Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1411 Sacubitril/Valsartan 200 mg tablet C09DX04-000-T32-03-XXX A* To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. i. For heart failure patients with reduced ejection fraction
ii. NYHA class II-IV
iii. Second line for patients intolerant of or not responding to ACEi or ARB.		 The recommended starting dose is one tablet of 100 mg twice daily.
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 200 mg twice daily, as tolerated by the patient.

For the following patients, initiate with sacubitril/valsartan 50 mg twice daily.
- Not currently on ACEI/ ARB
- Switching from low dose of ACEI/ ARB
- In patients with systolic BP ≥100 to 110 mmHg.
- In patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2)
- In patients with moderate hepatic impairment (Child-Pugh B classification)

For patients "Not currently on ACEI/ ARB" and "switching from low dose of ACEI/ ARB", double the dose every 3-4 weeks to achieve the target dose of 200 mg twice daily as tolerated by the patient.
1412 Salbutamol 0.5% Inhalation Solution R03AC02-183-A30-01-XXX B Indicated for the relief of bronchospasm in patients with reversible obstructive airway disease and acute bronchospasm. - 2.5 to 5mg (0.5ml – 1ml), repeat according to response and tolerability.

Dosing is individualised and according to product insert/protocol.
1413 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
1414 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
1415 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
1416 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
1417 Salbutamol 2mg/5ml Syrup R03CC02-183-L90-01-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
1418 Salbutamol 5mg/5ml Injection R03CC02-183-P30-02-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
1419 Salicylazosulphapyridine (Sulfasalazine) 500 mg Tablet A07EC01000T1001XX A/KK i) Treatment of inflammatory bowel disease of ulcerative colitis and Crohn's disease
ii) Rheumatoid arthritis		 i) ADULT, acute attack 1-2 g 4 times daily until remission occurs (if necessary corticosteroids may also be given), reducing to a maintenance dose of 500 mg 4 times daily, CHILD over 2 years, acute attack 40-60 mg/kg daily, maintenance dose 20-30 mg/kg daily

ii) ADULT, initially; 0.5-1 g/day, increase weekly to maintenance dose of 2 g/day in 2 divided doses, maximun 3 g/day. CHILD over 6 years, juvenile rheumatoid arthritis: 30-50 mg/kg/day in 2 divided doses up to a maximum of 2 g/day
1420 Salicylic Acid 2 - 10% Cream D01AE12000G1001XX C Seborrhoeic dermatitis, scalp psoriasis and hyperkeratotic skin conditions Apply sparingly to the affected area 2-3 times daily
1421 Salicylic Acid 2 - 10% Ointment D01AE12000G5001XX C Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin disorders Apply sparingly to the affected area 2-3 times daily
1422 Salicylic Acid 20% Ointment D01AE12000G5002XX C Plantar warts Apply daily and protect surrounding skin (eg with soft paraffin or specially designed plaster) ,may need to continue up to 3 months
1423 Salicylic Acid, Starch, Zinc Oxide Paste D01AE12952G6001XX C Use as a protective or base Apply the paste liberally and carefully to the lesions twice daily
1424 Salicylic acid, Sulphur and Liquid Coal Tar Ointment D05AA00-946-G50-01-XXX B Scalp psoriasis and severe seborrhoeic dermatitis None Rub a small amount into the scalp gently
1425 Salmeterol 25mcg and Fluticasone Propionate 125mcg Inhalation R03AK06-989-A21-02-XXX A* Regular treatment of reversible obstructive airway diseases including asthma. None ADULT and CHILD more than 12 years : 1 - 2 puff twice daily.
CHILD over 4 years : 1 puff twice daily
1426 Salmeterol 25mcg and Fluticasone Propionate 50mcg Inhalation R03AK06-989-A21-04-XXX A* Regular treatment of reversible obstructive airway diseases including asthma in children, where use of lower dose of a combination (bronchodilator and inhaled corticosteroids) is appropriate. Limited to paediatric population for the purpose of dose tapering CHILD more than 12 years : 2 puff twice daily.
CHILD over 4 years : 2 puff twice daily
No data on use for children aged under 4 years.
1427 Salmeterol 50mcg & Fluticasone Propionate 250mcg Inhalation R03AK06-989-A21-01-XXX A*, A/KK Prescriber Category A*:
i) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
ii) 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.

Prescriber Category A/KK:
- Regular treatment of reversible obstructive airways diseases including asthma.		 None ADULT and CHILD more than 12 years : 1 puff twice daily.
1428 Salmeterol 50mcg and Fluticasone Propionate 500mcg Inhalation R03AK06-989-A21-06-XXX A*, A/KK Prescriber Category A*:
i) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
ii) 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.

Prescriber Category A/KK:
- Regular treatment of reversible obstructive airways diseases including asthma.		 None ADULT and CHILD more than 12 years : 1 puff twice daily
1429 Saxagliptin 2.5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1001XX A Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. The recommended starting dose of in patients who need 5mg of saxagliptin and who are not currently treated with metformin is 5mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. In patients treated with metformin, the dose of should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Patients who need 2.5mg saxagliptin in combination with metformin extended-release may be treated with 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.
1430 Saxagliptin 5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1002XX A - Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. The recommended starting dose of in patients who need 5mg of saxagliptin and who are not currently treated with metformin is 5mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. In patients treated with metformin, the dose of should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Patients who need 2.5mg saxagliptin in combination with metformin extended-release may be treated with 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.
1431 Saxagliptin 5mg and Metformin HCl 500 mg Extended-Release Tablet A10BD10926T1003XX A - Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. The recommended starting dose of in patients who need 5mg of saxagliptin and who are not currently treated with metformin is 5mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin. In patients treated with metformin, the dose of should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Patients who need 2.5mg saxagliptin in combination with metformin extended-release may be treated with 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.
1432 Secukinumab 150mg powder for solution for injection L04AC10-000-P30-01-XXX A* Indicated for the treatment of moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. None Child (6 years and older): The recommended dose is based on body weight* and administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks).
*<25kg: 75mg; 25-50kg: 75mg; >/=50kg: 150mg (may be increased to 300mg)
1433 Secukinumab 150mg/ml solution for injection in a pre-filled pen L04AC10-000-P50-01-XXX A* i) Alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

ii) Indicated for the treatment of active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy.

iii) Indicated for the treatment of moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.		 INDIKASI (i):
To be prescribed by Rheumatologist only

INDIKASI (ii):
2nd or 3rd line, after failure of conventional DMARDs or TNF-inhibitors.
 i) 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4.
For patients who are anti-TNFα inadequate responders (IR) or patients with concomitant moderate to severe plaque psoriasis;
300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Each 300 mg dose is given as two subcutaneous injections of 150 mg.

ii) 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Based on clinical response, the dose can be increased to 300 mg.

iii) Adult: 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at week 4. Each 300 mg dose is given as two subcutaneous injections of 150 mg. For some patients, a dosage of 150 mg may be acceptable.
Child (6 years and older): The recommended dose is based on body weight* and administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks).
*<25kg: 75mg; 25-50kg: 75mg; >/=50kg: 150mg (may be increased to 300mg)
1434 Selegiline HCl 5 mg Tablet N04BD01110T1001XX A* Only for treatment of late stage Parkinsonism with on and off phenomenon 5 mg twice daily at breakfast and lunch.
Maximum 10 mg/day
1435 Selenium Sulphide 2.5% Shampoo D11AC03-180-L52-01-XXX A/KK Dandruff, seborrheic dermatitis of scalp None Apply onto wet hair, lather and leave on scalp for 3 minutes. Rinse. Repeat treatment. Rinse thoroughly. Use twice weekly at first, then as necessary as directed by the physician.
1436 Semaglutide 0.25 mg/dose (0.68 mg/mL) Solution for Injection in Pre-filled Pen A10BJ06-000-P50-09-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate semaglutide at 0.25 mg weekly, escalating every 4 weeks (0.5 mg, 1.0 mg, 1.7 mg) to the 2.4 mg weekly maintenance dose by Week 17. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. If clinically required, delay escalation or temporarily step down to the previously tolerated dose until symptoms resolve.
1437 Semaglutide 0.5 mg/dose (1.34 mg/mL) Solution for Injection in Pre-filled Pen A10BJ06-000-P50-01-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate semaglutide at 0.25 mg weekly, escalating every 4 weeks (0.5 mg, 1.0 mg, 1.7 mg) to the 2.4 mg weekly maintenance dose by Week 17. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. If clinically required, delay escalation or temporarily step down to the previously tolerated dose until symptoms resolve.
1438 Semaglutide 1 mg/dose (1.34 mg/mL) Solution for Injection in Pre-filled Pen A10BJ06-000-P50-01-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate semaglutide at 0.25 mg weekly, escalating every 4 weeks (0.5 mg, 1.0 mg, 1.7 mg) to the 2.4 mg weekly maintenance dose by Week 17. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. If clinically required, delay escalation or temporarily step down to the previously tolerated dose until symptoms resolve.
1439 Semaglutide 1.34 mg/ml (0.25mg, 0.5mg/Dose) Solution for Injection in Pre-Filled Pen A10BJ06-000-P50-01-xxx A* Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other glucose lowering medicinal products for the treatment of diabetes. i. HbA1c > 8.0% while on ≥2 Oral Glucose Lowering Drugs (OGLDs) and basal insulin AND
ii. BMI > 30 kg/m2 AND
iii. Very High CV Risk based on European Society of Cardiology (ESC) 2023 Risk Category:
a. Clinically established ASCVD or
b. Severe TOD (eGFR <45 mL/min/1.73m2 irrespective of albuminuria; or eGFR 45–59 mL/min/1.73m2 and microalbuminuria (UACR 30–300 mg/g; stage A2); or proteinuria (UACR >300 mg/g; stage A3); or presence of microvascular disease in at least three different sites or
c. 10-year CVD risk ≥20% using SCORE2-Diabetes
iv. To be prescribed by Endocrinologists only
Initiate semaglutide at a dose of 0.25 mg once weekly for 4 weeks, followed by an increase to 0.5 mg once weekly. If additional glycemic control is required after at least 4 weeks on the 0.5 mg regimen, the dose may be escalated to 1.0 mg once weekly. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. Weekly doses exceeding 1.0 mg are not recommended for this indication.
1440 Semaglutide 1.34 mg/ml (1mg/Dose) Solution for Injection in Pre-Filled Pen A10BJ06-000-P50-02-xxx A* Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other glucose lowering medicinal products for the treatment of diabetes. i. HbA1c > 8.0% while on ≥2 Oral Glucose Lowering Drugs (OGLDs) and basal insulin AND
ii. BMI > 30 kg/m2 AND
iii. Very High CV Risk based on European Society of Cardiology (ESC) 2023 Risk Category:
a. Clinically established ASCVD or
b. Severe TOD (eGFR <45 mL/min/1.73m2 irrespective of albuminuria; or eGFR 45–59 mL/min/1.73m2 and microalbuminuria (UACR 30–300 mg/g; stage A2); or proteinuria (UACR >300 mg/g; stage A3); or presence of microvascular disease in at least three different sites or
c. 10-year CVD risk ≥20% using SCORE2-Diabetes
iv. To be prescribed by Endocrinologists only
Initiate semaglutide at a dose of 0.25 mg once weekly for 4 weeks, followed by an increase to 0.5 mg once weekly. If additional glycemic control is required after at least 4 weeks on the 0.5 mg regimen, the dose may be escalated to 1.0 mg once weekly. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. Weekly doses exceeding 1.0 mg are not recommended for this indication.

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