Anda di sini
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. |