Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Dosage
1501 Sumatriptan 50 mg Tablet N02CC01000T1001XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1502 Sumatriptan 6 mg/0.5 ml Injection N02CC01000P5001XX A Treament of acute migraine attacks and cluster headache 6 mg given by SC as soon as possible after onset. Dose may be repeated once after not less than 1 hour if needed. Max. 12 mg in 24 hours. Child not recommended
1503 Sunitinib malate 12.5mg capsule L01XE04253C1003XX A* Treatment of advanced renal cell carcinoma (RCC) Restriction criteria: 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.
1504 Sunscreen 5 - 20% w/w Cream D02BA02000G1001XX B Photodermatitis Apply to exposed areas at least 30 minutes prior to solar exposure; reapply after swimming, prolonged perspiration and after 2 hours of continuos sun exposure
1505 Suxamethonium Chloride 50 mg/ml lnj M03AB01100P3001XX B Muscle relaxant as an adjunct to anaesthesia 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.
1506 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
1507 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.
1508 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.
1509 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.
1510 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 kidney transplant rejection: 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. ii) Prophylaxis of liver transplant rejection: 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. iii) Treatment of allograft rejection: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion 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. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage)
1511 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.
1512 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 kidney transplant rejection: 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. ii) Prophylaxis of liver transplant rejection: 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. iii) Treatment of allograft rejection: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion 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. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage)
1513 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.
1514 Tacrolimus 5mg Prolonged-Release Hard Capsule L04AD02000C2202XX 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 kidney transplant rejection: 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. ii) Prophylaxis of liver transplant rejection: 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. iii) Treatment of allograft rejection: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion 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. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage)
1515 Tacrolimus 5mg/ml Injection L04AD02000P3001XX 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. 0.01-0.05 mg/kg for liver transplant and 0.05-0.1 mg/kg for kidney transplant as 24-hours continuous infusion.
1516 Tamoxifen Citrate 20 mg Tablet L02BA01136T1001XX A Breast cancer 20 mg in 1-2 divided doses. Max: 40 mg/day
1517 Tamsulosin HCl 400 mcg Extended Release Tablet G04CA02110T5001XX A* Second line treatment of functional symptoms of benign prostatic hyperplasia (BPH) in patients who do not tolerate first line drugs or when first line drugs are inappropriate or contraindicated 400 mcg once daily
1518 Tar, Coal Tar and Oleyl Alcohol Liquid D05AA00952L5001XX A/KK Dandruff, seborrhoeic dermatitis and atopic dermatitis Massage into wet hair, rinse and repeat. Use once or twice weekly
1519 Technetium-99m Sterile Generator V09CA01000P3001XX A* Sodium pertechnetate is used for scintigraphy or nuclear scan particularly of the brain and thyroid to prepare various technetium-99m labelled injections for selective organ imaging Technetium-99m as pertechnetate is obtained by elution with a sterile solution of Sodium Chloride 0.9%. The dosage depend on type of scan i) Thyroid scintigraphy: 18.5-80 MBq (0.5-2.2 mCi) Scintigraphy performed 20 minutes after intravenous injection ii) Salivary gland scintigraphy: 40 MBq (1.1 mCi) Scintigraphy performed immediately after intravenous injection and at regular intervals up to 15 minutes iii) Meckel?s diverticulum scintigraphy: 400 MBq (10.8 mCi) Scintigraphy performed immediately after intravenous injection and at regular interval up to 30 minutes iv) Brain scintigraphy: 370-800 MBq (10-22 mCi) Rapid sequential images are taken immediately within the first minute after intravenous administration, static images 1 to 4 hours later. Thyroid and coriod plexus should be blocked to avoid non-specific 99mTc uptake v) Cardiac and vascular scintigraphy: 740-925 MBq (20-25 mCi) Red cells are labeled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images over 30 minutes vi) Gastrointestinal bleeding: 740-925 MBq (20-25 mCi) Red cells are labeled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minutes after intravenous administration, followed by regular images at appropriate intervals for up to 24 hours vii) Lacrimal duct scintigraphy: 2-4 MBq each eye (50-100 mCi) Drops are instilled into eye and dynamic images are taken over 2 minutes, followed by static images at appropriate intervals over 20 minutes
1520 Tegafur 100 mg & uracil 224 mg Capsule L01BC53980C1001XX A* i) Non small cell lung cancer; ii) Tegafur Uracil plus folinic acid (leucovorin) combination therapy is indicated for the treatment of colorectal cancer in: a) Metastatic stage; b) Adjuvant setting; c) Concurrent setting. i) 300-600 mg daily in 2-3 divided doses; ii) Adjuvant setting - 300mg/m2/day , Day 1-28, rest 7 days; Leucovorin Calcium 75 mg/day, Day 1-28, rest 7 days for 5 cycles; Concurrent setting - 300mg/m2/day; Leucovorin Calcium 25 mg /day, D8- D36, for 4 weeks; Metastatic stage - 300mg/m2/day , Day 1-28, rest 7 days; Leucovorin Calcium 75 mg/day, Day 1-28, rest 7 days for 5 cycles.
1521 Telbivudine 600 mg Tablet J05AF11000T1001XX A* Treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation ADULT and CHILD over 16 years: 600 mg once daily. Renal Dose Adjustment: 600mg every 48hours (30-49ml/min), 600 mg every 72hours. (<30ml/min; not requiring dialysis); 600mg every 96 days (ESRD)
1522 Telmisartan 40 mg Tablet C09CA07000T1001XX A/KK Hypertension in patients who cannot tolerate ACE inhibitors because of cough 40mg - 80mg once daily
1523 Telmisartan 80 mg & Hydrochlorothiazide 12.5 mg Tablet C09DA07000T1001XX A/KK Hypertension in patients who cannot tolerate ACE inhibitors because of cough 1 tablet daily
1524 Telmisartan 80 mg Tablet C09CA07000T1002XX A/KK i)Hypertension in patients who cannot tolerate ACE inhibitors because of cough ii)Reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors i) 40mg - 80mg once daily ii) 80mg once daily
1525 Temozolomide 100 mg Capsule L01AX03000C1003XX A* In patients with glioblastoma multiforme who fulfill all the following criteria: i. Total /near total resection ii. ECOG/WHO performance status 0-2 iii. Age less than 60 years Concomitant phase : 75mg/m2 daily with radiotherapy for 42 days, followed by 6 cycle of adjuvant treatment. Adjuvant phase: Additional 6 cycles of adjuvant phase. Cycle 1- 150mg/m2 once daily for 5 days followed by 23 days without treatment. Cycle 2-6 : 200mg/m2 once daily for 5 days per 28-day cycle
1526 Temozolomide 20 mg Capsule L01AX03000C1001XX A* In patients with glioblastoma multiforme who fulfill all the following criteria : i. total /near total resection ii. ECOG/WHO performance status 0-2 iii. Age less than 60 years Concomitant phase : 75mg/m2 daily with radiotherapy for 42 days, followed by 6 cycle of adjuvant treatment. Adjuvant phase: Additional 6 cycles of adjuvant phase. Cycle 1- 150mg/m2 once daily for 5 days followed by 23 days without treatment. Cycle 2-6 : 200mg/m2 once daily for 5 days per 28-day cycle
1527 Tenecteplase 10,000 unit (50 mg) Injection B01AD11000P4001XX A* Acute myocardial reinfarction where streptokinase is contraindicated due to previous streptokinase induced antibodies. [Indicated when antibodies was given more than 5 days and less than 12 months] Less than 60 kg: 30 mg, 60 - 69 kg: 35 mg, 70 - 79 kg: 40 mg; 80 -90 kg: 45 mg, 90 kg or above: 50 mg. Administer single IV bolus over 5-10 seconds
1528 Tenofovir Disoproxil Fumarate 300 mg & Emtricitabine 200 mg Tablet J05AR03964T1001XX A/KK Treatment of HIV-1 infection in adults in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors). 1 tablet once daily.
1529 Tenofovir Disoproxil Fumarate 300 mg Tablet J05AF07138T1001XX A* i)Treatment of HIV-1 infected adults in combination with other antiretroviral agents. ii)Use as first line monotherapy for chronic hepatitis B or as a rescue therapy for patients with drug resistance hepatitis B virus (according to resistant profile or treatment guidelines). 300mg once daily. Renal Dose Adjustment: 300mg every 48hours (30-49ml/min); 300mg every 72hours (10-29ml/min); 300mg every 7 days after dialysis (Hemodialysis)
1530 Terazosin HCl 1 mg Tablet G04CA03110T1001XX A/KK Only for treatment of Benign Prostatic Hyperplasia. Not to be used for treatment of hypertension Initially 1 mg at night, increased in a stepwise fashion to 2 mg, 5 mg or 10 mg once daily

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