Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1471 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection J01EE01961P3001XX A i) Severe or complicated infections when oral therapy is not feasible ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients 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
1472 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Tablet J01EE01961T1001XX B i) Severe or complicated infections due to susceptible infection ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients 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
1473 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
1474 Sulpiride 200 mg Tablet N05AL01000T1001XX B Acute and chronic psychotic disorders 200-1000mg daily
1475 Sumatriptan 100 mg Tablet N02CC01000T1002XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1476 Sumatriptan 50 mg Fast Disintegrating Tablet N02CC01000T5001XX A Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1477 Sumatriptan 50 mg Tablet N02CC01000T1001XX A/KK Treatment of acute migraine attacks 50 mg per attack and not more than 300 mg daily
1478 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.
1479 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
1480 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.
1481 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
1482 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.
1483 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.
1484 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.
1485 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.
1486 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.
1487 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.
1488 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.
1489 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 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.
1490 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.
1491 Tamoxifen Citrate 20 mg Tablet L02BA01136T1001XX A Breast cancer 20 mg in 1-2 divided doses. Max: 40 mg/day
1492 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
1493 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
1494 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
1495 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.
1496 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)
1497 Telmisartan 40 mg Tablet C09CA07000T1001XX A/KK Hypertension in patients who cannot tolerate ACE inhibitors because of cough 40mg - 80mg once daily
1498 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
1499 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
1500 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

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