Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Dosage
1411 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.
1412 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
1413 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
1414 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
1415 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
1416 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).
1417 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.
1418 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.
1419 Silver Nitrate 0.5% Lotion D08AL01221L6001XX B Use as antiseptic Apply undiluted to affected area for a limited period
1420 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
1421 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
1422 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
1423 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
1424 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
1425 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
1426 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
1427 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
1428 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
1429 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
1430 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.
1431 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
1432 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
1433 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
1434 Sodium Bicarbonate 5% w/v Ear Drops S02DC00131D1001XX C To soften the impacted ear wax 2-3 drops 3-4 times daily
1435 Sodium Bicarbonate 8.4% (1 mmol/ml) Injection B05XA02131P3002XX 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 According to the needs of the patient. In severe shock due to cardiac arrest: 50 ml by IV
1436 Sodium Bicarbonate and Magnesium Carbonate Compound Mixture A02AH00912L2101XX C Heartburn, for rapid relief of dyspepsia ADULT 10-20 ml 3 times daily
1437 Sodium Bicarbonate Mixture (Paediatric) A02AH00131L2101XX C Heartburn for rapid relief of dyspepsia CHILD up to 1 year 5 ml; up to 1-5 years 10 ml in 4 to 6 divided doses
1438 Sodium Bicarbonate, Citric Acid, Sodium Citrate and Tartaric Acid - 4 g per sachet B05CB10955M4001XX B For relieving of discomfort in mild urinary tract infection, symptomatic relief of dysuria to enchance the action to certain antibiotics especially some sulphonamides. In gout as urinary alkalinizers to prevent cystallisation of urates 4 - 8 g (1- 2 sachets) dissolved in a glass of cold water 4 times daily as prescribed
1439 Sodium Biphosphate 16%, Sodium Phosphate 6% Rectal Solution A06AG01162G2001XX A Bowel cleansing before colonic surgery, colonoscopy or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation ADULT 133 ml (1 bottle) administered rectally. CHILD more than 2 years half the adult dose (66.6ml)
1440 Sodium Biphosphate 16%, Sodium Phosphate 6% Solution A06AG01162L9901XX A Bowel cleansing before colonic surgery, colonoscopy or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation 45 ml diluted with half a glass (120 mL) of water, followed by one full glass (240 mL) of water. Timing of doses is dependent on the time of the procedure. For morning procedure, first dose should be taken at 7 a.m. and second at 7 p.m. on day before the procedure. For afternoon procedure, first dose should be taken at 7 p.m. on day before and second dose at 7 a.m. on day of the procedure. Solid food should not be taken during the bowel preparation period. However clear fluids or water can be taken liberally. CHILD under 12 years not recommended

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