Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1531 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.
1532 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.
1533 Tafluprost 15mcg/ml & Timolol 5mg/ml Opthalmic Solution (Preservative Free) S01ED51-990-D20-07-XXX A* Reduction of intraocular pressure (IOP) in adult patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops • As third line of treatment in patients with POAG or OHT who require fixed-dose combination therapy.
• To be prescribed by Glaucoma consultants only
 Instill 1 drop in the affected eye(s) once daily
1534 Tafluprost Ophthalmic Solution 0.0015% (Preservative-free) S01EE05-000-D20-01-XXX A* Indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. i. As monotherapy in patients who are better suited for eye drops without preservative;
ii. To be prescribed by Glaucoma consultants only
 Instill 1 drop in the affected eye(s) once daily
1535 Tamoxifen Citrate 20 mg Tablet L02BA01136T1001XX A Breast cancer 20 mg in 1-2 divided doses. Max: 40 mg/day
1536 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 Consultant/specialists for specific indications only, including Geriatricians 400 mcg once daily
1537 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
1538 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
1539 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.
1540 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)
1541 Telmisartan 40 mg Tablet C09CA07000T1001XX A/KK Patients intolerant to ACE inhibitors in:
i) Hypertension
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. Max: 160mg daily
ii) 80mg once daily

Dosing is individualised and according to product insert / protocol.
1542 Telmisartan 80 mg & Hydrochlorothiazide 12.5 mg Tablet C09DA07000T1001XX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Telmisartan/Hydrochlorothiazide 80mg/12.5mg once daily
Max: Telmisartan/Hydrochlorothiazide 160/25mg once daily

Dosing is individualised and according to product insert / protocol.
1543 Telmisartan 80 mg Tablet C09CA07000T1002XX A/KK Patients intolerant to ACE inhibitors in:
i) Hypertension
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. Max: 160mg daily
ii) 80mg once daily

Dosing is individualised and according to product insert / protocol.
1544 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
1545 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
1546 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
1547 Tenofovir Disoproxil Fumarate 300 mg & Emtricitabine 200 mg Tablet J05AR03-964-T10-01-XXX A/KK i. Treatment of HIV-1 infection in adults in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors).
ii. Indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.		 Indication (ii):
i. To prescribe Emtricitabine/Tenofovir Disoproxil as part of a comprehensive prevention strategy
ii. All uninfected individuals must be counselled to strictly adhere to the recommended Emtricitabine/Tenofovir Disoproxil dosing schedule
iii. A negative HIV-1 test must be confirmed immediately prior to initiating Emtricitabine/Tenofovir Disoproxil. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, starting of PrEP must be delayed for at least one month and HIV-1 status need to be reconfirmed, including acute or primary HIV-1 infection; and
iv. To screen HIV-1 infection at least once every 3 months while taking Emtricitabine/Tenofovir Disoproxil for PrEP.		 1 tablet once daily.
1548 Tenofovir Disoproxil Fumarate 300mg Tablet J05AF07-138-T10-01-XXX A*, A/KK Prescriber Category 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).

Prescriber Category A/KK:
iii. For antenatal patients only with chronic Hepatitis B with HBeAg reactive or HBV DNA more than 200,000 or deranged LFT.

iv. For adult patients with chronic Hepatitis B (CHB) eAg positive or eAg negative chronic hepatitis		 Indication iv:
For non-cirrhotic liver disease only.		 Indication i, ii & iv:
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).

Indication iii:
300mg once daily from 28 weeks of gestation and continue till 4 weeks postpartum
1549 Tenofovir Disoproxil Fumarate 300mg, Emtricitabine 200mg & Efavirenz 600mg Tablets (Fixed-dose combination) J05AR06-964-T32-01-XXX A/KK Indicated for the treatment of HIV-1 infection in adults None One tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms
1550 Terazosin HCl 1 mg Tablet G04CA03110T1001XX A/KK i) Treatment of Benign Prostatic Hyperplasia

ii) Hypertension		 i) Initial dose: 1 mg at bedtime. Maintenance dose: 5-10mg once daily

ii) Initial dose: 1mg at bedtime. Maintenance dose: 1-5mg once daily. Max: 20-40mg/day
1551 Terazosin HCl 2 mg Tablet G04CA03110T1002XX A/KK i) Treatment of Benign Prostatic Hyperplasia

ii)Hypertension		 i) Initial dose: 1 mg at bedtime. Maintenance dose: 5-10mg once daily

ii) Initial dose: 1mg at bedtime Maintenance dose: 1-5mg once daily. Max: 20-40mg/day
1552 Terazosin HCl 5 mg Tablet G04CA03110T1003XX A/KK i) Treatment of Benign Prostatic Hyperplasia

ii)Hypertension		 i) Initial dose: 1 mg at bedtime. Maintenance dose: 5-10mg once daily

ii) Initial dose: 1mg at bedtime. Maintenance dose: 1-5mg once daily. Max: 20-40mg/day
1553 Terbinafine 1% gel D01AE15-110-G30-01-XXXX A/KK Skin infections caused by dermatophytes, mould and candida. Second line treatment For adults and adolescents aged 12 years and over
Apply topically once daily for 1 week to 2 weeks.
1554 Terbinafine HCl 250 mg Tablet D01BA02110T1001XX A/KK Fungal infections especially onchomycosis caused by dermatophytes 250 mg once daily for 6 weeks for fingernails: 12 weeks for toenails
1555 Terbutaline Sulphate 0.5mg/ml Injection R03CC03-183-P30-01-XXX B Bronchial asthma, chronic bronchitis, emphysema and other lung diseases where broncoconstriction is a complicating factor None SC, IM or slow IV : 250-500 mcg up to 4 times daily. CHILD 2 - 15 years 10mcg/kg to a maximum of 300 mcg. Continuous IV infusion, as a solution containing 3 - 5 mcg/ml, 1.5 - 5 mcg/minute for 8 - 10 hours; reduce dose for children
1556 Terbutaline Sulphate 10mg/ml Nebulizer Solution R03AC03-183-A30-01-XXX B Asthma and other conditions associated with reversible airways obstruction None ADULT : 5 - 10 mg 2 -4 times daily, additional doses may be necessary in severe acute asthma. CHILD up to 3 years : 2 mg, 3 - 6 years : 3 mg, 6 - 8 years : 4 mg, over 8 years : 5 mg 2 - 4 times daily
1557 Teriflunomide 14 mg tablet L04AA31-000-T32-01-XXX A* Treatment of adult patients with relapsing remitting multiple sclerosis (MS) 14mg once daily.
1558 Terlipressin 1mg Injection H01BA04000P4001XX A* i. Acute oesophageal variceal bleeding
ii. Treatment of type 1 hepatorenal syndrome, characterised by spontaneous acute renal insufficiency, in patients suffering from severe cirrhosis with ascites.		 None indikasi i:
2 mg IV bolus over 1 minute. Maintenance: 1 - 2 mg IV bolus 4 - 6 hourly until bleeding is controlled, up to 24 - 36 hours. The maximum daily dosage is 120-150 mcg/kg body weight.

indikasi ii:
Terlipressin is usually started at a dose of 1 mg of terlipressin acetate every 4-6 hours. The dose can be increased to a maximum of 12 mg daily, or 2 mg every 4-6 hours, if serum creatinine levels has not decreased by at least 25% after 3 days of treatment.

As an alternative to bolus injection, terlipressin can be administered as a continuous intravenous (IV) infusion with a starting dose of 2 mg of terlipressin acetate/24 hours and increased to a maximum of 12 mg of terlipressin acetate/24 hours.
1559 Testosterone 250 mg/ml Injection G03BA03-000-P30-01-XXX A* i. In male: Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical test.
ii. In female: Additive therapy in cases of advanced breast cancer in postmenopausal women.		 By IM only. Hypogonadism 250 mg every 2-3 weeks. To maintain an adequate androgenic effect 250 mg every 3-6 weeks. Potency disorders 250 mg every 4 weeks. Male climateric disorders: 250 mg every 3-4 weeks. Repeated 6-8 weeks courses at 2-3 months interval
1560 Tetanus Toxoid Vaccine Injection J07AM01-000-P30-01-XXX C+ Immunisation against tetanus infection. None 0.5 mL by IM. Dosing is according to product insert.

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