Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1 Beclomethasone Dipropionate 100 mcg/dose Inhaler R03BA01-133-A21-01-XXX B Prophylaxis of asthma especially if not fully controlled by bronchodilators None Adults: The usual maintenance dose is one to two inhalations (200-400 mcg) twice daily.If needed,the dose can be increased up to 1600 mcg/day divided in two to four doses : Children 6-12 years old: One inhalation (200 mcg) two times daily and dose may be increased up to 800 mcg/day in divided two to four doses if necessary.
2 Beclomethasone dipropionate 100mcg and formoterol fumarate dihydrate 6mcg pressurized inhalation solution R03AK07-986-A21-01-XXX A*, A/KK Prescriber category A/KK:
i) Regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2 agonist) is appropriate in:
a) Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2 agonist, or
b) Patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

Prescriber category A*:
ii) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
iii) Treatment of COPD patients with blood eosinophil count of 100 cells/microliter and more with history of repeated exacerbation despite regular treatment with long-acting bronchodilators.		 None For asthma, the dosage is based on treatment approach:
i) Maintenance therapy (taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator):
Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.
ii) Maintenance and reliever therapy (taken as regular maintenance treatment and as needed in response to asthma symptoms):
Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.

For COPD:
2 puffs two times a day.
3 Beclomethasone Dipropionate 200mcg/dose Inhaler R03BA01-133-A21-02-XXX A/KK Prophylaxis of asthma especially if not fully controlled by bronchodilators None ADULT : 1 - 2 puff twice daily. May increase to 2 puff 2 - 4 times daily CHILD : 1 puff twice daily. May increase to 1 puff 2 - 4 times daily
4 Benralizumab 30mg Solution for Injection in Pre-filled Pen R03DX10-000-P50-01-xxx A* Benralizumab is indicated as an add-on maintenance treatment in adult patients from 18 years with severe eosinophilic asthma characterised by the following criteria:
a) At least two exacerbations in the past 12 months on the current standard therapy (high-dose inhaled corticosteroids plus long-acting bronchodilators) and/or need for treatment with systemic corticosteroids.
b) Eosinophil count in the blood of ≥0.3 G/L (corresponding to ≥300 cells/μL).		 To be prescribed by Respiratory Physician (Pulmonologist) only 30 mg of benralizumab every 4 weeks for the first 3 doses, and then every 8 weeks thereafter administered as subcutaneous injection
5 Budesonide 100mcg/dose Inhaler R03BA02-000-A21-01-XXX B Maintenance treatment of asthma as prophylactic therapy especially if not fully controlled by bronchodilators None ADULT:200 - 1600 mcg daily in 2-4 divided doses. Maintenance with twice daily dosing. CHILD more than 7 years: 200-800 mcg, 2 - 7 years: 200-400 mcg. To be inhaled in 2 - 4 divided doses.
6 Budesonide 160mcg and Formoterol 4.5mcg Inhalation R03AKO7-989-A21-01-XXX A*, A/KK Prescriber category A/KK:
i) Regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists. or
- Patients already adequately controlled on both inhaled corticosteroids and long- acting beta2-agonists.

ii) As a reliever treatment for mild asthma patients who do not adhere to regular inhaled corticosteroid


Prescriber category A*:
iii) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
iv) Treatment of COPD patients with blood eosinophil count of 100 cells/microliter and more with history of repeated exacerbation despite regular treatment with long-acting bronchodilators.		 None i) Asthma Maintenance therapy: Adult ≥18 yr 160 mcg to 320 mcg bd. Some patients may require up to a max of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd. Childn 6-11 yr 160 mcg bd, <6 yr Not recommended.

Maintenance & relief Adult and adolescent ≥12 yr 320 mcg/day either as 160 mcg bd or 320 mcg od either morning or evening. For some patients a maintenance dose of 320 mcg bd may be appropriate. Patients should take 160 mcg additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 960 mcg should be taken on any single occasion. A total daily dose of more than 1280 mcg is not normally needed, however a total daily dose of up to 1920 mcg could be used for a limited period. Patients using more than 1280 mcg daily should seek medical advice, should be reassessed & their maintenance therapy reconsidered.

ii) Asthma reliever-only therapy: 160 mcg as needed, but no more than 960 mcg to be taken on any single occasion.

Children <12 yr: Not recommended


iii & iv) COPD: Adult ≥18 yr 320 mcg bd.
7 Budesonide 1mg/2ml Nebuliser Solution R03BA02-000-A30-02-XXX B Treatment of asthma in patients where use of a pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate. None ADULT : Initially 1 - 2 mg twice daily.
CHILD 3 months - 12 years of age : 500 mcg - 1 mg. Maintenance dose : half of the above doses
8 Budesonide 200mcg/dose Inhalation R03BA02-000-A21-02-XXX B Maintenance treatment of asthma as prophylactic therapy especially if not fully controlled by bronchodilators None ADULT: 200-1600 mcg daily in 2-4 divided doses. Maintenance with twice daily dosing. CHILD more than 7 years: 200-800 mcg, 2 - 7 years: 200-400 mcg. To be inhaled in 2-4 divided doses.
9 Budesonide 500 mcg/2 ml Nebuliser Solution R03BA02-000-A30-01-XXX B Treatment of asthma in patients where use of a pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate. None ADULT : Initially 1 - 2 mg twice daily.
CHILD 3 months - 12 years of age : 500 mcg - 1 mg. Maintenance dose : half of the above doses
10 Ciclesonide 160mcg/dose Inhaler R03BA08-000-A21-01-XXX A* Prophylactic treatment of asthma in adults, adolescents and children over 6 years. The use of this drug in MOH is restricted to pediatric patient only. For adults and adolescents over 12 years of age with mild to moderate asthma is 160 to 640mcg per day: severe asthma dose may be increased to 1280mcg per day.
11 Cisatracurium Besylate 2mg/ml Injection M03AC11-197-P30-01-XXX A* As an adjunct to general anaesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation during surgery and to facilitate mechanical ventilation. Restricted to patients with lung problem such as asthma. None Administered as bolus intravenous injection. May be administered as infusion in ICU patients at a rate of 3mcg/kg/min. Adult dose: a) Induction: 0.15mg/kg over 5-10 secs, b) Maintenance: 0.03 mg/kg. Children 2-12 years: a) Induction: 0.1 mg/kg over 5-10 secs, b) Maintenance: 0.02 mg/kg
12 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
13 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
14 Ephedrine HCl 30mg/ml Injection R03CA02-110-P30-01XXX B Treatment of bronchial spasm in asthma, adjunct to correct haemodynamic imbalances and treat hypotension in epidural and spinal anaesthesia None By IM, SC or IV. Severe, acute bronchospasm : 12.5-25 mg. Further dosage should be determine by patient response.
When used as a pressor agent : ADULT 25 - 50 mg SC/IM. If necessary, a second IM dose of 50 mg or an IV dose of 25 mg may be given.

Direct IV injection, 10 - 25 mg may be given slowly. Maximum parenteral ADULT dose : 150 mg in 24 hours. CHILD : 3 mg/kg or 100 mg/m2 SC or IV daily, in 4 - 6 divided doses
15 Fluticasone Propionate 125mcg and Formoterol Fumarate Dihydrate 5mcg per actuation pressurized inhalation, suspension R03AK11-989-A21-01-XXX A/KK Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
- For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting β2 agonist.
- For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.		 None Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
16 Fluticasone Propionate 125mcg/dose Inhaler R03BA05-133-A21-01-XXX B Prophylactic treatment for asthma None ADULT and CHILD more than 16 years
i) Mild asthma : 100 mcg - 250 mcg twice daily
ii) Moderate asthma : 250 - 500 mcg twice daily
iii) Severe asthma : 500 mcg - 1000 mcg twice daily.
Alternatively, the starting dose of fluticasone dipropionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent administered by inhalation.
17 Fluticasone Propionate 250mcg and Formoterol Fumarate Dihydrate 10mcg per actuation pressurized inhalation, suspension R03AK11-989-A21-02-XXX A/KK Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
i) For patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist.
ii) For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.		 None Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
18 Indacaterol acetate/ glycopyrronium bromide/ mometasone furoate 150/50/160mcg inhalation powder hard capsules R03AL12-986-A20-01-XXX A As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. None one capsule to be inhaled once daily.
19 Ipratropium Bromide 0.0125% Nebulising Solution (125 mcg/ml) R03BB01-320-A30-01-XXX B Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Used concomitantly with inhaled beta-agonists in the treatment of acute bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and asthma.		 None Maintenance treatment:
i) Adult and adolescents over 12 years old: 500mcg per dose, 3 to 4 times daily.
ii) Children 6 - 12 years old: 250mcg per dose, 3 to 4 times daily.
iii) Children less than 6 years old: 100 - 250mcg per dose, 3 to 4 times daily.

Acute attacks (in combination with beta-agonist):
i) Adult and adolescents over 12 years old: 500mcg per dose, time interval between doses may be determined by the physician.
ii) Children 6 - 12 years old: 250mcg per dose, time interval between doses may be determined by the physician.
iii) Children less than 6 years old: 100 - 250mcg per dose, time interval between doses may be determined by the physician.


20 Ipratropium Bromide 0.025% Inhalation Solution (250mcg/ml) R03BB01-320-A30-02-XXX B Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Used concomitantly with inhaled beta-agonists in the treatment of acute bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and asthma.		 None Maintenance treatment:
i) Adult and adolescents over 12 years old: 500mcg per dose, 3 to 4 times daily.
ii) Children 6 - 12 years old: 250mcg per dose, 3 to 4 times daily.
iii) Children less than 6 years old: 100 - 250mcg per dose, 3 to 4 times daily.

Acute attacks (in combination with beta-agonist):
i) Adult and adolescents over 12 years old: 500mcg per dose, time interval between doses may be determined by the physician.
ii) Children 6 - 12 years old: 250mcg per dose, time interval between doses may be determined by the physician.
iii) Children less than 6 years old: 100 - 250mcg per dose, time interval between doses may be determined by the physician.


21 Ipratropium Bromide 20 mcg/dose Inhalation R03BB01-320-A10-01-XXX B Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis, emphysema and asthma. None Adult and children more than 6 years of age: 2 puffs 4 times daily. Total daily dose of 12 puffs.
22 Ipratropium Bromide 20mcg and Fenoterol 50mcg/dose Inhaler R03AK03-986-A21-01-XXX B Management of symptoms in chronic obstructive airway disorders with reversible bronchospasm such as bronchial asthma and chronic bronchitis with or without emphysema None ADULT & CHILD more than 6 years; Acute asthma 2 puffs. Severe cases: if breathing has not noticeably improved after 5 mins, 2 further puffs may be taken. Intermittent and long-term treatment 1-2 puffs for each administration, up to max 8 puffs/day (average: 1-2 puffs three times daily)
23 Montelukast Sodium 10 mg Tablet R03DC03-520-T10-01-XX A/KK Chronic treatment of asthma and relief of symptoms of seasonal allergic rhinitis for children more than 15 years and adults None CHILD more than 15 years and ADULT: 10 mg daily at bedtime
24 Montelukast Sodium 4mg Oral Granules R03DC03-520-F10-01-XXX A* Asthmatics, not controlled on high dose inhaled corticosteroids more than 1600 mcg/day and with co-morbid allergic disorders. Chronic treatment of asthma None 12 months - 5 years: 1 packet of 4mg oral granules daily at bedtime
25 Montelukast Sodium 5mg Tablet R03DC03-520-T20-01-XXX A* Asthmatics, not controlled on high dose inhaled corticosteroids more than 1600 mcg/day and with co-morbid allergic disorders. Chronic treatment of asthma None CHILD 6 - 14 years: One 5 mg chewable tablet daily at bedtime
26 Omalizumab 150mg powder and solvent for solution R03DX05-000-P30-01-XXX A* i) For adults and adolescents (≥12 years), for severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosetroids;
ii) For Children (6 to <12 years of age):
As add-on therapy to improve asthma control with severe persistent allergic asthma who have positive skin test or in vitro reactivity to a perennial aero allergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta 2 agonist.		 None i) Adult & adolescent ≥12 yr, 150-375 mg SC every 2-4 wk, according to body wt & baseline serum total IgE level.. For subcutaneous administration only. Do not administer by the intravenous or intramuscular route. ii) Appropriate dose and dosing frequency of omalizumab is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to initial dosing, patients should have their IgE level determined for their dose assignment. Based on these measurements 150-375mg in 1 -3 injections may be needed for each administration. Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dosing table should not be given omalizumab. For subcutaneous administration only.
27 Salbutamol 0.5mg/ml Injection R03CC02-183-P30-01-XXX A i. Asthma and other conditions associated with reversible airways obstruction
ii. For prevention of uncomplicated premature labour		 None i. 500 mcg by SC/IM injection 4 hourly or 250 mcg by slow IV. If required, by IV infusion, initially 5 mcg/min adjusted according to response and heart rate, usually in the range 3 - 20 mcg/min

ii. Infusions containing 5 mg in 500ml (10 mcg/ml) at the rate of 10 - 45 mcg/min increased at intervals of 10 minutes until evidence of patient response as shown by reduction of strength, frequency or duration of contractions; maintain rate for 1 hour after contractions have stopped, then gradually reduce by 50% every 6 hours
28 Salbutamol 100mcg/dose Inhalation R03AC02-183-A10-01-XXX B Asthma and other conditions associated with reversible airways obstruction None ADULT : 100 - 200 mcg up to 3 - 4 times daily.
CHILD : 100 mcg increased to 200 mcg if necessary
29 Salbutamol 200mcg/dose Inhaler R03AC02-183-A20-01-XXX B Asthma and other conditions associated with reversible airways obstruction None CHILD : 100 - 200 mcg. Maintenance : 100 - 200 mcg 2 - 4 times daily. ADULT : 100 - 400 mcg. Maitenance : 100 - 400 mcg 2 - 4 times daily
30 Salbutamol 2mg Tablet R03CC02-183-T10-01-XXX B Asthma and other conditions associated with reversible airways obstruction None CHILD
2 - 6 years : 1 - 2 mg 3 - 4 times daily
6 - 12 years : 2 mg 3 - 4 times daily.
over 12 years and ADULT : 2 - 4 mg 3 - 4 times daily

Pages