Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1471 Sodium Valproate 200mg Tablet N03AG01-520-T10-01-XXX B i. Epilepsy
ii. Treatment and prevention of mania associated with bipolar disorders		 None i. Epilepsy:
ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3-day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day).
CHILD:
- More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day.
- Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored.

ii. Treatment and prevention of mania associated with bipolar disorders:
ADULT: The recommended initial dose is 1000mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects. The recommended maintenance dosage for the treatment of bipolar disorder is between 1000mg and 2000mg daily. In exceptional cases, the dose may be increased to not more than 3000mg daily.
1472 Sodium Valproate 200mg/5ml Syrup N03AG01-520-L90-01-XXX B i) Treatment of generalized or partial epilepsy.
ii) Treatment and prevention of mania associated with bipolar disorder		 None i. Epilepsy:
ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3-day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day).
CHILD:
- More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day.
- Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored.

ii. Treatment and prevention of mania associated with bipolar disorders:
ADULT: The recommended initial dose is 1000mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects. The recommended maintenance dosage for the treatment of bipolar disorder is between 1000mg and 2000mg daily. In exceptional cases, the dose may be increased to not more than 3000mg daily.
1473 Sodium Valproate 400mg Injection N03AG01-520-P40-01-XX B Status epilepticus None ADULT and CHILD above 10 years: 10 to 15 mg/kg/day IV, may increase 5 to 10 mg/kg/week to achieve optimal clinical response (Maximum 60 mg/kg/day or less with a therapeutic range of 50 to 100 mcg/mL)
1474 Sofosbuvir 400mg & velpatasvir 100mg film coated tablet J05AP55-964-T32-01-XXX A*, A/KK For the treatment of chronic hepatitis C virus (HCV) infection in adults PRESCRIBER CATEGORY A/KK:
i. Non-cirrhotic patients who are treatment naïve to NS5A inhibitor, or

PRESCRIBER CATEGORY A*:
ii. With decompensated liver cirrhosis who are treatment naïve to NS5A inhibitor, or
iii. For direct-acting antiviral (DAA) experienced patients who failed to achieve sustained virological response (SVR) due to virological failure (preferably based on resistant associated substitution (RAS) report), or
iv. Uninfected recipients of liver and non-liver grafts of HCV-viremic donors who are treatment naïve to NS5A inhibitor, or
v. HCV-infected recipients post-liver transplant who are treatment naïve to NS5A inhibitor		 One tablet, taken orally, once daily with or without food.
Refer package insert for the recommended treatment and duration for all HCV genotypes
1475 Sofosbuvir 400mg tablet J05AP08-000-T32-01-XXX A/KK To be used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. None One 400 mg tablet, taken orally, once daily with food.
Sofosbuvir should be used in combination with other medicinal products. Monotherapy of sofosbuvir is not recommended.
1476 Solifenacin Succinate 5 mg Tablet G04BD08000T1001XX A* Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 5mg od. Dose can be increased to 10mg if necessary.
1477 Somatropin 10mg (30IU) Injection H01AC01-000-P50-02-XXX A* To be used in children for:
i) Growth failure due to growth hormone deficiency (GHD)
ii) Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii) Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i) Adult onset growth hormone deficiency (GHD)
ii) Childhood onset growth hormone deficiency (GHD)		 None Children:
i) 0.7-1 mg/m2/day or 0.025-0.035 mg/kg/day SC/IM.
ii) 1.3-2mg/m2/day or 0.045-0.05 mg/kg/day SC.
iii) 0.035 mg/kg/day or 1 mg/m2/day SC.

Adult:
i) Start treatment with a low dose of 0.1-0.3 mg/day. Titrate dosage gradually at monthly intervals based on patient's need and serum IGF-1. Maintenance dose: Vary from person to person, but seldom exceed 1.0 mg/day (equal to 3 IU/day).
ii)0.2-0.5mg/day with subsequent dose adjustment on the basis of IGF-I concentration determination.

The dosing is individualized according to product insert / protocol.
1478 Somatropin 12mg Injection H01AC01-000-P30-02-XXX A* To be used in children for:
i. Growth failure due to inadequate endogenous growth hormone.
ii. Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii. Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i. Adult onset growth hormone deficiency (GHD)
ii. Childhood onset growth hormone insufficiency		 To be prescribed by adult and paediatric endocrinologists only Recommended dosing in paediatric patient:
i. 0.025 – 0.035 mg/kg/day or 0.7 – 1.0 mg/m2/day
ii. 0.045 – 0.050 mg/kg/day or 1.4 mg/m2/day
iii. 0.035 mg/kg/day or 1.0 mg/m2/day

Recommended dosing in adult patient:
i. Adult-onset GHD: therapy should start with a low dose, 0.15 – 0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
ii. Childhood onset GHD: the recommended dose to restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration
1479 Somatropin 5.3 mg injection H01AC01-000-P30-01-XXX A* To be used in children for:
i. Growth failure due to inadequate endogenous growth hormone.
ii. Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii. Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i. Adult onset growth hormone deficiency (GHD)
ii. Childhood onse		 To be prescribed by adult and paediatric endocrinologists only Recommended dosing in paediatric patient:
i. 0.025 – 0.035 mg/kg/day or 0.7 – 1.0 mg/m2/day
ii. 0.045 – 0.050 mg/kg/day or 1.4 mg/m2/day
iii. 0.035 mg/kg/day or 1.0 mg/m2/day

Recommended dosing in adult patient:
i. Adult-onset GHD: therapy should start with a low dose, 0.15 – 0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
ii. Childhood onset GHD: the recommended dose to restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration
1480 Somatropin 5mg (15IU) Injection H01AC01-000-P50-01-XXX A* To be used in children for:
i) Growth failure due to growth hormone deficiency (GHD)
ii) Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii) Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i) Adult onset growth hormone deficiency (GHD)
ii) Childhood onset growth hormone deficiency (GHD)		 None Children:
i) 0.7-1 mg/m2/day or 0.025-0.035 mg/kg/day SC/IM.
ii) 1.3-2mg/m2/day or 0.045-0.05 mg/kg/day SC.
iii) 0.035 mg/kg/day or 1 mg/m2/day SC.

Adult:
i) Start treatment with a low dose of 0.1-0.3 mg/day. Titrate dosage gradually at monthly intervals based on patient's need and serum IGF-1. Maintenance dose: Vary from person to person, but seldom exceed 1.0 mg/day (equal to 3 IU/day).
ii)0.2-0.5mg/day with subsequent dose adjustment on the basis of IGF-I concentration determination.

The dosing is individualized according to product insert / protocol.
1481 Somatropin 6mg solution for injection H01AC01-000-P30-04-XXX A* i) Growth failure due to inadequate endogenous growth hormone
ii) Growth failure in girls due to gonadal dysgenesis (Turner syndrome)
iii) Growth failure in short children born small gestational age (SGA)		 For paediatric consultants/specialists use only

This medicine is for the following patients who will require the specific features of the supplied device for treatment optimization:
1. Young infants or toddlers who need very precise dose administration (for example 0.19 mg, 0.27 mg and etc.)
2. Other older patients who are unable to tolerate or who have poor medication compliance with other growth hormone preparations		 i) 0.025-0.035mg/kg/day
ii) 0.045-0.05mg/kg/day
iii) 0.035 mg/kg/day
1482 Somatropin 8mg (24IU) Injection H01AC01-000-P30-03-XXX A* i) Growth failure due to growth hormone insufficiency
ii)Growth failure in girls due to gonadal dysgenesis (Turner syndrome)
iii)Growth failure in short children born small gestational age(SGA)		 None i) 0.7-1 mg/m2/day or 0.025-0.035 mg/kg/day SC/IM
ii) 1.4 mg/m2/day or 0.045-0.05 mg/kg/day SC
iii) 0.035 mg/kg/day or 1 mg/m2/day SC
1483 Sotalol HCl 80 mg Tablet C07AA07110T1001XX A* Ventricular tachyarrythmias Supraventricular and ventricular arrhythmias Adult: Initially, 80 mg/day as single or in 2 divided doses, increased gradually every 2-3 days. Usual dose: 160-320 mg/day in 2 divided doses. Life-threatening ventricular arrhythmias Adult: Initially, 80 mg bid, increased gradually every 3 days to 240-320 mg/day in divided doses if needed. Maintenance: 160-320 mg/day in divided doses. Max: 480-640 mg in divided doses.
1484 Spironolactone 25 mg Tablet C03DA01000T1001XX B Oedema and ascites in cirrhosis of the liver, congestive heart failure ADULT: 100 - 200 mg daily in divided doses. Increase to 400 mg if required. CHILD: initially 3 mg/kg daily in divided doses
1485 Stavudine 30mg, Lamivudine 150mg & Nevirapine 200mg Tablet J05AR07-964-T10-01-XXX A/KK Fixed dose triple therapy for treatment of HIV infection in adults once patients have been stabilized on the maintenance regimen of nevirapine 200 mg twice daily and have demonstrated adequate tolerability to nevirapine None SLN 30: 30-60 kg 1 tablet twice daily. SLN 40 ≥60 kg 1 tablet twice daily
1486 Stavudine 40mg, Lamivudine 150mg & Nevirapine 200mg Tablet J05AR07-964-T10-02-XXX A* Fixed dose triple therapy for treatment of HIV infection in adults once patients have been stabilized on the maintenance regimen of nevirapine 200 mg twice daily and have demonstrated adequate tolerability to nevirapine None SLN 30: 30-60 kg 1 tablet twice daily. SLN 40 ≥60 kg 1 tablet twice daily
1487 Streptokinase 1,500,000 IU Injection B01AD01000P4001XX A* Acute myocardial infarction, acute pulmonary embolism Myocardial infarction: 1,500,000 units over 30 - 60 minutes. Pulmonary embolism: 250,000 units by IV infusion over 30 minutes, then 100,000 units every hour for up to 12-72 hours with monitoring of clotting factors
1488 Streptomycin Sulphate 1g Injection J01GA01-183-P40-01-XXX B i) Tuberculosis
ii) Brucellosis
iii) Bacterial endocarditis		 None 15 mg/kg daily (Max: 1 g daily)

Dosing is according to product insert.
1489 Sucralfate 1 g Tablet A02BX02000T1001XX A i) Benign gastric and duodenal ulceration ii) Stress ulcer prophylaxis i) 2 g twice daily or 1 g 4 times daily for 4-6 weeks or in resistant cases up to 12 weeks (maximum 8 g daily) ii) 1 g 6 times daily (maximum 8 g daily). CHILD not recommended
1490 Sugammadex 100 mg/ml Injection V03AB35000P3001XX A* Indicated for reversal of neuromuscular blockade induced by rocuronium and vecuronium in selective patient group: obese, elderly, underlying cardiovascular disease. For pediatric population, sugammadex is recommended for routine reversal 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of second twitch tension of the train-of-four (T2). 4 mg/kg sugammadex is recommended if recovery has reached at least 1- 2 post-tetanic counts (PTC). For immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended
1491 Sulfadoxine 500 mg and Pyrimethamine 25 mg Tablet P01BD51981T1001XX B Treatment of Plasmodium falciparum malaria in patients in whom chloroquine resistance is suspected and malaria prophylaxis for travellers to areas where chloroquine-resistant malaria is endemic Chloroquine resistant falciparum malaria acute attack Adult: Per tab contains pyrimethamine 25 mg and sulfadoxine 500 mg: 2-3 tabs as a single dose. Do not repeat for at least 7 days. Child: Pyrimethamine 25mg + Sulfadoxine 500mg (Tablet): <2 yr (5-10 kg): 1/2 (half) tab as a single dose; 2-5 yr (>10-20 kg): 1 tab as a single dose; 5-10 yr (< 20-30 kg): 1 1/2 (one and half) tab as a single dose; 10-14 yr (> 30-45 kg): 2 tab as a single dose. Do not repeat for at least 7 days. Renal impairment: Dose reduction may be needed. Severe: contra-indicated. Hepatic impairment: Dose reduction may be needed. Severe: contra-indicated.
1492 Sulphamethoxazole 200mg & Trimethoprim 40mg/5ml Suspension J01EE01-961-L80-01-XXX B Infections caused by susceptible pathogens None Mild to moderate infections: more than 2months: 8 - 12mg Trimethoprim/kg/day divided every 12hours. Serious Infections: 15-20mg Trimethoprim/kg/day divided every 6hours.
1493 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection J01EE01-961-P30-01-XXX A i) Severe or complicated infections when oral therapy is not feasible
ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients		 None i) ADULT: 960 mg twice daily increased to 1.44 g twice daily in severe infections. CHILD: 36 mg/kg daily in 2 divided doses increased to 54 mg/kg/day in severe infections.
ii) Treatment: ADULT & CHILD over 4 weeks: 120 mg/kg/day PO/IV infusion in 2 - 4 divided doses for 14 days. Prophylaxis: ADULT: 960 mg once daily or 960 mg on alternate days (3 times a week) or 960 mg twice daily on alternate days (3 times a week). CHILD 6 weeks - 5 months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg
1494 Sulphamethoxazole 400mg & Trimethoprim 80mg Tablet J01EE01-961-T10-01-XXX B i) Severe or complicated infections due to susceptible infection.
ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients		 None i) ADULT: 1 - 3 tablets twice daily ii) Treatment: ADULT & CHILD over 4 weeks: 120 mg/kg/day in 2 - 4 divided doses for 14 days. Prophylaxis: ADULT: 960 mg once daily or 960 mg on alternate days (3 times a week) or 960 mg twice daily on alternate days (3 times a week). CHILD; 6 weeks - 5 months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg
1495 Sulphur 2% & Salicylic Acid 2% Cream D10AB02951G1001XX C Acne vulgaris and seborrhoeic dermatitis When used in scalp disorders, a small amount of cream should be rubbed gently into the roots of the hair. When used in skin disorders, the cream should be applied sparingly to the affected area. Apply once daily or until noticeable improvement, then once or twice a week
1496 Sulpiride 200 mg Tablet N05AL01000T1001XX B Acute and chronic psychotic disorders 200-1000mg daily
1497 Sumatriptan 100 mg Tablet N02CC01000T1002XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1498 Sumatriptan 50 mg Fast Disintegrating Tablet N02CC01000T5001XX A Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1499 Sumatriptan 50 mg Tablet N02CC01000T1001XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1500 Sunitinib malate 12.5mg capsule L01XE04-253-C10-03-XXX A* Treatment of advanced renal cell carcinoma (RCC) i) KPS ≥70%
ii) Clear cell histology
iii) No brain metastases
iv) Haemoglobin ≥9g/dl
v) Creatinine ≤2x the ULN
vi) Corrected calcium <12mg/dl
vii) Platelet count of >100 x 103/uL
viii) Neutrophil count>1500/mm3		 50 mg orally once daily for 4 consecutive weeks, followed by a 2-week off period to comprise a complete cycle of 6 weeks.

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