Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1381 Ropivacaine HCl 2 mg/ml Injection N01BB09110P3001XX A* i) Surgical anaesthaesia including obstetrics
ii) Acute pain management		 Dose adjusted according to patient physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml of 7.5 mg/ml solution in incremental doses ( max . total dose 150 mg).
ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution
1382 Ropivacaine HCl 7.5 mg/ml Injection N01BB09110P3002XX A* i) Surgical anaesthaesia including obstetrics
ii) Acute pain management		 Dose adjusted according to patient physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml of 7.5 mg/ml solution in incremental doses ( max . total dose 150 mg).
ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution
1383 Rosuvastatin 10 mg Tablet C10AA07390T1002XX A/KK Dyslipidaemia not responsive to atorvastatin 40mg or equivalent doses of other statins Initially 5-10 mg once daily (5mg in patients with pre-disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily
1384 Rosuvastatin 20mg Tablet C10AA07390T1003XX A/KK Dyslipidaemia not responsive to atorvastatin 40 mg or equivalent doses of other statins Initially 5-10 mg once daily (5mg in patients with pre-disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily
1385 Ruxolitinib 15mg tablet L01XE18162T1002XX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
iii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³:
Limited information to recommend a starting dose for patients. The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1386 Ruxolitinib 20mg tablet L01XE18-162-T10-03-XXX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
iii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³: Limited information to recommend a starting dose for patients.
The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1387 Ruxolitinib 5mg tablet L01XE18-162-T10-01-XXX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
ii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³:
Limited information to recommend a starting dose for patients. The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1388 Sacubitril/ Valsartan 100 mg tablet C09DX04-000-T32-02-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 of sacubitril/valsartan 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.
1389 Sacubitril/ Valsartan 50 mg tablet C09DX04-000-T32-01-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 of sacubitril/valsartan 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.
1390 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.
1391 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.
1392 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
1393 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
1394 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
1395 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
1396 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
1397 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
1398 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
1399 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
1400 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
1401 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
1402 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
1403 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
1404 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
1405 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.
1406 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.
1407 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
1408 Saxagliptin 2.5 mg Tablet A10BH03000T1001XX A/KK FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) As add on therapy in type 2 diabetes patients inadequately controlled on metformin monotherapy and high risk of hypoglycaemia, especially elderly patients with co-morbidities. ii) As add on therapy in type 2 diabetes patients inadequately controlled with a sulphonylure and intolerant/contraindicated for metformin therapy iii) As add on therapy in type 2 diabetes patients inadequately controlled on metformin and sulphonylurea combination therapy iv) In patients with renal failure where metformin contraindicated Not to be used in patients with HbA1c > 8% on single/combination OAD, as insulin initiation is preferred. Recommended starting dose and maintenance dose in patients with normal renal function and mild renal insufficiency (CrCl more than 50 ml/min) is 5 mg once daily. For patients with moderate to severe renal insufficiency (CrCl less than or equal to 50 ml/min) dose is 2.5 mg once daily
1409 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.
1410 Saxagliptin 5 mg Tablet A10BH03000T1002XX A/KK i) As add on therapy in type 2 diabetes patients inadequately controlled on metformin monotherapy and high risk of hypoglycaemia, especially elderly patients with co-morbidities.
ii) As add on therapy in type 2 diabetes patients inadequately controlled with a sulphonylure and intolerant/contraindicated for metformin therapy
iii) As add on therapy in type 2 diabetes patients inadequately controlled on metformin and sulphonylurea combination therapy
iv) In patients with renal failure where metformin contraindicated Not to be used in patients with HbA1c > 8% on single/combination OAD, as insulin initiation is preferred.		 As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. 2.5-5mg once daily. Patients with CrCl < 50ml/min, and when coadministered with strong CYP450 3A4/5 inhibitors: 2.5mg OD

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