Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1351 Ropinirole HCI 2 mg Extended Release Tablet N04BC04110T5003XX A* Treatment of idiopathic Parkinson?s disease. It may be used as monotherapy or in combination with levodopa ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate-realease to prolonged-release tablet; dose of ropinirole prolonged release tablet should be based on the total daily dose of ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided.
1352 Ropinirole HCI 4 mg Extended Release Tablet N04BC04110T5004XX A* Treatment of idiopathic Parkinson?s disease. It may be used as monotherapy or in combination with levodopa ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate-realease to prolonged-release tablet; dose of ropinirole prolonged release tablet should be based on the total daily dose of ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided.
1353 Ropinirole HCl 0.25 mg Tablet N04BCO4-110-T10-01-XXX A* i) Treatment of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa ii) Treatment of restless leg syndrome i) 0.25 mg 3 times daily gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day ii) Initial: 0.25mg ON for 2 days then increased if tolerated to 0.5mg ON. Further dose increment of 0.5mg/week can be made until optimal response is achieved
1354 Ropinirole HCl 1 mg Tablet N04BCO4-110-T10-02-XXX A* i) Treatment of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa ii) Treatment of restless leg syndrome i) 0.25 mg 3 times daily gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day ii) Initial: 0.25mg ON for 2 days then increased if tolerated to 0.5mg ON. Further dose increment of 0.5mg/week can be made until optimal response is achieved
1355 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
1356 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
1357 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
1358 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
1359 Ruxolitinib 15mg tablet L01XE18162T1002XX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. To be used as 3rd line after hydroxyurea and other best available treatment such as danazol and S.C. Interferon The recommended starting dose: a) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients b) Platelet count of >200,000/mm³: 20 mg twice daily for patients c) 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.
1360 Ruxolitinib 20mg tablet L01XE18162T1003XX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. To be used as 3rd line after hydroxyurea and other best available treatment such as danazol and S.C. Interferon The recommended starting dose: a) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients b) Platelet count of >200,000/mm³: 20 mg twice daily for patients c) 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.
1361 Ruxolitinib 5mg tablet L01XE18162T1001XX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with: a) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or b) post-polycythemia vera myelofibrosis; or c) post-essential thrombocythemia myelofibrosis. To be used as 3rd line after hydroxyurea and other best available treatment such as danazol and S.C. Interferon The recommended starting dose: a) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients b) Platelet count of >200,000/mm³: 20 mg twice daily for patients c) 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.
1362 Sacubitril/ Valsartan 100 mg tablet C09DX04-000-T32-02-XXX A* Treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction. i) NYHA class II-IV ii) Patients who are symptomatic despite being on optimized treatment with an ACEi / ARB, a beta blocker, a diuretics and an mineralocorticoid receptor agonist (MRA). 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.
1363 Sacubitril/ Valsartan 50 mg tablet C09DX04-000-T32-01-XXX A* Treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction. i) NYHA class II-IV ii) Patients who are symptomatic despite being on optimized treatment with an ACEi / ARB, a beta blocker, a diuretics and an mineralocorticoid receptor agonist (MRA). 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.
1364 Sacubitril/Valsartan 200 mg tablet C09DX04-000-T32-03-XXX A* Treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction. i) NYHA class II-IV ii) Patients who are symptomatic despite being on optimized treatment with an ACEi / ARB, a beta blocker, a diuretics and an mineralocorticoid receptor agonist (MRA). 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.
1365 Salbutamol 0.5 % Inhalation Solution R03AC02183A3001XX B Asthma and other conditions associated with reversible airways obstruction 2 ml may be inhaled up to 4 times daily over a period of 3 minutes per inhalation (0.5 ml diluted in 2.5 ml of normal saline by inhalation over 5 to 15 minutes)
1366 Salbutamol 0.5 mg/ml Injection R03CC02183P3001XX A i. Asthma and other conditions associated with reversible airways obstruction ii. For prevention of uncomplicated premature labour 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
1367 Salbutamol 100 mcg/dose Inhalation R03AC02183A1001XX B Asthma and other conditions associated with reversible airways obstruction ADULT : 100 - 200 mcg up to 3 - 4 times daily. CHILD : 100 mcg increased to 200 mcg if necessary
1368 Salbutamol 2 mg Tablet R03CC02183T1001XX B Asthma and other conditions associated with reversible airways obstruction CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times daily, 6 - 12 years : 2 mg 3 - 4 times daily. CHILD over 12 years and ADULT : 2 - 4 mg 3 - 4 times daily
1369 Salbutamol 2 mg/5 ml Syrup R03CC02183L9001XX B Asthma and other conditions associated with reversible airways obstruction CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times daily, 6 - 12 years : 2 mg 3 -4 times daily
1370 Salbutamol 200mcg/dose Inhaler R03AC02183A2001XX B Asthma and other conditions associated with reversible airways obstruction CHILD : 100 - 200 mcg. Maintenance : 100 - 200 mcg 2 - 4 times daily. ADULT : 100 - 400 mcg. Maitenance : 100 - 400 mcg 2 - 4 times daily
1371 Salbutamol 5 mg/5 ml Injection R03CC02183P3002XX A i. Asthma and other conditions associated with reversible airways obstruction ii. For prevention of uncomplicated premature labour 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
1372 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
1373 Salicylic Acid 1 - 2% in Hydrocortisone 1% Ointment D07XA01952G5001XX B Seborrhoeic capitis Apply sparingly to affected areas 1-2 times daily
1374 Salicylic Acid 2 % Lotion D01AE12000L6001XX B Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin conditions Apply sparingly to the affected area 2-3 times daily. Wash with cleanser 2 - 3 times per day
1375 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
1376 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
1377 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
1378 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
1379 Salmeterol 25 mcg and Fluticasone Propionate 125 mcg Inhalation R03AK06989A2102XX A* Regular treatment of reversible obstructive airway diseases including asthma. ADULT and CHILD more than 12 years : 1 - 2 puff twice daily. CHILD over 4 years : 1 puff twice daily
1380 Salmeterol 25mcg and Fluticasone Propionate 50mcg Inhalation R03AK06989A2104XX 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.

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