Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
31 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.
32 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.
33 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.
34 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.
35 Albendazole 200mg Tablet P02CA03-000-T10-01-XXX C+ i) Single or mixed infestations of intestinal parasites
ii) Strongyloides infection		 None i)Child 12-24months: 200mg as a single dose
ii) Adult & Child above 2 years: 400mg as a single dose for 3 consecutive days; Child 12 - 24months: 200mg as a single dose for 3 consecutive days
36 Albendazole 200mg/5 ml Suspension P02CA03-000-L80-01-XXX C+ i) Single or mixed infestations of intestinal parasites
ii) Strongyloides infection		 None i)Child 12-24months: 200mg as a single dose

ii) Adult & Child above 2 years: 400mg as a single dose for 3 consecutive days; Child 12 - 24months: 200mg as a single dose for 3 consecutive days
37 Alcohol 70% Solution D08AX08-000-L99-01-XXX C+ Use as antiseptic and disinfectant None Apply to the skin undiluted or when needed
38 Alectinib 150mg Hard Capsule L01XE36-110-C11-01-XXX A* As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). To be prescribed by Oncologist only 600 mg twice daily with food (total daily dose of 1200 mg).
Treatment with alectinib should be continued until disease progression or unacceptable toxicity.
39 Alendronate Sodium 70mg and Cholecalciferol 5600 IU Tablet M05BB03-972-T10-02-XXX A* i) Osteoporosis in postmenopausal women with a history of vertebral fracture and whom oestrogen replacement therapy is contraindicated
ii) Male Osteoporosis		 None 1 tablet once weekly [70mg/5600 IU]. Patient should receive supplemental calcium or vitamin D, if dietary vitamin D inadequate.
The tablet should be taken at least half and hour before the first food, beverage, or medication of the day with plain water only. To facilitate delivery to stomach and thus reduce the potential for esophageal irritation, it should only be swallowed upon arising for the day with a full glass of water and patient should not lie down for at least 30 minutes and until after their first food of the day.
40 Alendronate Sodium 70mg Tablet M05BA04-520-T10-01-XXX A*, A/KK Kategori preskriber A*:
Osteoporosis (Male)

Kategori preskriber A/KK:
Indicated for the treatment of osteoporosis in high-risk postmenopausal women		 None 70 mg once weekly. Swallow the tablet whole with a full glass of plain water only on an empty stomach at least 30 minutes before breakfast (and any other oral medication); stand or sit upright for at least 30 minutes and do not lie down until after eating breakfast
41 Alfacalcidol 0.25mcg Capsule A11CC03-000-C10-01-XXX A/KK i) Chronic kidney disease mineral bone disorder
ii) Osteoporosis
iii) Hypoparathyroidism and pseudohypoparathyroidism
iv) Rickets and osteomalacia		 None Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily;
CHILD under 20kg body weight : 0.05 mcg/kg/day.
Maintenance dose : 0.25 mcg to 2 mcg daily

Dosing is individualised based on serum calcium level and according to product insert/protocol
42 Alfacalcidol 1mcg Capsule A11CC03-000-C10-02-XXX A/KK i) Chronic kidney disease mineral bone disorder
ii) Osteoporosis
iii) Hypoparathyroidism and pseudohypoparathyroidism
iv) Rickets and osteomalacia		 None Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily;
CHILD under 20kg body weight : 0.05 mcg/kg/day.
Maintenance dose : 0.25 mcg to 2 mcg daily

Dosing is individualised based on serum calcium level and according to product insert/protocol
43 Alfacalcidol 2 mcg/ml Injection A11CC03-000-P30-01-XXX A* i) Chronic kidney disease mineral bone disorder
ii) Osteoporosis
iii) Hypoparathyroidism and pseudohypoparathyroidism
iv) Rickets and osteomalacia		 None Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily;
CHILD under 20kg body weight : 0.05 mcg/kg/day.
Maintenance dose : 0.25 mcg to 2 mcg daily

Dosing is individualised based on serum calcium level and according to product insert/protocol
44 Alfacalcidol 2mcg/ml Drops A11CC03-000-D50-01-XXX A* i) Neonatal hypocalcemia
ii) Osteoporosis
iii) Hypoparathyroidism and pseudohypoparathyroidism
iv) Rickets and osteomalacia		 None NEONATES : 0.1 mcg/kg/day

Dosing is individualised based on serum calcium level and according to product insert/protocol
45 Alfentanil HCl 0.5 mg/ml Injection N01AH02-110-P30-01-XXX A* For use as short acting narcotic analgesic in short procedures and day-care surgical procedures None Initial dose: 20 - 40 mcg/kg.

Supplemental dose: 15 mcg/kg or infusion 0.5 - 1.0 mcg/kg/min
46 Alfuzosin HCl 10mg Tablet G04CA01-110-T10-01-XXX A* Treatment of functional symptoms related with benign prostatic hypertrophy (BPH) None 10 mg once a day pre bed
47 Alglucosidase alfa 5 mg/ml Injection A16AB07-000-P40-01-XXX A* Infantile-onset Pompe disease None 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion. Monitoring It is suggested that patients be monitored periodically for IgG antibody formation. Patients who experience Infusion-associated reactions suggestive of hypersensitivity may be tested for IgE antibodies to alglucosidase alfa. Treated patients who experience a decrease in benefit despite continued treatment with Alglucosidase Alfa, in whom antibodies are suspected to play a role, may be tested for neutralization of enzyme uptake or activity.
48 Alkaline Nasal Douche R01A000-999-L50-01-XXX B To remove nasal plug None To be diluted with an equal volume of warm water before use
49 All-Trans Retinoic Acid (Tretinoin) 10 mg Capsule L01XX14-000-C10-01-XXX A* Acute promyelocytic leukaemia None Induction: 45 mg/m2 daily for 30 - 90 days. Maintenance: 45 mg/m2 daily for 2 weeks every 3 months. Renal/or hepatic insufficiency: 25mg/m2 daily for 30-90 days.

Refer to protocols
50 Allopurinol 100 mg Tablet M04AA01-000-T10-02-XXX A/KK i) Frequent and disabling attacks of gouty arthritis (2 or more attacks/year).
ii) Clinical or radiographic signs of erosive gouty arthritis.
iii) The presence of tophaceous deposits.
iv) Urate nephropathy.
v) Urate nephrolithiasis.
vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia		 - Initial dose: 50-100 mg daily. Maintenance: 300-900mg daily (depending on renal function).
51 Allopurinol 300 mg Tablet M04AA01-000-T10-01XXX A/KK i) Frequent and disabling attacks of gouty arthritis (2 or more attacks/year).
ii) Clinical or radiographic signs of erosive gouty arthritis.
iii) The presence of tophaceous deposits.
iv) Urate nephropathy.
v) Urate nephrolithiasis.
vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia		 - Initial dose: 50-100 mg daily. Maintenance: 300-900mg daily (depending on renal function).
52 Alprazolam 0.25mg Tablet N05BA12-000-T10-01-XXX A/KK Anxiety disorders None 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children
53 Alprazolam 0.5mg Tablet N05BA12-000-T10-02-XXX A Anxiety disorders None 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children
54 Alprazolam 1mg Tablet N05BA12-000-T10-03-XXX A Anxiety disorders None 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children
55 Alprostadil 500 mcg/ml Injection C01EA01-000-P30-01-XXX A* For treatment of congenital heart diseases which are ductus arteriosus dependent None 0.05 - 0.1 mcg/kg/min by continuous IV infusion, then decreased to lowest effective dose
56 Alteplase 50 mg per vial Injection B01AD02-000-P40-01-XXX A* Thrombolytic treatment of acute ischaemic stroke. - 0.9 mg/kg (maximum of 90 mg) infused over 60 minutes with 10% of the total dose administered as an initial intravenous bolus. Treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging technique.
57 Amantadine HCl 100mg Capsule N04BB01-110-C10-01-XXX B Parkinson's disease None Initial dose: 100 mg daily and is increased to 100 mg twice daily (not later than 4 p.m.) after a week. Elderly over 65 years: less than 100 mg or 100 mg at intervals of more than 1 day
58 Amikacin 125 mg/ml Injection J01GB06-183-P30-03-XXX A Infections due to susceptible organisms None ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day 8 - 12 hourly. Maximum: 1.5 g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day
59 Amikacin 250mg/ml Injection J01GB06-183-P30-02-XXX A Infections due to susceptible organisms None ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day 8 - 12 hourly. Maximum: 1.5 g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day
60 Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet C03EA01-900-T10-01-XXX B i) Diuretic as an adjunct to the management of oedematous states
ii) Hypertension		 None i) Initially 1 - 2 tab daily adjusted according to response. Max : 4 tabs daily.

ii) 1 -2 tabs daily as a single or divided dose

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