Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1591 Tirzepatide 12.5 mg/dose (20.8 mg/mL) Solution for Injection in Pre-filled Pen A10BX16-000-P50-05-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate tirzepatide at 2.5 mg weekly for 4 weeks, then increase to 5 mg weekly. If clinically required, escalate in 2.5 mg increments at minimum 4-week intervals to recommended maintenance doses of 5 mg, 10 mg, or a maximum of 15 mg weekly.
1592 Tirzepatide 15.0 mg/dose (25 mg/mL) Solution for Injection in Pre-filled Pen A10BX16-000-P50-06-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate tirzepatide at 2.5 mg weekly for 4 weeks, then increase to 5 mg weekly. If clinically required, escalate in 2.5 mg increments at minimum 4-week intervals to recommended maintenance doses of 5 mg, 10 mg, or a maximum of 15 mg weekly.
1593 Tirzepatide 2.5 mg/dose (4.17 mg/mL) Solution for Injection in Pre-filled Pen A10BX16-000-P50-01-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate tirzepatide at 2.5 mg weekly for 4 weeks, then increase to 5 mg weekly. If clinically required, escalate in 2.5 mg increments at minimum 4-week intervals to recommended maintenance doses of 5 mg, 10 mg, or a maximum of 15 mg weekly.
1594 Tirzepatide 5.0 mg/dose (8.33 mg/mL) Solution for Injection in Pre-filled Pen A10BX16-000-P50-02-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate tirzepatide at 2.5 mg weekly for 4 weeks, then increase to 5 mg weekly. If clinically required, escalate in 2.5 mg increments at minimum 4-week intervals to recommended maintenance doses of 5 mg, 10 mg, or a maximum of 15 mg weekly.
1595 Tirzepatide 7.5 mg/dose (12.5 mg/mL) Solution for Injection in Pre-filled Pen A10BX16-000-P50-03-xxx A* Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of:
i. ≥ 30 kg/m2 (obesity) or
ii. ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).		 i. Adults above 18 years old with T2DM, BMI≥ 32.5 kg/m2 who had:
• Failed lifestyle intervention AND
• Failed one GLP-1 receptor agonist for T2DM

OR

Adults above 18 years old with BMI≥ 37.5 kg/m2 who had:
• Failed lifestyle intervention AND
• With at least one obesity-related comorbidity [obstructive sleep apnoea (OSA), heart failure (HF), chronic kidney disease (CKD) or metabolic dysfunction-associated steatohepatitis (MASH)]

ii. To be prescribed by Endocrinologists only
 Initiate tirzepatide at 2.5 mg weekly for 4 weeks, then increase to 5 mg weekly. If clinically required, escalate in 2.5 mg increments at minimum 4-week intervals to recommended maintenance doses of 5 mg, 10 mg, or a maximum of 15 mg weekly.
1596 Tocilizumab 162mg/0.9ml solution for injection in prefilled syringe (for subcutaneous injection) L04AC07000P3003XX A* Indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients:
i) with inadequate respond or intolerance to conventional disease- modifying antirheumatic drugs (DMARDS)
ii) who has failed antitumour necrosis factors (antiTNFs)
iii) where TNF is contraindicated (patients with history of pulmonary tuberculosis [PTB])
It also can be used as monotherapy or with combination with methotrexate (MTX) and/ or other DMARDS.		 Adult patients: 162mg given once every week as a subcutaneous injection.
1597 Tocilizumab 20 mg/ml Injection L04AC07-000-P30-01-001 A* Indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients:
i) with inadequate respond or intolerance to conventional disease- modifying antirheumatic drugs (DMARDS)
ii) who has failed antitumour necrosis factors (antiTNFs)
iii) where TNF is contraindicated (patients with history of pulmonary tuberculosis [PTB]) It also can be used as monotherapy or with combination with methotrexate (MTX) and/ or other DMARDS.		 Recommended dose for rheumatoid arthritis of tocilizumab for adult patients is 8mg/kg given once every 4 weeks as a single-drip IV infusion over 1 hour. It should be diluted to 100 ml by a healthcare professional with sterile 0.9% w/v sodium chloride solution over 1 hour. For patients whose body weight is more than 100kg, doses exceeding 800mg per infusion are not recommended
1598 Tofacitinib citrate 5mg film coated tablet L04AA29136T3201XX A* Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). One tablet twice daily
1599 Tolterodine Tartrate ER 4 mg Capsule G04BD07-123-C20-02-XXX A* Treatment of overactive bladder with symptoms of urinary, frequency or urge incontinence - 4 mg once daily. May decrease to 2 mg once daily depending on response and tolerability
1600 Topiramate 100 mg Tablet N03AX11-000-T10-03-XXX A* As adjunctive therapy for adults and children (2 years and above) with:
i) partial onset seizures and generalized tonic-clonic seizures
ii) seizures associated with Lennox Gastaut syndrome.		 ADULT: Usual daily dose: 200-400 mg/day.
CHILD: Daily doses up to 30mg/kg/day

Dosing is according to product insert.
1601 Topiramate 25 mg Capsule Sprinkle N03AX11000C1002XX A* Add-on therapy for intractable partial epilepsy ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 and above: Approx 5-9 mg/kg/day in 2 divided doses. Titrate at 25mg (or less, based on a range of 1-3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.
1602 Topiramate 25 mg Tablet N03AX11-000-T10-01-XXX A* As adjunctive therapy for adults and children (2 years and above) with:
i) partial onset seizures and generalized tonic-clonic seizures
ii) seizures associated with Lennox Gastaut syndrome.		 ADULT: Usual daily dose: 200-400 mg/day.
CHILD: Daily doses up to 30mg/kg/day

Dosing is according to product insert.
1603 Topiramate 50 mg Tablet N03AX11-000-T10-02-XXX A* As adjunctive therapy for adults and children (2 years and above) with:
i) partial onset seizures and generalized tonic-clonic seizures
ii) seizures associated with Lennox Gastaut syndrome.		 ADULT: Usual daily dose: 200-400 mg/day.
CHILD: Daily doses up to 30mg/kg/day

Dosing is according to product insert.
1604 Trace Elements and Electrolytes (Adult) Solution B05XA30905P3001XX A* Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition 10 ml added to 500-1000 ml solution, given by IV infusion
1605 Trace Elements and Electrolytes (Paediatric) Solution B05XA30905P3002XX A* Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition According to the needs of the patient. INFANT and CHILD weighing 15 kg or less: Basal requirements of the included trace elements are covered by 1 ml/kg/day to a maximum dose of 15 ml. CHILD weighing 15 kg or more, a daily dose of 15 ml, should meet basic trace element requirements. However, for patients weighing more than 40 kg the adult preparation trace element should be used
1606 Tramadol HCl 50mg Capsule N02AX02-110-C10-01-XXX A/KK Moderate to severe acute or chronic pain (eg. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) ADULT: 50mg initially, can take another 50mg after 30 - 60 min if pain not relieved. Max 400 mg daily. CHILD: 1mg/kg/dose repeated every 6 hours (Max: 2mg/kg/dose and 100mg/dose)
1607 Tramadol HCl 50mg Tablet N02AX02-110-T10-01-XXX A/KK Moderate to severe acute or chronic pain (e.g. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) None ADULT: 50mg initially, can take another 50mg after 30 - 60 min if pain not relieved. Max 400 mg daily.
CHILD: 1mg/kg/dose repeated every 6 hours (Max: 2mg/kg/dose and 100mg/dose
1608 Tramadol HCl 50mg/ml Injection N02AX02-110-P30-01-XXX A/KK Moderate to severe acute or chronic pain (eg. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) None ADULT: IV/IM/SC 50 - 100mg. (IV inj over 2-3 min or IV infusion). Initially 100 mg then 50 - 100 mg every 4 - 6 hours. . Max: 400 mg daily.
CHILD (1 year and above): 1 - 2mg/kg/dose
1609 Tranexamic Acid 100mg/ml Injection B02AA02000P3001XX B Haemorrhage associated with excessive fibrinolysis ADULT: Slow IV 0.5-1 g (10 - 15 mg/kg) 3 times daily. Continuous infusion at a rate of 25 - 50 mg/kg daily. CHILD: slow IV 10 mg/kg/day 2-3 times daily
1610 Tranexamic Acid 250 mg Capsule B02AA02000C1001XX B Haemorrhage associated with excessive fibrinolysis ADULT: 1-1.5 g (15-25 mg/kg) 2-4 times daily. CHILD: 25 mg/kg/day 2-3 times daily. Menorrhagia (initiated when menstruation has started), 1 g 3 times daily for up to 4 days; maximum 4 g daily
1611 Trastuzumab 440mg Injection L01XC03-000-P40-01-XXX A* i) Used only in adjuvant setting for patients with HER2 over-expressed breast cancer, that is HER2 3+ by immunohistochemistry and over-expressed by FISH (Fluorescence in situ hybridization) and high risk group

ii) Treatment of HER2-positive non-metastatic breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumours >2cm in diameter.		 ii) To be prescribed by oncologists only i) Initial loading dose is 4 mg/kg administered as a 90 minutes IV infusion. Subsequent doses is 2 mg/kg administered as 30 minutes IV infusion weekly for 51 weeks

ii) Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion.
1612 Trastuzumab 600mg/5ml Solution for Injection (for subcutaneous) L01XC03-000-P30-01-XX A* Used only in adjuvant setting for patients with HER2 over-expressed breast cancer, that is HER2 3+ by immunohistochemistry and over-expressed by FISH (Fluorescence in situ hybridization) and high risk group. None The recommended fixed dose of trastuzumab 600mg is 600mg irrespective of the patient's body weight. No loading dose is required. This dose should be administered over 2-5 minutes every three weeks.
1613 Travoprost 0.004% & Timolol 0.5% Eye Drops S01ED51-990-D20-03-XXX A* To decrease intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to other topical anti glaucomas None 1 drop in the affected eye(s) once daily
1614 Tretinoin 0.01% Gel D10AD01000G3001XX A/KK Acne vulgaris, recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once daily or twice daily. Avoid exposure to sunlight. Duration of treatment: 8-12 weeks is required before any noticeable response
1615 Tretinoin 0.05% Cream D10AD01-000-G10-01-XXX A/KK Acne vulgaris and recalcitrant cases of acne (comedonal type) None Apply once daily to the affected area, at bedtime, after cleansing with soap and water.
1616 Tretinoin 0.1% Cream D10AD01000G1002XX A Acne vulgaris and recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once daily or twice daily. Avoid exposure to sunlight. Duration of treatment: 8 - 12 weeks is required before any noticeable response
1617 Triamcinolone Acetonide 0.1% Oral Paste A01AC01-351-G31-01-XXX B As an adjunctive treatment and for the temporary relief of symptoms associated with inflammatory or ulcerative lesions of oral mucosa resulting from trauma. - Apply thin film to affected areas 2 to 3 times daily
1618 Triamcinolone Acetonide 10 mg/ml Injection H02AB08-351-P30-01-XXX A Inflammation of joints, bursae and tendon sheaths - Smaller joints: 2.5 - 5 mg and larger joints: 5 - 15 mg. Treatment should be limited to 1 mg/injection site to prevent cutaneous atrophy
1619 Triamcinolone Acetonide 40 mg/ml Injection H02AB08-351-P30-02-XXX A/KK Allergies, dermatoses, rheumatoid arthritis and inflammatory opthalmic diseases - 40-80 mg deep into the gluteal muscle
1620 Trifluoperazine HCI 5 mg Tablet N05AB06-110-T10-01-XXX B i) Schizophrenia, other psychotic disorder
ii) Treatment of behavioural disorders in adults and in children		 ADULT: Initially 5 mg twice daily, increase by 5 mg after 1 week, then at 3-day intervals. Maximum 40 mg/day. CHILD up to 12 years: Initially up to 5 mg daily in divided doses adjusted to response, age and body weight.

Elderly reduce initial dose by at least half.

Pages