Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1501 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.
1502 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
1503 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
1504 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.
1505 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
1506 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
1507 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
1508 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
1509 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.
1510 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
1511 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
1512 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.
1513 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
1514 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
1515 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
1516 Sulpiride 200 mg Tablet N05AL01000T1001XX B Acute and chronic psychotic disorders 200-1000mg daily
1517 Sumatriptan 100 mg Tablet N02CC01000T1002XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1518 Sumatriptan 50 mg Fast Disintegrating Tablet N02CC01000T5001XX A Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1519 Sumatriptan 50 mg Tablet N02CC01000T1001XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1520 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.
1521 Sunscreen SPF 30-50 Cream D02BA02-000-G10-01-XXX B Photodermatitis None Apply to exposed areas at least 15 minutes prior to solar exposure; reapply after swimming, prolonged perspiration and after 2 hours of continuous sun exposure.
1522 Suxamethonium 50mg/ml lnjection M03AB01-100-P30-01-XXX B As an adjunct to general anaesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation during surgery and to facilitate mechanical ventilation Intravenous: Muscle relaxant in general anaesthesia Adult: As chloride: single dose of 0.3-1.1 mg/kg injected; supplementary doses of 50-100% of the initial dose may be given at 5-10 min intervals. Max dose (repeated IV injection or continuous infusion): 500 mg/hr Child: As chloride: <1 yr: 2 mg/kg; 1-12 yr: 1 mg/kg. Intramuscular: Muscle relaxant in general anaesthesia Adult: As chloride: 3-4 mg/kg. Max total dose: 150 mg Child: As chloride: <1 yr: Up to 4-5 mg/kg; ≥1 yr: Up to 4 mg/kg. Max dose: 150 mg.
1523 Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection H01AA02000P3001XX A Diagnostic test to differentiate primary adrenal from secondary (pituitary) adrenocortical insufficiency Diagnostic test for investigation of adrenocortical insufficiency Adult: As plain preparation: Measure plasma cortisol concentration immediately before and exactly 30 min after IM/IV inj of 250 mcg. Post-inj rise in plasma cortisol concentration ≥200 nmol/l (70 mcg/l) if normal adrenocortical function. As depot preparation (if inconclusive results with plain preparation): Measure plasma cortisol concentration before and exactly 30 min, 1, 2, 3, 4 and 5 hr after an IM inj of 1 mg tetracosactide acetate depot. Adrenocortical function normal if the post-inj rise in plasma cortisol concentration increases 2-fold in 1st hr, and continues to rise steadily. Expected levels in 1st hr: 600-1,250 nmol/l, increasing slowly up to 1000-1800 nmol/l by 5th hr. Child: IV 250 mcg/1.73 m2 BSA. Intramuscular
1524 Tacrolimus 0.03% Ointment D11AH01000G5002XX A* For short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies Adult ≥16 years: Apply 0.03% or 0.1% to the affected skin twice daily and rub in gently and completely.
Children ≥ 2 years: Apply 0.03% ointment thinly to the affected skin bd and rub in gently and completely. Treatment should be continued for 1 week after clearing of signs & symptoms of atopic dermatitis.
1525 Tacrolimus 0.1% Ointment D11AH01000G5001XX A* For short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies Adult ≥16 years: Apply 0.03% or 0.1% to the affected skin twice daily and rub in gently and completely.
Children ≥ 2 years: Apply 0.03% ointment thinly to the affected skin bd and rub in gently and completely. Treatment should be continued for 1 week after clearing of signs & symptoms of atopic dermatitis.
1526 Tacrolimus 0.5 mg Capsule L04AD02000C1003XX A* i) Primary immunosuppression in liver and kidney allograft recipients.
ii) Liver and kidney allograft rejection resistant to conventional immunosuppressive agents.
It is recommended to be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only.		 0.1-0.2 mg/kg/day for liver transplantation and at 0.15-0.3 mg/kg/day for kidney transplantation administered as 2 divided doses.
1527 Tacrolimus 0.5mg Prolonged-Release Hard Capsule L04AD02000C2203XX A* i) Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
ii) Treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult.		 i) Prophylaxis of transplant rejection:
a) Kidney Transplant:
Tacrolimus PR therapy should commence at dose of 0.20-0.30 mg/kg/day administered once daily in the morning.
Administration should commence within 24 hours after completion of surgery.

b) Liver Transplant
Tacrolimus PR therapy should commence at a dose of 0.10-0.20 mg/kg/day administered once daily in the morning.
Administration should commence within 12-18 hours after completion of surgery.

ii) Treatment of allograft rejection:
For conversion:
a) From other immunosuppressants to once daily Tacrolimus PR:
Treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for
prophylaxis of transplant rejection.
b) From Tacrolimus to Tacrolimus PR:
Allograft transplant patients maintained on twice daily Tacrolimus capsules dosing requiring conversion to once daily
Tacrolimus PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the
morning.
1528 Tacrolimus 1 mg Capsule L04AD02000C1001XX A* i) Primary immunosuppression in liver and kidney allograft recipients.
ii) Liver and kidney allograft rejection resistant to conventional immunosuppressive agents. It is recommended to be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only.		 0.1-0.2 mg/kg/day for liver transplantation and at 0.15-0.3 mg/kg/day for kidney transplantation administered as 2 divided doses.
1529 Tacrolimus 1mg Prolonged-Release Hard Capsule L04AD02000C2201XX A* i) Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
ii) Treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult.		 i) Prophylaxis of transplant rejection:
a) Kidney Transplant:
Tacrolimus PR therapy should commence at dose of 0.20-0.30 mg/kg/day administered once daily in the morning.
Administration should commence within 24 hours after completion of surgery.

b) Liver Transplant
Tacrolimus PR therapy should commence at a dose of 0.10-0.20 mg/kg/day administered once daily in the morning.
Administration should commence within 12-18 hours after completion of surgery.

ii) Treatment of allograft rejection:
For conversion:
a) From other immunosuppressants to once daily Tacrolimus PR:
Treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for
prophylaxis of transplant rejection.
b) From Tacrolimus to Tacrolimus PR:
Allograft transplant patients maintained on twice daily Tacrolimus capsules dosing requiring conversion to once daily
Tacrolimus PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the
morning.
1530 Tacrolimus 5 mg Capsule L04AD02000C1002XX A* i) Primary immunosuppression in liver and kidney allograft recipients.
ii) Liver and kidney allograft rejection resistant to conventional immunosuppressive agents.
It is recommended to be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only.		 0.1-0.2 mg/kg/day for liver transplantation and at 0.15-0.3 mg/kg/day for kidney transplantation administered as 2 divided doses.

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