Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1411 Salbutamol 0.5% Inhalation Solution R03AC02-183-A30-01-XXX B Indicated for the relief of bronchospasm in patients with reversible obstructive airway disease and acute bronchospasm. - 2.5 to 5mg (0.5ml – 1ml), repeat according to response and tolerability.

Dosing is individualised and according to product insert/protocol.
1412 Salbutamol 0.5mg/ml Injection R03CC02-183-P30-01-XXX A i. Asthma and other conditions associated with reversible airways obstruction
ii. For prevention of uncomplicated premature labour		 None 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
1413 Salbutamol 100mcg/dose Inhalation R03AC02-183-A10-01-XXX B Asthma and other conditions associated with reversible airways obstruction None ADULT : 100 - 200 mcg up to 3 - 4 times daily.
CHILD : 100 mcg increased to 200 mcg if necessary
1414 Salbutamol 200mcg/dose Inhaler R03AC02-183-A20-01-XXX B Asthma and other conditions associated with reversible airways obstruction None CHILD : 100 - 200 mcg. Maintenance : 100 - 200 mcg 2 - 4 times daily. ADULT : 100 - 400 mcg. Maitenance : 100 - 400 mcg 2 - 4 times daily
1415 Salbutamol 2mg Tablet R03CC02-183-T10-01-XXX B Asthma and other conditions associated with reversible airways obstruction None CHILD
2 - 6 years : 1 - 2 mg 3 - 4 times daily
6 - 12 years : 2 mg 3 - 4 times daily.
over 12 years and ADULT : 2 - 4 mg 3 - 4 times daily
1416 Salbutamol 2mg/5ml Syrup R03CC02-183-L90-01-XXX B Asthma and other conditions associated with reversible airways obstruction None CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times daily, 6 - 12 years : 2 mg 3 -4 times daily
1417 Salbutamol 5mg/5ml Injection R03CC02-183-P30-02-XXX A i. Asthma and other conditions associated with reversible airways obstruction

ii. For prevention of uncomplicated premature labour		 None 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
1418 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
1419 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
1420 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
1421 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
1422 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
1423 Salicylic acid, Sulphur and Liquid Coal Tar Ointment D05AA00-946-G50-01-XXX B Scalp psoriasis and severe seborrhoeic dermatitis None Rub a small amount into the scalp gently
1424 Salmeterol 25mcg and Fluticasone Propionate 125mcg Inhalation R03AK06-989-A21-02-XXX A* Regular treatment of reversible obstructive airway diseases including asthma. None ADULT and CHILD more than 12 years : 1 - 2 puff twice daily.
CHILD over 4 years : 1 puff twice daily
1425 Salmeterol 25mcg and Fluticasone Propionate 50mcg Inhalation R03AK06-989-A21-04-XXX 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.
1426 Salmeterol 50mcg & Fluticasone Propionate 250mcg Inhalation R03AK06-989-A21-01-XXX A*, A/KK Prescriber Category A*:
i) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
ii) Treatment of COPD patients with blood eosinophil count of 100 cells/microliter and more with history of repeated exacerbation despite regular treatment with long-acting bronchodilators.

Prescriber Category A/KK:
- Regular treatment of reversible obstructive airways diseases including asthma.		 None ADULT and CHILD more than 12 years : 1 puff twice daily.
1427 Salmeterol 50mcg and Fluticasone Propionate 500mcg Inhalation R03AK06-989-A21-06-XXX A*, A/KK Prescriber Category A*:
i) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
ii) Treatment of COPD patients with blood eosinophil count of 100 cells/microliter and more with history of repeated exacerbation despite regular treatment with long-acting bronchodilators.

Prescriber Category A/KK:
- Regular treatment of reversible obstructive airways diseases including asthma.		 None ADULT and CHILD more than 12 years : 1 puff twice daily
1428 Saxagliptin 2.5mg and Metformin HCl 1000mg Extended-Release Tablet A10BD10926T1001XX 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.
1429 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.
1430 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.
1431 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)
1432 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)
1433 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
1434 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.
1435 Semaglutide 1.34 mg/ml (0.25mg, 0.5mg/Dose) Solution for Injection in Pre-Filled Pen A10BJ06-000-P50-01-xxx A* Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other glucose lowering medicinal products for the treatment of diabetes. i. HbA1c > 8.0% while on ≥2 Oral Glucose Lowering Drugs (OGLDs) and basal insulin AND
ii. BMI > 30 kg/m2 AND
iii. Very High CV Risk based on European Society of Cardiology (ESC) 2023 Risk Category:
a. Clinically established ASCVD or
b. Severe TOD (eGFR <45 mL/min/1.73m2 irrespective of albuminuria; or eGFR 45–59 mL/min/1.73m2 and microalbuminuria (UACR 30–300 mg/g; stage A2); or proteinuria (UACR >300 mg/g; stage A3); or presence of microvascular disease in at least three different sites or
c. 10-year CVD risk ≥20% using SCORE2-Diabetes
iv. To be prescribed by Endocrinologists only
Initiate semaglutide at a dose of 0.25 mg once weekly for 4 weeks, followed by an increase to 0.5 mg once weekly. If additional glycemic control is required after at least 4 weeks on the 0.5 mg regimen, the dose may be escalated to 1.0 mg once weekly. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. Weekly doses exceeding 1.0 mg are not recommended for this indication.
1436 Semaglutide 1.34 mg/ml (1mg/Dose) Solution for Injection in Pre-Filled Pen A10BJ06-000-P50-02-xxx A* Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other glucose lowering medicinal products for the treatment of diabetes. i. HbA1c > 8.0% while on ≥2 Oral Glucose Lowering Drugs (OGLDs) and basal insulin AND
ii. BMI > 30 kg/m2 AND
iii. Very High CV Risk based on European Society of Cardiology (ESC) 2023 Risk Category:
a. Clinically established ASCVD or
b. Severe TOD (eGFR <45 mL/min/1.73m2 irrespective of albuminuria; or eGFR 45–59 mL/min/1.73m2 and microalbuminuria (UACR 30–300 mg/g; stage A2); or proteinuria (UACR >300 mg/g; stage A3); or presence of microvascular disease in at least three different sites or
c. 10-year CVD risk ≥20% using SCORE2-Diabetes
iv. To be prescribed by Endocrinologists only
Initiate semaglutide at a dose of 0.25 mg once weekly for 4 weeks, followed by an increase to 0.5 mg once weekly. If additional glycemic control is required after at least 4 weeks on the 0.5 mg regimen, the dose may be escalated to 1.0 mg once weekly. Administer the injection subcutaneously once weekly at any time of day, irrespective of meals. Weekly doses exceeding 1.0 mg are not recommended for this indication.
1437 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.
1438 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).
1439 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.
1440 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.

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