Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Dosage
1561 Tinzaparin sodium 20,000 anti-Factor Xa IU/ml Injection in Prefilled syringe/cartridge B01AB10520P5002XX A* i)Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), not amounting to hemodynamic instability. ii)Prevention of post-operative DVT in patients undergoing general and orthopaedic surgery. i)Treatment of DVT and PE, in conjunction with warfarin: 175 anti-Factor Xa IU/kg SC once daily for at least 6 days. ii)Thromboprophylaxis in patients with:Moderate risk of thrombosis (general surgery):3,500 anti-Factor Xa IU SC 2 hrs before surgery and postoperatively, 3,500 anti-Factor Xa IU once daily for 7-10 days. High risk of thrombosis (eg. total hip replacement):4,500 anti-Factor Xa IU SC or 50 anti-Factor Xa IU/kg body weight SC 2 hrs before surgery and then once daily until the patients has been mobilized.
1562 Tioconazole 100 mg Vaginal Tablet G01AF08000S1001XX A Vulvovaginal candidiasis Adult & Child > 12yr: Insert nightly on retiring for 3-6 or 14 days
1563 Tiotropium 2.5mcg and Olodaterol 2.5mcg per actuation, inhalation R03AL06-989-A10-01-XXX A* As a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) 2 puffs once daily, at the same time of the day
1564 Tiotropium 2.5mcg/puff solution for inhalation R03BB04320A3001XX A/KK i) Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD) in which the diagnosis of COPD is confirmed by spirometry. ii) As add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800µg budesonide/day or equivalent) and long-acting β2-agonist and who experienced one or more severe exacerbations in the previous year. 5 mcg (2 puff) once daily, at the same time of the day
1565 Tirofiban HCl 0.25 mg/ml Injection B01AC17110P9901XX A* Unstable angina or non-ST segment elevation myocardial infarction with the following: elevated cardiac markers, refractory chest pain, ST-segment changes and thrombolysis in myocardial infarction (TIMI) risk score 4 By IV infusion, 0.4 mcg/kg/min for 30 minutes, then 0.1 mcg/kg/min for at least 48 hours, maximum 108 hours
1566 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.
1567 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
1568 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
1569 Tolterodine Tartrate ER 4 mg Capsule G04BD07123C2002XX 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
1570 Topiramate 100 mg Tablet N03AX11000T1003XX 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.
1571 Topiramate 15 mg Capsule Sprinkle N03AX11000C1001XX 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.
1572 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.
1573 Topiramate 25 mg Tablet N03AX11000T1001XX 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.
1574 Topiramate 50 mg Tablet N03AX11000T1002XX 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.
1575 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
1576 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
1577 Tramadol HCl 100 mg Suppository N02AX02110S2001XX A Post-operative pain, chronic cancer pain, analgesia/pain relief for patients with impaired renal function 100mg rectally up to qds
1578 Tramadol HCl 100 mg/ml Drops N02AX02110D5001XX A Post-operative pain, chronic cancer pain, analgesia/pain relief for patients with impaired renal function. 50 - 100 mg every 4 hours. Max : 400 mg daily. Not recommended in children
1579 Tramadol HCl 50 mg Capsule N02AX02110C1001XX 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)
1580 Tramadol HCl 50 mg/ml Injection N02AX02110P3001XX A 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: 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
1581 Tranexamic Acid 100 mg/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
1582 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
1583 Trastuzumab 440 mg Injection L01XC03000P4001XX 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 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
1584 Trastuzumab 600mg/5ml Solution for Injection (for subcutaneous) L01XC03000P3001XX 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. 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.
1585 Travoprost 0.004% & Timolol 0.5% Eye Drops S01ED51990D2003XX A* To decrease intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to other topical anti glaucomas 1 drop in the affected eye(s) once daily
1586 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
1587 Tretinoin 0.05% Cream D10AD01000G1001XX A/KK 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
1588 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
1589 Triamcinolone Acetonide 0.1% Oral Paste A01AC01351G3101XX B Oral and perioral lesions Apply a thin layer to affected area 2-4 times daily
1590 Triamcinolone Acetonide 10 mg/ml Injection H02AB08351P3001XX 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

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