Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Dosage
1411 Salmeterol 50 mcg and Fluticasone Propionate 500 mcg Inhalation R03AK06989A2106XX A/KK Category of prescriber A/KK is only approved for indication (i): i) Regular treatment of reversible obstructive airways diseases including asthma. The following indication is still under category of prescriber A*: ii) Chronic obstructive pulmonary disease including chronic bronchitis and emphysema i) ADULT and CHILD more than 12 years : 1 puff twice daily ii) ADULT 1 puff twice daily
1412 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
1413 Saxagliptin 2.5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1001XX A FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. 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. 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.
1414 Saxagliptin 5 mg Tablet A10BH03000T1002XX 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. 2.5-5mg once daily. Patients with CrCl < 50ml/min, and when coadministered with strong CYP450 3A4/5 inhibitors: 2.5mg OD
1415 Saxagliptin 5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1002XX A FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - 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. 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.
1416 Saxagliptin 5mg and Metformin HCl 500 mg Extended-Release Tablet A10BD10926T1003XX A FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - 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. 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.
1417 Secukinumab 150mg/ml injection L04AC10000P5001XXX A* i) Psoriatic Arthritis: Secukinumab, 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) Ankylosing spondylitis: Secukinumab is indicated for the treatment of active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy. Prescribing Restriction: 2nd or 3rd line, after failure of conventional DMARDs or TNF-inhibitors. iii) Plaqu psoriasis: Secukinumab is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy i)Psoriatic arthritis (PsA): Recommended dose: 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; Recommended dose: 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) Ankylosing Spondylitis (AS): Recommended dose: 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. iii) Plaque psoriasis: The recommended dose is 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.
1418 Selected Plasma Protein 5 g/100 ml Injection B05AA02000P3001XX B For treatment of shock due to burns, crushing injuries, abdominal emergencies and where there is a predominant loss of plasma fluids and red blood cells, emergency treatment of shock due to haemorrhage and in infants and small children in the initial therapy of shock due to dehydration and infection ADULT 12.5-25 g (250-500 ml) by IV. CHILD usual dose 33 ml/kg body weight at rate of 5-10 ml/min
1419 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
1420 Selenium Sulphide 2.5% Shampoo D11AC03180L5201XX A/KK Dandruff, seborrheic dermatitis of scalp Dandruff: apply 5-10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse thoroughly. Seborrheic dermatitis of scalp: apply 5-10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse thoroughly
1421 Sertraline HCI 50 mg Tablet N06AB06110T1001XX B Major depression, obsessive-compulsive disorder (OCD), panic disorder Depression, obsessive-compulsive disorder: 50 mg/day, may increase in steps of 50mg at weekly interval, max:200mg/day. Panic disorder: Initially 25 mg/day. After 1 week, increase dose to 50 mg/day. All dose changes should be made at intervals of more than 1 week, max: 200 mg/day
1422 Sevelamer 800mg Tablet V03AE02121T1001XX A* Control of hyperphosphatemia in adult patients receiving haemodialysis and peritoneal dialysis. Restriction: Sevelamer carbonate 800mg tablet should be used in context of multiple therapeutic approach which include calcium supplement, 1, 25-hydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. Starting dose is one or two 800mg tablets three times per day with meals. Adjust by one tablet per meal in two weeks interval as needed to obtain serum phosphorus target (1.13 to 1.78mmol/L).
1423 Sevoflurane Liquid N01AB08000L5001XX A* To be used only for i) induction and ii) maintenance of anaesthesia i) Adult: Given via a calibrated vaporiser: Up to 5% v/v with oxygen or a mixture of oxygen and nitrous oxide. Child: Given via a calibrated vaporiser: Up to 7% v/v. ii) Adult: 0.5-3% v/v with or without nitrous oxide. Child: 0.5-3% v/v with or without nitrous oxide.
1424 Sildenafil Citrate 20 mg Film-coated Tablet G04BE03136T1004XX A* Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. ADULTS ≥ 18 years: The recommended dose is 20mg three times a day. Tablets should be taken approximately 6 to 8 hours apart with or without food. ELDERLY (≥65 years): Dosage adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients. IMPAIRED RENAL FUNCTION: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30ml/min). A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated. IMPAIRED HEPATIC FUNCTION: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B). A downward dose adjustment to 20mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
1425 Silver Nitrate 0.5% Lotion D08AL01221L6001XX B Use as antiseptic Apply undiluted to affected area for a limited period
1426 Silver Sulfadiazine 1% Cream D06BA01199G1001XX B Prevention and treatment of infections in severe burns, leg ulcers where infections may prevent healing and for the prophylaxis of infections in skin grafting Burns: Apply 3 mm thick layer twice daily with sterile applicator. Leg ulcer: apply at least 3 times a week
1427 Simvastatin 10 mg Tablet C10AA01000T1001XX B Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 - 20 mg once daily. Maximum: 80 mg daily
1428 Simvastatin 20 mg Tablet C10AA01000T1002XX B Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 - 20 mg once daily. Maximum: 80 mg daily
1429 Simvastatin 40 mg Tablet C10AA01000T1003XX B Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 - 20 mg once daily. Maximum: 80 mg daily
1430 Sitagliptin 100 mg Tablet A10BH01000T1003XX A* FUKKM Restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes in patients with renal failure where metformin/sulphonylurea is contraindicated/untolerated and elderly with multiple co-morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%. ADULT over 18 years, 100 mg once daily: 100mg once daily CrCl ≥ 30 to < 50ml/min: 50mg once daily CrCl < 30 ml/min: 25mg once daily
1431 Sitagliptin 25 mg Tablet A10BH01000T1001XX A* FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes in patients with renal failure where metformin/sulphonylurea is contraindicated/untolerated and elderly with multiple co morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%. ADULT over 18 years, 100 mg once daily: 100mg once daily CrCl ≥ 30 to < 50ml/min: 50mg once daily CrCl < 30 ml/min: 25mg once daily
1432 Sitagliptin 50 mg and Metformin HCl 1000 mg Tablet A10BD07926T1003XX A* FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other antidiabetics who are inadequately controlled on metformin or sitagliptin alone or already being treated with the combination of sitagliptin and metformin. ii) Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics. 50 mg/500 mg twice daily. The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1433 Sitagliptin 50 mg and Metformin HCl 500 mg Tablet A10BD07926T1001XX A* FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i)Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other antidiabetics who are inadequately controlled on metformin or sitagliptin alone or already being treated with the combination of sitagliptin and metformin. ii)Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics. 50 mg/500 mg twice daily. The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1434 Sitagliptin 50 mg and Metformin HCl 850 mg Tablet A10BD07926T1002XX A* FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other antidiabetics who are inadequately controlled on metformin or sitagliptin alone or already being treated with the combination of sitagliptin and metformin. ii) Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics. 50 mg/500 mg twice daily. The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1435 Sitagliptin 50 mg Tablet A10BH01000T1002XX A* FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes in patients with renal failure where metformin/sulphonylurea is contraindicated/untolerated and elderly with multiple co morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%. ADULT over 18 years, 100 mg once daily: 100mg once daily CrCl ≥ 30 to < 50ml/min: 50mg once daily CrCl < 30 ml/min: 25mg once daily
1436 Sodium Alginate 1000 mg/10 ml & Potassium Bicarbonate 200 mg/10 ml Suspension A02BX13915L8001XX A* Treatment of symptoms of gastro-oesophageal reflux eg. acid regurgitation, heartburn, indigestion due to the reflux of stomach contents not responding to conventional antacids or as an addition to PPI when PPI alone fails to control the symptoms Adult, elderly & children ≥12 year: 5-10 mL.
1437 Sodium and Meglumine Diatrizoate 58-60% Injection V08AA01993P3002XX B For IV pyelography Depend on the type of procedure and the degree and extent of contrast required
1438 Sodium Bicarbonate 1 g/15 ml Mixture A02AH00131L2102XX B i) Relief of discomfort in mild urinary tract ii) Alkalinisation of urine i) 3 g in every 2 hours until urinary pH exceeds 7 ii) Maintenance of alkaline urine 5-10 g daily
1439 Sodium Bicarbonate 4.2% (0.5 mmol/ml) Injection B05XA02131P3001XX B For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH) and for acidosis IV infusion of 2 - 5 mmol/kg body weight over a period of 4 - 8 hours or according to the needs of the patients
1440 Sodium Bicarbonate 5% w/v Ear Drops S02DC00131D1001XX C To soften the impacted ear wax 2-3 drops 3-4 times daily

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