Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1441 Semaglutide 1.7 mg/dose (2.27 mg/mL) Solution for Injection in Pre-filled Pen A10BJ06-000-P50-08-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.
1442 Semaglutide 2.4 mg/dose (3.2 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.
1443 Sertraline HCI 50mg Tablet N06AB06-110-T10-01-XXX B i) Major depression
ii) Obsessive-compulsive disorder (OCD)
iii) Panic disorder
iv) Social anxiety disorder (social phobia)
v) Post-traumatic stress disorder		 i) Initial: 50mg per day
Titration: 50mg increments at intervals of at least a week Max: 200mg per day

ii) Initial: 50mg per day
Titration: 50mg increments at intervals of at least a week Max: 200mg per day
Therapeutic dose range: 50 – 200 mg per day

iii), iv) & v)
Initial: 25mg per day. Increase to 50mg per day after 1 week. Titration: Adjust dose at intervals of at least a week
Max: 200mg per day

Dosing is individualised and according to product insert/ protocol.
Should not be used in patients under 18 years old except for the treatment of OCD. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms.
1444 Sevelamer 800mg Tablet V03AE02121T1001XX A* Control of hyperphosphatemia in adult patients receiving haemodialysis and peritoneal dialysis. 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).
1445 Sevoflurane Liquid N01AB08-000-L50-01-XXX 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.
1446 Sildenafil Citrate 20 mg Film-coated Tablet G04BE03-136-T10-04-XXX A* Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. - 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.
1447 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
1448 Simvastatin 10 mg Tablet C10AA01000T1001XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1449 Simvastatin 20 mg Tablet C10AA01000T1002XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1450 Simvastatin 40 mg Tablet C10AA01000T1003XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1451 Sitagliptin 100 mg Tablet A10BH01000T1003XX A/KK Indicated as adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, as monotherapy when metformin is contraindicated or not tolerated and as add-on therapy to other glucose-lowering agents when adequate glycaemic control is not achieved despite dose optimisation. None ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1452 Sitagliptin 25 mg Tablet A10BH01000T1001XX A/KK Indicated as adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, as monotherapy when metformin is contraindicated or not tolerated and as add-on therapy to other glucose-lowering agents when adequate glycaemic control is not achieved despite dose optimisation. None ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1453 Sitagliptin 50 mg and Metformin HCl 1000 mg Tablet A10BD07926T1003XX A* 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.		 Consultant/specialists for specific indications only, including Geriatricians
As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea.		 50 mg/500 mg twice daily. The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1454 Sitagliptin 50 mg and Metformin HCl 500 mg Tablet A10BD07926T1001XX A* 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.		 Consultant/specialists for specific indications only, including Geriatricians
As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea.		 50 mg/500 mg twice daily.
The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1455 Sitagliptin 50 mg and Metformin HCl 850 mg Tablet A10BD07926T1002XX A* 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.		 Consultant/specialists for specific indications only, including Geriatricians
As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea.		 50 mg/500 mg twice daily.
The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin
1456 Sitagliptin 50 mg Tablet A10BH01000T1002XX A/KK Indicated as adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, as monotherapy when metformin is contraindicated or not tolerated and as add-on therapy to other glucose-lowering agents when adequate glycaemic control is not achieved despite dose optimisation. None ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1457 Sodium Acid Phosphate (500mg Phosphorus) Effervescent Tablet B05XA09-902-L50-01-XXX A For supplemental ionic phosphorus for correction of hypophosphataemia According to the needs of the patient
1458 Sodium Alginate 1000 mg/10 ml & Potassium Bicarbonate 200 mg/10 ml Suspension A02BX13-915-L80-01-XXX 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.
1459 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
1460 Sodium Bicarbonate 8.4% (1 mmol/ml) Injection B05XA02131P3002XX B i) For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH)
ii) For metabolic acidosis secondary to underlying diseases		 According to the needs of the patient.
In severe shock due to cardiac arrest: 50 ml by IV
1461 Sodium Bicarbonate and Magnesium Carbonate Compound Mixture A02AH00912L2101XX C Heartburn, for rapid relief of dyspepsia ADULT 10-20 ml 3 times daily
1462 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
1463 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)
1464 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
1465 Sodium Chloride 0.18% with Dextrose 10% Injection B05XA03904P6001XX B For replenishing fluid and energy and for restoring or maintaining the concentration of sodium and chloride ions According to the needs of the patient
1466 Sodium Chloride 0.18% with Dextrose 4.23% Injection B05XA03904P6004XX B For replenishing fluid and energy and for restoring or maintaining the concentration of sodium and chloride ions According to the needs of the patient
1467 Sodium Chloride 0.45% Injection B05XA03100P6001XX B For replenishing fluid and for restoring / maintaining the concentration of sodium and chloride ions 100 - 1000 ml by IV or according to the needs of the patient
1468 Sodium Chloride 0.45% with Dextrose 10% Injection B05XA03904P6002XX B For replenishing fluid and energy and for restoring or maintaining the concentration of sodium and chloride ions According to the needs of the patient
1469 Sodium Chloride 0.45% with Dextrose 5% Injection B05XA03904P6005XX B For replenishing fluid and energy and for restoring or maintaining the concentration of sodium and chloride ions According to the needs of the patient
1470 Sodium Chloride 0.9% Eye Drops S01XA03-000-D20-01-XXX C Irrigation of conjunctival sac None 1 - 2 drops every 3 - 4 hours

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