Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1621 Trimetazidine 20 mg Tablet C01EB15110T1001XX B Prophylactic treatment of episodes of angina pectoris 20 mg 3 times daily
1622 Trimetazidine 35mg MR Tablet C01EB15110T5001XX B Prophylactic treatment of episodes of angina pectoris 35 mg twice daily in the morning and evening with meals
1623 Trimethoprim 100mg Tablet J01EA01-000-T10-01-XXX B Treatment of urinary tract infections due to susceptible pathogens None ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. CHILD: 6-8 mg/kg/day in 2 divided doses. 6 - 12 years: 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily
1624 Trimethoprim 300mg Tablet J01EA01-000-T10-02-XXX B Treatment of urinary tract infections due to susceptible pathogens None ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. CHILD: 6 - 12 years: 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily
1625 Trioxsalen 5 mg Tablet D05BA01000T1001XX A Vitiligo 5 - 10 mg daily, 2 - 4 hours before exposure to sunlight. To increase pigmentation: 10 mg daily, 2 hours prior to UV irradiation
1626 Triprolidine HCl 1.25mg and Pseudoephedrine HCl 30mg/5ml Syrup R01BA52-110-L90-01-XXX B Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and sinusitis. Doses to be taken twice daily or three times daily None Adult and children over 12 years: 10ml 3 times a day (max 4 times a day).
CHILD:
6 - 12 years: 5 ml (6-8 hourly).
2 - 5 years: 2.5 ml (6-8 hourly).
1627 Triprolidine HCl 2.5mg and Pseudoephedrine HCl 60mg Tablet R01BA52-988-T10-02-XXX B Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and aerotitis None ADULT 2.5 mg every 4 - 6 hours; maximum dose 10 mg/day.
CHILD (syrup) 6 - 12 years : 1.25 mg every 4 - 6 hours; maximum dose 5 mg/day 4 - 6 years : 0.938 mg every 4 - 6 hours; maximum dose 3.744 mg/day 2 - 4 years : 0.625 mg every 4 - 6 hours; maximum dose 2.5 mg/day
1628 Triptorelin 3.75 mg Injection L02AE04000P2001XX A i) Treatment of confirmed central precocious puberty (preterm sexual development) (before 8 years in girls and 10 years in boys)
ii) Genital and extragenital endometriosis (stage I to stage IV). Treatment should not be administered for more than 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.		 1 intramuscular injection every 4 weeks. The treatment must be started in the first 5 days of the menstrual cycle. The duration of treatment depends on the initial severity of the endometriosis and the changes observed in the clinical features. In principle, the treatment should be administered for at least 4 months and for at most 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.
1629 Triptoreline 11.25mg Powder and Solvent for Suspension for Injection L02AE04-127-P40-01-xxx A i. Treatment of confirmed central precocious puberty (preterm sexual development) (before 8 years in girls and 10 years in boys)
ii. Genital and extragenital endometriosis (stage I to stage IV). Treatment should not be administered for more than 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.
iii. Treatment of locally advanced prostate cancer when used alone or as concomitant and adjuvant radiotherapy.
iv. Treatment of metastatic prostate cancer.		 Indikasi i: First-line treatment for central precocious puberty
Indikasi ii: Second-line treatment for genital and extragenital endometriosis		 indikasi i:
Children over 20 kg in body weight: One intramuscular injection of triptorelin 11.25 mg administered every 3 months.

Treatment should be stopped around the physiological age of puberty in boys and girls and it is recommended that treatment is not continued in girls with a bone maturation of more than 12 to 13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13 to 14 years.

Indikasi ii:
One intramuscular injection of triptorelin repeated every 3 months. The subcutaneous administration has not been studied in women. The treatment must be started in the first five days of the menstrual cycle.

Duration of treatment: This depends on the initial severity of the endometriosis and the changes observed in the clinical features (functional and anatomical) during treatment. The treatment should not be administered for more than 6 months

Indikasi iii & iv:
11.25mg every 3 months
1630 Tropicamide 1% Eye Drops S01FA06-000-D20-02-XXX A/KK Topical use to produce cycloplegic refraction for diagnostic purposes None 1 - 2 drops several times a day
1631 Trospium Chloride 20mg coated tablet G04BD09-100-C10-01-XXX A* Symptomatic treatment for urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (eg. Idiopathic or neurologic detrusor overactivity) Place in therapy: As first line treatment for overactive bladder in patients with Parkinsonism, Alzheimer's or other cognitive disease 1 tablet twice daily. Tablet should be swallowed whole with a glass of water before meals on empty stomach. Severe renal impairment (CrCl between 10 & 30 mL/min/1.73 m2): 1 tab daily or every other day
1632 Tuberculin PPD Injection V04CF01000P3001XX B For routine Mantoux (tuberculin sensitivity) test 10 units is injected intradermally
1633 Typhoid Vaccine Capsule J07AP01000C1001XX B Active immunization against typhoid fever in adult and child 6 years of age or older ADULT and CHILD 6 years of age or older, 1 capsule on days 1, 3 and 5
1634 Typhoid Vaccine Injection J07AP02000P3001XX B Active immunization against typhoid fever in adult and child more than 2 years 0.5 ml single IM injection into the deltoid or vastus lateralis, may reimmunize with 0.5 ml IM every 3 years if needed.
1635 Ulipristal Acetate 30mg Tablet G03AD02-122-T10-01-XXX A Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse for sexual assault victim. - 30mg orally as soon as possible, but no later than 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure.
1636 Umeclidinium 62.5mcg and Vilanterol 25mcg inhalation R03AL03-989-A20-01-XXX A* Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). None One inhalation daily
1637 Upadacitinib 15mg Extended-Release Film Coated Tablet L04AA44-020-T50-01-XXX A* 1. Indicated for the treatment of severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

2. Indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. May be used as monotherapy or in combination with methotrexate.

3. Indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

4. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

5. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (severe atopic dermatitis):
i. As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to: 
• Intensive and optimized topical treatment 
• Phototherapy 
• At least two immunosuppressants 
ii. To be prescribed by Dermatologists only.

Indication 2 (active psoriatic arthritis): To be prescribed by Rheumatologist only

Indication 3 (moderate to severe active rheumatoid arthritis):
i. To be prescribed after failing/ intolerance/ contraindicated to csDMARDs (as per Malaysian Consensus on Biologic Usage) and one biologic DMARDs.
ii. To be prescribed by Rheumatologist only

Indication 4 (active ulcerative colitis):
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 5 (Crohn's disease) - None		 Indication 1 (severe atopic dermatitis):
Adults: The recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation (Refer to package insert). The lowest effective dose for maintenance should be considered.

Adolescents (from 12 to 17 years of age): The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 40 kg.

Upadacitinib can be used with or without concomitant topical therapies (Refer package insert)

Indication 2 & 3 (active psoriatic arthritis & moderate to severe active rheumatoid arthritis): 15 mg once daily

Indication 4 (active ulcerative colitis):
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 5 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.
1638 Upadacitinib 30mg Extended-Release Film Coated Tablet L04AA44-020-T50-02-xxx A* 1. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

2. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (active ulcerative colitis)
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 2 (Crohn's disease) - None		 Indication 1 (active ulcerative colitis)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 2 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

1639 Upadacitinib 45mg Extended-Release Film Coated Tablet L04AF03-020-T50-01-xxx A* 1. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

2. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (active ulcerative colitis)
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 2 (Crohn's disease) - None		 Indication 1 (active ulcerative colitis)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 2 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

1640 Urofollitropin (FSH) 150 IU Injection G03GA04-000-P30-02-XXX A* For stimulation of follicular growth in the treatment of infertility To be individualised. Initial: 75 IU-150 IU daily for 7 days and then may be increased or decreased by 75 IU/day according to follicular response.
Max : 450 IU/day. In-vitro fertilisation: Initial: 150 IU daily from Cycle Day 2 or Day 3 until sufficient follicular development is attained.
1641 Urofollitropin (FSH) 75 IU Injection G03GA04-000-P30-01-XXX A* For stimulation of follicular growth in the treatment of infertility - To be individualised. Initial: 75 IU-150 IU daily for 7 days and then may be increased or decreased by 75 IU/day according to follicular response.
Max : 450 IU/day.

In-vitro fertilisation: Initial: 150 IU daily from Cycle Day 2 or Day 3 until sufficient follicular development is attained
1642 Urokinase 250,000 IU Injection B01AD04-000-P40-04-XXX A Treatment of thromboembolic disease such as mycocardial infarction, peripheral artery occlusion, pulmonary embolism, retinal artery thrombosis and other ophthalmologic use ADULT: Acute pulmonary embolism: IV loading dose 4400 iu/kg over 10 mins, maintenance 4400 iu/kg/hour for 12 hours. Peripheral vascular occlusion: infuse 2500 iu/ml into clot at a rate of 4000 iu/min for 2 hours. This may be repeated up to 4 times. Hyphaema: 5000 IU in 2 ml saline solution is injected and withdrawn repeatedly over the iris. If residual clot remains, leave 0.3ml in the anterior chambers for 24-48 hours to facilitate futher dissolution
1643 Ursodeoxycholic Acid 250 mg Capsule A05AA02-000-C10-01-XXX A Cholestatic liver diseases (eg. primary biliary cholangitis, primary cholangitis etc.) - 10-15 mg/kg daily in 2 to 3 divided doses

Dosing is individualised based on body weight and according to product insert/protocol
1644 Ustekinumab 90 mg/ml Injection L04AC05000P3002XX A* Treatment of moderate to severe plaque psoriasis in adults who failed to, or who have contraindication to, or are intolerant to conventional systemic therapies including ciclosporin, methotrexate and photochemotherapy (PUVA). Body weight less than 100kg: Initial dose of 45 mg SC, followed by 45 mg 4 weeks later, then every 12 weeks thereafter. Body weight more than 100 kg: initial dose 90 mg SC, followed by 90 mg 4 weeks later, & then every 12 weeks thereafter.
1645 Valganciclovir 450mg Tablet J05AB14-110-T10-01-XXX A* For the prevention of cytomegalovirus (CMV) disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor None For adult patients who have received other than kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days post-transplantation. For adult patients who have received a kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post-transplantation.
1646 Valproic Acid and Sodium Valproate (ER) 500mg Tablet N03AG01-520-T50-01-XX B i) In the treatment of generalized or partial epilepsy, particularly with the following patterns of seizures:absence, myoclonic, tonic-clonic, atonic-mixed as well as, for partial epilepsy:simple or complex seizures, secondary generalized seizures, specific syndrome (West, Lennox-Gastatut).
ii) Treatment and prevention of mania associated with bipolar disorders.		 None i) Adults: Dosage should start at 500mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day.
Children: >20KG: 500mg/day (irrespective of weight) with spaced increases until control is achieved.

ii) Initial dose of 1000mg/day, to be increase rapidly as possible to achieve lowest therapeutic dose, which produce desired clinical effects. Recommend initial dose is 1000mg & 2000mg daily. Max dose 3000mg daily.
1647 Valsartan 160 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03935T1005XX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1648 Valsartan 160 mg Tablet C09CA03000T1002XX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.
1649 Valsartan 80 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03-935-T10-01-XXX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1650 Valsartan 80 mg Tablet C09CA03-000-T10-01-XXX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.

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