Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
541 Duloxetine 30 mg Capsule N06AX21110C1001XX A* i) Major depressive disorder
ii) Diabetic peripheral neuropathic pain
iii) Generalised Anxiety Disorder		 i) & ii) ADULT: 60 mg once daily up to a maximum dose of 120mg/day (in divided doses) CHILD and ADOLESCENT under 18 years not recommended

iii) Generalised Anxiety:
Initial dose: 30 mg OD with or without food Maintenance dose: 60 mg OD
542 Duloxetine 60 mg Capsule N06AX21110C1002XX A* i) Major depressive disorder
ii) Diabetic peripheral neuropathic pain
iii) Generalised Anxiety Disorder		 i) & ii) ADULT: 60 mg once daily up to a maximum dose of 120mg/day (in divided doses) CHILD and ADOLESCENT under 18 years not recommended

iii) Generalised Anxiety:
Initial dose: 30 mg OD with or without food Maintenance dose: 60 mg OD
543 Dupilumab 200mg Solution for Injection in Prefilled Syringe D11AH05-000-P50-01-xxx A* Dupilumab is indicated in adults and adolescents 12 years and older as an add on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO). Dupilumab is indicated as maintenance therapy for oral corticosteroid-dependent asthma. i.Raised blood eosinophils (150 cells/microlitre or more) and/or raised (25 parts per billion or more) fraction of exhaled nitric oxide (FeNO).
ii.To be prescribed by Respiratory Physician (Pulmonologist) only
 • An initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week as subcutaneous injection

• For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults witsh co-morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week as subcutaneous injection
544 Dupilumab 300mg Solution for Injection in Pre-filled Syringe D11AH05-000-P50-01-XXX A* (i) Indicated for the treatment of adult patients with severe atopic dermatitis (AD) whose disease is not adequately controlled with systemic immunosuppressants and / or phototherapy or when those therapies are not advisable. Dupilumab can be used with or without topical corticosteroids.

(ii) Dupilumab is indicated in adults and adolescents 12 years and older as an add on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO). Dupilumab is indicated as maintenance therapy for oral corticosteroid-dependent asthma.		 Indication (i):
As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to:
- Intensive and optimized topical treatment
- Phototherapy
- At least two immunosuppressants

(To be prescribed by Dermatologists only)

Indication (ii):
i.Raised blood eosinophils (150 cells/microlitre or more) and/or raised (25 parts per billion or more) fraction of exhaled nitric oxide (FeNO).
ii.To be prescribed by Respiratory Physician (Pulmonologist) only
 Indication (i):
The recommended dose is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.

Indication (ii):
• An initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week as subcutaneous injection

• For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults witsh co-morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week as subcutaneous injection
545 Dutasteride 0.5mg and Tamsulosin 0.4mg Capsule G04CA52-953-C10-01-XXX A* Combination therapy for the treatment of moderate to severe symptoms of BPH with:
i) Large prostate (>30g)
ii) Poor risk or not fit for surgery
iii)Those who are awaiting their turn for surgery		 None One capsule daily
546 Dutasteride 0.5mg Capsule G04CB02-000-C10-01-XXX A* Benign prostatic hyperplasia in men with an enlarged prostate gland None 0.5 mg daily
547 Dydrogesterone 10mg Tablet G03DB01-110-T10-01-XXX A/KK i) Dysmenorrhoea
ii) Endometriosis
iii) Dysfunctional uterine bleeding (to arrest and to prevent bleeding)
iv) Threatened abortion
v) Habitual abortion
vi) Post menopausal complaints (hormone replacement therapy in combination with oestrogen)		 None i) 10 mg bd from day 5 - 25 of cycle
ii) 10 mg bd - tds from day 5 - 25 of the cycle or continuously
iii) To arrest bleeding :10 mg bd with an estrogen once daily for 5 - 7 days, To prevent bleeding : 10 mg bd with an oestrogen once daily from day 11 - 25 of the cycle
iv) 40 mg at once, then 10mg 8hrly until symptoms remit
v) 10 mg bd until 20th week of pregnancy
vi) 10-20 mg daily during last 12-14 days of each cycle
548 Ear Wax Softener S02DA30-900-D10-XX-XX B Occlusion or partial occlusion of the external auditory meatus by soft wax or wax plug None Instill 5 drops into the ears. Refer product information leaflet
549 Edoxaban 30mg Film Coated Tablets B01AF03-707-T32-02-XXX A* Indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, and age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). None The recommended dose is 60 mg edoxaban once daily.
Therapy with edoxaban in NVAF patients should be continued long term.

The recommended dose is 30 mg once daily in patients with one or more of the following clinical factors:
• Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min)
• Low body weight ≤ 60 kg
• Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole.

550 Edoxaban 60mg Film Coated Tablets B01AF03-707-T32-03-XXX A* Indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, and age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). None The recommended dose is 60 mg edoxaban once daily.
Therapy with edoxaban in NVAF patients should be continued long term.

The recommended dose is 30 mg once daily in patients with one or more of the following clinical factors:
• Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min)
• Low body weight ≤ 60 kg
• Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole.
551 Edrophonium Chloride 10 mg/ml Injection N07AA00100P3001XX B i) For reversal of neuromuscular block ii) Diagnosis of myasthenia gravis i) Intravenous injection on over several minutes, 500 - 700 mcg/kg (after or with atropine sulphate 600 mcg) ii) Intravenous injection 2 mg followed by 8 mg if no response occurs within 30 seconds. CHILD: 20 mcg followed by 80 mcg/kg after 30 seconds
552 Efavirenz 100mg Capsule J05AG03-000-C10-02-XXX A* Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) None ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg
553 Efavirenz 200mg Capsule J05AG03-000-C10-03-XXX A/KK Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) None ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg
554 Efavirenz 200mg Tablet J05AG03-000-T10-03-XXX A/KK Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) - ADULT: 600 mg once daily.
ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily.
No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg
555 Efavirenz 50mg Capsule J05AG03-000-C10-01-XXX A* Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) None ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg
556 Efavirenz 600mg Tablet J05AG03-000-T10-01-XXX A/KK Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) None ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg
557 Eltrombopag Olamine 25 mg Film-coated Tablet B02BX05999T1001XX A* Short term use in idiopathic thrombocytopenic purpura patients as bridging therapy for splenectomy or surgery and in cases of severe bleeding. Individualised dosage based on the patient's platelet count. Adult Initially 50 mg once daily. East Asian patient 25 mg once daily. Then, adjust dose to maintain platelet count ≥50,000/microliter. Max: 75 mg daily.
558 Emicizumab 150mg/ml solution for Injection B02BX06-000-P30-02-XXX A* i. For routine prophylaxis of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
ii. For routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency), without factor VIII inhibitors who have, severe disease (FVIII < 1%)		 Indikasi i:
To be prescribed by consultant haematologists only

Indikasi ii:
1. For paediatric patients aged 8 years and below
2. To be prescribed by Consultant Haematologists only
 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks
559 Emicizumab 30mg/ml solution for injection B02BX06-000-P30-01-XXX A* i. For routine prophylaxis of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
ii. For routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency), without factor VIII inhibitors who have, severe disease (FVIII < 1%)		 Indikasi i:
To be prescribed by consultant haematologists only

Indikasi ii:
1. For paediatric patients aged 8 years and below
2. To be prescribed by Consultant Haematologists only
 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks
560 Empagliflozin 10mg tablet A10BK03-000-T32-01-XXX A/KK Indication 1:
Indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as: Add-on combination therapy: In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Indication 2:
Indicated in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD) to reduce the risk of cardiovascular (CV) death: As an adjunct to diet, exercise and standard of care, to reduce the risk of cardiovascular (CV) death.

Indication 3:
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV).

Indication 4:
For cardiorenal protection in adult patients with chronic kidney disease, with or without type 2 diabetes mellitus, with eGFR ≥20mL/min/1.73m2, or eGFR at least 45mL/min/1.73m2 with a urinary albumin-to-creatinine ratio of ≥200mg/g receiving
maximal tolerated treatment with ACEi or ARB.		 Indication 1:
Patients with HbA1c between 6.5%-10.0% while on single / combination anti-diabetic therapy.

Indication 2:
Patients with HbA1c not more than 10.0% while on adequate trial of metformin.

Indication 3:
i. Treatment to be initiated in hospital setting before continuation of treatment for stable patients by Family Medicine Specialist (FMS) in the primary care setting.
ii. All patients must be counselled regarding risk of euglycemic ketoacidosis before initiation of treatment
 Indication 1 & 2:
- Starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
- In patients tolerating empagliflozin 10 mg once daily and need tighter glycaemic control, the dose can be increased to 25 mg once daily.
- The maximum daily dose is 25 mg.

Indication 3 & 4:
10mg once daily
561 Empagliflozin 25mg tablet A10BK03-000-T32-02-XXX A/KK Indication 1:
Indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as: Add-on combination therapy: In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Indication 2:
Indicated in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD) to reduce the risk of cardiovascular (CV) death: As an adjunct to diet, exercise and standard of care, to reduce the risk of cardiovascular (CV) death.		 Indication 1: Patients with HbA1c between 6.5%-10.0% while on single / combination anti-diabetic therapy.
Indication 2: Patients with HbA1c not more than 10.0% while on adequate trial of metformin.
- Starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
- In patients tolerating empagliflozin 10 mg once daily and need tighter glycaemic control, the dose can be increased to 25 mg once daily.
- The maximum daily dose is 25 mg
562 Emulsificants Ointment D02AC00-952-G50-01-XXX C As an emollient for the symptomatic relief of dry skin conditions and as soap-substitute for skin-bathing. None Apply to the affected area as required or as in package insert
563 Enalapril 10mg Tablet C09AA02-253-T10-02-XX B i) Hypertension
ii) Heart failure
iii) Prevention of coronary ischemic events in patients with left ventricular dysfunction		 None i) Initial: 5mg once daily. Maintenance: 10-20mg once daily Max. 40mg daily in 1-2 divided doses

ii) & iii)
Initial: 2.5mg once daily Maintenance: 20mg in 1-2 divided doses
Max. 40mg daily in 2 divided doses

Dosing is individualised and according to product insert / protocol.
564 Enalapril 20mg Tablet C09AA02-253-T10-03-XX B i) Hypertension
ii) Heart failure
iii) Prevention of coronary ischemic events in patients with left ventricular dysfunction		 None i) Initial: 5mg once daily. Maintenance: 10-20mg once daily Max. 40mg daily in 1-2 divided doses

ii) & iii)
Initial: 2.5mg once daily Maintenance: 20mg in 1-2 divided doses
Max. 40mg daily in 2 divided doses

Dosing is individualised and according to product insert / protocol.
565 Enalapril 5mg Tablet C09AA02253T1001XX B i) Hypertension
ii) Heart failure
iii) Prevention of coronary ischemic events in patients with left ventricular dysfunction		 None i) Initial: 5mg once daily. Maintenance: 10-20mg once daily Max. 40mg daily in 1-2 divided doses

ii) & iii)
Initial: 2.5mg once daily Maintenance: 20mg in 1-2 divided doses
Max. 40mg daily in 2 divided doses

Dosing is individualised and according to product insert / protocol.
566 Enoxaparin Sodium 20 mg Injection B01AB05520P5001XX A*, A/KK KATEGORI PRESKRIBER A*:
i. Prophylaxis of venous thromboembolic diseases (DVT and PE) especially in perioperative, high risk surgical cases and medical patients with acute illness at increased risk of VTE

ii. Treatment of venous thromboembolic diseases (DVT and PE).

iii. Acute coronary syndrome:
a. Treatment of unstable angina and Non-ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
b. Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

KATEGORI PRESKRIBER A/KK:
Prevention of DVT in antenatal and/or postnatal women with VTE risk scoring of 3 or more. A written consent form by the patient is necessary prior treatment initiation. Healthcare facilities are advised to refer to “Panduan Penggunaan Ubat- Ubatan yang Mengandungi Unsur Tidak Halal”.		 KATEGORI PRESKRIBER A*
i. Moderate risk: 20mg SC 2 hours before surgery then 20mg SC once daily
High risk: 40mg SC 12 hours before surgery then 40mg SC once daily
Medical patients: 40mg once daily

ii. 1.5mg/kg once daily or 1mg/kg twice daily

iii. 1 mg/kg every 12 hours

KATEGORI PRESKRIBER A/KK:
<50 kg: 20mg OD
50-90 kg: 40mg OD
91-130 kg: 60mg OD
131-170 kg: 80mg OD
>170 kg: 0.6mg/kg/day
567 Enoxaparin Sodium 40 mg Injection B01AB05520P5002XX A*, A/KK KATEGORI PRESKRIBER A*:
i. Prophylaxis of venous thromboembolic diseases (DVT and PE) especially in perioperative, high risk surgical cases and medical patients with acute illness at increased risk of VTE

ii. Treatment of venous thromboembolic diseases (DVT and PE).

iii. Acute coronary syndrome:
a. Treatment of unstable angina and Non-ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
b. Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

KATEGORI PRESKRIBER A/KK:
Prevention of DVT in antenatal and/or postnatal women with VTE risk scoring of 3 or more. A written consent form by the patient is necessary prior treatment initiation. Healthcare facilities are advised to refer to “Panduan Penggunaan Ubat- Ubatan yang Mengandungi Unsur Tidak Halal”.		 KATEGORI PRESKRIBER A*
i. Moderate risk: 20mg SC 2 hours before surgery then 20mg SC once daily
High risk: 40mg SC 12 hours before surgery then 40mg SC once daily
Medical patients: 40mg once daily

ii. 1.5mg/kg once daily or 1mg/kg twice daily

iii. 1 mg/kg every 12 hours

KATEGORI PRESKRIBER A/KK:
<50 kg: 20mg OD
50-90 kg: 40mg OD
91-130 kg: 60mg OD
131-170 kg: 80mg OD
>170 kg: 0.6mg/kg/day
568 Enoxaparin Sodium 60 mg Injection B01AB05520P5003XX A*, A/KK KATEGORI PRESKRIBER A*:
i. Prophylaxis of venous thromboembolic diseases (DVT and PE) especially in perioperative, high risk surgical cases and medical patients with acute illness at increased risk of VTE

ii. Treatment of venous thromboembolic diseases (DVT and PE).

iii. Acute coronary syndrome:
a. Treatment of unstable angina and Non-ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
b. Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

KATEGORI PRESKRIBER A/KK:
Prevention of DVT in antenatal and/or postnatal women with VTE risk scoring of 3 or more. A written consent form by the patient is necessary prior treatment initiation. Healthcare facilities are advised to refer to “Panduan Penggunaan Ubat- Ubatan yang Mengandungi Unsur Tidak Halal”.		 KATEGORI PRESKRIBER A*
i. Moderate risk: 20mg SC 2 hours before surgery then 20mg SC once daily
High risk: 40mg SC 12 hours before surgery then 40mg SC once daily
Medical patients: 40mg once daily

ii. 1.5mg/kg once daily or 1mg/kg twice daily

iii. 1 mg/kg every 12 hours

KATEGORI PRESKRIBER A/KK:
<50 kg: 20mg OD
50-90 kg: 40mg OD
91-130 kg: 60mg OD
131-170 kg: 80mg OD
>170 kg: 0.6mg/kg/day
569 Entacapone 200 mg Tablet N04BX02000T1001XX A Parkinson's Disease. An adjunct to standard levodopa/benserazide or levodopa/carbidopa for use in patients with parkinson's disease and end of dose motor fluctuations, who cannot be stabilised on those combinations 200 mg to be taken with each daily dose of levodopa/dopa-decarboxylase inhibitor. Max 2g daily. May be taken with or without food
570 Entecavir 0.5mg Tablet J05AF10-000-T10-01-XXX A* First line treatment of Chronic Hepatitis B in patients who satisfy the criteria for treatment and require long-term therapy or have a very high baseline viral load None 0.5-1mg once daily. Renal Dose Adjustment: 0.5-1mg every 48hours (30-49ml/min); 0.5-1mg every 72hours (10-29ml/min); 0.5mg-1mg every 5-7 days (<10ml/min; HD or CAPD).

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