Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1 2-deoxy-2-[18F] fluoro-D-glucose [18F] FDG Injection V09IX04-000-P30-02-XXX A* Indicated for positron emission tomography (PET) imaging in the following setting:
i. Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer
ii. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
iii. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci or epileptic seizures		 To be prescribed by Nuclear Medicine Specialist only The recommended dose is 6 Mbq/kg (0.162 mCi/kg). Example, for an adult with a body weight of 70 kg, the recommended dose is 420 Mbq (11 mCi)
2 Abacavir Sulphate 300mg tablet J05AF06-183-T10-01-XXX A* Antiretroviral combination therapy of HIV infection in adults and adolescents from 12 years of age. i. Patients unsuitable or failed other HAART treatment
ii. Patients who have renal impairment (CrCl < 50ml/min) when Abacavir and Lamivudine fixed-dose combination is not recommended		 Adult:
300mg twice daily or 600mg daily

Children:
i. Weighing 14 to <20kg: one-half of a scored abacavir tablet twice daily
ii. Weighing ≥20kg to <25kg: one-half of a scored abacavir tablet in the morning and one whole tablet in the evening
iii. Weighing at least 25kg: according to adult dose
3 Abacavir Sulphate 600mg and Lamivudine 300mg Tablet J05AR02-964-T10-01-XXX A* Antiretroviral combination therapy of HIV infection in adults and adolescents from 12 years of age with the following criteria:
i)Patients unsuitable or failed other HAART treatment.
ii)Patients who are at high risk of renal impairment.
iii)Patients with osteoporosis or at high risk of bone loss.		 None ADULTS & ADOLESCENT (> 12 years of age):
Recommended dose is one tablet once daily. Not to be used in adults or adolescents weigh less than 40kg.
CHILDREN : Not recommended
4 Abiraterone acetate 250mg tablet L02BX03-000-T10-01-XXX A* With prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men. Prescribing restrictions:
i. Those who have progressed on OR failed prior docetaxel
chemotherapy
ii. Those who are contraindicated or unsuitable for
chemotherapy		 1,000mg once daily
5 Acetazolamide 250mg Tablet S01EC01-000-T10-01-XXX B Reduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma None 250mg 1-4 times a day, the dosage being titrated according to patient response
6 Acetazolamide 500mg Injection S01EC01-000-P40-01-XXX B Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma None Adult : 250-1000mg per 24hours, usually in divided doses for amounts over 250mg daily
7 Acetylcysteine 200mg/ml Injection V03AB23-520-P30-01-XXX A* Antidote for paracetamol poisoning None Diluted with dextrose 5% and infused IV. Initial, 150 mg/kg IV in 200 ml over 60 minutes, then 50 mg/kg IV in 500 ml over 4 hours, followed by 100 mg/kg IV in 1000 ml over 16 hours. Total dose: 300mg/kg in 20 hour
8 Acetylsalicylic Acid 100 mg & Glycine 45 mg Tablet B01AC06-259-T10-01-XXX B i) Prevention of myocardial infarct, stroke, vascular occlusion and deep vein thrombosis.
ii) Transient ischaemic attacks		 None 1 tablet daily
9 Acetylsalicylic Acid 150mg Dispersible Tablet N02BA01-000-T40-03-XXX C Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk.
Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke		 None 150mg to be taken daily.
Dose to be individualised.
Use in children under 16 years old is not recommended
10 Acetylsalicylic Acid 300 mg Soluble Tablet N02BA01-000-T40-01-XXX C Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk. Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke. None 150mg to be taken daily.
Use in children under 16 years old is not recommended
11 Acetylsalicylic Acid 75mg Dispersible Tablet N02BA01-000-T40-02-XXX C Initial treatment of cardiovascular disorders such as angina pectoris and myocardial infarction and for the prevention of cardiovascular events in patients at risk. Other such uses include the treatment and prevention of cerebrovascular disorders such as stroke None Dose to be individualised.
150mg to be taken daily.
Use in children under 16 years old is not recommended
12 Acitretin 10mg Capsule D05BB02-000-C10-01-XXX A* i) Severe form of psoriasis including erythrodermic psoriasis and local or generalized pustular psoriasis.
ii) Severe disorders of keratinization, such as -congenital ichthyosis -pityriasis rubra pilaris -Darier's disease -other disorders of keratinization which may be resistant to other therapies		 None ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according to response, usually within range 25-50 mg daily for further 6-8 weeks (max: 75 mg daily).
In disorders of keratinization, maintenance therapy of less than 20mg/day and should not exceed 50mg/day

CHILD: 0.5mg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods
13 Acitretin 25 mg Capsule D05BB02-000-C10-02-XXX A* i) Severe form of psoriasis including erythrodermic psoriasis and local or generalized pustular psoriasis.
ii) Severe disorders of keratinization, such as -congenital ichthyosis -pityriasis rubra pilaris -Darier's disease -other disorders of keratinization which may be resistant to other therapies		 None ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according to response, usually within range 25-50 mg daily for further 6-8 weeks (max: 75 mg daily). In disorders of keratinization, maintenance therapy of less than 20mg/day and should not exceed 50mg/day

CHILD: 0.5mg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods
14 Acriflavine 0.1% Lotion D08AA03-000-L60-01-XXX C+ Infected skin, lesions, cuts, abrasions, wounds and burns. None Apply undiluted three times daily to the affected part .
15 Actinomycin D (Dactinomycin) 500 mcg/ml Injection L01DA01-110-P40-01-XXX A i) For solid tumours
ii) Gestational trophoblastic disease		 None i) ADULT: 500 mcg IV daily for max of 5 days.

CHILD: 1.5 mg/m2 once every 3 weeks (if weight less than 10 kg, 50 mcg/kg) ii) 500 mcg IV on Days 2, 4, 6, 8, 10, repeat every 7 - 10 days or 500 mcg IV bolus on Days 1 and 2, repeat every 15 days
16 Acyclovir (Aciclovir) 200mg Tablet J05AB01-000-T10-01-XXX A/KK i) Treatment of Herpes simplex & Varicella zoster infections

ii) Prophylaxis of Herpes simplex infections in immune-compromised patients		 None Indication (i)
Treatment for Herpes Simplex:
ADULT - 200mg 5 times daily; In severely immune-compromised patients: dose can be doubled to 400 mg.
CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose.

Treatment for Varicella Zoster:
ADULT - 800mg 5 times daily;
CHILD
6 years and over: 800 mg four times daily,
2 - < 6 years: 400 mg four times daily,
Under 2 years: 200 mg four times daily.

Indication (ii)
ADULT - Immune-compromised patients: 200 mg four times daily. Severely immune-compromised patients: dose can be doubled to 400 mg.
CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose.

Dosing is according to Product Information Leaflet.
17 Acyclovir (Aciclovir) 200mg/5 ml Suspension J05AB01-000-L80-01-XXX A* i) Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients
ii) Primary and recurrent Varicella Zoster infection in immunocompromised and AIDS patients
iii) Severe Kaposi Varicella Eruption (Eczema herpeticum)
iv) Severe primary HSV infections (eg. Neonatal herpes, encephalitis, eczema herpeticum, genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes)
v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans)
vi) Severe zoster infection in paediatrics (eg.Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster)		 None i) ADULT: initially 400 mg 5 times daily for 7 - 14 days.
CHILD less than 2 years: 200 mg 4 times daily,
CHILD more than 2 years: 400 mg 4 times daily

ii), iii) and iv)
ADULT: 200 - 400 mg 4 times daily.
CHILD : less than 2 years, half adult dose; more than 2 years, adult dose.

v) ADULT: 800 mg 5 times daily for 7 days

vi) ADULT: 20 mg/kg (maximum: 800 mg) four times daily for 5 days,
CHILD 6 years: 800 mg four times daily.
CHILD: less than 2 years; 400mg 4 times daily, more than 2 years; 800 mg 4 times daily
18 Acyclovir (Aciclovir) 250mg Injection J05AB01-000-P4-001-XXX A* i)Treatment of Herpes simplex & Varicella zoster infections

ii)Prophylaxis of Herpes simplex infections in immune-compromised patients		 None ADULT: 5 mg/kg by IV infusion 8 hourly for 5 days, doubled to 10mg/kg every 8 hourly in varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for at least 10 days in encephalitis; possibly for 14 - 21 days).

NEONATE & INFANT up to 3 months with disseminated herpes simplex: 20mg/kg every 8 hourly for 14 days (21 days in CNS involvement), varicella-zoster 10-20mg/kg every 8 hourly usually for 7 days.

CHILD, 3 months - 12 years: Herpes simplex or Varicella Zoster: 250 mg/m2 8 hourly for 5 days, doubled to 500 mg/m2 8 hourly for varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for 10 days in encephalitis)
19 Acyclovir (Aciclovir) 3% Eye Ointment S01AD03-000-G51-01-XXX A* Only for the treatment of herpes simplex keratitis None Apply 1 cm 5 times daily. Continue for at least 3 days after healing
20 Acyclovir (Aciclovir) 5% Cream D06BB03-000-G10-01-XXX A* Herpes simplex infections of the skin, including initial and recurrent labial and genital herpes simplex infections None Apply every 4 hours for 5 - 10 days
21 Acyclovir (Aciclovir) 800 mg Tablet J05AB01-000-T10-02-XXX A/KK i)Treatment of Herpes simplex & Varicella zoster infections

ii)Prophylaxis of Herpes simplex infections in immune-compromised patients		 None Indication (i)
Treatment for Herpes Simplex: ADULT - 200mg 5 times daily; In severely immune-compromised patients: dose can be doubled to 400 mg. CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose.

Treatment for Varicella Zoster: ADULT - 800mg 5 times daily; CHILD - 6 years and over: 800 mg four times daily, 2 - < 6 years: 400 mg four times daily, Under 2 years: 200 mg four times daily.

Indication (ii)
ADULT - Immune-compromised patients: 200 mg four times daily. Severely immune-compromised patients: dose can be doubled to 400 mg.
CHILD - two years and above should be given adult dosages, infants and children below two years old should be given half the adult dose.

Dosing is according to Product Information Leaflet.
22 Adalimumab 40mg Injection L04AB04-000-P50-01-XXX A* i) Third line treatment of:
- Severe rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis after failure of conventional DMARDs or other biologics

ii)Treatment of adults with moderate to severe chronic plaque psoriasis who have not responded to, have contraindication or are unable to tolerate phototherapy and/or systemic therapies including acitretin, methotreaxate and cyclosporine

iii) Crohn's Disease
a) For treatment of moderately to severely active Crohn's Disease in adult patients who have inadequate response to conventional therapy
b) For treatment of moderately to severely active Crohn?s Disease in adult patients who have lost response to or are intolerant to infliximab

iv) Ulcerative Colitis
- For treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies		 None i)Severe rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis : Subcutaneous 40 mg every other week

ii)Chronic plaque psoriasis : Initial, 80 mg SC, followed by 40 mg SC every other week starting one week after the initial dose

iii) & iv) Crohn's disease & Ulcerative colitis:
160mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80mg at week 2. After induction treatment, the recommended maintenance dose is 40mg every other week via subcutaneous injection.
23 Adapalene 0.1% Cream D10AD03-000-G10-01-XXX A* Acne vulgaris where comedones, papules and pustules predominate in those sensitive to benzoyl peroxide or topical tretinoin [third line treatment] None Apply once daily to the affected areas after washing at bedtime
24 Adapalene 0.1% Gel D10AD03-000-G30-01-XXX A/KK Treatment for acne vulgaris where comedones, papules and pustules predominate None Apply once daily to the affected areas after washing at bedtime
25 Adenosine 3 mg/ml Injection C01EB10-000-P30-01-XXX B Rapid conversion of paroxysmal supraventricular tachycardia to sinus rhythm None ADULT: Initially: 3 mg given as a rapid IV bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia with in 1 or 2 minutes, 6 mg should be given also as a rapid IV bolus. Third dose: If the second dose does not result in elimination of the supraventicular tachycardia with in 1-2 minutes, 12 mg should be given also as a rapid IV bolus
26 Adrenaline Acid Tartrate (Epinephrine) 1 mg/ml Injection C01CA24-123-P30-01-XXX B Cardiopulmonary resuscitation None 1 mg by intravenous injection repeated every 3-5 minutes according to response
27 Afatinib Dimaleate 30mg Film-Coated Tablet L01XE13-253-T32-02-XXX A* First-line monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). i) Adenocarcinoma histology.
ii) Patient's ECOG Performance Status 0-1.

**To be prescribed by Consultants/Specialists from disciplines of oncology and oncology-trained respiratory physician)**		 40mg once daily to be taken without food. Maximum dose is 50mg once daily.
28 Afatinib Dimaleate 40mg Film-Coated Tablet L01XE13-253-T32-03-XXX A* First-line monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). i) Adenocarcinoma histology.
ii) Patient's ECOG Performance Status 0-1.

**To be prescribed by Consultants/Specialists from disciplines of oncology and oncology-trained respiratory physician)**		 40mg once daily to be taken without food. Maximum dose is 50mg once daily.
29 Aflibercept 40mg/ml solution for injection (vial) S01LA05-000-P30-01-XXX A* i) Treatment of neovascular (wet) age-related macular degeneration (wet AMD)
ii) Visual impairment due to diabetic macular edema (DME)
iii) Macular Oedema secondary to Retinal Vein Occlusion (branch RVO or central RVO)		 For indication (ii):
a) Treatment of naive patients with visual acuity equal or worse than 20/50; or
b) Patients with poor response to treatment with ranibizumab.

For indication (iii):
a) First line for patient not able to comply with monthly ranibizumab injection after initial loading doses
b) Second line for patient who are refractory to ranibizumab injection
c) To be prescribed by Ophthalmologist only		 i) The recommended dose is 2mg aflibercept, equivalent to 0.05mL (50 μL) given as intra-vitreal injection. Aflibercept treatment is initiated with one injection per month for three consecutive doses, followed by one injection every two months.

ii) 2 mg aflibercept (equivalent to 50 microliters) administered by intravitreal injection monthly for the first 5 consecutive doses, followed by one injection every 2 months. There is no requirement for monitoring between injections.

iii) 2 mg aflibercept (equivalent to 50 microliters) administered by intravitreal injection monthly. The interval between two doses should not be shorter than one month.
30 Agomelatine 25mg Tablet N06AX22-000-T10-01-XXX A* Major depression None The recommended dose is 25mg once daily at bedtime, maybe increased to 50mg once daily at bedtime.

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