Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1411 Saxagliptin 5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1002XX 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.
1412 Saxagliptin 5mg and Metformin HCl 500 mg Extended-Release Tablet A10BD10926T1003XX 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.
1413 Secukinumab 150mg powder for solution for injection L04AC10-000-P30-01-XXX A* Indicated for the treatment of moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. None Child (6 years and older): The recommended dose is based on body weight* and administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks).
*<25kg: 75mg; 25-50kg: 75mg; >/=50kg: 150mg (may be increased to 300mg)
1414 Secukinumab 150mg/ml solution for injection in a pre-filled pen L04AC10-000-P50-01-XXX A* i) 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) Indicated for the treatment of active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy.

iii) Indicated for the treatment of moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.		 INDIKASI (i):
To be prescribed by Rheumatologist only

INDIKASI (ii):
2nd or 3rd line, after failure of conventional DMARDs or TNF-inhibitors.
 i) 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;
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) 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at Week 4. Based on clinical response, the dose can be increased to 300 mg.

iii) Adult: 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.
Child (6 years and older): The recommended dose is based on body weight* and administered by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks).
*<25kg: 75mg; 25-50kg: 75mg; >/=50kg: 150mg (may be increased to 300mg)
1415 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
1416 Selenium Sulphide 2.5% Shampoo D11AC03-180-L52-01-XXX A/KK Dandruff, seborrheic dermatitis of scalp None Apply onto wet hair, lather and leave on scalp for 3 minutes. Rinse. Repeat treatment. Rinse thoroughly. Use twice weekly at first, then as necessary as directed by the physician.
1417 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.
1418 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).
1419 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.
1420 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.
1421 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
1422 Simvastatin 10 mg Tablet C10AA01000T1001XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1423 Simvastatin 20 mg Tablet C10AA01000T1002XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1424 Simvastatin 40 mg Tablet C10AA01000T1003XX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 i) & ii)
10 - 40 mg once daily.
Maximum: 80 mg daily
1425 Sitagliptin 100 mg Tablet A10BH01000T1003XX A* 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%. 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		 ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1426 Sitagliptin 25 mg Tablet A10BH01000T1001XX A* 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%.		 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.		 ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1427 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
1428 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
1429 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
1430 Sitagliptin 50 mg Tablet A10BH01000T1002XX A* 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%. 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.		 ADULT over 18 years, 100 mg once daily
CrCl ≥ 30 to < 50ml/min: 50mg once daily
CrCl < 30 ml/min: 25mg once daily
1431 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
1432 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.
1433 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
1434 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
1435 Sodium Bicarbonate and Magnesium Carbonate Compound Mixture A02AH00912L2101XX C Heartburn, for rapid relief of dyspepsia ADULT 10-20 ml 3 times daily
1436 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
1437 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)
1438 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
1439 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
1440 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

Pages