonists (eg. isoprenaline,
phenylephrine); may require an increase in
dose at cessation of smoking due to a
decrease in circulating catecholamines with
smoking cessation. Other effects, associated
with smoking, include reduced analgesic
efficacy with propoxyphene, reduced diuretic
response to frusemide and reduced rates of
ulcer healing with H2-antagonists.
Adverse effect
Mild skin reactions, erythema, itching, oedema
and aphtous ulcers, headache, dizziness,
nausea and vomiting, palpitations.
11
D08AC52137
L9902XX
Chlorhexidine Gluconate
2% in Alcohol 70%
Solution
C
Indication
Use in central venous catheter care bundle
Dose
Skin Preparation:
Use Chlorhexidine Gluconate 2% in Isopropyl
Alcohol 70% and allow to dry
(SteriPrep®)
Cost
RM3.80 per 60ml bottle
Catheter acces:
Apply to catheter ports or hubs prior to
accessing the line for administering fluids or
injections
Precaution
Avoid contact with eyes.
Contraindication
Hypersensitivity to chlorhexidine gluconate or
any component of the formulation
Interaction
Not known
Adverse effect
Defatting of the skin resulting in dryness,
cracking and dermatitis (with repeated or
prolonged contact), ingestion may cause
gastrointestinal disturbances. Inhalation of high
concentration may cause breathing difficulties,
headaches, dizziness or unconsciousness.
12
M05BB0397
2T1002XX
(Fosamax Plus®)
Indication
Osteoporosis in post menopausal women with
a history of vertebral fracture and whom
oestrogen replacement therapy is
contraindicated
Cost
RM21.31 per tablet
Dose/ Precaution/ Contraindication/Interaction
/Adverse effect
Alendronate Sodium
70mg and Cholecalciferol
5600 IU Tablet
A*
Same as Alendronate Sodium 70mg and
Cholecalciferol 2800 IU Tablet
PFUKKM
September 2010 -
2/10
7/12
TERHAD - Edaran dalaman sahaja
3. TAMBAHAN DAN PINDAAN FORMULASI/ KATEGORI/ BENTUK DOSEJ/ INDIKASI YANG
DILULUSKAN UNTUK DIMASUKKAN KE DALAM FORMULARI UBAT KKM
A. Tambah Formulasi/ Kekuatan
No
MDC
1
C09CA0150
0T1002XX
Generic Name
Brand name
Price quoted
Losartan Potassium 100
mg Tablet
Prescriber
Category
A/KK
(Cozaar 100mg®)
Cost
RM37.50/30’s (1.25 per
tab)
Details
Indications
Patients intolerant of ACE inhibitors, only in the
treatment of
i) Hypertensive patient with left ventricular
hypertrophy
ii) Hypertension in diabetics with proteinuria or
nephropathy
Dose
Hypertension: Usual starting dose: 50 mg once
daily. May be increased to 100 mg once daily.
Precautions/ Contraindications/ Interactions
/Adverse effects
Same as Losartan 50mg tablet
2
N05AH0413
8T5001XX
Quetiapine Fumarate 50
mg Extended Release
Tablet
(Seroquel XR®)
Cost
RM 4.53 per tablet
A*
Indications
i) Schizophrenia
ii) Moderate to severe manic episodes in bipolar
disorder
iii) Major depressive episodes in bipolar disorder
Dose
i) & ii) 300 mg once daily on Day 1 then 600 mg
on Day 2. Maintenance dose: 400 to 800 mg
once daily. Maximum dose: 800 mg daily.
iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg
on Day 3 and 300 mg on Day 4. Recommended
daily dose is 300 mg. May be titrated up to 600
mg daily
In elderly or hepatic impairment:
Start with 50mg/ day, may be increased in
increments of 50mg /day to an effective dose.
Precautions/ Contraindications/ Interactions/
Adverse effects
Same as Quetiapine Fumarate Extended
Release 300mg & 400mg Tablets.
PFUKKM
September 2010 -
2/10
8/12
TERHAD - Edaran dalaman sahaja
4. PERUBAHAN KEPADA MDC /GENERIC NAME DALAM FORMULARI UBAT KKM
A. Perubahan MDC
NO
1
GENERIC NAME
OLD MDC
NEW MDC CODE
Vitamin B Complex Tablet
A11EX00
901T1001XX
A11EA00
901T1001XX
REASON TO CHANGE
The product only contain
vitamin B Complex, plain
not combination
B. Perubahan Generic name
NO
1
Old Generic name
Hyperimmune Gamma
Globulin Injection
New Generic Name
Human Normal Globulin Injection
MDC
J06BA02000P3001XX
5. PERMOHONAN-PERMOHONAN YANG TIDAK DILULUSKAN
A. Proforma B
NO
EXISTING DRUG
(GENERIC NAME)
Irbesartan 300 mg/
Hydrochlorothiazide
12.5 mg Tablet
PROPOSED
ALTERATION
Change prescriber
category from A* to A/KK
REASON/S FOR NON-APPROVAL
2
Losartan Potassium
100 mg/
Hydrochlorothiazide
12.5 mg Tablet
Change prescriber
category from A* to A/KK
Alternatives available in the Formulary are sufficient.
3
Activated Charcoal
250mg Tablet
i. Add strength and
dosage form:
 Cost of the ready-mix charcoal powder is very
expensive (RM52.00 per bottle).
Activated Charcoal 50g
Powder
 Demand for the product is low. Only kept in
Emergency Department and used ‘when needed’
basis.
1
ii. Add indication; acute
oral poisoning and drug
overdose
4
5
Activated Charcoal
250mg Tablet
Ciclesonide MDI 160
mcg.
Add strength and dosage
form:
Activated Charcoal
200mg Capsule
Change indication:
From: Prophylactic
treatment of asthma in
adults and adolescents
12 years of age and older
To: Prophylactic
treatment of asthma in
adults, adolescents and
children over 6 years
PFUKKM
Alternatives available in the Formulary are sufficient.
 Product can be requested through ‘KPK request’
if necessary.
Activated charcoal 250mg tablet which is already
available in the formulary is sufficient. No added
advantage was proven.
 Recommended dose range for children over 6
years old is 80mcg-160mcg per day. Currently
only Ciclesonide 160mcg is available in the
Formulary thus, proper dose titration in this group
of patients will not be possible before listing of the
80mcg MDI.
 Several alternatives are already available in the
Formulary.
September 2010 -
2/10
9/12
TERHAD - Edaran dalaman sahaja
NO
EXISTING DRUG
(GENERIC NAME)
PROPOSED
ALTERATION
REASON/S FOR NON-APPROVAL
 Non-favourable cost-effectiveness ratio
compared to alternatives already available in the
Formulary.
 A corticosteroid inhaler: Caution on safety in
children until more studies carried out in this
group of patients
6
Benzydamine HCl
0.15% Solution
Add Formulation:
Benzydamine
Hydrochloride 3.0 mg/ml
Throat Spray
7
Deferiprone 500 mg
Tablet
Add Dosage Form :
Deferiprone 100mg/ml
Oral Solution
8
Mycophenolate
Mofetil 250mg
Capsule & 500mg
Tablet
Add indication (Off-label):
Induction and
maintenance treatment
for non-renal
manifestations of
systemic lupus
erythematosus (SLE)
Change Prescriber
Category from A* to A/KK
Low usage. Submit a ‘KPK request’ if really needed.
 Request not supported by JKK Paediatric.
 Limited evidences on efficacy. Published data on
bioavailability in children not available. Efficacy of
standard dose could possibly be lower in children
due to higher metabolism.
 Limited evidences on safety in children. Low
‘level of evidence’ of the studies presented.
 Indication has to be approved by DCA first before
it can be added to the Formulary.
 Submit a KPK request when required.
9
Insulin Glargine
300units/3ml
Injection
10
Risperidone 1mg &
2mg Tablets
Change Prescriber
Category from A to B
Initiation of treatment for psychiatric cases should be
done by psychiatrist.
11
Quetiapine Fumarate
200mg Immediate
Release Tablet
Change Formulation from
IR (immediate release) to
XR (extended release)
Tender for Quetiapine Fumarate 200mg Tablet IR is
still effective until 11/1/2011
 High prevalence of diabetes. Change in category
will have profound budget impact.
 Complex diabetic cases requiring Insulin Glargine
should be referred to specialists in hospitals.
B. Proforma D
NO
DRUG (GENERIC NAME)
1
Moxifloxacin Hydrochloride 400 mg
Injection & 400 mg Tablet
2
Topotecan 4 mg Injection
REASON/S FOR NON-APPROVAL



No major advantage to current drugs.
Reserve for multidrug-resistant tuberculosis.
Not supported by JKK Antimicrobial.
Ovarian cancer:
 Lack of evidences on efficacy.
 Tendency of toxicity related to Topotecan usage such as
anaemia, leucopenia and neutropenic fever which will
result in increased overall treatment cost.
 Needs 5 days infusion compared to only 1 day for other
regimens (inconvenient).
Cervical cancer:
 There were some setbacks and limitations in the GOG 179
PFUKKM
September 2010 -
2/10
10/12
TERHAD - Edaran dalaman sahaja
NO
DRUG (GENERIC NAME)
REASON/S FOR NON-APPROVAL


3
Paricalcitol 5 mg/ml Injection

4
Paricalcitol 1 mcg & 2 mcg
Capsules



study besides small sample size. Dose used was low and
life span was lower compared to combination of chemo
agents.
GOG protocol 204 study did not show any advantage of
Topotecan over other regiments.
Listing not supported by JKK Oncology
Cost is significantly higher than currently available
alternatives.
Evidence from randomized controlled trials suggested that
the benefits and side effects of Paricalcitol are similar to
calcitriol.
For patients who are intolerant to or do not respond to
existing calcitriol or alphacalcidol, application to use
paricalcitol can be made through ’KPK request’
Listing not supported by JKK Urology & nephrology
5
Cilostazol 50 mg Tablet


Limited data on efficacy.
Conditions indicated for cilostazol use is not specifically
defined thus usage of drug may not be easily controlled.
High Budget Impact: estimated cost for 100 patients per
year is RM 65,700.00 to RM 131,400.00
6
Fluticasone Furoate 27.5
mcg/dose Nasal Spray

No major advantage over the currently available
corticosteroid nasal sprays in terms of safety and efficacy.
Alternatives available in the Formulary are sufficient.

7
Nicotine 10 mg/dose Inhaler
8
Nicotine 2 mg & 4 mg Gum



About 50% of adult males are smokers in Malaysia.
High Budget Impact: Estimated treatment cost for 100
patients is RM 100,800.00 to RM 268,800.00 for inhaler
and RM 60,480.00 to RM 107,856.00 for gum.
Gums are available in retail pharmacy outlets for patients to
buy.
9
Travoprost 40 mg/ml & Timolol
5mg/ml Ophtalmic Solution


Alternatives available in the Formulary are sufficient.
Travoprost (single preparation) not yet listed in the
Formulary thus treatment response to the drug not known
in our patients.
10
Teriparatide 250mcg/ml Injection

Duration of treatment limited to 18 months due to increased
risk of osteosarcoma
18 times more expensive (more if injection pen counselling
cost is included).
Cost-effectiveness shown only when used in group of
postmenopausal women having severe osteoporosis.
Patients need to be counselled for proper injection
techniques.
A cheaper bone forming agent (Strontium Ranelate: oral
form) is available in FUKKM.




PFUKKM
September 2010 -
2/10
11/12
TERHAD - Edaran dalaman sahaja
6. TAMBAHAN UBAT KE DALAM SENARAI UBAT KLINIK 1MALAYSIA
No
Generic Name
1
Albendazole 200 mg Tablet
2
Albendazole 200 mg/5 ml
Suspension
Details (as in MOH Drug Formulary)
Indication
i) Single or mixed infestations of intestinal parasites
ii) Strongyloides infection
Dose:
i) ADULT and CHILD over 2 years : 400 mg as a single dose
ii) 400 mg as a single dose for 3 consecutive days. CHILD 12 - 24
months : half adult dose
Precaution
Discontinue therapy if liver function test elevations are significant, retinal
lesions, cerebral hypertensive episodes, pregnancy, hepatic disease,
retinal lesions
Contraindication
Patients with hypersensitivity to albendazole or to the benzimidazole
drug class, pregnancy (avoid pregnancy for at least one month following
therapy)
Interaction
Concurrent use with dexamethasone may result in an increased risk of
albendazole adverse effects.
Adverse effect
Gastrointestinal discomfort, dizziness, headache, erythema multiforme,
Stevens-Johnson syndrome, agranulocytosis, aplastic anemia,
leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity
3
Bisacodyl 5 mg Tablet
Indication
i) Constipation
ii) Bowel preparation for radiological procedures and surgery
Dose
i) ADULT and CHILD over 10 years 5-10 mg, CHILD 4-10 years 5 mg.
To be taken at night for effect on the following morning
ii) ADULT 10-20 mg the night before procedures, CHILD over 4 years 5
mg the night before procedures
Precaution
Prolonged use, abdominal pain, inflammatory bowel disease, sudden,
persistent change in bowel habits
Contraindication
Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding,
appendicitis
Interaction
Milk, antacids, warfarin
Adverse effect
Rarely,electrolyte and fluid imblances, abdominal discomfort, diarrhoea,
rectal burning, vomiting
PFUKKM
September 2010 -
2/10
12/12